biosig corporate presentation - november 2015
DESCRIPTION
BioSig Corporate Presentation - November 2015TRANSCRIPT
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This presentation contains forward-looking statements including statements that address activities, events ordevelopments that BioSig expects, believes or anticipates will or may occur in the future, such as predictions offinancial performance, approvals and launches by BioSig of new products, market acceptance of BioSig’s products,market and procedure projections, financing plans, and related documents. Forward-looking statements are basedon BioSig’s experience and perception of current conditions, trends, expected future developments and otherfactors it believes are appropriate under the circumstances and are subject to numerous risks and uncertainties,many of which are beyond BioSig’s control.
These risks and uncertainties include the timing of approvals for BioSig products, rate and degree of marketacceptance of products, BioSig’s ability to develop and market new and enhanced products, the timing of andability to obtain and maintain regulatory clearances and approvals for its products and the impact of failure toobtain such clearances and approvals on its ability to promote its products and train doctors in the use of itsproducts, the timing of and ability to obtain reimbursement if required of procedures utilizing BioSig’s products andthe potential impact of current healthcare reform initiatives thereon, competition from existing and new productsand procedures or BioSig’s ability to effectively react to other risks and uncertainties described from time to time inBioSig’s SEC filings, such as fluctuation of financial results, reliance on third party manufacturers and suppliers,litigation or other proceedings (including by the FDA), government regulation, negative publicity, current worldwideeconomic conditions and share price volatility.
BioSig does not guarantee any forward-looking statements, and actual results may differ materially from thoseprojected. Unless required by law, BioSig undertakes no obligation to update any forward-looking statement,whether as a result of new information, future events or otherwise.
Disclaimer
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Arrhythmias (Irregular Heartbeats) 1 in 18 (14.4M) Americans Suffer
ATRIAL FIBRILLATION (AF)Rapid/irregular heart rate that commonly
causes poor blood flow
• US = 3.4M 2012 8-12M by 2050
• 1 In 4 Adults ≥ 65
• ↑ risk of Stroke 4- to 5-fold (5th Leading Cause of Death in US)
• Total Direct/Indirect Costs $26B/yr
VENTRICULAR TACHYCARDIA (VT)Rapid/irregular heartbeat in lower chambers
of the heart
Ventricular tachycardia (VT) and ventricular fibrillation (VF) are rapidly fatal if not reversed
Accounts for >350,000/yr Sudden Cardiac Deaths in the US
American Heart Association data
BioSig’s Goal: Better Outcomes for Patients with Complex Arrhythmias
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Current Way
PURE EP: The High Fidelity Solution
• BioSig offers improved clarity of acquired cardiac data even at the very low, until now, undetectable signal levels for better clinical decisions and diagnostics/outcomes
• PURE EP System is different from current recording systems: its proprietary hardware and signal processing provides enhanced real-time information
Diagnosing Arrhythmias
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Solving the EP Problem: PURE EP™ System
• Information Unobtainable From Any Other EP Device Today
• Proprietary Hardware / Signal Processing Capabilities / Ability to Open Multiple Review Windows
• To Assist in Clinical Decision Making in Real-Time
• To Maximize Ablation Efficacy & Minimize Need for Repeat Procedures
• To Shorten & Simplify EP Procedures
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Large & Fast Growing MarketAblation becoming First Line of Therapy
EP Labs: Estimated 4,000 WW; 2,800 in the US In 2014: Over 260,000 US total catheter ablation procedures; greater than 600,000 WW Average ablation procedure price (USD): $15,000
Sources: 1. Electrophysiology Devices Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 – 2019 2. HRI 2013 “Global Opportunities in Medical Devices & Diagnostics” report; triangulation of multiple sources; *AF includes left atrial tachycardia, left WPW, left atrial flutter
$2.5
$5.5
$- $1.0 $2.0 $3.0 $4.0 $5.0 $6.0
2012 2019
EP Devices: 12.1% CAGR is One of the Fastest Growing Medical Device Segments1
$ Billions
97,250
160,000
-
50,000
100,000
150,000
200,000
2012 2017
U.S. AF & VT Complex Catheter Ablation Procedures2
Forecasted to grow 10.5% annually through 2017Current EP Market is ~$3.5 B worldwide
GE Healthcare
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EP Recorder Competitive Landscape$750 MILLION - $1 BILLION Global Market
EP Workmate35%
CardioLab50%
Lab System Pro15%
Installed Global Unit Market Share
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Shortcomings of Existing Treatments
DRUG THERAPIES OFTEN INEFFECTIVE
TECHNOLOGY FOR ABLATION TREATMENTS NEED IMPROVEMENT• Predominantly anatomical markers• Insufficient information and signal
quality from existing recording systems
LONG ABLATION PROCEDURE TIMES 2-8 hours depending on complexity, clinician experience
HIGH RATES OF RECURRING ARRHYTHMIAS Many undergo multiple procedures
Electrophysiology (EP) procedures: Catheters are advanced through a patient’s vessels and placed on cardiac tissue to record intracardiac
electrogram signals for diagnostic EP studies
During ablation treatments, RF energy is applied to cardiac tissue to destroy abnormal electrical pathways
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Proven Management Team
Kenneth L. Londoner, MBA Founder, Executive Chairman, Director; Endicott Management Partners, LLC, J & W Seligman & Co
Gregory D. Cash President, CEO and Director; Pres: Argent International, NeuroTherm, Heartsine Tech, Vasomedical, Datascope, Eminent Tech; Mgmt: U.S. Surgical, Boston Scientific, Medtronic
Steve Chaussy, CPA CFO; Liberski Inc, Anna & Co, Penske Automotive, Ford Hogg and Cobbe
Jay O. Millerhagen, MS, MBA
VP Clinical Research; VP Clinical/Mkt Dev: RESPICARDIA, Inc.; VP/Sr Dir Clinical: St Jude Medical; Dir New Product Planning, Brady Mktg, Heart Failure R&D/Mktg, Bus Alliance Mktg with J&J, GE Healthcare: Boston Scientific
Brian McLaughlin VP Corporate Finance, Investor Relations; President & COO: Ridgeback Capital; Head of Equity Trading: Sigma Capital; Trader:SAC Capital & JP Morgan & Co.
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Board of Directors
Kenneth L. Londoner, MBA Founder, Executive Chairman, Director; Endicott Management Partners, J & W Seligman & Co
Gregory D. Cash President, CEO and Director: U.S. Surgical, Boston Scientific, Medtronic
Roy T. Tanaka Director; Former CEO of BioSense Webster, Johnson & Johnson; Volcano Corp, VytronUS, Coherex Medical
Seth H. Z. Fischer Director; Current CEO & Dir: Vivus, Inc; Former WW Chairman: Johnson & Johnson, Cardiovascular
Patrick J. Gallagher, MBA Director; Managing Director Laidlaw & Co.; Kinex Pharma; Founder BDR Research Group, Kidder Peabody
Jeffrey F. O’Donnell, Sr. Director; CEO, Chair: Trice Medical; Chair: Mela Sciences; Founder: Embrella Cardiovascular
Jerome B. Zeldis, MD, PhD Director; CEO of Celgene Global Health & Chief Medical Officer of Celgene Corporation; Chairman: Alliqua
David Weild IV, MBA Director; Founder & CEO: Weild & Co.; Vice Chairman: NASDAQ; Head of Corporate Finance Prudential
Donald E. Foley Director; CEO & Chair: Wilmington Trust; Sr VP, Treas, & Dir: ITT Corp; Asst Treas: Int’l Paper Co.
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World-Class Scientific Advisory Board Top authorities in electrophysiology
Andrea Natale, MD, Chairman Executive Medical Director, Texas Cardiac Arrhythmia Institute, St. David’s Medical Center
Samuel Asirvatham, MDProfessor of Medicine & Vice Chair of Division of Cardiovascular Diseases, Department of Medicine; program director Clinical Cardiac Electrophysiology Training Program, Mayo Clinic in Rochester, Minnesota
K. L. Venkatachalam, MD Assistant Professor of Medicine, Division of Cardiovascular Diseases, Mayo Clinic in Jacksonville, Florida
Kalyanam Shivkumar, MD, PhD Director, UCLA Cardiac Arrhythmia Center; Professor of Medicine & Radiology
Mauricio Arruda, MD Director, Clinical Electrophysiology & Pacing, University Hospitals Case Medical Center
Vivek Reddy, MD Director, Cardiac Arrhythmia Service and a Helmsley Trust Professor of Medicine, Mount Sinai Medical Center in New York
Luigi Di Biase, MD, PhD Senior Researcher at Texas Cardiac Arrhythmia Institute; Associate Professor, Albert Einstein College of Medicine, Adjunct Professor at the UT Austin
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PURE EP – Novel Information System Collaborating with Leading Centers
June 2011 – Concept Developed with Texas Cardiac Arrhythmia InstituteJune 2013 – PURE EP System Proof of Concept (POC) Test at UCLASeptember 2014 – PURE EP System Prototype Test at UCLADecember 2014 – Visit to Mayo Clinic to plan Pre-Clinical StudiesMarch, June & November 2015 – Pre-Clinical Studies at Mayo Clinic October 2015 – Pre-Clinical Studies at UCLA
Other Collaborations:Mount Sinai Medical CenterUH Case Medical Center in ClevelandWilliam Beaumont Hospital in Michigan
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PURE EP: A Few Key Advantagesas stated by Dr. Samuel Asirvatham, Mayo Clinic
“The improved resolution may translate to better ability to pick up specific signals and relate them to specific structure and substrate.”
"The dynamic range of the system is larger - likely will translate into better ability to see both large and small (frequency and amplitude) signals with similar resolution. This is a major problem with present systems, where in order to see smaller signals, we have to amplify the signals, and in doing so, we lose the ability to see larger signals without saturating these signals.”
"The display options are also more intuitive and flexible. For example, different filtering can be applied to the same signal and displayed as separate, simultaneous signals. Presently this is not possible with the existing systems to my knowledge."
MDDI - http://www.mddionline.com/article/cutting-out-noise-target-arrhythmias-07-08-15
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• Sales & Marketing in US Requires a 510(k) Clearance
• PURE EPTM System Qualifies as a Class II Device
• Extensive Clinical Work is Not Required
• Estimated Time for Clearance is Late 2016
PURE EPTM System: Path to Market
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2015 2016 2017Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
AF Symposium HRS Meeting AF Symposium HRS Meeting
Mayo HRS Abstract
Mayo Manuscript
Submit Abstracts
510 (k) Clearance
Market IntroductionLaunch Ver. 1.0 Phase 2
Detailed Design
Engineering Confidence Testing &
Alpha Build
Phase 3Design
Refinements
Beta Design
Phase 1Design
Requirements
Design Plan Risk
Reduction
Phase 4Beta Build
Verification Testing
Pre-production
activities
FDA Review
Launch Prep & Production
Builds
Marketing Launch Preparation
PURE EPTM System: Path to Market
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EP Sector M&A Activity
Company Proo
f of
Conc
ept
Prot
otyp
e
Clin
ical
Da
ta
CE M
ark
FDA
Sale
s Acquirer/Investor Valuation
nContactFormed 2005 • • • • Atricure
$149 millionOct 2015
CardioInsightFormed 2006 • • • • • • Medtronic
$272 millionJune 2015
Topera MedicalFormed 2010 • • • • • Abbott
$350 millionDec 2014
Bard EPDivision of CR Bard
• • • • • • Boston Scientific $275 millionNov 2013
Rhythmia MedicalFormed 2004 • • • Boston Scientific
$410 millionOct 2012
Ablation FrontiersFormed 2004 • • • • Medtronic
$465 millionFeb 2009
EP MedsystemsFormed 1993 • • • • • St. Jude
$92.1 millionJuly 2008
CryocathFormed 1995 • • • • • Medtronic
$380 millionNov 2008
Endocardial SolutionsFormed 1992 • • • St. Jude
$272 millionJan 2005
Prucka EngineeringFormed 1988 • • • • • GE
UndisclosedNov 1999
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UPLIST TO NASDAQ
• Q2 2016• Sell Side Research/Conferences
BUSINESS DEVELOPMENT
• Technology Partnerships• International• Distribution
FDA 510(k) CLEARANCE
• Q4 2016/Q1 2017
Catalysts for Shareholder Value
PRE-CLINICAL DATA
• Mayo Clinic Peer Review Cardiology Journal Mar 2016
• Engineering JournalFeb 2016
• Heart Rhythm SocietyMay 2016
• UCLA 2H 2016
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• Large & Growing Cardiac Arrhythmia Patient Population ⇒ Ablations Increasing 10%+ Annually
• $3B Total Addressable Market for EP Devices at a 12.1% CAGR ⇒ High Demand for New Technologies
• World-Class Management Team, Board of Directors & Scientific Advisory Board
• Aggressive M&A Activity ⇒ High Growth Sector
BioSig Investment Highlights
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Ken LondonerFounder, Executive Chairman
(203) 644-5200 [email protected]
Gregory CashPresident & Chief Executive Officer
(612) [email protected]
Brian McLaughlinVP, Corporate Finance & Investor Relations
(917) 370-9817 [email protected]
This document is being provided on a confidential basis by BioSig Technologies, Inc. solely for the information of those persons to whom it is transmitted. No person in any jurisdiction may treat thisdocument as constituting either an offer to sell or solicitation of an offer to buy any securities in the Company. A prospective subscriber must rely solely on the terms of and disclosure of informationincluding important information regarding risks and conflicts of interest contained in the Company's final offering memorandum and related documents, the only basis on which subscriptions may be made.
Contact BioSig
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Deficiencies In Present Ablation
First Line Therapy for First Stages of AF:Pulmonary Vein Isolation (PVI) -
Areas around Pulmonary Veins are ablated (blocked from firing inappropriate impulses)
ISSUES:• PV reconnects• Inability to detect gaps in ablation lines• Late stage AF needs more than PVI
VENTRICULAR TACHYCARDIA (VT)Scars are Main Ablation Targets
Viable myocardium within scar is responsible for arrhythmia
ISSUE:• Identification of ablation targets
within the scar is difficult due to low signal levels and presence of noise
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KEY COMPANY DATA (11/18/15) Recent price: $1.5052-week range: $1.15 - $4.80Primary shares i/o 15.86 millionMarket cap: $23.8 millionHeadquarters: Minneapolis, MN
BioSig Technologies, Inc. (BSGM)
OTCQB: BSGMWWW.BIOSIGTECH.COM