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The AdvaMed Business Development Issue, including all of the companies that presented at AdvaMed2008: The MedTech Conference

FALL 2008: AdvaMed2008 Business Development Issue

20/20 Gene Systems, Inc.AcryMedAdnavance Technologies, Inc.Allegro Diagnostics, Inc.Apelotius Vision ScienceAureonAvita MedicalAxial BiotechBecton, Dickinson and CompanyBioControlBioCure, Inc.BioMarker StrategiesBoneGrafix, Inc.ChemicaClarient ClearantCNS ResponseCohera MedicalCritical Care Innovations, Inc.CrosponCryolifeCVRxDeltexDymedix CorporationElcam Medical, Inc.Eleme MedicalElminda, Ltd.EndocareEndovalveEnvisioneering MedicaleSight CorporationeToims Medical Technology g-Nostics, Ltd.HemCon Medical TechnologiesIkonisys, Inc.ISTO TechnologiesIvivi TechnologiesLife Recovery Systems MagForce Nanotechnologies AGMedtronicMesynthesMicro TransponderMicrophage

mNEMOSCIENCE GmbHmtm LaboratoriesMystic PharmaceuticalsNanonixNeoPharmNerites CorporationNitric BioNovaDelNovaVisionNoxilizerOrla Protein TechnologiesOrSensePEAK SurgicalPercSysProDrive Systems QuidelRS MedicalScientific IntakeSeno Medical Instruments, Inc.Sleep SolutionsStarion LaboratoriesSymbios Medical Products, LLCSymphony MedicalSyntheMedSyntheMedThe Radiology GroupTherapeutic Monitoring SystemsThromboVisionTrod MedicalUrovalve, Inc.VeraLight VitalWear, Inc.Xylos Corporation

AdvaMed 2008: The MedTech Conference is the premier medical technology conference for business leaders, policy-makers, patient groups, news media, financiers, and service providers. September 21st- 24th in Washington, D.C.

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Volume 4 / Fall 2008Investment Digest

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This special issue of the Digest is dedicated to coverage of AdvaMed2008: the MedTech Conference. It contains summary profiles of 57 companies that applied and were selected to present their technology at the largest gathering of business development executives in the United States. They are member companies of AdvaMed, the association of medical technology companies.

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Companies, Topics & People

ABC20/20 Gene Systems 41Accordion Stone Management Device 22, 25Acrymed 65Addiction 34ADHD 34, 48Adhesions 31, 63, 64Adhesive (surgical, tissue) 32, 61, 63Adnavance Technology 42

Aesthetics 11, 30, 64Age-Related Macular Degeneration (ARMD, AMD) 26, 49-50Aggarwal, Vijay 12Ahmann, Frank 21Airflow and Snore Sensor 53Algisyl-LVR 20, 21Allegro Diagnostics 42Allograft 24, 32Alltracel Pharmaceuticals 17American Medical Alert 28Andara OFS 22Anderson, Steven G. 32Andrews, Ron 10Anesthetic 20AngioDynamics 30Antibody Detection 22, 46Antidepressant 43Apeliotus Vision Science 49Arbios Systems 28Arrhythmia 21, 23Assay 10, 44, 52Asthma 45Athey, Dale 54Atrial Fibrillation 21Aureon Laboratories 12, 20Australian Institute for Eye Research 65Autograft 51Autoinjector, needle-shielding 47Autologous Cell Replacement 59Avita Medical 59Axial Biotech 50Bacteria (pathogen, detection, anti-bacterial) 20, 24, 26, 45, 52, 54, 65Bacteriophage Amplification Technol-ogy 45Bandages 17Bariatric (Device, Surgery) 58, 61Becton, Dickinson, and Co. (BD) 52Behl, Robert 25Benign Prostatic Hyperplasia (BPH) 55Berkley, Seth 28Bernstein, James 53

Bident Bipolar Tissue Management System 22Biocellulose 64BioControl Medical 38Biocure, Inc. 65BioDisc 32BioFoam 32BioGlue 32Bioject 22Biomarker Strategies 43Biomarkers 10, 34, 41, 42, 44, 48, 50

Bi-Op Laboratories 30Birch, Laurence P. 27 Bladder Management 55Block, Bill 20Body Shaping 11Bone Health 46BoneGrafix 51Brace (knees, etc.) 56Brandt, Leonard 34Brazilian Ministry of Health 22Breast (Cancer, Augmentation, etc.) 20, 48, 60, 65Briefs, Nancy M. 11Brintnall, John 38Campbell, Janet 48Cancer Research UK 43Cancer, Cervical 44Cancer, Lung 41, 42Cancer/Oncology 10, 12, 16, 20, 27, 43, 44, 46-48, 56, 62CapLite 45Carbon Dioxide 45Carbon-based Absorbents 52Cardiac Arrest 39Cardiac Rhythm Disease Manage-ment 58Cardinal Health 17Cardio Q 57Cardiopulmonary bypass 39Cardiovascular 14, 20-22, 26, 30-32, 38-39, 60-61, 63-64CareLink Network 58Cartilage 15, 51Castonguay, Jean T. 54CE Mark 17, 20, 22, 32, 38, 43-44, 47, 52, 55, 58Cell Optics 44Cell-based Therapy 51Celleration 26Cellspray 59Cellulite 11, 20Cepheid 30Chagas Disease 22, 30Chembio 22, 28, 30Chemica Technologies 52

Chemical Isolation and Separation Technologies 52Chemotherapy 46ChitoFlex 17Chordae Tendineae 22Chu, Jennifer 55CIBA Vision 65CINtec 44Cintredexin Besudotox 27Clarient 10, 20, 28Clearant 20, 24

Climaco, John 50Clinical Cell Culture 59CNS Response 20, 34Cohen, Ehud 38Cohen, Jonathan 41Cohen, Raymond W. 21Cohera Medical 61Columbia University 14Cooling System 39, 57Cooling, Heating, and Compression System 57Corbett, Gary 23Cotinine 43Craniomaxillofacial Reconstruc-tion 51Crawford, Mark 18Critical Care Innovations 46Crospon 61Cryocare TCAP 16CryoLife, Inc. 20, 32Cryotherapy 16, 32, 46Curnes, Jordan 56CVRX 38Cyberkinetics Neurotechnology Systems 22, 28Cyclodextrin 52Cynosure 30

DEFDaly, Patrick 61Davenport, Craig T. 16Degenerative Disc Disease 51Deltex Medical 57DeNovo ET 15, 51Dental Handpiece 54Depression 20, 34Dept. of Defense 48Diabetes 40-41, 49, 52, 56, 58Diagnostics 12, 18, 23, 42-45, 48, 52, 54Dialysis 30Dick, Robert H. 22DiCorno, Charles 12Disposable Pain Pumps 47DNA 28, 42, 50

Dolphin, William 59Drug Delivery 19, 27, 31, 33, 46-47, 52, 53, 64Drug Metabolism 45Drug Therapy 10, 43, 52Duke University 18Dymedix Corporation 53Eating Disorders 20, 34Edelman, Howard 57Edwards, John 49EEG 48Elcam Medical 47Electro-Optical Sciences 28Electrotherapy 56, 60Eleme Medical 11, 20, 30Elminda, Ltd. 48Embolotherapy 65Encage 22, 29Endocare 16, 20, 28EndoFLIP 61Endologix 26Endovalve 39Envisioneering Medical 18, 22Esight Corporation 49eToims Medical Technology 55Fanjoy, Stephen 59Faure, Andre 29FDA 11, 15, 17, 21-24, 26, 28, 30, 32-33, 38-41, 43-44, 46-47, 51-56, 58, 63-64Fecal Occult Blood Test 46FISH 10, 44Flexi-Q DV 47Flexi-Q PFS 47Fluid Management 47fMRI 48Force 3 Medical 22, 30Frank, Milton 39Freedman, Robert 39

GHIGadot, Ronen 48Galli, Joseph 26Garfield, Jon 24Gastroenterology 61Gastroesophageal Reflux Disease (GERD) 61Gel Coil 65Gemini 53George Steinfels 51Gill, Scott 15, 51Glaucoma 19, 49Glioblastoma Multiforme (GBM) 27Gluckstein, Steven 60Glucose Monitoring 40g-Nostics, Ltd. 43GO Pump 47Goldstein, Irwin 26Graft, bone (substitutes, extenders, etc.) 15, 51, 58Graft, Skin 59Greatbatch 28Green, Adam 13Green, Michael 13Greenblatt, James 20Gruener, Garrett 45Haemacure 26Halperin, Amir 47Handpiece Experts 54

References to companies,

clinical topics, and people

appearing in this research

report.


To view pages 38-68, see the full research report here.



Harold, Thomas 26Hart, Nick 17, 20Hawkins, William A. 58Headache (Migraine) 22Health Canada 30, 31Healthcare Reform 28HealthTronics 28Heart Failure (Congestive) 20, 38, 58Heart valve 20, 32HemCon Medical Technologies 17, 20, 26

Hemodynamic Monitoring 57Hemostase MPH 20, 32Hemostatic Technology 17, 32Her-2/Neu gene 44Hertz, Horace 34Hickey, Robert P. 31, 64Hill, Andy 57HIV/AIDS 22, 28, 30Homan, Harvey 55Hotel Dieu Hospital 49Human metapneumovirus (hMPV) 30Hunter, Adrian 65Hyaluronic Acid 51Hydrogel 65Hydrogen peroxide 20, 26Hypertension 38Hypovolemia 57ICU Medical 30Ikonisys, Inc. 44Image Processing 49Imaging 18, 22, 28, 48-49Imaging, Opto-acoustic 48Immunohistochemistry 10Infection Control 65Infectious Disease 30 , 45, 46, 52Injection (Devices) 22, 47, 52Inovio BioMedical 28InQu 51Insomnia 33Intramuscular Stimulation 55Ionic Silver 65ISTO Technologies 15, 51IT Sligo 17, 22, 26Ivivi Technologies 60

JKLJohns Hopkins University 43Johnson & Johnson 18, 38, 41, 50Joyce, Christopher 11Kavanagh, Hugh 61Kensey Nash 26Kidney (renal) 22Kirtland, J.C. 14Kolanski, Roger 46Koop, Stefan 62

Lalaji, Anand 13Lalaji, Tejal Anand 13Land, Raymond J. 10Langer, Inc. 30Layered Thin Film (LTF) 46Lee, D. Ashley 32Life Recovery Systems 39Lithotripsy 25Liver 22Longley, William 58Ludwig, Edward J. 52

Lumen 61Luminex 30Lundy, Steve 45

MNOMaayan, Lion 40MagForce Nanotech 62Maryland Technology Development Corp. 41Maschek, Uwe 62Mason, Caren 46MassArray 28Mawhinney, Louise 44McMaken, Jack D. 65McNulty, Mark S. 64Medical Device & Diagnostic Industry (MDDI) 19, 20, 30Medicare 57MediTrack System 23Medtronic 58Medtronix 26Mehta, Navroze 50Mental Illness 34Merial Limited 22Merryman, Ron 56Mesa-Tejada, Ricardo 12Mesynthes 60Metalized-DNA (m-DNA) 42MicroLattice Technology 65Microphage, Inc. 45Microtransponder, Inc. 56Mills, Robert G. 18Miniaturo 38Minrad 20Mitral Valve (Regurgitation, Replace-ment) 39mNEMOSCIENCE GmbH 62Morgan, John 17Motion Processing Implants 50Mozer, Tom 64mtm Laboratories AG 44Multi-Drug Resistant S. Aureus (MRSA) 42, 45Mystic Pharmaceuticals 19, 20, 30Nakae, Keay 28

Nanoelectronics 45Nanomix 45Nanotechnology 54, 62National Cancer Institute (NCI) 48National Institutes of Health (NIH) 48, 55, 56NeoChord 22Neopharm, Inc. 27Nerites Corporation 63Nerve, Peripheral Injury 22Neurology 34, 48

NeuroMetrix, Inc. 22, 28, 30Neuromodulation 58Neuromuscular 55-56Neuroplasticity 48, 50Neuropsychology 48Neurostimulation 22, 38, 48, 55Neurosurgery 22, 64New Enterprise Association 38New York University Medical Center 18NexMed 26NicAlert 43NicoTest 43Nitric Bio 66Nitric Oxide (NO) 38, 45, 65-66NitroMist Oral Spray 33Non Small Cell Lung Cancer (NSCLC) 20NovaDel Pharma 22, 26, 33Novartis 65NovaSom QSG 22, 23NovaVision 50Noxilizer 53NuQu 15,51NuVasive 26NxStage Medical 30Obesity 58O’Dea, John 61Olson, Karen 43Onychomyosis 26Ophthmalology 19, 28, 49-50Opththalmic Imaging Systems (OIS) 28Optivol Fluid Status Monitoring Alert 58Orla Protein Technologies, Ltd. 54OrlaMatrix 54Ortho-Clinical Diagnostics, Inc. 41Orthopedics 22, 32, 50, 56, 65Oxford University 43

PQRp16INK4a 44PACS 13Pain (back, knee, etc.) 51, 55, 60

Pain Management 47-48, 55-57Palme, Christian 62Paperboy Ventures, LLC. 62Patient Monitoring 57-59PCR 46PEAK Surgical 63Percutaneous Systems (PercSys) 22, 25Personalized Medicine 41Pharmacogenetics 43Photomology 11Plasma (Protein Extraction, Technol-ogy, etc.) 26, 63Platelet Aggregation 40Plavix 40Plexisyl-AF 20, 21Point-Of-Care Test 43, 46Polymers 21, 62, 64POM Wonderful 26Post-Operative/Surgical (Recovery, Rehabilitation, etc.) 56-57, 60PowerAssert Radiofrequency Guide-wire 26PreMD 28ProDrive Systems 54Prostate 12, 16, 18, 20, 22, 29Prostate Px 20Protein Array Technology, Engineer-ing 41, 54Psychiatry 34, 48Pulmonary Fibrosis 27PULSAR Generator 63Quickvue 46Quidel Corporation 45Radiofrequency 29, 30Radiology 13, 16, 30Ratoff, Steven B. 33Recovery Wrap 57referenced-EEG (r-EEG) 20, 34Regenerative Medicine 26, 59-60Reliant Technologies 30REPEL-AFIB 31, 64REPEL-CV 22, 30, 31, 64Reproductive Health 46Respiratory Problems 46Retinitis Pigmentosa 49Retractable Technologies 28Rheos Hypertension Therapy 38Rippy, Daniel 42Robotic Microscopy 44Rodriguez, Michael 16Rossellini, Will 56RS Medical 56

STUScaffold 60, 65Scar Tissue 64Scientific Intake 58Scoliosis 50Scout DS 41ScyFIX 26Self-Medication 47Senft, W. Herbert, II 47Seno Medical Instruments 48Sequenom 28Sevoflurane 20Sexual Health 26Seyedin, Mitchell 15,51Shahaf, Godad 48Shovlin, Robert 12




report.





Shovlin, Robert 12Sickle Cell Disease 30Signalife 28SilvaGard 65Silvasorb 65Silverman, Bob 44Sivertson, Eric 53Sleep Apnea 23, 53Sleep Disorders 22, 23, 33, 53Sleep Solutions, Inc. 23Small Bone Innovations, Inc. 22

Smartlipo 30Smoking Cessation 43SmoothShapes 11, 20SnapPath platform 43SofPulse 60Soft Tissue Ablation 22Spectroscopy 40-41Spicer, Michael 33Spinal (disorders, surgery, etc.) 15, 50, 51, 58Sports Medicine 15, 51Stancic, Ana 12Starion Instruments 14, 20Stem Cells 59Stent 26, 61Stereotaxis 26, 28Sterilization, gas 53Stroke 50Study Life Cycle Management 13 Stylli, Harry 28Sullivan, Jim 13Sullivan, Timothy 19, 20, 30Sumatriptan 22, 26Supplies, medical and laboratory 52Supra Q 57Surgenor, Timothy 28Surgery 14, 57, 61-64Surgery, Cardiothoracic 21Surgery, Electrosurgery 22Symbios Medical Products 47Symphony Medical 20, 21Synergetics 22SynerGraft 32Synthemed 22, 30, 31, 64Systems Pathology 12Targeted Pulsed Electromagnetic Field (tPEMF) 60TargetScan 18, 22Taxol 27Teitel, Edward 40Terrell, Rick 56T-Guide 40The Radiology Group 13,20,30Therapeutic Monitoring Systems 59Thermage 26, 28, 30

Thermal Ligating Shears 14Thermosuit 39Thomas, Michael J. 23Thrombovision, Inc. 40Tissue Dissection 63Tissue Engineering 49, 59Tissue Welding Technology 14, 20TissuGlu 61Torus Palatinus 58Trauma 51Traumatic Brain Injury (TBI) 50

Trod Medical 22, 29Tsipouras, Petros 44Tsukamoto, Takuji 52Tucker, Mark 43Tumor Cell Processing, Testing 43University of Southern California (USC) 18Urology 14, 25, 38, 55Urovalve, Inc. 55UroVysion 44

VWXYZVagus Nerve 38van Avermaete, David 41Venture Investors, LLC 63VersiDoser 19Viscogliosi, Anthony G. 22Visiomed Group, Ltd. 59Vision Acuity, Enhancement 49Vision Restoration Therapy 50Vital Wrap 57VitalWear 57VRN 13Ward, Brian 60Washington University of St. Louis 18Wearable Display Technology 49White, V. Randy 42Wilkins, Robert 39Wonsettler, Rich 62Wound Care 17, 26, 59, 60, 64-66Xylos Corporation 64Yared, Nadim 38Zimmer, Inc. 51




report.


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ABC20/20 Gene Systems, Inc. 41AcryMed 65Adnavance Technologies, Inc. 42Allegro Diagnostics, Inc. 42Apelotius Vision Science 49 Aureon 12Avita Medical 59 Axial Biotech 50Becton, Dickinson and Company 52BioControl 38 BioCure, Inc. 65 BioMarker Strategies 43BoneGrafi x, Inc. 51Chemica 52 Clarient 10Clearant 24 CNS Response 34 Cohera Medical 61Critical Care Innovations Crospon 61Cryolife 32 CVRx 38

DEFDymedix Corporation 53Elcam 47Eleme Medical 11Elminda, Ltd. 48 Endocare 16 Endovalve 39Envisioneering Medical 18 eSight Corporation 49eToims Medical Technology 55

PQRPEAK Surgical 63PercSys 25ProDrive Systems 54Quidel 46RS Medical 56

STUSeno Medical Instruments, Inc. 48 Sleep Solutions 23 Starion Laboratories 14Symbios Medical Products LLC 47Symphony Medical 21SyntheMed 31, 64The Radiology Group 13ThromboVision 40 Trod Medical 29 Urovalve, Inc. 55

VWXYZVeraLight 41 VitalWear, Inc. 57Xylos Corporation 64

GHIg-Nostics, Ltd. 43HemCon Medical Technologies, Inc. 17Ikonisys, Inc. 44ISTO Technologies 15, 51Ivivi Technologies 60

JKLLife Recovery Systems 39

MNOMagForce Nanotechnologies AG 62Mesynthes 60 Micro Transponder 56 Microphage 45mNEMOSCIENCE GmbH 62mtm Laboratories 44Mystic Pharmaceuticals 19Nanomix 45NeoPharm 27 Nerites Corporation 63Nitric Bio 66NovaDel 33Novavision 50 Noxilizer 53 Orla Protein Technologies 54 OrSense 40


Companies Profiled in this IssueCompanies Profiled in this Issue

Clarient accelerates the drug development processClarient, Inc. provides access to technologies and services for the characterization, assessment and treatment of cancer, leading to accurate diagnoses by pathologists, better treatment decisions by oncologists, and efficient ways to reduce the cost and accelerate the drug development process.

Services for the clinical cancer diagnostic industryThe company offers a full range of diagnostic technologies and ser-vices for the clinical cancer diagnostics industry including immuno-histochemistry, flow cytometry, in-house molecular testing, complete tumor work-up and consultation services to follow-up and monitor disease after diagnosis.

Client services include: diagnosing solid tumors, cancer sub-typing, classifying patients into prognostic categories (i.e. low, medium and high risk groups), identifying which drugs or therapy paths are best for patients, monitoring patient on therapy, searching for residual dis-ease during and post therapy, and detecting relapse or cancer trans-formation.

Robust library of cancer markersClarient has over 230 different Immunohistochemistry (IHC) mark-ers in its library. Each one of Clarient’s IHC assays goes through an extensive validation process. The company’s extensive IHC menu empowers clients to perform complex tumor workups without having to reference expensive markers from an outside laboratory.

The company uses the latest instrumentation in multi-color analysis and has more than 30 different FISH markers in its library; these markers are used to detect gene amplification, translocation or dele-tion and gene additions in a number of solid and hematological cancers. These markers are important factor in understanding cell growth and proliferation, as well as therapeutic response. New tools for clinical pathologistsRecent advances in DNA, RNA and polymerase chain reaction (PCR) technology have expanded the company’s ability to analyze genetic material, leading to new tests which provide a previously unobtain-able level of information about disease. Diagnostic molecular mark-ers offer clinical pathologists the ability to quantify and detect subtle genetic changes. At Clarient, the latest molecular technologies, tech-niques, and applications are used in practicing laboratory medicine. This includes the use of predictive biomarkers for treatment response and disease progression through quantification and trending analy-sis in tracking genetic abnormalities over a period of time.

Advances in targeted drug therapiesMost recently, the company has increased its focus on targeted ther-apy assessment. The emergence of effective cancer treatment is one of the major medical advances of targeted drug therapy. In certain neoplasms, therapy is often curative, and the promise of long-term survival makes therapy worth the increased financial costs.

Clarient, Inc.NASDAQ: CLRT Aliso Viejo, CA

Biomarker Assays to the General Clinical Oncology Marketplace

Contact

CEO: Ron Andrews Web: www.clarientinc.com CFO: Raymond J. Land Tel: (949) 425-5700

Management

President and CEO: Ron AndrewsRon Andrews has been CEO of Clarient since July 2004. From August 2002, Andrews was Senior Vice President Global Marketing and Commercial Business Development at Roche Molecular Diagnostics. In that role, he developed and led the strategic execution for all diagnostic commercial operations.

According to SG Cowen Equity Research and BioBridge Consulting, the opportunity for advanced oncology testing services will expand dramatically in the next several years.


SmoothShapes® System: Longer Lasting Results on Cellulite That Patients Can See and Feel

Elemé Medical Focuses on Body ShapingElemé Medical Inc., an emerging venture backed aesthetics company, is dedicated to providing market-leading technology in all areas of body shaping. SmoothShapes® system with Photomology® technol-ogy is the company’s preeminent product to launch. SmoothShapes is a medical device with FDA clearance to market for the temporary reduction in the appearance of cellulite. Targeted markets include plastic surgeons, dermatologists, OB/ GYN and primary care special-ists, medical spas, aesthetic clinics and executive health facilities.

85% of women will develop celluliteCellulite can’t be controlled or improved by diet or exercise. More than 85% of women will develop it at some point in their life – even ath-letes and supermodels. Dimpled, orange-peel-like skin that is bumpy and lax is actually the outward symptom of cellulite. Cellulite is a skin condition that results from enlarged fat cells trapped in an inflexible network of collagen located in the hypodermis. Women’s skin visibly displays cellulite because their subcutaneous fat layer is separated by thin vertical columns in contrast to a crisscross network in men. Several factors contribute to the underlying causes of cellulite. These include: genetics, hormones, vascular changes and inflammation.

The SmoothShapes system with Photomology technology ad-dresses both the physical manifestations of cellulite and its underlying causes The SmoothShapes system is based on the company’s proprietary Photomology platform – a process that treats cellulite and subcu-taneous fat by combining dynamic light and laser energy along with vacuum and massage to stimulate the restoration of healthy cell activity. The system addresses both the physical manifestations of cellulite and its underlying causes providing longer lasting results that patients can see and feel.

The device’s vacuum component positions the skin for optimal laser and light penetration. SmoothShapes’ 915nm laser penetrates into tissue and is preferentially absorbed by lipids causing fat liquefac-tion; 650nm light energy makes the cell membrane permeable, allowing liquefied fat to move into the interstitial space where the contoured rollers of the SmoothShapes device assist in evacuating the liquefied fat into the lymphatic system. The 650 also improves the cells’ metabolism and stimulates new collagen production. Results for patients are the improved appearance of cellulite with tighter, smoother skin.

SmoothShapes treatments feel like a deep tissue massage; patients find it relaxing. There is no pain medication required when receiving treatment and there is no downtime. A typical treatment protocol is eight treatments, twice a week for four weeks. Treatment time is 20 minutes for a set of body parts (for example back of legs or buttocks). SmoothShapes helps women achieve SmoothThighs, SmoothBut-tocks, SmoothArms, SmoothKnees, SmoothHips, SmoothAbdomen, SmoothWaist and SmoothBack.

Clinical StudiesIn a 74 patient, multicenter, prospective, randomized and controlled clinical study of the SmoothShapes sys-tem (“Physiological effects of transcutaneous multiwave-length laser light administra-tion”), 81 percent of treated patients showed a “significant volumetric reduction in sub-cutaneous fat” in treated vs. untreated leg, (Abt Associates Clinical Study Report). Although not part of the protocol, five patients from the study had elective MRIs 13 months post treatment and 4 of the 5, or 80%, had maintained their result.

Body shaping market could be worth $8.1 billion by 2011In 2006, the body shaping market generated $4.5 billion in device sales, procedures and fees. By 2011, the market could grow to $8.1 billion, says Michael Moretti, in his Global Body Shaping Market Analysis, published in 2006. Expansion will be “driven both by rising demand from consumers and expanding supply from practitioners,” says Moretti.

Recently completed $18 million roundIn July, Elemé Medical Inc. raised $18 million in a “Series C” financ-ing led by L Capital Partners. The round also included Hambrecht & Quist. The funds will be used to commercialize the SmoothShapes System and to further the company’s pipeline of body shaping tech-nologies.

Elemé MedicalPrivateMerrimack, NH

Improve the Appearance of Cellulite with FDA-Cleared SmoothShapes

The contoured rollers of the SmoothShapes device assist in evacuating liquefied fat into the lymphatic system.

Management

President & CEO: Nancy M. Briefs

ContactCEO: Nancy M. Briefs Web: smoothshapes.comCFO: Christopher Joyce Tel: (603) 816-1920

Nancy Briefs, a serial entrepreneur, is the Founding CEO of Elemé Medical and has been involved in four previous start-ups: Percardia, Vista Medical Technologies, Stryker, Target Therapeutics and Oximetrix (Abbott). She began her career at American Edwards Laboratories. Ms. Briefs was the first female Chairperson of the Medical Device Manufacturers Association (MDMA), and an inventor on four issued and three pending U.S. patents related to cardiovascular innovations. Briefs earned her MBA at Golden Gate University in San Francisco.

11 | OMP Investment Digest | Summer 2008 Research Report

Fig. 1a

Prostate cancer strikes one-in-six American menMore than 186,000 men in the U.S. will be diagnosed with pros-tate cancer this year. Because all treatments can have side effects, such as erectile dysfunction and urinary incontinence, treatment discussions often focus on balancing the goals of therapy with the risks of lifestyle alterations.

More informed decision makingAureon Laboratories’ Prostate PxO uses biopsy tissue, at cancer diagnosis, to assist physicians as they counsel patients on the range of possible treatment options and the patient’s risk for disease pro-gression.

The company has developed a high throughput Systems Pathology technology platform to predict individual clinical outcomes. Aureon technology uses routinely obtained tissue biopsies. Patients who are diagnosed with prostate cancer and are surgical candidates can order the company’s Prostate PxO at the time of diagnosis.

A Comprehensive Data Analysis ApproachData obtained from patients is integrated with an analysis of each patient’s cancer using spatial, mathematical analysis of tissue his-tology and molecular biomarkers, such as androgen receptor, asso-ciated with disease progression.

In August 2008, a study published in the Journal of Clinical Oncol-ogy, validated Aureon’s ability to predict prostate cancer progression using prostatectomy tissue. Researchers found that integrating clin-icopathologic variables with imaging and biomarker data resulted in an accurate tool for predicting clinical failure five years after pros-tatectomy. Clinical failure was defined as evidence of metastasis, an increasing PSA in a castrate state or death attributed to prostate cancer.

Experienced leadershipAureon was co-founded by leading physician-scientists at Memo-rial Sloan-Kettering Cancer Center, Yale Cancer Center, and Albert Einstein College of Medicine. Investors include New Leaf Venture Partners/Sprout Group, BD Ventures, Pfizer Strategic Investments and Atlas Venture.

Aureon LaboratoriesPrivateYonkers, NY

Helping Physicians with Objective, Actionable Information at Diagnosis

Management

Contact

CEO: Vijay Aggarwal Tel: (914) 377-4000 CFO: Ana Stancic Web: www.aureon.com COO: Robert ShovlinDirector of Laboratories: Dr. Charles J. DiComoMedical Director/VP Pathology: Dr. Ricardo Mesa-Tejada

President and CEO: Vijay AggarwalDr. Vijay Aggarwal has over 20 years of senior executive experience in both pharmaceutical services and clinical diagnostics. Previously, he served as President of AAI Development Services, a company dedicated to providing contract research and development services to the pharmaceutical and biotech industry. In addition, Dr. Aggarwal has held the positions of President, Quest Diagnostic Ventures where he had responsibility for new technology, new business models, clinical trials testing, and direct-to-consumer strategies.

Figure 2. Multiplexed in situ protein detection uses fluorescently-tagged antibodies combined with spectral imaging.

Figure 1. Aureon PathoMetrix™ is an automated machine vision tissue image analysis system that uses advanced image processing algorithms in order to segment and measure properties of histopathological objects.

+

+

A: Digital Image Capture B: Image Segmentation

C: Image Classification (green: stromal nuclei, blue: epithelial cells, dark pink: stroma, light pink: cytoplasm)

D: Generation of Figure Statistics


The Radiology GroupDuluth, GA Private

Better, faster radiology services for a lower cost.

Not your average teleradiology serviceThe Radiology Group’s mission is to bring academic-quality servic-es to rural locations. The end result for the hospital is better and faster radiology services at lower cost. CEO Anand Lalaji adds, “We don’t provide just a teleradiology service for general radiology exam reading and off-hours coverage. We can deliver a virtual full-service department that provides a complete range of specialty interpreta-tions, dictation and final reports and even insurance billing.”

Its list of imaging solutions can be adapted to address a physician’s specific needs.

Clients of The Radiology Group can expect:

• 24/7 remote coverage with final reports by board-certified

subspecialty radiologists.

• Guaranteed stat and non-stat turnaround times.

• Complete management of radiology department with placment

of onsite radiologist in combination with subspecialty remote

needs.

• Nighthawk services with preliminary or final reports.

• Radiology-department-managed consultations.

• Overflow supplement and virtual locums.

• State-of-the-art technology to read images and issue reports.

• Voice software that translates the spoken word into a written

report and significantly reduces turnaround times.

• Support and coverage 24 hours a day, seven days a week.

No large upfront costsThere is no large upfront cost required for the technology, and its platform can integrate with a site’s existing PACS to support remote image communications as well as off-site disaster recovery (DR) and business continuity. TRG can also offer a low-cost, web-based PACS system if the client does not have one in place. Users simply plug in a VRN Gateway, available as an integrated ‘black box’ or a Web-based software download, and they’re ready to go. TRG’s utilization of Neurostar’s unique platform provides ultra-fast image access across multiple facilities. A thin-client image management, communication and archiving solution, the VRN downloads from a central server bank. It is customizable so that wherever radiologists work, they can access the same familiar digital environment. The VRN relies on the Internet to provide connectivity among multiple locations, making it easy to install and extremely cost effective. Neurostar’s offsite data center provides storage with multiple levels of redundancy for “anywhere, “any time” image access.

In the future, location will be truly irrelevantThe solution is ideal for physicians who rotate among multiple facili-ties: dynamic auto-routing identifies the users’ current location and speeds the appropriate images to them. Comprehensive individual user worklists include studies assigned through multiple client fa-cilities that are automatically updated, helping keep workflow on track. Additionally, Study Life Cycle Management enables tracking of turnaround times (TATs) on a per-study basis and prioritizes each worklist based on the group’s commitments to various clients. Fi-nally, workload balancing tools ensure that the reading is optimally split among the group. Dr. Lalaji paints a picture of what he believes to be the future of radiology: “In the future, location will be truly irrelevant. Every hospital will offer patients the benefits of fast, spe-cialized diagnoses through a group of sub-specialists who operate virtually just as we do today,” he said. “At many hospitals, general reading will continue to be handled by onsite radiologists, providing an anchor for the department, while small, rural facilities may have an entire virtual staff.”

Management

CEO: Anand Lalaji, M.D.

ContactWeb: www.theradiologygroup.org

Tel: (678) 748-5842

Mr. Lalaji, chief executive officer and founder of The Radiology Group, has been a board certified radiologist since 1999. After earning his medical degree from SUNY Downstate Medical Center, he completed his internship at Chestnut Hill Hospital in Pennsylvania (University of Pennsylvania) and his radiology residency at Montefiore Medical Center (Albert Einstein College of Medicine). In 2004, he completed a musculoskeletal radiology fellowship at Wake Forest University Baptist Hospital. He is an active member of the Society of Skeletal Radiology.


CEO: Anand Lalaji, M.D. Co-Founder: Tejal Anand Lalaji, M.D.CMO: Adam Green, M.D.Chief Strategy & Development Officer: Jim SullivanCFO: Michael Green

Proprietary Tissue Welding TechnologyStarion products are based on the company’s Tissue Welding tech-nology, licensed exclusively from Columbia University. By employing a proprietary temperature and pressure profile to modify proteins, Starion instruments create a high-integrity seal and a clean division. No electrical current passes through the body during this process.

The heating element is powered by low voltage direct current. A graded thermal profile offers a narrow higher temperature zone for cutting and a lower temperature-coagulating zone on each side. By simultaneously sealing and dividing tissue, Starion instruments mini-mize unintended thermal injury. This facilitates use near vital and del-icate tissue structures with less risk than competing technologies.

Better suited to delicate proceduresCompeting devices use intermediate forms of energy, predominately monopolar and bipolar radio frequency or ultrasonic vibration, each of which can present risks to patients and surgeons. By applying direct heat instead of electrical, radio frequency or ultrasonic energy, Starion products can reduce unintended thermal injury, minimize instrument exchange, improve visibility by reducing smoke and splat-ter, and can be used in close proximity to vital and delicate struc-tures.

Available for use in a wide range of proceduresStarion’s products are used in a wide variety of open and endoscopic cardiac, gynecological, general surgical, otolaryngologic and urologic surgical procedures.

In the urology space, Starion recently launched ‘next-generation’ Thermal Ligating Shears, which feature two active jaws with heating elements on each, creating a uniform, higher integrity seal in less time. The ability to grasp and dissect soft tissue, as well as seal and divide, reduces the need for instrument exchanges. Because of the underlying simplicity of the company’s Tissue Welding technology, many surgeons find Starion equipment easier to operate.

Now available in ChinaA study published in the January issue of The American Surgeon found Starion’s Tissue Welding technology minimized intraoperative blood loss, postoperative complications and may reduce the develop-ment of facial paresis in parotidectomy procedures. In April, the com-pany received regulatory approval to market its products in China.

Starion InstrumentsPrivateSunnyvale, CA

Focused Heat and Pressure to Simultaneously Seal and Divide Tissue

When using an ultrasonic device to seal a blood vessel, there is extensive collateral damage, denoted by the separation and disruption of tissue layers (top). When using a Starion Instrument, there is no change in the vessel wall beyond the actual welded area - the dark break pictured (bottom).

Management

CEO: J.C. Kirtland

ContactCEO: J.C. Kirtland Web:www.starioninstruments.com Tel: (408) 522-5200

Mr. Kirtland has over 19 years of medical device management experience, including a position as Executive Vice President of EndoTex Interventional Sys-tems, where he was responsible for Clinical, Regulatory, Marketing, Finance, and was a principal in the negotiations with Boston Scientific. At Guidant, Mr. Kirtland was Corporate Accounts Manager, structuring major buying deals across Guidant’s three cardiac business units, representing revenue in excess of $50 million. Prior to Guidant, he served as Program Manager for Origin Medsystems, directing the R&D and marketing of the first true needlescope video system, the Pixie.

Starion Instruments develops open and laparoscopic surgery products. Starion devices seal and divide soft tissue through the application of direct heat and pressure.


Unmet Market OpportunityCartilage regeneration is often called the “holy grail” of orthope-dics. Degeneration in the knee and spinal disc is a leading cause of pain, loss of mobility, and disability to people worldwide. Each year, orthopedic surgeons perform over 600,000 surgical procedures in the U.S. to repair damaged cartilage in the knee. Currently, the only FDA-approved biologic product for repairing knee cartilage uses the patient’s own cartilage cells in a two-step surgical process. How-ever, to date, no available procedures have proven to regenerate and restore these tissues on a consistent and cost effective basis.

The ISTO DifferenceISTO Technologies, a clinical-stage com-pany, develops products for sports med-icine, spinal therapy and trauma. The company’s orthobiologic products are intended for the repair and regeneration of damaged cartilage in knee joints and spinal discs. ISTO’s difference lies in a patented process that uses juvenile cell technology, proven to be more effective than other methods of generating carti-lage tissue. It is the only company with this patented cell expansion technology and its versatility allows for commercial scalability and, ultimately, broad clinical applications.

The Knee: Phase III Clinical Trials PendingISTO’s lead cartilage product, DeNovo®ET, is a scaffold-free cartilage graft grown from juvenile cartilage cells using the company’s cell-based platform technology. These laboratory-grown cartilage cells result in commercially viable living cartilage implants for joint repair. Because juvenile cells are naturally programmed to produce hyaline cartilage (not fibro) better than adult cells, it is anticipated that the implant will integrate more effectively with the native tissue. DeNo-voET is offered as an off-the-shelf product for repair and regeneration of knee cartilage. DeNovo ET is in Phase I/II human clinical trials at three U.S. sites. Pending FDA agreement, the company anticipates entering Phase III clinical trials in first quarter 2009. The Spine: Regenerating Damaged Spinal DiscsBack pain, mostly due to degeneration of the spinal disc, represents one of the most prevalent medical conditions worldwide. To date, no therapy exists that can reverse or heal damaged cartilage in a degen-erated disc, leaving surgical intervention as the only option. Surgeons perform more than 400,000 lumbar discectomies and 450,000 spi-nal fusions each year in the U.S. alone. Neither procedure addresses the underlying conditions that lead to irreversible disc degeneration and are often the cause for additional problems that restrict mobility and continue degeneration of affected discs.

NuQu™, a cell-based injectable therapy, is being developed by ISTO to offer a therapeutic solution and early intervention for disc degen-eration. NuQu is composed of a protein-based carrier and culture-expanded juvenile articular cartilage cells, proven to have far greater regenerative potential than their adult counterpart. Degeneration of disc cartilage begins in the nucleus, the innermost disc component, and is accompanied by cell death and tissue destruction. Recent pre-clinical data suggests that NuQu injected into the nucleus can regen-erate cartilage in the disc nucleus. NuQu has been developed for use in conjunction with a minimally invasive procedure. ISTO intends to complete preclinical studies by the second half of 2008 and file for an IND by the first quarter of 2009.

ISTO TechnologiesPrivateSt. Louis, MO

Orthobiologics for Sports Medicine and Spinal Repair

ManagementPresident and CEO: Mitchell Seyedin, PhD

Contact

CEO: Mitchell Seyedin Web: www.istotech.com CFO: Scott Gill Tel: (314) 995-6049

Seyedin joined ISTO in 2003 with more than 25 years of experience in the medical technology field, concentrating on developing orthobiologic products. He has been the founded and lead several startup companies, including Metra Biosystems (acquired by Quidel) and Orquest (acquired by Johnson&Johnson).

The projected number of nucleus regeneration procedures may surpass 300,000 by 2010

Funding future growth: FDA-approved Bone Graft ExtenderInQu®, ISTO’s first-to-market product, launched in March 2008, tar-gets the spine fusion and orthopedics market. InQu received 510(k) clearance as a bone graft extender and substitute in 2007, and is a biomaterial scaffold of synthetic and biologic polymers. InQu studies uncovered “gold standard” results in posterolateral fusion, which is the most difficult application. The company plans to leverage sales of the InQu product line to generate early revenue and sustain its business over the long term. InQu is distributed through independent sales executives. The company is also exploring additional applica-tions in the soft-tissue and osteochondral markets.

Existing treatments for cartilage repair involve shaving, debridement and microfracture


234,000+ cases of prostate cancer seen annuallyEach year over 234,000 new cases of prostate cancer are diag-nosed in the U.S. Treatment options include surgery, radiation therapy, hormone therapy, “watchful waiting” and cryotherapy. Treatment depends on factors including the patient’s age, the stage of the cancer and the presence of other pre-existing medi-cal conditions.

Traditional treatments carry side effectsTo date, radical prostatectomy has been the preferred treatment —surgically removing the cancerous tissue carries a high success rate, but is often associated with unwanted side effects such as impotence and incontinence. Radiation therapy, which includes traditional external radiation and interstitial radioactive seed ther-apies (brachytherapy), is used to treat the early-stage disease. Hor-mone therapy and chemotherapy are used to slow the growth of cancer and reduce tumor size, but are generally not intended to be curative.

Cryotherapy provides a minimally invasive, repeat-able treatment optionCryotherapy, a relatively new treatment option, involves controlled freezing of tissue to destroy cancerous cells. Outcomes are comparable to surgery and radiation therapy in low risk cases and compa-rable or superior in medium to high risk cases. The proce-dure is minimally invasive and typically results in a shorter recovery period. It may also result in a lower incidence of incontinence. Finally, unlike radiation therapy or surgery, cryotherapy can be repeated if the cancer recurs; it can also be used on patients who have been previously treated with surgery or radiation therapy.

Cryocare CS offers a con-trolled, simplified processEndocare’s Cryocare TCAP (Targeted CryoAblation of the

Prostate) procedure uses the Cryocare CS system. It includes the AutoFreeze, a computer controlled automated freezing mechanism. This integrated Ultrasound technology provides visualization of the prostate gland using CryoGuide planning and mapping software.

The argon gas-based system delivers lethal ice in a controllable and repeatable fashion and the FastTrac, a percutaneous access device, offers a simplified one-step insertion process to signifi-cantly reduce procedure time.

Endocare developing new applicationsTo date, the majority of Endocare’s cryotherapy procedures have been performed in medium to high risk patients. The company has developed a nerve-sparing procedure for lower risk patients that may reduce the incidences of impotence. Several clinical studies are underway to determine the success rates attainable with this procedure. The company is also expanding its focus to include the ablation of tumors in the lung and liver, as well as management of

EndocareNASDAQ: ENDOIrvine, CA

Cryotherapy - Another Option for Treating Prostate Cancer

Endocare’s Cryocare® CS™ system provides a prostate can-cer treatment called Cryocare® TCAP™ (Targeted CryoAblation of the Prostate).

Cryocare TCAP is a minimally invasive procedure that uses ice to destroy prostate cancer.

ManagementCEO: Craig T. Davenport

ContactCEO: Craig T. Davenport Web: endocare.com CFO: Michael R. Rodriguez Tel: (949) 450-5400

Craig T. Davenport was named CEO of Endocare in December 2003 and was appointed Chairman of in January 2004. Prior to Endocare, Mr. Davenport was CEO and Managing Partner of The D.W. Group. He also held positions at Tokos Medical and American Hospital Supply. Mr. Davenport is a board member of several private medical device companies and private equity healthcare funds. He graduated from Ohio University with a B.G.S. degree.

Prostate Bladder

Ice ballsforming

Rectum

Cryoprobes

UltrasoundTransducer


Hemostatic HemCon® Bandages are the result of a three-year collaborative effort between HemCon and the U.S. Army launched in 2001. The device was designed for use by first responders in military, emergency medical and other out-of-hospital environments where the rapid control of bleeding is of critical importance. Deployed since 2003, HemCon dressings remain a top choice of military forces worldwide.

When in contact with blood, the HemCon Bandage becomes extremely adherent; this adhesive-like action seals the wound. The bandage acts as a barrier between an open wound and infectious bacteria. It is a pliable, sterile, chitosan dressing capable of stopping severe external hemorrhage following trauma and penetrating injury – even high-pressure, high-flow arterial bleeds. The device does not contain human proteins or clotting factors, and it does not generate heat.

an antibacterial barrier clearance from the FDA and are effective against a wide spectrum of 24 micro-organisms including MRSA, VRE and acinetobacter baumannii.

For medics who need to address severely bleeding penetrating injuries, such as those resulting from small arms fire or shrapnel that cannot be addressed by other means, HemCon has introduced ChitoFlex®. ChitoFlex is designed to be packed into a wound track to control bleeding. ChitoFlex and the entire HemCon dressings product line carry the European Union CE marking. With this certification, HemCon is has increased its distribution into countries requiring the CE marking including Great Britain, Germany, Italy and the rest of the EU.

HemCon Dental Dressings offer periodontists, oral surgeons and general dentists a unique new dressing to seal soft tissue wounds – including extractions, palatal and gingival grafts and other oral surgeries. The dressings are self-adhesive and require no sutures. They provide a protective layer that can be custom cut to fit a patient’s needs. The device seals the wound surface while reducing pain and operative time. The bandage is designed to dissolve within seven days.

HemCon completed an international acquisition in May 2008 with the purchase of Alltracel Pharmaceuticals, PLc and its wholly owned subsidiary, Synpart Ltd. This addition broadens the line of technology platforms HemCon offers, adding Nanospider™ technology for industrial-scale nanofiber production and a controlled release antimicrobial technology which may prove effective against common, hard-to-cure fungi and other bacteria. The Synpart subsidiary, in addition, provides the company with strong design and manufacturing capabilities to service the global, private label oral care market. HemCon’s main hemostatic manufacturing and corporate headquarters are located in Portland, Oregon. Additional offices are located in Ireland, Germany and in the United Kingdom. Oral care manufacturing takes place in India and China.

HemCon Medical Technologies, Inc.PrivatePortland, OR

Hemostatic Technology: Saving Lives on the Battlefield and at Home

ManagementCEO: John Morgan

Contact

John W. Morgan is President and Chief Executive Officer and has been with HemCon since May 2004. Morgan has more than 21 years of general management experience with four multi-national healthcare manufacturing and distribution organizations. He launched his career at Baxter Interna-tional where he served as President of the Mid America Region and led a $500 million regional company that covered twelve states and several regional offices.

HemCon’s Dental Dressings are ideal for oral trauma, extractions and gin-gival grafts.

The HemCon Bandage received FDA approval in July 2005, after being ushered through the FDA clearance process in only 48 hours. Since its release, over 1,000,000 HemCon Bandages have shipped and the dressings are continuously credited with saving lives – with no adverse events reported to date.

Technology for the Civilian MarketIn 2007 HemCon Medical Technologies, Inc. partnered with global leader Cardinal Health (CAH) to offer an exlcusive, co-branded line of hemostatic dressings for the civilian hospital and surgery center markets. The re-designed 2” x 2” and 2” x 4” HemCon Bandages use the same materials and technology as the original HemCon Bandage, but are engineered specifically for civilian trauma, emergency and procedural arterial bleeding care. The sizes were chosen to address the wounds seen in civilian medical arena, including cath and IR labs, as well as emergency and trauma, including arterial and venous percutaneous access sites, lacerations, knife injuries, motor vehicle accidents, and gunshot wounds. The smaller HemCon Bandages are thinner and more flexible than the original HemCon Bandage yet remain capable of controlling severe arterial bleeding. All HemCon dressings carry CEO: John Morgan Web: www.hemcon.com

CFO: Nick Hart Tel: (503) 245-0459

HemCon bandages engineered for civilian use.


Answering physicians’ callsIn a 2003 Reviews in Urology report, Samir Taneja, MD, director of urologic oncology at New York University Medical Center, wrote, “…an optimal strategy for accurate and judicious detection of early prostate cancer is imperative.”

Four years later, Dr. Taneja may have found the answer to his call. As the co-primary investigator for a clinical trial, today Dr. Taneja and a team of researchers from across the country are testing Envi-sioneering Medical Technologies’ TargetScan, the first complete system to diagnose and treat prostate disease. Preliminary tests indicate that TargetScan can improve physicians’ ability to detect prostate cancer, which in turn could lead to more targeted treat-ments that reduce life-altering side effects, including impotence and incontinence.

Time for changeDr. Taneja and his international colleagues aren’t alone in their desire for improved prostate-cancer detection and treatment. Presenting the highest incidence of male cancer, more than 218,000 men are diagnosed with prostate cancer each year in the U.S., and prostate cancer remains the second-leading cause of cancer death. With an aging and educated baby-boomer population, TargetScan addresses patients’ angst with current detection systems that render false neg-atives, inconclusive positives and leave patients with the confound-ing circumstance known as “watchful waiting.”

Medical community’s viewUnlike conventional technology, TargetScan combines 3-D image acquisition with a hands-free, stationary probe to support planned and executed prostate biopsies. With the stationary probe in place, TargetScan generates a 3-D image in a matter of seconds. Tar-getScan’s proprietary software then calculates the planned biopsy sampling sites to ensure an even distribution of sampling through-out the prostate gland.

During the biopsy procedure, TargetScan’s fixed probe prevents prostate movement while its attached proprietary guide and bend-able NITINOL prostate biopsy needle allows for methodical prostate sampling. The system records exactly where a biopsy sample was taken to ensure, for the first time, accurate sampling of the entire gland, and to allow for repeatable biopsies as needed. For physi-cians and their patients, this means that TargetScan biopsies can more accurately identify the extent, location and the grade of can-cer, as reported in the Washington University School of Medicine 2005 study “Evaluation of TargetScan Device in Prostate Cancer Detection.”

In contrast, current prostate biopsy procedures require urologists to hold and pivot a probe with one hand while performing a needle biopsy with the other hand. According to some leading urologists, the inherent variables of this existing biopsy technique can force doctors to miss potential cancers. As more physicians move toward

focal therapies, the need for TargetScan technology that can pin-point and map clinically significant cancerous cells will continue to grow.

Targeted cancer treatmentsTargetScan’s precise prostate sam-pling also supports treatment plan-ning. Radiation oncologists rely on TargetScan’s stationary probe to pre-cisely deliver prostate-sparing cancer treatments to pre-planned targets. TargetScan’s treatment applications support the medical community’s growing demand for less-invasive options, including brachytherapy, cryotherapy and high-dose localized radiation. These procedures call for precise needle placement into tar-geted cancer sites of a stabilized prostate to reduce the risk of impo-tence, incontinence and other side effects.

Future demandA multi-center study is underway at New York University Medical Center, the University of Michigan, Duke, University of Southern California and Washington University in St. Louis, testing 250 patients to compare TargetScan’s ability to detect cancer to conventional technologies. The preliminary find-ings validate TargetScan’s diagnostic and treatment benefits and have led to higher reimbursements for physicians who employ Tar-getScan to undertake planned prostate biopsies. The indications of clinical success and higher reimbursements are prompting early sales of the device across the country.

With the study underway and initial sales success, Envisioneering is creating a manufacturing system that supports ongoing technology enhancements and higher sales volumes for the TargetScan system.

Envisioneering MedicalPrivateSt. Louis, MO

On Target

Management

President: Robert G. Mills

ContactPresident: Robert Mills Web: www.envisioneeringmedical.com CFO: Mark Crawford Tel: (314) 429-7367

Mills offers more than 20 years experience in the medical products industry. Prior to Envisioneering, Mills served as vice president and general manager for Endovascular, a division of Mallinckrodt. He also has held positions at Boston Scientific and Johnson & Johnson.

Envisioneering’s TargetScan System uses 3D ultrasound technology to perform precise, tar-geted prostate biopsies


An innovative approach to cost effectively package in a sterile, preservative free unit dosage form

Mystic Pharmaceuticals, has developed an innovative approach to cost effectively package in a sterile, preservative free unit dos-age form, precision dosing, precision drug delivery, reduce waste, reduced cost, simplified administration and enhanced compliance tracking benefits for consumers. Mystic develops drug delivery technologies for pharmaceuticals, biologic agents, vaccines and other compounds used in ophthalmic, intranasal and other applica-tions. In addition to licensing its delivery platforms, Mystic is devel-oping its own pipeline of generic or soon to be off patent drugs and combining these with its drug delivery systems. The products will be marketed as “Mystic” branded generics.

Unit dose drug delivery for wide range of applications

Mystic has developed two unit dose drug delivery platform tech-nologies. Both platforms are capable of packaging a wide range of liquid pharmaceutical drugs or biologic agents in a sta-ble, sterile, and preservative free, unit dose form. Using a Blow Fill Seal process, Mystic is able to produce containers in a wide

range of sizes and shapes. This UniDoser technology will be manu-factured under a partnering arrangement with Cardinal Health. The VersiDoser Platform uses a Form Fill Seal (FFS) manufacturing pro-cess to produce unit dose, liquid filled blisters. Each blister incor-porates a VelocityJet micropump which controls precision dosing, delivery and spray plume geometry.

Precision dose & delivery into the eye

Mystic’s ophthalmic devices provide precision dose and delivery into the eye with the push of a button. The devices operate from normal head and hand orientation, aid in holding open the eyelid dur-ing administration and have a compliance tracking sys-tem that tracks the number of doses used and remain-ing. The devices are compact and designed to be carried in a purse or pocket. Pharma-ceuticals under development include products to treat: glaucoma, infection, inflam-mation, allergy, and dry-eye.

Low cost single use intranasal drug delivery Intranasal drug administration is expanding as a preferred route because it avoids the issue of drug degradation in the gastrointes-tinal tract, provides a faster onset of action and is a painless alter-native to injections. Mystic’s “SwordfishV” intranasal disposable device offers single dose drug delivery and can be manufactured and filled at highly competitive costs in global scale volumes. It incorporates a proprietary micropump called the VelocityJet, which controls the critical factors of spray plume geometry and precision dosing. The VelocityJet will be combined with branded and generic drugs or biologic agents to target conditions such as migraine, can-cer pain, sleep disorders, and chemo-induced nausea. The com-pany expects these products to reach the market starting in 2010.

Mystic PharmaPrivateCedar Park, TX

Versatile unit-dosing drug delivery platform

Management

Contact

CEO: Timothy Sullivan www.mysticpharmaceuticals.com Tel: (212) 809.3131

President and CEO: Timothy SullivanMr. Sullivan is a Co-Founder, President and CEO of Mystic Pharmaceuticals. He is co-inventor of Mystic’s Drug Delivery Technology platforms. Formerly a principal with INFUSE Corporation, a strategy-consulting firm based in Austin, Texas, Mr. Sullivan has served as a strategy consultant for organizations ranging from Fortune 500 companies to emerging companies. He has held executive management positions with Questor Energy, Inc., Data Retrieval Corporation, Scien-tific & Engineering Software, Inc., CFI, Inc., and DAZEL Corporation, as a technology commercialization consultant to NASA, and cofounded the SBR Institute, a technology commercialization center at the University of Houston. Sullivan was selected as one of the Medical Device & Diagnostic Industry magazine’s 100 notable people in the medical device industry in 2008.


The VersiDoser™

Nautilus™ (above) and Slider (below) Ophthalmic Devices

STORAGE READY TO DISPENSE DISPENSED

SwordfishV™ Intranasal Device


CryoLife announced on July 31, 2008, that revenues for the second quarter of 2008 increased 18 percent to $27.2 million, compared to $23.0 million in the second quarter of 2007. Excluding orthopaedic tissue processing revenues of $297,000 in the second quarter of 2008, total revenues increased 23 percent for the second quarter of 2008. The company also presented positive mid-term performance data on the CryoValve SG decellularized pulmonary human heart valve on June 28, 2008 at the 34th Annual Western Thoracic Surgical Association Meeting. CryoLife received the CE Mark in June 2008 for use of the BioGlue Sur-gical Adhesive in periosteal fixation following endoscopic browplasty (brow lift), a reconstructive plastic surgery procedure. It has also begun distribution in France of Hemostase MPH, a plant-based powder engineered to rapidly dehydrate blood, for use in general, cardiac and vascular surgery.

Endocare, developer of minimally invasive technologies for tissue and tumor ablation announced that its board of directors had unanimously rejected the unsolicited proposal from HealthTronics, Inc. to purchase all of the outstanding shares of Endocare for $2.28 per share. Revenues for the three months ended June 30, 2008, totaled $7,930,000, up from $7,901,000 during the same period in 2007. Six-month revenues in 2008 increased to $16,073,000, up from $15,447,000 in 2007.

HemCon Medical acquired Alltracel in May 2008. This was followed by the worldwide exclusive licensing agreement with IT Sligo to commercialize a controlled-release hydrogen peroxide technology that provides broad spectrum antibacterial and antiseptic properties. This proprietary platform technology provides a full range of product solutions for the wound care, oral care and personal care markets, ranging from antimicrobial professional products to personal hygiene solutions for consumers. The company also announced the promotions of Bill Block to president and Nick Hart as CFO.

Minrad reported revenue of $ 4.2 million in the second quarter of 2008, com-pared to $4.3 million for the second quarter of 2007. As of July 28, 2008, Minrad announced that it has AFSSAPS (French pharmaceutical regulatory agency) approval to open as a French pharmaceutical establishment. Its laboratory in Wasquehal, developed in cooperation with Mylan, will complete batch release testing for its pharmaceutical partners in the European community. Minrad suc-cessfully completed a BSI quality systems audit as well as 3-year stability testing of its Sojourn Sevoflurane anesthetic agent to enable its 3-year expiration dat-ing. The company has also received renewal of its CE certification.

Mystic Pharmaceuticals, developers of advanced proprietary drug delivery technologies, announced that its president and CEO, Timothy Sullivan, was recognized for his contributions to the medical device industry by the editors of Medical Device & Diagnostic Industry (MD&DI). Sullivan was selected as one of the magazine’s 100 notable people in the medical device industry and was profiled in the cover story of its June 2008 edition. The company reported in May 2008 that it had expanded its management, engineering and scientific team with eight new hires over the past four months.

Aureon introduced the biopsy-based test Prostate Px+ in May 2008 at the American Urological Association’s annual meeting. The company also an-nounced its collaborative research endeavor with the University of Texas M.D. Anderson Cancer Center, which will apply Aureon’s systems pathology platform in the analysis of non-small cell lung cancer (NSCLC) tissue. The goal of the study is to quantify and evaluate biomarkers associated with disease progres-sion and survival. On August 26, 2008, the company announced that data from a clinical study published in the Journal of Clinical Oncology (JCO) supports the Systems Pathology approach underlying its new test Prostate Px+.

Starion Instruments has been distributing its proprietary tissue welding technology worldwide since January 2008. In April 2008, the company announced that China’s State Food and Drug Administration (SFDA) had granted regulatory approval for the sale of its devices.

Clarient enjoyed exceptional revenue growth in the second quarter of 2008 of $16.9 million, a 71% increase compared with $9.9 million in the comparable period in 2007, and a 6% increase from the $15.9 million reported in the first quarter of 2008. The increase over the second quarter of 2007 was driven by higher testing volume, favorable service mix and higher Medicare reimbursement rates. As of June 30, 2008, the company’s cash and cash equivalents were $2.1 million, compared with $1.5 million as of December 31, 2007. Clarient launched its KRAS laboratory-developed test in July 2008, with plans to launch the Clarient Insight Dx Breast Cancer Profile in the coming weeks.

Clearant, developer and marketer of pathogen-inactivation technology that reduces the risk of contamination of biological products, announced its third consecutive quarter-over-quarter growth. Revenues for the second quarter period ending June 30, 2008 increased 194% to a record $0.50 million, up from $0.17 million in the same period of 2007. Revenues for the six month period ending June 30, 2008 increased 62% to a record $0.97 million from $0.60 million in the same period of 2007. Direct distribution revenue grew to a record $0.76 million for the first six months of 2008 compared to $0.30 million in the first six months of the prior year. Revenues from licensing, fee for service, and contract research activities that the Company intends to de-emphasize in the future de-clined to $0.21 million from $0.30 million for the first six months of 2008 and 2007, respectively.

CNS Response reported the results of a study presented at the American Psychiatric Association (APA) 161st Annual Meeting by Dr. James Greenblatt, M.D., Chief Medical Officer, Walden Behavioral Care Inpatient Psychiatry and Eating Disorder Programs. The study demonstrated that rEEG successfully guided physician selection of each patient’s medications in the series, leading to a dramatic relief of depression and eating disorder symptoms. Dr. Greenblatt commented, “Despite the small sample size of this study, the results support the promise of rEEG as an effective tool for determining medication programs for treatment-refractory patients with eating disorders and depression. The de-crease in depressive symptoms, as well as significant improvement in eating disorder symptoms and weight, for the eight patients in the trial was striking, considering that, prior to the study, each had required either partial hospitaliza-tion or inpatient care...However, following rEEG medication recommendations, hospitalization days for the patients decreased dramatically.”

The Radiology Group was founded with the mission is to administer academic-level radiology services, for a lower cost, to rural areas, TRG currently works with twenty hospitals and four clinics in Georgia, Alabama, and Louisiana. It plans to expand into additional markets, including Colorado and Montana, and to develop physician hubs in New York and Miami. TRG also hopes to consolidate all individual hospital systems into a single, web-based platform.

Symphony Medical successfully concluded a multicenter, randomized safety study of its Plexisyl-AF™ device to prevent post-operative atrial fibril-lation in heart surgery patients. It expects to initiate a small optimization study prior to engaging in a pivotal efficacy trial. Also, the company is currently conclud-ing extensive preclinical studies of its Algisyl-LVR™ device for treatment of Con-gestive Heart Failure. A First-In-Man study is expected to begin by early 2009. In a business development transaction, the company obtained an exclusive world-wide license from Angiotech to use its proprietary PEG-based (polyethylene gly-col) biomaterials in post-operative atrial fibrillation.

Eleme Medical announced in September that it received its CE mark and in July that it has raised $18 million in a Series C financing led by L Capital Partners. The company’s SmoothShapes® System, a medical device with FDA clearance to market for the temporary reduction in the appearance of cellulite, was unveiled at the American Academy of Dermatology annual meeting in San Antonio, TX in February 2008, and has received considerable press coverage (i.e., Boston Globe, The Today Show) in the subsequent months.

Symphony MedicalPrivateLaguna Hills, CA

Biopolymer Therapeutics to Treat Heart Failure and Arrhythmias

Management

ContactCEO: Raymond W. Cohen Web: www.symphonymed.com COO: Frank Ahmann Tel: (949) 215-3613

CEO: Raymond W. CohenCohen has more than 25 years experience in healthcare. Before joining Symphony, he was CEO of Cardiac Science, a U.S. manufacturer of public-access defibrillators that merged with Quinton Cardiology Systems in 2005 and operates today under the name Cardiac Science Corporation.

Economic Impact of Congestive Heart Failure exceeds $ 29 billion annuallyWith an ageing and more sedentary population, Congestive Heart Fail-ure (CHF) has become one of the most prevalent chronic diseases in the United States. Presently affecting about 5 million Americans, the number of patients is expected to double by the year 2020 becom-ing the most common form of heart disease. The economic impact that now surpasses $29 billion per year is expected to rise accord-ingly. Approximately 60% of the cost is taken up by hospitalization-related expenses. CHF also represents the most common reason for hospitalization in patients who are 65 years and older. Since curative therapies are not available (except for a heart transplant), patients are managed with a variety of pharmacologic agents and modifica-tion of lifestyle. Ultimately, if patients reach the most advanced stage of heart disease, 50% of them die within a year.

Disappointing Outcomes in Treatment of CHFCHF occurs when the heart’s output or pumping capacity is insuffi-cient for the body’s needs. The cause for this deficiency may include several underlying diseases such as ischemia, hypertension, obe-sity, and valvular disease. Regardless, in a large population of CHF patients, the left ventricle begins to dilate, the muscle wall becomes thinner, and the chamber looses its proper shape in an effort to compensate pumping capacity. Once it is set in motion, this nega-tive chain of events cannot be reversed. The use of various drugs is aimed at improving symptoms and slow down the progression of the disease. Stem cells are also being used experimentally with marginal benefits to regenerate muscle. Lastly, a number of invasive devices and pump assist devices are being developed with mixed success to stop disease progression.

Stopping and Reversing CHF through Ventricular Augmentation Symphony Medical, Inc., a privately held company with proprietary biopolymer and biotherapeutic devices, has developed a novel thera-peutic approach to prevent and reverse the progression of CHF. The approach consists of administering an inert, biocompatible biopoly-mer to the left ventricular wall in order to re-shape and thicken it, thus re-establishing pumping efficiency and reducing cardiac wall stress. In essence, the strategically placed biopolymer reconstructs or augments the dilated chamber so that it assumes its more natu-ral, healthy form. The implanted material does not cause negative immune reactions and it coexists permanently with the heart’s mus-cle. The regulatory pathway as a device is clear, and the efficacy end-points for the therapy are well defined and generally accepted.

Strong product pipeline with near term potentialThe company’s lead product, Algisyl-LVR® for treatment of CHF, is in the final stages of preclinical development. The company expects to initiate human clinical trials by the beginning of 2009.

Symphony’s second prod-uct, Plexisyl-AF, is a prophy-lactic method of preventing sustained post-operative atrial fibrillation, a common side affect of the approxi-mate one million coronary artery bypass grafting and cardiac valve replacement surgeries performed each year around the world. Plex-isyl-AF consists of a PEG-biopolymer that is injected into specific nerve bundles or relays termed ganglion-ated plexi which are located on the surface of the heart where they regulate vagal nerve input. The biopolymer provides a temporary block-age of the ganglionated plexi that limits aberrant nerve signals typically seen in the first few days after heart surgery and thought to cause post-operative atrial fibrillation. The com-pany has completed a multicenter, randomized Phase I/II study in Germany to establish safety and feasibility. After performing a small additional study to optimize the mechanism of action, the Company expects to engage in a pivotal efficacy study in the United States.

Capital effi cient approachA capital-efficient approach toward product development has allowed Symphony to achieve significant milestones with under $20 million in venture financing. The majority of research is conducted in the Uni-versity setting and at commercial laboratories. The company’s near term goals include establishing the safety and efficacy of its biother-apeutics. To that end, two clinical studies are planned for 2008 and 2009 including a first-in-man study for its heart failure product and a pivotal trial for its post-operative AF product. With solid evidence of efficacy Symphony believes its will be able to secure optimal strate-gic distribution alliances and licensing partnerships to maximize the value of its technologies.


Sites of alginate injections

Left ventricle

Right ventricle

Alginate implants

Left ventricular wall

Alginate

Myocardium


Trod Medical announced on June 26, 2008 that it had received the ISO Certificate for Medical Devices. The company officially introduced ENCAGE, its patented minimally invasive breakthrough technology for soft tissue ablation for the prostate, kidney, liver and other organs, at the AUA 2008 conference in July 2008.

Chembio total revenues for the second quarter of 2008 were the highest of any quarter, totaling $2.72 million. This represents an 8.6% increase compared with second quarter 2007 revenues of $2.50 million. The increased product rev-enues for the second quarter of 2008 included an increase in rapid HIV test revenues of $61,500 to $2.21 million, or 2.9% from $2.15 million in the same period of 2007. Total revenues for the first half of 2008 were $5.08 million, an 11.9% increase compared with first half 2007 total revenues of $4.54 million. In addition to posting record quarterly total revenue, the company posted its lowest quarterly operating loss in the second quarter of 2008. Chembio announced the completion of all studies required to file for CE Marking of its FDA-approved HIV tests, as well as the completed development of the three DPP products in con-nection with the company’s contract with the Brazilian Ministry of Health: tests for antibody detection of canine Leishmaniasis, Leptospirosis and a point of care test for the confirmation (as compared with screening) of HIV.

Cyberkinetics Neurotechnology Systems announced in February 2008 that it had commenced a joint venture with NeuroMetrix, Inc. to develop and commercialize a therapeutic product for peripheral nerve injury based on Cyberkinetics’ Andara Oscillating Field Stimulator neurostimulation technology platform. Each company will have equal ownership in the new venture, called PNIR, LLC. In May 2008, Cyberkinetics announced the closing of the sale of its Salt Lake City Research Products business to I2S Micro Implantable Systems Inc. The Research Products business provides neurotechnology equipment-including neural recording arrays, array insertion devices and data acquisition systems-to academic researchers worldwide.

Sleep Solutions announced that it had secured $20.5 million in addition-al venture funding from the TPG Biotechnology II fund in May 2008. NovaSom QSG is currently available with a prescription and is fully reimbursable by most U.S. health insurance firms.

Percutaneous Systems is in the midst of driving a five-year series of unique product introductions for urology. The company’s first product, Perc-Sys Accordion 7mm Stone Management Device, was introduced in mid-2007 at the American Urological Association (AUA) meeting, and the second product release coincided with the AUA’s 2008 meeting. PercSys currently is in market development in selected geographies and plans a commercialization financing and full-scale commercial launch in Q1 2009.

Synergetics announced that Robert H. Dick has been appointed Chairman of the Board of Directors. The company initiated field sales operations reorgani-zation in July 2008. The company manufactures and sells bipolar electrosurgi-cal generators and other generators, based on its DualWave technology, and complementary instrumentation and disposable products for use in neurosurgery, spine surgery, pain control and in dental applications The company’s Bident Bi-polar Tissue Management System allows dentists to work in direct contact with metal implants, nerves, bone, and blood vessels, eliminating collateral tis-sue damage from current spread and heat buildup.

NeoChord raised $1,765,000 via a convertible debt offering in 2007 and has been seeking $6.5 million in the Series A Institutional Round of Funding, as of January 2008. The company’s minimally invasive surgical techniques for the implantation of artificial chordae tendineae while the heart is still beating was performed in two patients at the Mayo Clinic in 2006; both are reported to be in good shape in 2008. NeoChord is currently involved in discussions with the FDA regarding regulatory pathway and clinical trial parameters. It plans to commence a feasibility trial by the end of 2008.

NovaDel Pharma announced the results of its pilot efficacy study of its oral spray formulation of sumatriptan (marketed as Imitrex/Imigran). Sumatrip-tan is the leading triptan for the treatment of migraine headaches, which affect over 30 million Americans. Triptans account for almost $2 billion in sales, with the tablet form of triptans representing approximately 80% of prescriptions. Early results indicate that the NovaDel oral spray can relieve migraine headaches at lower dosages than sumatriptan tablets. Earlier they had reported a net loss of $3.2 million, or $0.05 per share for the quarter ended June 30, 2008, compared to a net loss of $5.3 million, or $0.09 per share, for the quarter ended June 30, 2007. For the six months ended June 30, 2008, the company reported a net loss of $5.2 million, or $0.09 per share, as compared to a net loss of $10.7 million, or $0.18 per share for the six months ended June 30, 2007. . On May 20, 2008. BioAlliance Pharma SA acquired the European rights for NovaDel’s Ondansetron oral spray. In August 2008, the American Stock Exchange (AMEX) accepted No-vaDel’s plan to regain compliance with its continued listing standards.

Bioject announced in June 2008 that it signed a new long-term exclusive license, development and supply agreement with Merial Limited (“Merial”), a world leading animal health company, for a next generation companion animal device which allows for the delivery of injectables. This new spring-powered device will allow Merial to deliver certain of their companion animal vaccines with a single device. Terms of the agreement include an upfront license payment, development milestone payments, a provision for capital equipment and a long-term supply agreement extending up to ten years. Bioject has also completed a new strategic business plan, advised by several key opinion leaders and experts in the therapeutic field, that combines drug+device. It has engaged regulatory experts to identify the most expedient path for FDA clearance and has enlisted the support from therapeutic and reimbursement experts.

Envisioneering Medical will launch the new TargetScan Touch™ mod-el in the Fall of 2008. TargetScan Touch features a touch-screen monitor and compact, streamlined design to enhance biopsy and treatment efficiency, patient comfort and ease of transport for multiple practice locations. The TargetScan system allows a physician to generate a true solid 3D image, manipulate it, and precisely plan and undertake a multi-sample biopsy of a targeted tissue mass in the prostate, improving a physicians’ diagnostic capabilities for detecting cancer and other diseases of the prostate.

SyntheMed announced in July 2008 that REPEL-CV received Health Cana-da approval for use in pediatric patients undergoing open heart surgery. REPEL-CV will be marketed throughout Canada by Force 3 Medical, Inc., a Montreal-based distributor of cardiac surgery products. In September 2007, the Advisory Panel of the FDA recommended approval of the REPEL-CV Adhesion Barrier for use in pediatric patients (21 and younger) likely to need secondary open heart surgery. The FDA approved the company’s PMA application for the pedi-atric indication.

Small Bone Innovations Chairman & CEO Anthony G. Viscogliosi stated in September 2008 that “Despite the pressures in the financial markets, demand in the small bone and joint market for arthroplasty, trauma and tissue repair products has remained buoyant. Our agreement to purchase the S.T.A.R. (total ankle replacement system) represents an important milestone for SBi and is designed to help us capture a significant share of this high growth potential market.”

Colby Pharmaceutical’s lead drug is a oral therapeutic for both An-drogen-dependent & -Independent PCa and is scheduled to enter a Phase I/IIa PCa trial in 1Q 2009. Colby’s co-lead drug is also prostate-directed and irrevers-ably inactivates the oxidase which generates hydrogen peroxide in the prostate. This drug treats early stage prostate disease in mice and data enabling an IND will be complete in 2009. Colby’s third drug is a mitochondria targeted therapeutic for prostate tumors resistant to radiation-, hormone- and chemo-therapies. This drug passes the blood brain barrier and is active with therapy resistant brain tumors & cancer stem cells. Colby and collaborators create NCEs having desired characteristics and have several NCEs for sale.

OSA a significant health riskFor those living with Obstructive Sleep Apnea (OSA) going to sleep can pose a significant health risk. Each obstructive event is associ-ated with cyclical increases in systemic and pulmonary artery pres-sure. The apnea related hypoxemia can cause oxygen saturation to drop, sometimes dramatically.

Cardiac arrhythmias during sleep are often associated with OSA. There are several reports suggesting an increased risk of myocardial infarction, stroke and death with OSA. The long term physiological effects include an increased risk for the development of hyperten-sion, as well as increased risk under anesthesia, and during recov-ery from surgery. Impairment of daytime functioning in OSA patients ranges from mild to severe; excessive daytime sleepiness may be the primary effect of chronic sleep disturbance and hypoxemia.

Children with OSA (usually caused by tonsillar hypertrophy) can suf-fer from impaired growth, weight loss, poor concentration and other behavioral problems. Recent reports suggest a causal role of pediat-ric OSA in attention deficit hyperactivity disorder.

Of 18 million Americans living with OSA, only 5% have been diagnosedCurrently, OSA afflicts as many as 18 million Americans of which only 5% have been diagnosed. The U.S. represents approximately half of the worldwide market opportunity for OSA testing. Once properly diagnosed, highly effectively treatments are available. The standard method for diagnosing OSA requires placing the patient in a sleep laboratory overnight and performing polysomnography. This process is expensive, ranging from $1,000 to over $2,500 per night. The esti-mated 2,200 sleep laboratories in the U.S. can only accommodate a fraction of the patients that require diagnosis. Patients often resist submitting to this uncomfortable and expensive procedure.

Sleep Solutions offers at home testing solutionSleep Solutions, a privately held diagnostic service provider for home testing and evaluation of sleep-disordered breathing, offers the Nova-Som QSG Diagnostic Service to sleep medicine professionals as an immediate, cost-efficient approach to quickly and accurately identify patients suffering from sleep-disordered breathing, especially OSA, without additional staff or equipment.

NovaSom QSG is the first physician-prescribed at-home diagnos-tic device for OSA that has undergone rigorous clinical validation. Delivered directly to the patient through Sleep Solutions’ diagnostic service, the system is the only one cleared by the U.S. Food & Drug Administration specifically designed for unattended and unassisted use in the patient’s home and clinically proven to be equivalent to in-laboratory PSG. NovaSom QSG utilizes patented audio digital-sig-

nal processing (DSP) technology to sense, analyze, and process the patient’s respiratory sounds and convert these sounds to airflow vol-ume. The device collects up to three nights of sleep data using three small sensors easily applied by the patient, and is then returned to Sleep Solutions for analysis.

Suite of tools complements diagnostic deviceSleep Solutions’ Study Viewer electronic data analysis system uti-lizes proprietary algorithms for automated scoring and generation of a comprehensive diagnostic report. The physician or technician is no longer required to perform manual analysis of test data or wave-forms. Sleep Solutions’ MediTrack System is a comprehensive pro-gram for cost-efficient, direct-to-patient delivery of testing services and medical products. With MediTrack, Sleep Solutions’ service can be provided to any patient, anytime, anywhere –eliminating geo-graphic and socioeconomic barriers.

Sleep SolutionsPrivatePasadena, MD

At Home Diagnostic for Obstructive Sleep Apnea

Management

President & CEO: Michael J. Thomas

ContactCEO: Michael J. Thomas Web: sleepsolutions.comVP Operations: Gary Corbett Tel: (877) 753-3775

Thomas has over 18 years of experience in the healthcare industry in various executive, sales, marketing, and business development positions. He joined Sleep Solutions in 2001 and became CEO in June 2003. Thomas was instrumental in raising over $30MM in venture capital investments for three healthcare start-ups. Thomas also sits on the Board of Directors of AdvaMed, the largest and most prestigious medical device trade association in the world.

NovaSom QSG offers physicians and their patients a more expe-ditious, cost-effective, accurate, and comfortable alternative to in-laboratory sleep studies.


Dangerous pathogens can be found in biologicsCurrently, during a tissue-implant procedure such as an ACL repair, human tissue is donated by a cadaver or donor. Although allografts offer several advantages over autografts — such as a single surgical site, reduced discomfort and post-operative problems, decreased recovery times, and increased availability — there are safety con-cerns that have impeded wider usage of allograft tissue. While actual infections are rare, a recent study by the Centers for Disease Control and Prevention found that 70% of allografts tested revealed positive cultures for micro-organisms.

In 2006, the concern over tissue quality and safety rose when major tissue suppliers were closed down due to serious deficiencies and difficulties in maintaining appropriate tissue testing and process-ing quality, as well as the possible illegal harvesting of tissue from cadavers. In addition, The Musculoskeletal Transplant Foundation (MTF) tested positive for Chyseobacterium meningosepticum, which has been reported to be fatal.

Sterilization process addresses safety concernsClearant develops and markets proprietary sterilization processes for biomedical products. The Clearant Process is a pathogen-inactivation method designed to substantially reduce all types of pathogens in biological products. Using a combination of patented technologies based on gamma irradiation, the Clearant Process tackles all types of pathogens, including viruses, bacteria, fungi and spores. The treatment inactivates all types of viruses (includ-ing HIV, hepatitis A and C) and achieves a level of microbial sterility that meets or exceeds the level of medical-device sterility without damaging the integrity of the tissue.

In procedures where the Clearant Process is not used, tissues are usually treated superficially with chemicals. This does not remove bacteria or viruses from the inside of the tissue and so does not sterilize the tissue to the standard of a medical device.

Poised to benefit from higher FDA safety standards In May 2005, FDA enacted the Good Tissue Practice, which recom-mends much higher levels of sterility in donor tissue for implanta-tion. The Clearant Process has been reviewed by FDA and not only achieves the sterility standards that the agency applied to devices, but also meets the viral safety standards applied to pharmaceuti-cals and plasma products.

Currently, Clearant is penetrating the orthopedic allograft segment by marketing allografts used in tissue implants. Clearant obtains tissue from accredited tissue banks, sterilizes the tissue and then distributes the tissue to the surgeon. Clearant is marketing to ortho-pedic surgeons by educating them that a safer standard of care is available and to use Clearant tissue versus non-sterile tissue.

Platform technology to address multiple marketsThe Clearant Process is a platform technology with many potential applications outside of the orthopedic allograft implant market, including combination biologic and non-biologic medical devices, plasma protein therapeutics, and recombinant drug products.

The company is exploring acquisitions, consolidations and partner-ing opportunities in the U.S. and internationally. The Clearant Pro-cess is protected by approximately 100 patents or patents pending. According to Healthpoint, the combined spine and orthopedic bio-logic market was $19.9 billion in 2004.

ClearantCLRI.OBLos Angeles, CA

Powerful Pathogen Inactivation Technology

Management

Contact

CEO: Jon M. Garfield Web: www.clearant.com Tel: (310) 479-4570

CEO: Jon GarfieldGarfield has served as president and CEO of Clearant since January 2007. He joined the company in August 2005 as CFO. Prior to joining Clearant, Garfield had served as CFO of a telecom service provider and a software developer, and VP of Coach USA, a ground transportation consolidator. From 1991 to 1996, Garfield served as Corporate Assistant Controller of Maxxim Medical.


Step 1Grafts are pre-treated with a biocompatible radioprotectant and then frozen or freeze-dried. These processes in combination neutral-ize free radicals and, thus, protect tissue integrity.

Step 2Tissue is subjected to a powerful controlled radiation dose of 50kGy., Specialized dose mapping ensures even distribution of gamma energy preventing ineffective under- or over-radiated tissue.

Step 3Irradiation is conducted at a very low temperature (about -70°C) to limit free radical mobility.

Step 4The Clearant Process® is applied in the final package ready for opening in the operating room to achieve tissue integrity with sterility that equals the level for medical devices.

The Clearant Process ®

Positioned for growth as procedures shift from the hospital to the office and clinicThe mission of Percutane-ous Systems, Inc. (PercSys) is to develop devices that make urologic and endo-scopic procedures easier, less traumatic and more effective therapeutically. While its current devices influence outcomes of pro-cedures performed in the operating room, devices in the pipeline will help move procedures from the hos-pital into the office envi-ronment.

Newly introduced stone management device streamlines operationsApproximately 5 percent of

Americans will be affected by urinary stones at some point in their life. The incidence of a kidney stone is among the most painful and prevalent of urologic disorders.

If a stone becomes large enough, it can block or otherwise create pressure, pain, and infection in the kidney or ureter, the duct that carries urine from the kidneys to the bladder. Many patients experi-encing urinary stones can be managed with medications and large amounts of fluids. In patients with larger stones, external or mini-mally invasive surgical intervention may be required.

The PercSys Accordion® Stone Management Device can be used to entrap and remove stones and other foreign objects from the ure-

ter. The device combines the attributes of multiple endo-scopic stone management tools into a single device. The Accordion device tracks past the stone like a guidewire and can be monitored with fluoroscopic or endoscopic imaging. Once formed, the device’s film occlusion con-forms to and fills the ureter and is designed to prevent retrograde migration of stone fragments. During stone fragmentation, the

Accordion device facilitates distal rinsing of smaller frag-ments in order to keep the field of view clear. Following fragmentation, the device can sweep larger fragments into the bladder or a ure-teral access sheath, thereby eliminating the tedious and often time-consuming serial basketing of individual frag-ments. These benefits com-bine to simplify endoscopic lithotripsy procedures.

The company offers a 7mm Accordion device, ideal for use in stone procedures in the lower and middle ureter and a 10mm version designed to occlude the upper ureter in order to prevent stone/fragment migration in both uretero-scopic and percutaneous nephrolithotomy (PCNL) stone procedures.

Innovative product pipeline and extensive clinical devel-opment drive future growthPercSys is conducting randomized, prospective research into the potential to reduce both the operative time and disposable instru-ment use facilitated by the adoption of the Accordion device in ure-teroscopic stone procedures. In addition, the company is investigating the Accordion device’s capability to influ-ence the effectiveness and outcomes of extracorpo-real shock wave lithotripsy (ESWL) of stones in the ure-ter. Finally, through both internal development and outside collaboration, Perc-Sys has identified a portfolio of additional products that have the capability both to improve upon significantly the current stone treat-ment options and eventu-ally to supplant the outdated patient management paradigm for stone disease. Through these efforts, PercSys seeks to become a leading provider of urological devices for the management of kidney/ureteral stones.

Percutaneous SystemsPrivatePalo Alto, CA

Innovative Solutions to Urological Conditions

ManagementCEO: Robert Behl

ContactCEO: Robert Behl Web: www.percsys.com Tel: (650) 493-4200

Deployed Accordion Device

Undeployed Accordion Device

The flexible tip facilitates entry and maintains access to the ureteral orifice; the undeployed device tracks past impacted stones, Radiopaque markers allow easy monitoring of procedure.

Once deployed, the multi-fold film occlusion is designed to prevent retro-grade migration of the stone or small fragments and the telescoping design enables the Accordion to release easily from intact stones when required.

Film occlusion conforms to and fills the lumen of the ureter allowing irrigant inflow to continually rinse lithotripsy fragments. Compliant occlusion film enables the device to disengage easily from stone fragments that are too large for extraction.

Mr. Behl is a serial entrepreneur with line management experience in R&D, Marketing, and Business Development for American Hospital Supply, Ohmeda/BOC, and Sybron, Mr. Behl founded Sybron’s Clinical Technology Division, InnerDyne, and RadioTherapeutics, and served as CEO of Menlo Care. He has licensed or invented thirteen medical products and received twenty-two U.S. medical device patents.


Could Sumatriptan Oral Spray Relieve Investor’s Headaches?This week, NovaDel announced results of its pilot efficacy study of its oral spray formulation of sumatriptan (marketed as Imitrex/Imigran). Sumatriptan is the leading triptan for the treatment of migraine headaches. Migraine headaches affect over 30 million Americans and triptans account for almost $2 billion in sales with the tablet form of triptans representing approximately 80% of prescriptions.9 September 2008

[Device Profile] Long Term Data Supports Use of PowerlinkEndologix’s Powerlink System is a minimally-invasive procedure, using a one-piece, self-expanding device with a durable cobalt-chromium stent. The stent graft is attached to the aorta and diverts blood away from the weakened area. The unique delivery mechanism requires only a small incision in one leg (via the femoral artery), allowing the Powerlink System to be used in patients with small access vessels. 8 September 2008

Thermage Rejects Unsolicited BuyoutThermage, a company that has readily maintained its position in an otherwise weak aesthetics market, rejected the previously announced offer to acquire its outstanding shares for $5.50 a piece. 5 September 2008

HemCon Expands Reach with New Licensing AgreementHemCon has signed an agreement with Institute of Technology Sligo, Ireland, to license a controlled release hydrogen peroxide technology. The technology has broad spectrum antibacterial and antiseptic properties and has particular promise as a treatment for fungal nail infection. 3 September 2008

[Video Profile] Interview with Thomas Harold, Founder & CEO of ScyFIXAge-Related Macular Degeneration (AMD) is the leading cause of blindness in persons over 50 throughout the western hemisphere. ScyFIX is currently in FDA clinical trials with a microcurrent device that, if successful, could provide sight-saving treatment to millions of AMD patients. 2 September 2008

FDA Clears Stereotaxis Guidewire for Peripheral Chronic Total OcclusionsOn Wednesday, Stereotaxis announced that it received FDA clearance to use its PowerAssert radiofrequency guidewire to cross chronic total occlusions (CTO) in the peripheral vasculature. 29 August 2008

NexMed Gets Nailed, Stock Price DerailsOn Tuesday, NexMed announced that it would shelve its previously filed NDA for an onychomycosis treatment (NM100060) following disappointing Phase III clinical results. Onychomycosis, or toenail fungus, affects six to eight percent of the adult U.S. population. 28 August 2008

[Video] Interview with Dr. Irwin Goldstein, Director of Sexual Medicine at Alvarado HospitalSan Diego Sexual Medicine at Alvarado Hospital, led by physician Irwin Goldstein, attempts to improve sexual health through the prevention, diagnosis, treatment, and rehabilitation of conditions or diseases that involve sexual function. 27 August 2008

[Video] POM Wonderful: Seriously Profitable Science-Backed MarketingPOM Wonderful was founded by Stewart and Lynda Rae Resnick, who purchased a 100-acre pomegranate orchard in 1987. The company launched its namesake juice in 2002. From 2003 to 2006, annual sales climbed from $12 million to $91 million. The company is now the largest grower and distributor of pomegranates and pomegranate juice in the U.S. This must be some seriously profitable juice.26 August 2008

Kensey Nash Q4: A Well Oiled MachineRevenues at Kensey Nash grew to a record $22 million in the company’s latest quarter, a 29% increase over the same period last year. Net sales grew to $15.0 million, a 42% increase from the $10.5 million reported in Q4 2007. 25 August 2008

Celleration Raises $30 Million to Accelerate Sales & MarketingUltrasound wound healing device developer Celleration has successfully completed a Series D financing, raising $30 million. Heron Capital, Venture Investors and Clarian Health led the round. 22 August 2008

[Video Profile] Interview with Joseph Galli, President & CEO of HaemacureHaemacure is developing human biological adhesives, hemostats and thera-peutic proteins. The company’s research and development efforts are driven by a proprietary plasma protein extraction process. Haemacure’s product development activities focus on surgical hemostats wound management, drug delivery in select therapeutic areas, regenerative medicine, adhesion prevention and combination with biomaterials. 21 August 2008

Medtronic Alleges Patent Infringement by NuVasiveDevice giant Medtronic Sofamor Danek has filed a complaint against NuVasive, alleging patent infringement by certain NuVasive products. Nuvasive is in the process of reviewing the complaint and assessing its defenses. 20 August 2008

Nanogen and The Elitech Group to MergeNanogen, a molecular and point-of-care diagnostics company, will merge with The Elitech Group, a private French diagnostics company. Elitech has been on a tear of late. In 2007, the company acquired Wescor and Vital Scientific. 19 August 2008

NeoPharm is engaged in the research, development and commercialization of new and innovative anti-cancer drug candidates for therapeutic applications. The company’s drug development program includes two novel proprietary technologies: Tumor-targeting technology and the NeoLipid® drug delivery technology.

Tumor Targeting TechnologyCintredekin Besudotox, or IL13-PE38QQR, is a recombinant, tumor-targeted, chimeric cytotoxin, currently in development for two indications, treatment of Recurrent Glioblastoma Multiforme (GBM) and for the treatment of Idiopathic Pulmonary Fibrosis (IPF). GBM is the most common type of malignant primary brain tumor in adults. Treatment success has not significantly changed over the last 20 years, with most patients living less than one year after diagnosis despite aggressive surgery, radiation and chemotherapy. The greatest barrier to treatment is targeting and destroying tumor cells without damaging the adjacent healthy brain tissue. GBM is intrinsically resistant to most chemotherapy and very few drugs cross the blood brain barriers. Radiation therapy has been the most effective adjuvant therapy for these tumors, but the inherent resistance to radiation therapy and the risk of damaging the adjacent normal brain tissue limits overall efficacy. These tumors highly over-express IL-13 receptors, which provide a specific target for the treatment of the disease, thereby sparing the normal healthy tissue. (Fig 1)

Cintredekin Besudotox: Glioblastoma MultiformeNeoPharm’s Cintredekin Besudotox, delivered via convection- enhanced delivery (CED) directly into the brain, is designed to molecularly target the tumor cells while sparing healthy brain tissue, as healthy tissue does not have IL-13 receptors. This form of regional and molecular targeting represents one of the first scientifically sound treatment regimens, potentially overcoming difficulties in brain tumor therapy. NeoPharm signed a contract to begin a confirmatory Phase III trial that will commence in late 2008.

Liposome-Based Drug Delivery System:A Liposome is a spherical vesicle with a bilayer membrane, composed of phospholipid and cholesterol. It has central hydrophilic and peripheral hydrophobic regions, containing hydrophilic (water soluble) and hydrophobic (water insoluble) drugs (Fig 2).

NeoPharm, Inc.NASDAQ: NEOLLake Bluff , IL

Next Generation Cancer Therapeutics

Fig 1. Tumor-Specific Action of IL13-PE38QQR

Fig 2. Schematic Diagram of Liposome

Water-soluble drug

Water-insoluble drug

Liposomes are versatile drug carriers that can act as solubil-ity enhancers, serve as sustained release systems, provide protection from degradation and help to overcome multidrug resistance to anticancer drugs. The newly grown blood vessels (angiogenesis) in tumors are “leaky”. Because tumor blood vessels are more permeable than blood vessels in other tis-sues, liposomes loaded with drugs enter into the tumors very easily. This effect is known as the enhanced permeability and retention effect (Fig 3).


NeoLipid Drug Delivery Technology:Our NeoLipid Drug Delivery technology offers many advantages over other existing technologies, including reduced drug toxicity and multidrug resistance by using a unique lipid, cardiolipin; improved pharmacokinetics and drug release profile; enhanced intracellular penetration into the tumor tissue; higher therapeutic efficacy (anticancer effects); increased stability of our lyophilized easy-to-use (ETU) products, which is important for storage, reconstitution and administration to patients and enables more convenient scale-up manufacturing in a cGMP environment

LEP-ETU - Phase II Trial Underway: LEP-ETU is NeoPharm’s liposomal formulation of the widely used cancer drug paclitaxel, approved and sold in the U.S. as Taxol®. The Company began enrolling its first patients in its multi-center open-label Phase II clinical trial of Liposomal Paclitaxel (LEP-ETU) for efficacy and safety in patients with Metastatic Breast Cancer in March 2008. In the Phase I clinical trial, LEP-ETU offered a better tolerability, safety and efficacy than Taxol®, the standard of care for many tumors, especially breast and ovarian cancer.

LE-DT – Phase I Trial Underway: In May 2008, NeoPharm also began enrollment for its Phase I clinical trial for LE-DT, a novel, proprietary liposomal delivery system of docetaxel, the active ingredient in Taxotere®, which is used for the treatment of metastatic solid tumors. The objectives of the study are to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT); the pharmacokinetics (PK); and therapeutic efficacy in the patients with advanced solid tumors.

Management

ContactCEO: Laurence P. Birch Web: www.neopharm.com Tel: (847) 887-0800

President & CEO: Laurence P. BirchMr. Birch comes to NeoPharm with over 25 years of extensive business and financial expertise in and out of the pharmaceutical industry. Most recently, Mr. Birch served in a senior operating position at Ohio Medical Corporation. Prior to that, he served as Senior Vice President and Chief Financial Officer and interim President and Chief Executive Officer of Aksys, Ltd.

Dr. Rahman is one of the founders of NeoPharm Inc., and currently serves as the Company’s Chief Scientific Advisor. Dr. Rahman has more than 20 years of research experience in developing new modalities of treatment for cancer patients, and holds 15 patents. He has served as an Adjunct Professor in the Department of Radiation Medicine at Georgetown University and has been an author of over a hundred peer reviewed publications.

Chief Scientific Officer: Aquilur Rahman, PH.D.

Dr. Ali joined NeoPharm in 2001 as an Associate Director and was key in establishing the Research and Development function. Since joining the company, he has held various positions, most recently as Vice President of Biological Evaluations. During his 36-year career in research and development, he has gained knowledge and expertise in the fields of Enzyme Regulation, Inhalation Therapeutic Intervention and Liposome-Based Drug Delivery Technology.

Executive VP, Research & Development: Dr. Shahid Ali

NeoPharm, Inc.NASDAQ: NEOLLake Bluff , IL

Tu m o r

L e s s E x p o s u re to N o rm a l T is s u e

N o rm a l B lo o d Ve s s e l

L e a k y a n d d is to rte d b lo o d v e s s e lw ith in tu m o r

lip o s o m e

Fig 3. Liposome Delivers its Drugs by Enhanced Permeability and Retention (EPR) in Tumors

LE-rafAON – Preclinical:LE-rafAON is designed to inhibit activated c-raf-1 genes, which have been associated with the cell growth, proliferation, migration differentiation and survival of cancer cells. Raf-1 antisense oligodeoxynucleotides (AONs) are short single-stranded molecules which bind to intracellular mRNA to inhibit the expression of raf-1 proteins. The company anticipates filling an IND in combination with gemcitabine for pancreatic cancer with the FDA in late 2008.

Cintredekin Besudotox: Idiopathic Pulmonary Fibrosis NeoPharm also announced that it is pursuing additional indications for Cintredekin Besudotox for the treatment of Idiopathic Pulmonary Fibrosis (IPF). Approximately five million people are suffering from IPF, of which 200,000 are in the US. A growing body of literature suggests that IL-13 receptors are over-expressed in IPF patients. Few treatments exist and there is no known cure. The Company is expected to submit an IND to the FDA by early 2009.

Trod Medical is a medical device start-up founded in Besancon, France, a region well known for technology companies. Its commer-cial headquarters to Bradenton, FL.

Precise and controlled tissue destructionTrod’s principal product is Encage, a patented, single-use, mini-mally invasive, percutaneous device to ablate prostate cancer using radio frequency under image guidance provided by transrec-tal ultrasound.

Encage allows for precise and controlled percutaneous tissue destruction, especially relevant when dealing with prostate abla-tion. The annual target market revenue for Encage is approximately one billion Euros. The device has additional potential applications in kidney and liver tumor ablation.

Pending FDA 510(k) clearanceThe Encage procedure is similar to existing minimally invasive per-cutaneous techniques such as brachytherapy and classic biopsy procedures. Consequently, there is no complex learning curve for surgeons, which the company believes will help speed market acceptance. Radio frequency energy, the technology utilized in the Encage device, is easy to use and well accepted by the international medical community.

Encage has been submitted for FDA 510(k) clearance; approval is expected by Q4 2008. The device was introduced in the U.S. at the 2008 American Urological Association Annual Meeting in Orlando, FL where it was selected as an “Innovative Breakthrough Technol-ogy.”

Advantages over BrachytherapyDue to the minimally invasive nature of the procedure, brachyther-apy (a type of radiation therapy in which radioactive materials are placed in direct contact with the tissue being treated) is most com-petitive with Trod’s technology. Trod believes Encage is both more effective and less expensive than brachytherapy, a technology that has experienced declining market share in recent years.

Experienced management teamEncage was developed by Trod Medical’s engineering team in con-junction with key international technical partners. Trod will be man-aged by an experienced and skilled team of business professionals and entrepreneurs.

Trod MedicalPrivateParrish , FL

Innovative Treatment for Prostate Cancer

Management

Contact

CEO: Andre Faure Web: trodmedical.com Tel: (941) 776-5127

President and CEO: Andre Faure

The Encage surgical system (shown with guide and Needle Plus) allows for precise percutaneous ablation of target tissue with well-defined margins, while leaving surrounding tissue unaffected.

The Power Cage Plus, Bipolar RF-Generator precisely controls the ablation.

Dr. Faure founded Trod Medical and serves as its Worldwide President and Chief Executive Officer, and as Chief Medical Officer of Trod Medical U.S. In addition to inventing the EncageTM device, he has filed several patents in the field of surgical use medical devices and has lead multi-national R&D programs for years, mainly in developing new radio-frequency-based medical devices. Dr. Faure has high-level international partner-ships with companies, research centers, major hospitals and opinion leaders in the USA and in Europe.


Predicting the End of PreMD: FDA Rejects PREVU 510(k)The FDA has upheld its decision regarding PreMD’s not substantially equiv-alent letter received in connection with the company’s 510(k) submission for an expanded regulatory claim on its skin cholesterol test. 20 August 2008

[Video Profile] Interview with Harry Stylli, President & CEO of SequenomSequenom’s MassARRAY system is a DNA analysis platform that measures the amount of genetic target material and variations therein. MassARRAY delivers reliable and specific data from biological samples and from genetic target material that is only available in trace amounts. 19 August 2008

After a Weak Second Quarter, Ophthalmic Imaging Systems Eyes EMR BusinessIt’s been tough going for Ophthalmic Imaging Systems (OIS). The digital imaging company reported second quarter net revenues of $3.2 million, compared with net revenues of $3.6 million for the same period last year. The company lost $249,000 in the second quarter of 2008. In its second quarter last year, net income at OIS was $458,000. 15 August 2008

Inovio Biomedical Extends Agreement with the International AIDS Vaccine InitiativeSeth Berkley, head of the International AIDS Vaccine Initiative (IAVI ) believes the majority of HIV vaccines now under development need to be abandoned. These vaccines tweak cell-based immunity, a strategy first explored by Merck. Berkley wants to focus IAVI’s substantial energies on vaccines that mobilize antibodies to neutralize HIV in the bloodstream. Along these lines, IAVI has begun to explore intramuscular delivery of DNA vaccines using Inovio Biomedical’s electropor-ation technology. 14 August 2008

American Medical Alert Builds Defensible, Recurring Revenue StreamAmerican Medical Alert (AMAC), developer of Ready Response, which aids the elderly when they fall and can’t get up, announced strong Q2 performance this week. Second quarter revenues were $9.5 million, a 7% increase over the same period last year. 13 August 2008

Retractable Technologies Gets it TogetherIn May, I reported stagnation at Retractable Technologies, a Texas-based safety needle manufacturer. Pointing to a robust balance sheet, I recommended the company makes some moves. I’d like to think my call to action were responsible for this quarter’s promising results. 12 August 2008

Thermage Q2: Robust Results in Ailing Aesthetics MarketDespite the slowdown seen in the aesthetics market, second quarter revenue at Thermage totaled $17.9 million, a 2% increase over Q2 2007. International revenue increased 10 percent while domestic revenues declined four percent. 12 August 2008

[Video] Healthcare Reform 2008: Evolution or Revolution?Healthcare reform is high on the political agenda this year. The upcoming Presi-dential and Congressional elections promise to focus public and business leaders’ attention on proposals to heal our ailing healthcare system. This requires more than force of will or mere innovation. Everyone would agree that the current system is unsustainable. What is the best way to change the system? Full market-based? Governmental-run system? 11 August 2008

Signalife Throws in the TowelAfter battling for over a year to retain its AMEX listing, Signalife has thrown in the towel. The company will voluntarily withdraw its common stock from listing and trading on AMEX and will move to the over the counter bulletin boards. 11 August 2008

HealthTronics Proposes Endocare AcquisitionHealthTronics has made an unsolicited bid to buy Endocare for $26.9 million in cash. The offer represents a 20% premium over Endocare’s closing stock price on August 6th. HealthTronics’ product portfolio includes lithotripters and surgical lasers. 8 August 2008

[Video] Interview with Timothy Surgenor, President & CEO of Cyberkinetics NeurotechnologyCyberkinetics Neurotechnology, at one time an oft-discussed early stage device firm, has seen a steady decline in share price. Current market conditions are largely to blame: investors have little patience for products with long, windy, paths to commercial success, even if they offer significant patient upside.8 August 2008

Arbios Systems Runs Out of SteamArbios Systems has suspended operations and laid-off employees while it focuses on raising additional funds. If the company fails to secure financing by the end of August, Arbios will consider liquidating its assets. 7 August 2008

Clarient Q2 Revenues Up 71%Not wanting to break a winning streak, Clarient delivered its 16th consecutive quarter of quarterly revenue growth. The company posted revenues of $16.9 million in its most recent quarter, a 71% increase over the same period last year. 7 August 2008

NeuroMetrix: Revenues Decline, NC-Stat Prospects BleakNeuroMetrix reported quarterly revenues of $8.5 million yesterday, down approx-imately 26% from the same period in 2007. The company generated a scant $510,000 (or 6% or revenues) from the sale of devices, including NC-stat System and the newer Advance. 6 August 2008

Chembio Q2 Results: Record Revenues, Net Loss DecreasesChembio Diagnostics reported second quarter revenues of $2.72 million, an 8.6% increase over Q2 2007 and higher than any previous quarter. The lion’s share of revenues came from the company’s rapid HIV test. 5 August 2008

[Video] On Greatbatch, Stereotaxis: Interview with Keay Nakae, Analyst at Collins StewartIn this video, Keay discusses Greatbatch, which he believes is a compelling buy based on its current valuation. Keay also discusses Stereotaxis. The company has had a hard time getting its catheter, which treats irregular heartbeats, to market.4 August 2008

Electro-Optical Sciences Nears Pivotal Trial CompletionElectro-Optical Sciences (EOS), developer of The MelaFind System, a hand held imaging device that detects melanomas at an early stage, has completed patient accrual in its blinded pivotal trial. The trial will serve as the basis for the company’s Pre-Market Approval application with the FDA.4 August 2008

SyntheMed’s strategic focus on proprietary anti-adhesion productsSyntheMed is a biomaterials company engaged in the development and commercialization of anti-adhesion and drug delivery products. SyntheMed’s products under development, all of which are based on the company’s proprietary bioresorbable polymer technology, are primarily medical devices designed to reduce the formation of adhe-sions (scar tissue) following a broad range of surgical procedures.

In September 2007, a Circulatory System Devices Advisory Panel of the FDA recommended approval of REPEL-CV Adhesion Barrier for use in pediatric patients (21 and younger) who are likely to need sec-ondary open heart surgery. The Panel also recommended the develop-ment of additional clinical data as a basis for expanding the indicated use to include adult patients. Once approved, SyntheMed plans to use its own sales force to market the product in the U.S.

Large market opportunityThe annual worldwide market opportunity for anti-adhesion products is estimated to be $2-3 billion. Comparable products on the market today generate around $200 million in revenue. With several other products exploiting its bioresorbable polymer technology (bioresorb-able polymers are those polymers that serve a temporary function in the body and then safely degrade into fragments, which are either metabolized or eliminated via normal excretory routes) in pre-clinical development, the SyntheMed appears well positioned to capitalize on the large market opportunity in anti-adhesion products.

Product pipeline has market potential of over $2 billionSyntheMed has a healthy pipeline of products under development, which, if successful, can tap into an estimated $2 billion market. In addition to REPEL-CV, anti-adhesion products are in development for use in gynecologic, general and spine surgery. The company is also exploring the use of its materials in site-specific drug delivery; for example, REPEL-AFIBTM, a drug delivery vehicle designed to pre-vent the onset of atrial fibrillation following open heart surgical pro-cedures.

SyntheMedSYMD.OB Iselin, NJ

Novel Bioresorbable Adhesion Barriers

Adhesions are fibrous structures that connect tissues or organ surfaces that are not normally joined. They are an undesirable side effect of the body’s normal healing process

Adhesions cause a host of surgical complicationsAdhesions are fibrous structures that connect tissues or organ sur-faces that are not normally joined. This is an undesirable side effect of the body’s normal healing process following tissue damage. Adhe-sions can cause significant complications such as bowel obstruction following abdominal surgery, infertility following gynecological sur-gery, serious complications during secondary cardiovascular surgical procedures, and restricted limb motion following orthopedic surgery.

Annual U.S. healthcare cost resulting from adhesions tops $1.2 billion annuallyAdhesions that form as a result of surgery can increase the com-plexity, duration and risk of subsequent surgery. For example, in the U.S. alone surgeons perform an estimated 450,000 abdominal oper-ations annually to remove adhesions. There are another 300,000 similar procedures performed in Europe. The annual cost in the U.S. for the removal of such adhesions is approximately $1.2 billion in inpatient treatment charges.

REPEL-CV® could be fi rst FDA approved anti-adhesion product in open heart surgeryThe company’s lead product, REPEL-CV Bioresorbable Adhesion Bar-rier is designed for use in open-heart surgical procedures. It is placed over the heart at the end of the surgery and is intended to block the transmission of fibrin which can lead to the formation of adhesions. In September 2006, SyntheMed announced the initial results of the multi-center, pivotal clinical trial in which REPEL-CV was shown to pro-vide a significant reduction in adhesions. SyntheMed has received CE Mark approval and has established a network of independent dis-tributors throughout Europe and South East Asia.

REPEL-CV is a bioresorbable membrane designed to be placed over the surface of the heart at the conclusion of the surgical procedure.

Management

President & CEO: Robert Hickey

Contact

CEO and CFO: Robert Hickey Web: synthemed.com Tel: (732) 404-1117

Robert Hickey has served as President and CEO since May 1996, Chief Financial Officer since March 2000 and a Director since August 1996. Prior to SyntheMed he was founder and president of Roberts Healthcare Resources, a company engaged in project consulting to Fortune 500 and leading edge companies in the healthcare industry. He also held various positions at Johnson & Johnson.


Langer Cuts the Fat: Sells Bi-Op Subsidiary for Less than 2003 Purchase PriceLanger, Inc. has completed the sale of Bi-Op Laboratories for $2,125,000 in cash. Buyers include a group of investors and Raynald Henry, the current Bi-Op GM. The Bi-Op sale is part of Langer’s stated strategy of simplifying the company’s business and reducing corporate and compliance expenses.1 August 2008

[Video] Thermage Buys Reliant for $95 MillionSome older news, in video form, care of our team at OneMedPlace TV. Thermage announced it would acquire Reliant Technologies earlier this month. The stock and cash transaction was valued at ≈ $95 million. 31 July 2008

[Video Profile] Interview with Dr. Anand Lalaji, President & CEO of The Radiology GroupThe Radiology Group has developed a virtual, full-service radiology department with a complete range of specialty interpretations. The company aims to match the appropriate physician with the appropriate exam in an effort to raise the standards of health care imaging while lowering costs.31 July 2008

NeuroMetrix Cost Cutting and Product Introductions Not Enough to Appease InvestorsNeuroMetrix continues to get hammered by investors who have left the company for dead. In May, NeuroMetrix laid off 15% of its work force. The direct sales team was cut from 54 to 34 individuals.30 July 2008

Cynosure Q2: Continued Growth and ProfitabilityQuarterly revenues at Cynosure, a developer of laser-based aesthetic systems, grew 30% year-over-year, from $30.1 million in Q2 2007 to $39.2 million in the most recent quarter. The results were in line with the Street’s expectations.29 July 2008

Cepheid: Q2 Revenues Up 55 Percent, Loss WidensOn Thursday, Cepheid reported $42.1 million in quarterly revenues, a 55% jump from the $27.2 million reported in the same period last year. Growth has been driven by hospitals intent on countering the growing scourge of healthcare associated infections (HAI). 28 July 2008

AngioDynamics Reports Better Than Expected Quarterly ProfitRegular readers will know I’m bullish on AngioDynamics. Yesterday, the Queensbury NY-based company reported better than expected quarterly profit, buoyed by strong sales in its interventional product line. The news sent shares soaring 15% to $16-plus.25 July 2008

[Video] New Developments at Chembio DiagnosticsChembio Diagnostics develops, manufactures and markets rapid, point-of-care tests for the detection of HIV 1/ 2, Chagas and Sickle Cell disease as well as other human and veterinary infectious diseases, including tuberculosis (TB).24 July 2008

Tattoo Regret Could be a Boon for Device ManufacturersI’ll never get a tattoo. Call me conservative, but the thought of having an ink-based design etched permanently into my skin is more than the old man in me can tolerate. Conservative or not, my foresight stands a good chance of being rewarded. According to the American Society of Dermatological surgery, over 50% of everyone with a tattoo wants it removed. 24 July 2008

NxStage Releases New Patient Data; Remains Committed to Top Line GrowthNxStage Medical, a Lawrence, MA company that makes dialysis systems, has released new end-stage renal-disease (ESRD) patient data. The information was derived from a registry of NxStage patients who undergo hemodialysis at home using the company’s System One.23 July 2008

Cynosure’s Smartlipo Gets CE Mark; U.S. Sales to Impact Second Quarter ResultsFor the morbidly obese (BMI > 40), liposuction is not really an option. But for a much broader set of women – those with fat deposits in ‘problem areas’ that respond poorly to diet and exercise – liposuction is a perfect fit. And if you’re going the lipo route, one of the best options is Smartlipo MPX by Cynosure. Cynosure, a developer of a broad array of laser-based aesthetic systems, received a CE Mark for Smartlipo this week.22 July 2008

Q2 Earnings Report: ICU MedicalSan Clemente, CA-based ICU Medical nearly doubled net income despite stagnating top line growth and a poor-performing critical care business. Second quarter revenue was $48.6 million, compared to $48.9 million in the same period last year.21 July 2008

Elemé Medical Raises $18 Million to Commercialize Cellulite TreatmentTreatment for cellulite is a healthcare holy grail – second only (in this author’s opinion) to a cure for male pattern baldness. As the bane of women the world over, interest the space is hearty. Elemé Medical has developed the FDA-cleared SmoothShapes system, a proprietary technology (dubbed Photomology) to treat the underlying causes of cellulite. 17 July 2008

Luminex Acquires Human MetapneumovirusLuminex has acquired the worldwide rights to ViroNovative’s human metapneu-movirus (hMPV) intellectual property; hMPV will be incorporated into the company’s xTAG Respiratory Viral Panel (RVP), making it the first and only test cleared by FDA for the detection of hMPV.15 July 2008

SyntheMed’s REPEL-CV Now Available in CanadaREPEL-CV, SyntheMed’s bioresorbable adhesion barrier film used following cardiac surgery, has received Health Canada approval for use in pediatric patients who undergo open heart procedures. The product will be marketed by Force3 Medicale.15 July 2008

Timothy Sullivan Honored by Medical Device & Diagnostic Industry MagazineTimothy Sullivan, President and CEO of Mystic Pharmaceuticals, has been recognized by the editors of Medical Device & Diagnostic Industry as one of the magazine’s 100 notable people in the device industry.14 July 2008

Rapture: AngioDynamics’ Lung Cancer Treatment Shows PromiseBack in 2004, shares of Rita Medical surged as much as 67 percent after it reported positive results for its radio-frequency ablation (RFA) technology in a trial of lung cancer patients. The RFA system, which uses radio-frequency energy to heat tissue to a high enough temperature to kill cells, achieved a 91 percent survival rate in a trial of patients with primary nonsmall-cell lung cancer after both 12 months and 18 months. 14 July 2008

CryoLife a leader in CryopreservationFounded more than twenty years ago, CryoLife primarily focuses on the transplantation of human tissues specifically for use in reconstructive cardiac, vascular and orthopedic surgeries. The company leads the market in allograft tissue processing and preservation and has received several patents related to cryopreservation.

Expanding product line includes innovative heart valveCryoLife is continually expanding the reach of its allograft business. In February 2008, the company received FDA 510(K) clearance for its SynerGraft heart valve. The SynerGraft device is based on the company’s patented antigen reduction SynerGraft technology. The technology decellularizes allografts and xenografts, removing antigens and leaving a collagen matrix, which allows for the potential recellularization of the graft by the patient’s own cells. CryoLife’s heart valves are already popular with cardiovascular surgeons, with demand typically exceeding production capacity.

BioGlue sales reach $43.9 million in 2007CryoLife also operates in the implantable medical device market with its BioGlue product and other bioprosthetic devices. BioGlue is a two-component surgical adhesive composed of a purified bovine serum. The glue is used to bond or reinforce soft tissue in a variety of indications and has received FDA and CE Mark approval as an adjunct to standard methods of surgical repair. The product is applied using either a pre-filled disposable syringe or a reusable delivery “gun.” BioGlue, currently being sold in over 50 countries, is responsible for nearly 47% of CryoLife’s revenues, having achieved $43.9 million in sales in 2007; revenues for the product increased 22% year-over-year.

Company expands into surgical hemostats marketsUnder a private label agreement entered into in April 2008, CryoLife distributes Hemostase MPH, a plant-based, flowable powder engineered to rapidly dehydrate blood, facilitating the formation of a resilient, natural clot within just a few minutes.

Hemostase MPH is provided in a ready to use convenient delivery applicator. Unlike many hemostatic agents, Hemostase MPH does not require either additional preparation steps in the operating room or special storage conditions, thereby saving valuable operating room time and resources. Pre-clinical evaluations, clinical studies and surgical use have shown the hemostatic capabilities to be comparable to other commercially-available surgical hemostatic materials, while its unique formulation allows for rapid absorption by the body.

BioDisc appears successful in early trialsA substantial portion of CryoLife’s R&D efforts are focused on Protein Hydrogel Technologies, including the BioDisc for spinal repair and BioFoam for severe wounds. A clinical study is currently underway for BioDisc; the company filed a CE Mark submission for the product in February 2007. The implantation of BioDisc into the spinal disc void is intended to prevent or reduce spine instability, preserve disc height, and prevent recurrent disc herniation. CryoLife believes that there are few companies with similar technology under development in what it estimates to be an $800 million market.

CryoLife, Inc. NYSE: CRYKennesaw, GA

CryoLife Strengthens Its Allograft Business and Expands Into New Markets

Management

President and CEO: Steven G. Anderson

ContactCEO: Steven G. Anderson Web: www.cryolife.comCFO: D. Ashley Lee Tel: (800) 438-8285

Mr. Anderson has specialized in the development and marketing of implantable medical devices for over 35 years. Prior to founding CryoLife in 1984, he was Sr. Executive VP of Intermedics, Inc. (which became Guidant), a manufacturer of implantable heart pacemakers, intraocular lenses and ortho-pedic prostheses. He also served as vice president of marketing at Intermedics for six years.

BioGlue® is a two-component surgical adhesive. The adhesive solutions are mixed in a predefined ratio within the applicator tip, where cross-linking begins.


CryoLife’s SynerGraft heart valves

The Finance Forum is held at the Sir Francis Drake Hotel, San Francisco, CA.

Register now for the 2nd Annual Meeting: OneMedForum. Space is limited. www.onemedplace.com

Sir Francis Drake Hotel450 Powel StreetUnion Square

2009

Jan 13th-14th, 2009 Focused eduation and networking connects companies with investors and strategic partners Disrupters & Drivers

Interviews/panels with top executives from leading US fi rms about what they see as the “drivers and disrupters” facing their sector will provide insight into the types of fi rms and technologies that these market leaders are investing.

Networking and Company Exhibits

Focused networking session in which investors can gain a quick understanding of fast growing public and private companies in the fi elds of: Cardiology, Orthopedics, CNS, Diagnostics, Devices/Drug delivery, Urology, Surgery/Wound Care, and Healthcare IT.

Less Known Small Public Companies

Many of the most promising public companies with market capital-izations below $500 million and limited research coverage will be making presentations. Over 50 companies are expected to present.

Networking

Held at the Sir Francis Drake Hotel, tthe conference space has been designed to facilitate networking in a comfortable setting for those interested in emerging and smaller companies. Cocktail receptions will be held each evening.

About OneMedPlace

OMP’s mission is to contribute to the overall vibrancy of the health-care industry by helping emerging companies access investors, resources and peers that can maximize their potential. Visit www.onemedplace.com to learn more.

NovaDel develops easy-to-use drug delivery systemNovaDel Pharma has developed an oral spray technology with appli-cations in a broad range of therapeutic areas and product catego-ries. Instead of swallowing pills, patients may soon be able to use oral sprays to administer the same medicine. Spray formulations contain the drug in solution, ready to be absorbed through the oral mucosa directly into systemic circulation. Oral spray technology pro-vides an easy-to-use delivery system that could increase patient compliance and eliminate the need for injections, gels, patches, or

pills. This is especially cru-cial for patients suffering from Parkinson’s, MS or other seizure disorders and useful for pediatric and geri-atric drugs.

Oral spray may speed drug uptake and lower dosages When oral spray is utilized the drug can potentially reach effective blood levels in as little as 10-15 minutes. In bypassing the GI tract and liver, the same therapeutic benefits can be achieved more quickly. Spray formu-lations may provide faster relief of migraine, sleepless-ness, and other conditions where time to relief is impor-tant. It may also be possible to achieve the same effect with a lower dose, which may help improve side effect profiles of certain drugs.

Fast track regulatory approval strategy

NovaDel has secured eight patents in the U.S. and another fifty-three in the EU and Canada; the company has over 80 patents pending globally. NovaDel’s regulatory strategy uses the 505(b) (2) path which allows a sponsor to rely upon the FDA’s findings of safety and efficacy for a previously approved drug. This shortens the develop-ment time frame to approximately 2-3.5 years from conception to submission.

Benefits pharma partners facing patent expirationNovaDel can provide either a life cycle extension strategy for phar-maceutical partners whose products are facing patent expiration or a new product development opportunity for companies who wish to develop their own brand of a competitor’s drug. NovaDel’s revenue will initially be based on milestone payments and royalties, but the company may consider marketing certain future drugs on its own.

FDA approval for NitroMist™NitroMist™, NovaDel’s first product approval for its oral spray tech-nology, was cleared by the FDA in November 2006. NitroMistTM is an oral spray containing nitroglycerin and is indicated for acute relief of an attack or acute prophylaxis of angina due to coronary artery disease. NovaDel is currently investigating commercializa-tion plans for this important drug in markets throughout North America and Europe.

Insomnia Product Shows PromiseZolpiMist™ Oral Spray, for the short-term treatment of insomnia. for treatment of insomnia, incorporates the active ingredient in Ambien®. In January 2008, the company filed for a New Drug Appli-cation (NDA) to support an FDA review of the product.

Cowen & Company estimated the total non-benzodiazepine pre-scription market in the U.S. for the treatment of insomnia in 2006 was approximately $3.4 billion, growing to $3.8 billion by 2011.

NovaDel PharmaAMEX: NVDFlemington, NJ

Oral Spray an Alternative to Injections, Gels and Pills

NovaDel’s technology utilizes an oral spray system to deliver drugs through the oral mucosa into the systemic blood circulation. Drug delivery using oral spray formulations achieves therapeutic levels in a shorter time and therefore provides patients with faster relief.

ContactCEO: (INTERIM) Steven B. Ratoff Web: novadel.com CFO: Michael E. Spicer Tel: (908) 782-3431

NovaDel has a robust pipeline of drug candidates in all stages of development, with one approved product in the U.S., several product candidates currently under late stage development, and multiple candidates in earlier stages of development and clinical review.


ManagementCEO: (INTERIM) Steven B. RatoffMr. Ratoff was appointed by NovaDel’s Board in July, 2007, to serve as Interim President and CEO. Mr. Ratoff, a private investor, joined NovaDel’s Board in January 2006 and was elected Chairman in September 2006. He has served as a Venture Partner with ProQuest Investments, a health care venture capital firm, and is a member of the Board of Directors of TorreyPines Therapeutics, Inc. He also served as Chairman of the Board and Interim CEO of CIMA Labs, Inc. prior to its sale to Cephalon, Inc., and as Senior VP and CFO of the Pharma-ceutical Group at Bristol-Myers Squibb. Mr. Ratoff brings extensive creden-tials to the Company from his distinguished career in the pharmaceutical and consumer goods industries.

CNS Response (CNSO) is commercializing a patented system aiding physicians in identifying appropriate and effective medications for patients with certain behavioral (mental or addictive) disorders.

Central nervous system disorders prevalent The psychiatric treatment market accounts for 7.4% of healthcare spending, second only to heart disease. Depression affects more than 18 million people in the U.S.; physicians write 11 million pre-scriptions per month to treat depression. Other central nervous sys-tem disorders include anxiety, addiction, ADHD, eating disorders, bipolar, OCD and schizophrenia. Approximately 25% of Americans possess at least one of these (or similar) diagnosable behavioral ill-nesses,

Current diagnosis and treatment: trial and errorPsychiatrists are currently attempting to treat what are, arguably, the most complicated disorders affecting the most advanced func-tions of the most highly developed organ in the body with some of the most powerful medications on the market-primarily on the basis of patient observation, interviews and history. The psychiatrist mostly relies on conversation for data, as opposed to EKG or blood tests. As may be expected, the likelihood of complete treatment success is about equal to the likelihood of treatment failure (estimated at 30% for each).

Quantitative analysis used to guide treatmentCNSO has developed the only proven quantitative data analysis to guide treatment of patients with behavioral disorders. Using a sim-ple non-invasive digital electroencephalogram (reference-EEG, or rEEG), CNS Response analyzes and compares the output to a data-base of 13,000 patient histories. The physician receives a report on the responses of patients with similar brain physiology to various treatment options. For the first time, a physician can consider simi-lar brain function, not just similar symptoms, in preparing treatment plans for patients.

rEEG has shown proven resultsCNSO has reported on three controlled studies involving depression, ADHD, anorexia and bulimia. Six additional case series have reported benefits in these areas, as well as in general psychiatry and addic-tion treatments. Over 500 patients participated in these trials, most of them having failed previous treatment efforts. Results have been relatively consistent in these studies; 75% of patients, on average, demonstrated significant improvement. By comparison, use of stan-dard therapies in the largest study of treatment-resistant depression presented treatment success rates of only 14% - 24%.

2008 at a glanceCNSO announced dramatic results of an eating disorder study and will announce additional results of its treatment-resistant depres-sion study. Planned economic cost-benefit studies and an evidence-based review are expected to reinforce the compelling benefits of rEEG. The company announced its first reimbursement relationship for rEEG this year, with more expected in the near future. Training and marketing activities will potentially complete a national network of physician providers servicing patients and payers. Revenues will be generated through primary and follow up analyses of EEG data. The company currently receives approximately $400 for each test.

New applications being examinedCNSO acquired its first clinic in 2007 and currently uses this site to develop marketing activities for other clinics in its network. It also plans to leverage its extensive patient database to steer new drug development and indications, and to develop novel combinations of existing drugs. The potential use of rEEG biomarker patient selection in rescuscitating failed drug development programs can yield dra-matic economic benefits to the pharmaceutical industry.

CNS ResponseCNSO.OBCosa Mesa, CA

New Technology to Improve Treatment of Mental and Addictive Illness

Treatment directed by rEEG has led to positive outcomes in approximately 75% of the 500+ patients who have previously failed to respond to traditional treatments.

ManagementPresident & CEO: Leonard Brandt

Contact

CEO: Leonard Brandt Web: www.cnsresponse.comCFO: Horace Hertz Tel: (714)997-5435

Mr. Brandt has been involved in the creation of health care ventures for 20 years. From 1980 to 1990 he was a partner with Norwest Venture Capital. After retiring for four years Len began part-time venture consulting for numerous (primarily healthcare) companies. Partnering with two others, he formalized this practice founding Mill City Venture Devel-opment. Mr. Brandt holds a BA from University of Illinois and a MBA from Harvard.


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SLIMMER & SEXIER

ITUATION: BARE CUPBOARD. Once upon a time, a privatelyheld and virtually unknown biotech company approached RTAand asked if we could help raise awareness of the company

among investors and business-development execs via the media. Thechallenge? The little biotech company had… no data… no part-ners… no pipeline… no revenues…no outside financing, and… no news.And, all RTA had to work with was anincomplete and outdated businessplan.STRATEGY: CREATE ‘SOMETHING’

OUT OF ‘NOTHING.’ RTA is a bigbeliever that every company’s storymust first be ‘packaged’ effectively forinvestors and the media. We are ableto think like reporters and editors andwrite like reporters and editorsbecause some of us have been workingjournalists. And, we are able to thinklike investors because some of us arelong-time and successful investors.PROCESS. Consequently, RTA’s first step with the little biotech

company was to develop a customized Information Kit that includ-ed five flagship documents—‘Company Fact Sheet’ (which posi-tioned the company from a ‘30,000-foot’ perspective); ‘CorporateProfile’ (which included perspectives of outside authorities), ‘CSOProfile’ (in which we dubbed the company’s CSO as “The Father ofInterferon”, because he is); ‘Product Profile’ and ‘Technology Profile’(complete with high-quality ‘mechanism of action’ illustrations thatclearly showed how the company’s platform and products work).These documents were able to stand independently, or as a criticalmass of persuasive evidence—that the little unknown biotech com-pany was, indeed, a ‘company to watch—now.’

Once the company’s story was packaged effectively, the nextimportant step in our process was to identify as many ‘hard news’opportunities for the company as possible. Unfortunately, there wasonly one:a very modest government grant award of about (yawn) $1million.CONSEQUENCE: A MIRACLE, REALLY! Not only was RTA able to

orchestrate ‘monster publicity’ in many of the most widely read pub-lications in the Life Sciences sector (such as Pharmaceutical Executive,PharmaVoice, BioWorld Today, R&D Focus, Cancer Drug News, GeneticEngineering News, Investor’s Business Daily, Biotechnology News,Healthology, Bioventure View, etc.), but RTA also was able to orches-trate the little unknown biotech company’s participation at a veryspecial industry conference, attended by numerous investors andpharma/biotech business development execs. Because of the SuccessRTA was able to orchestrate as a Consequence of its proprietaryProcess, potential corporate partners and investors are knocking onthe little but-no-longer-unknown biotech company’s door.

Success…the consequence of

Process

GLOBAL MUSCLEAs a member of PublicRelations OrganisationInternational (‘PROI’),Ronald TrahanAssociates Inc. offersits clients access tomore than 3,000professionals in 85cities around theworld. PROI-partnerfirms are generally thetop firm within theirmarket. Combined2007 fee billingsexceeded $285+million.

“Nothing good everhappens by sheeraccident. Success isa consequence ofprocess—of surefiremethods which,when capablyapplied, producecertain predictableresults,”says Ronald C. Trahan, APR,

President and CEO ofRonald Trahan Associates Inc.,headquartered near Boston.

S“Ron Trahan isa hands-on PRpro. He hascertainly beeninstrumental inhelping us to

position our company’sstory effectively with themedia and investors. Bestof all, he keeps three stepsahead of us.”

Patrick SabariaChief Executive Officer

Arterial Remodeling TechnologiesParis, France

“Ron Trahantook chargeright from thestart. He’srequired noheavy lifting of

us, yet has played a trulycritical role in helping toposition our company effec-tively while putting —andkeeping— us on the map.”

Jacques Séguin, MD, PhDChairmanCoreValve

Paris, France

“Trahan worksfast and smart.He’s very adeptat identifyingnewsworthyevents and then

making something goodhappen as a result. I alsoappreciate his energy andprofessionalism.”

Gary TureskiPresident

Harvest Technologies CorporationPlymouth, Massachusetts

“Trahan’s firmwas stronglyrecommendedby our majorinvestor. He isadept at spin-

ning a compelling story andarresting attention fromthe media and investors.But what I like most of allis that he makes us feel asif we’re his only client.”

Laurent Levy, PhDChief Executive Officer

NanobiotixParis, France

What the top executives of importantmedtech companies are saying about RTA...

940 High Street • Suite 386 • Westwood, MA • 02090 • (508) 359-4005 • www.ronaldtrahan.com

Ronald Trahan Associates, Inc.Public and Investor Relations Counsel • www.ronaldtrahan.comSince 1992, helping emerging companies, public and private, communicate effectively and cost-effectively with the media and investors.

“As the CEO ofan emergingcompany, Idepend on RonTrahan to giveme expert PR

counsel because he is anindustry veteran. But healso is not afraid to roll-uphis sleeves for us, which is atrait that I value highly.”

Nancy BriefsChief Executive Officer

Elemé MedicalMerrimack, New Hampshire

“Ron Trahancame highlyrecommendedto us by ourinvestors. Hehasn’t disap-

pointed. His enthusiasm,creativity and intelligenceare helping us shape apowerful corporate story.Trahan is a pro’s pro.”

Thomas WoodChief Executive Officer

Applied Spine TechnologiesNew Haven, Connecticut

“Ron Trahan isone of the best,no doubt, atidentifying thedistinctiveaspects of new

technology, creating andexecuting the media posi-tioning, and buildingexcitement for it.”

George PitarraPresident

Emergence LLCBerkeley, California

“I have beenimpressed withRon Trahan’sability to tell astory and thenseek attention

for it with investors andthe media. He is certainlya superb communicator, aquick study, and doesn’tshy away from going theextra yard for us.”

Gonzague IssenmannChief Executive Officer

StentysParis, France

Cardiology

BioControl 38 (also Urology)CVRx 38 Endovalve 39 Life Recovery Systems 39ThromboVision 40 (also Diagnostics)

Diabetes

OrSense 40 (also Patient Monitoring)VeraLight 41 (also Diagnostics)

Diagnostics

20/20 Gene Systems, Inc. 41 Adnavance Technologies, Inc. 42Allegro Diagnostics, Inc. 42 BioMarker Strategies 43 g-Nostics, Ltd. 43 Ikonisys, Inc. 44 mtm Laboratories 44 Microphage 45 Nanomix 45 Quidel 46

Drug Delivery

Critical Care Innovations, Inc. 46Elcam Medical, Inc. 47 Symbios Medical Products, LLC 47 (also Pain Management)

Imaging

Elminda, Ltd. 48 (also CNS/Neurology)Seno Medical Instruments, Inc. 48 (also Diagnostics)

Ophthalmology

Apelotius Vision Science 49 (also Diag-nostics)eSight Corporation 49 NovaVision 50 (also CNS/ Neurology)

Orthopedics Axial Biotech 50 (also Diagnostics)BoneGrafix, Inc. 51 ISTO Technologies 51 Pain Management eToims Medical Technology 55 (also Re-generative Medicine)Micro Transponder 56 (also Regenerative Medicine)RS Medical 56 (also Orthopedics)VitalWear, Inc. 57 Patient Monitoring Deltex 57 (also Cardiology)Medtronic 58 Scientific Intake 58 Therapeutic Monitoring Systems 59 Regenerative Medicine Avita Medical 59 (also Wound Care)Ivivi Technologies 60 (also Pain Manage-ment)Mesynthes 60 (also Wound Care) Surgery Cohera Medical 61 Crospon 61 MagForce Nanotechnologies AG 62 (also Oncology)mNEMOSCIENCE GmbH 62 Nerites Corporation 63 PEAK Surgical 63 SyntheMed 64 Xylos Corporation 64 (also Wound Care)

Companies Presenting at AdvaMed2008 by Research AreaCompanies Presenting at AdvaMed2008 by Research Area

Wound Care AcryMed 65 BioCure, Inc. 65 (also Surgery)Nitric Bio 66 Other

Becton, Dickinson and Company 52 (General Medical Equipment) Chemica 52 (Chemical Engineering)Dymedix Corporation 53 (Sleep Disorders)Noxilizer 53 (Sterilization)Orla Protein Technologies 54 (Protein Technologies)ProDrive Systems 54 (Dental) (also Sur-gery)Urovalve, Inc. 55 (Urology )

See more about

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profiled in this

report, including

interviews with

their executives, at

onemedplace.com.



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