bio derm press kit

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The first new technology for male bladder control in 50 years

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bebeawareaware There are 4 million men in the United States that deal with

bladder control (BC) everyday.

There are over 12 diseases and diagnosis that can cause

BC challenges for men, but our users share one very

important need: they all want their lives to be long and

fulfilling.

DemographicsDemographicsCurrent BC MethodsCurrent BC Methods ReferencesReferences

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bebeawareaware Current methods for managing male incontinence are

decades old and unsafe. Each method greatly increases

risk of urinary tract infection and can be harmful to the

skin and internal tissue.

Current BC MethodsCurrent BC Methods

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DIAPERS & PADS

Learn more about…

FOLEY CATHETERS

CONDOM CATHETERS

DemographicsDemographicsCurrent BC MethodsCurrent BC Methods ReferencesReferencesStatisticsStatistics

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Learn more about…

bebeawareaware FOLEY CATHETERS

Increase hospital morbidity and mortalityeven when used for as little as one day.

Risk injury to urinary tract and are identified as having the most costly complications

“Catheter-associated urinary infections account for about 40% of all Nosocomial Infections and increase the duration of hospital stays, the costs, and mortality.”

Hospital acquired catheter-associated UTI will no longer be reimbursed by Medicare: CMS 1533

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Current BC MethodsCurrent BC Methods

DIAPERS & PADS

CONDOM CATHETERS

References: Kunin1,2,3, CMS 100-074


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Learn more about…

bebeawareaware Current BC MethodsCurrent BC Methods

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Rapidly cause pressure sores bytrapping urine against the skin.

38% UTI rate

4-6 daily changes increase labor and laundry costs exponentially (by more than 200%).

Not reimbursable under Medicare and most private insurances

Uncomfortable smell and social isolation contribute to the stigma of incontinence

FOLEY CATHETERS

CONDOM CATHETERS

References: CMS100-074, Kernon5, Braden Score6, Leung7


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Learn more about…

bebeawareaware Current BC MethodsCurrent BC Methods

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CONDOM CATHETERS

High condom catheter pop-off rates inhospital setting.

Skin Breakdown/Tearing

Inflammation/Discomfort

Difficult to fit retracted, small anduncircumcised anatomy

63% Catheter Associated UTI rateDIAPERS & PADS

FOLEY CATHETERS

References: Saint8, FDA9, Doughty10, Johnson11


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bebeawareaware DemographicsDemographics

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The 4 million incontinent men in the U.S. suffer from one or more

of these diagnoses.

References: BioDerm Incontinent Male Population15


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Catheter associated urinary infections account for about ‐ 40% of all infections acquired in the hospital.

38% of indwelling urinary catheters inserted in the hospital have no justifiable indication.

(In 2000) the total cost of UTI was $19.5 billion.

The estimated annual cost of nosocomial urinary tract infection in the United Sates ranges between $424 and $451 million

Catheter associated UTIs add an additional ‐ 90,000 hospital days per year.

Nosocomial (hospital-acquired) UTIs contribute to an additional 6500 deaths per year.

Effective October, 2008, Medicare will no longer reimburse payors for the costs of treating catheter associated urinary tract infections acquired while in the hospital.

bebeawareaware StatisticsStatistics

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References: Kunin2, CMS4, Munasinghe12, The-Wei13, Gokula14


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bebeinnovativeinnovative WHAT IS LIBERTY?

Liberty is the first new method for male BC in over 50 years. The completely external design and gentle seal make it the safest, simplest solution for BC in the world.

Liberty is about a state of being!Being dry and comfortable – all day, everyday.Being free to do what you want to do, when you want to do it.Being able to live an active lifestyle

Liberty gives men the opportunity to overcome BC challenges. With Liberty, men are victors, free to work, free to travel, free to play and free to live. Liberty is designed to make life easy.Easy to getEasy to useEasy to fit into every man’s lifestyle

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Cost AnalysisCost AnalysisFeatures & BenefitsFeatures & Benefits CoverageCoverage TestimonialsTestimonials ReferencesReferences

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Cost AnalysisCost Analysis

$0.00

$10.00

$20.00

$30.00

$40.00

$50.00

$60.00

$70.00

Foley High Risk Condom Catheters

All Condom Catheters

Adult Diapers Liberty - 24 hrs.

Liberty - 48 hrs.

Cost of Product

Cost of ComplicationsWhen considering the costs of BC methods, it is

important to note the cost of their complications.

References: R. Kernon5, Newman16, Golgi17, Bejany18, NCHS19, Pajk20, Kumar21, Resnick22


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CoverageCoveragebebeinnovativeinnovative LIBERTY IS COVERED UNDER THE FOLLOWING:

Medicare

Medi-Cal

Most state Medicaids

Most private insurances

GSA Advantage (www.gsaadvantage.gov)Keyword: BioDerm

VA Formulary

FOR MEDICARE REIMBURSEMENT:

Medicare requires a Letter of Medical Necessity and Nurse’s (Progress) Note to be supplied before offering coverage of Liberty to their patients. It includes information about the patients’ diagnosis as well as why they are not medically eligible to use a condom catheter.


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bebeinnovativeinnovative “I have ALS, and I didn’t think there was a bladder control device on the market that would enable me to have the quality of life I have with Liberty. Thank you!”Gary in Colorado

“Liberty is terrific. I can keep doing what I want to do, without having to worry about running to the bathroom or changing my clothes. It’s a Godsend.”John in Arizona

“Liberty saved my husband’s life.”Mrs. B in Arizona

“It was impossible for me to put on a condom catheter without a caregiver. Sometimes the condom catheter would kink. I generally had two pop offs a week. I wish I had tried it [Liberty] years ago when my doctor first recommended it.”Greg in Florida

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Company ValuesCompany ValuesMission StatementMission Statement HistoryHistory ProductsProducts Media ContactMedia Contact

BASED out of Largo, Florida, BioDerm, Inc. is a locally owned and operated durable

medical device manufacturer.

BIODERM was founded in 1990 by Dr. Dennis Kay, a physician with extensive

medical device industry experience. Before founding BioDerm, Dr. Kay provided

consulting services to the senior management of several major medical device

manufacturers, focused on product research and business development for

incontinence, wound care, infection control and ostomy products. Dr. Kay invented

the External Continence Device (ECD) for men, which was introduced in 1998. In

1999, NASA adopted the device for use during manned space flight missions.

Subsequently, BioDerm has grown its family of products to include: CathGripTM Tube

Holder, BioPadTM Skin Adhesive Barrier Prep, and Liberty.

WE have a talented team of hardworking persons, who are fueled by the dedication

of our meaningful and worthwhile mission – creating products that adhere to the

highest standards of quality and health.

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bebeadvancedadvanced BIODERM will strive to continually improve upon outdated

methods of practice in healthcare, utilizing innovation and

leading-edge technology to create medical devices that will

improve patient outcomes, physically and financially.

Through consistent analysis of the stagnant areas of healthcare,

BioDerm will always deliver on it’s pledge of finding and offering

“a better way”.

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UALITY We are inspired by the impact quality healthcare can make in the lives of the people we help. We focus on creating improved methods in healthcare products and ensuring the well-being of each person our products aid.

NDERSTANDING We empathize with the challenges that patients face when managing activities of daily living and create products that help them overcome their challenges with comfort and dignity.

XCELLENCE We continuously look for ways to exceed expectations in every facet of our performance. Our continued success is a direct result of the leadership each member of our team demonstrates.

ERVICE We provide our customers and constituents with the highest level of respect at every interaction. We always keep in mind that quality service creates success.

ECHNOLOGY We strive to make all of our products more innovative than any others on the market. By challenging industry standards, we challenge ourselves to maintain the leading-edge.


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Company ValuesCompany Values


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HistoryHistory


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ECD (EXTERNAL CONTINENCE DEVICE) The ECD utilizes the same hydrocolloid technology and innovative design as Liberty. The ECD is sold in

international markets, providing a safe solution for male bladder control the world over.

CATHGRIPTM

The BioDerm CathGripTM anchors a wide array of tubing. The tube locks allow repeated removal and replacement of tubing without trauma to the skin or the tube. Once locked in place, tubing will not shift or move. Fits 18-36 French size tubing. BIOPAD TM

The BioPad TM provides a safe, protective barrier film over the skin that is useful for wound

protection, incontinence and peristomal care. The alcohol-free, skin-friendly formula is gentle and

will not interfere with wound healing.


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ProductsProducts


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bebeadvancedadvanced LESLIE MATTERNPUBLIC RELATIONS COORDINATOR

Mail:BioDerm, Inc.12320 73rd Court NLargo, FL 33773

E-mail:[email protected]

Telephone:727.507.7655, ext. 2015

Fax:727.507.7645

Website:www.BioDerm.us

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HomeHome

URINE CONTROL FOR MEN: THE RIGHT PRODUCT FOR THE BEST HEALTHBy Marilyn Lou Webb, PhD, NP-BC, CCCN. SCI Life July/August, 2006Dr. Webb discusses “the good, the bad, and the ugly” issues regarding male bladder control.

A NEW OPTION FOR THE MANAGEMENT OF MALE URINARY INCONTINENCEBy Dorothy Doughty, MN, RN, FNP, CWOCN, FAAN. Extended Care Product News. September/October, 2003.Doughty elaborates on the indications and contraindications of various methods for managing urinary incontinence.

THE BIODERM EXTERNAL CONTINENCE DEVICE: EVIDENCE & ASSESSMENT FOR USEBy Mandy Wells, British Journal of Nursing. Vol. 17, No. 9, 2008Wells identifies demographics who could benefit most from BioDerm’s ECD (Liberty for international markets)THE BIODERM EXTERNAL CONTINENCE DEVICE: EVIDENCE & ASSESSMENT FOR USEBy Sue Woodward, Editor-in-Chief, British Journal of Neuroscience Nursing. Vol.3, No. 12, December 2007Woodward compares the advantages and disadvantages of BioDerm’s ECD (Liberty for international markets) with Condom Catheters

If you have questions or

ideas for specific content, contact:

Leslie MatternLeslie Mattern

Previously Published ArticlesPreviously Published Articles

http://www.bioderm.us/SCI Life Article - Webb.pdf

http://www.bioderm.us/ECPN Dorothy Doughty.pdf

http://www.bioderm.us/British Journal of Nursing ECD.pdf



http://www.bioderm.us/Woodard 12.07.pdf



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If you have questions or

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Leslie MatternLeslie Mattern

Articles for PublicationArticles for Publication

ENGINEER WITH MS PERFORMS DEFENSE WORK FROM HOME Bill CosnerIncontinence does not trump leading a fulfilling life, as exemplified by one Liberty user.

PDF or Word Document

THE TOP 15 THINGS YOU NEED TO KNOW ABOUT URINE CONTROL Dr. Dennis KayA list of 15 hints that help people with bc challenges overcome and keep going.


GERM WARFARE – HEALTHY HABITS TO DEFEAT UTI Dr. Dennis KaySimple tips to avoid UTIs, plus bonus cranberry recipes ripe with UTI fighting power.


MEN FIND FREEDOM WITH NEW BLADDER CONTROL PRODUCT Bill CosnerLiberty was the solution for one man who didn’t want to be give up his hobbies.


http://www.bioderm.us/engineer_with_ms_-_feature_article.pdf

http://www.bioderm.us/engineer_with_ms_-_feature_article.doc

http://www.bioderm.us/15_things_to_know_about_incontinence.pdf

http://www.bioderm.us/15_things_to_know_about_incontinence.doc

http://www.bioderm.us/germ_warfare_-_healthy_habits_to_avoid_uti.pdf

http://www.bioderm.us/germ_warfare_-_healthy_habits_to_avoid_uti.doc

http://www.bioderm.us/active_living_for_a_man_with_incontinence_-_feature_article.pdf

http://www.bioderm.us/active_living_for_a_man_with_incontinence_-_feature_article.doc

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bebeassuredassured • Kunin C.M., Douthitt S., Dancing J., Anderson J. and Moeschberger M. “The Association Between the Use of Urinary Catheters and Morbidity

and Mortality among Elderly Patients in Nursing Homes” American Journal of Epidemiology 1992; Vol. 135, No. 3: 291-301.

• Kunin, Calvin M. “Nosocomial Urinary Tract Infections and the Indwelling Catheter: What is New and What is True?” Chest 2001; 120: 10-12.

• Kunin, Calvin M. “Urinary-Catheter-Associated Infections in the Elderly” International Journal of Antimicrobial Agents. 2006 Aug; 28 Supplement 1:S78-81. E-Publication 2006 Jul 10

• Centers for Medicare and Medicaid Services (CMS). CMS Manual System Pub. 100-07 State Operations Provider Certification). Transmittal 8. June 28, 2005.

• R. Kernon. Administrator, Indigo Manor Nursing Home, Daytona Beach, Florida. Personal Communication, 2005.

• Braden Score. “By the Numbers: Braden Score Interventions” Advances in Skin & Wound Care, April 2004.

• Leung, K.S. Et al. “Urinary Incontinence: an Ignored Problem in Elderly Patients”. Hong Kong Medical Journal. 1997; 3:27-33.

• Saint S., Kaufman S., Rogers M., Baker P., Ossenkop K., Lipsky B. “Condom Versus Indwelling Urinary Catheters: A Randomized Trial.” Journal of American Geriatric Society, 2006 Jul; 54(7): 1055-61.

• FDA Center for Devices and Radiological Health Database. <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM> 2008.

• Doughty, Dorothy B. “A New Option for the Management of Male Urinary Incontinence.” Extended Care Product News. p. 30-2; September/October 2003.

• Johnson, Edwin T. “The Condom Catheter Urinary Tract Infection and Other Complications.” Southern Medical Journal. 1983 May;76(5):579-82.

• Munasinghe, Rajika L. MD. Et al. “Appropriateness of Use of Indwelling Urinary Catheters in Patients Admitted to the Medical Service”. Infection Control and Hospital Epidemiology. October, 2001. Vol.22 No.10. 647-9

• The-Wei Hu, et al. “Costs of Urinary Incontinence and Overactive Bladder in the United States: A Comparative Study”. Urology. 63(3), 2004.

References: References: PAGE 1PAGE 1

References: Page 3References: Page 3References: Page 2References: Page 2

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bebeassuredassured • Gokula, Radha Ramana Murthy, et al. “Inappropriate use of urinary catheters in elderly patients at a midwestern community teaching

hospital”. American Journal of Infection Control. June, 2004. 196-9.

• BioDerm Analysis of Male Incontinent Population by Diagnoses National Spinal Cord Injury Statistical Center from http://www.spinalcord.uab.edu About MS: What is Multiple Sclerosis? National Multiple Sclerosis Society brochure, www.nationalmssociety.org/what%20is%20MS.asp Brook, Michael H. A Clinician’s View of Neuromuscular Diseases. Baltimore: Williams & Wilkins, c1986. Oklahoma University Medical Center, Carson Wong, MD, FRCSC, FACS - www.oumedcenter.com Kidney & Urologic Disease Statistics for the US - www.kidney.niddk.nih.gov/kudiseases/pubs/kustats/index.htm National Cancer Institute - The Prostate Cancer Outcomes Study - www.nci.nih.gov/newscenter/pcos Spina Bifida Association - www.spaa.org Tri-state Incontinence Support Group - Help for Incontinent People (HIP) www.tis-group.org Internet Stroke Center - www.strokecenter.org/pat/stats.htm National Institute of Neurological Disorders and Stroke - www.intelihealth.com/IH/ihtPrint/WSHIHW000…. United Cerebral Palsy Cerebral Palsy Facts and Figures Retrieved from the World Wide Web at

http://www.ucp.org/ucp_generaldoc.cfm/1/9/37/37-37/447 National Library of Medicine, PubMed, Dev Med Child Neurol 2001, Feb;43(2):75 - www.ncbi.nlm.nih.gov/entrez/query Amyotrophic Lateral Sclerosis Association Who Gets ALS? http://www.alsa.org/als/who.cfm?CFID=43828&CFTOKEN=48446726 Centers for Disease Control and Prevention (CDC); cited in Christopher & Dana Reeve Paralysis Resource Guide Traumatic Brain Injury: Hope Through Research: National Institute of Neurological Disorders and Stroke www.ninds.nih.gov/disorders/tbi/

detail_tbi_pr.htm Centers for Disease Control and Prevention (CDC) Injury Fact Book 2001-2002 Atlanta, GA: Centers for Disease Control and Prevention,

2001 National Parkinson Foundation, www.parkinson.org We Move - Movement Disorders Virtual University www.mdvu.org/emove/article.asp?ID=823



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bebeassuredassured • Newman, E., Price, M. “Bacteriuria in Patients with Spinal Cord Lesions: Its Relationship to Urinary Drainage Appliances,” Archive of Physical

Medicine Rehabilitation, Vol. 58, October 1977.

• Golji, H. “Complications of External Condom Drainage,” Paraplegia. 1981; 189-197.

• Bejany, D.E., Lockhart, J.L., Rhamy, R.K. “Malignant Vesical Tumors Following Spinal Cord Injury.” The Journal of Urology. Vol. 138, December 1987; 1390-1392.

• National Center for Health Statistics (NCHS). National Nursing Home Survey. 1999; 12, 24.

• Pajk, Marilyn. “Pressure Sores,” Merck Manual of Geriatrics. Section 15, Chapter 124. Internet Edition provided by Medical Services, USMEDSA, USHH. Published by Merck and Co. Inc, 2000.

• Kumar, R.N., Gupchap, G.V., Dodd, M.A., Shah, B., Iskedjian, M., Einarson, T.R., Raisch, D.W. “Direct Health Care Costs of 4 Common Skin Ulcers in New Mexico Medicaid Fee for Service Patients.” Advances in Skin Wound Care. April 2004; 17(3), 143-9. University of Michigan College of Pharmacy, Ann Arbor, MI.

• Resnick, Neil M. “Urinary Incontinence.” Merck Manual of Geriatrics. Section 12, Chapter 99. Published by Merck and Co. Inc, 1995-2002.



bio derm press kit

Health & Medicine

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indwelling urinary catheters

nosocomial hospital

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urinary tract infections

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