pure ep™ system...sources: 1. electrophysiology devices market - global industry analysis, size,...
TRANSCRIPT
![Page 1: PURE EP™ System...Sources: 1. Electrophysiology Devices Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 – 2019 2. HRI 2013 “Global Opportunities](https://reader034.vdocument.in/reader034/viewer/2022042219/5ec4c2ff7c87645d1d4ce379/html5/thumbnails/1.jpg)
Symbol: BSGM
PURE EP™ System
![Page 2: PURE EP™ System...Sources: 1. Electrophysiology Devices Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 – 2019 2. HRI 2013 “Global Opportunities](https://reader034.vdocument.in/reader034/viewer/2022042219/5ec4c2ff7c87645d1d4ce379/html5/thumbnails/2.jpg)
Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
Disclaimer
This presentation contains forward-looking statements including statements that address activities, events or developmentsthat BioSig expects, believes or anticipates will or may occur in the future, such as predictions of financial performance,approvals and launches by BioSig of new products, market acceptance of BioSig’s products, market and procedureprojections, financing plans, and related documents. Forward-looking statements are based on BioSig’s experience andperception of current conditions, trends, expected future developments and other factors it believes are appropriate underthe 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 market acceptance ofproducts, BioSig’s ability to develop and market new and enhanced products, the timing of and ability to obtain andmaintain regulatory clearances and approvals for its products and the impact of failure to obtain such clearances andapprovals on its ability to promote its products and train doctors in the use of its products, the timing of and ability toobtain reimbursement if required of procedures utilizing BioSig’s products and the potential impact of current healthcarereform initiatives thereon, competition from existing and new products and procedures or BioSig’s ability to effectively reactto other risks and uncertainties described from time to time in BioSig’s SEC filings, such as fluctuation of financial results,reliance on third party manufacturers and suppliers, litigation or other proceedings (including by the FDA), governmentregulation, negative publicity, current worldwide economic conditions and share price volatility.
BioSig does not guarantee any forward-looking statements, and actual results may differ materially from those projected.Unless required by law, BioSig undertakes no obligation to update any forward-looking statement, whether as a result ofnew information, future events or otherwise.
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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
Arrhythmias (Irregular Heartbeats) 1 in 18 (14.4M) Americans Suffer
2
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
BioSig’s Goal: Better Outcomes for Patients with Complex Arrhythmias
VENTRICULAR TACHYCARDIA (VT)Rapid/irregular heartbeat inlower 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
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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
Diagnosing Arrhythmias
3
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
Current Way
PURE EP: The High Fidelity Solution
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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
Solving the EP Problem: PURE EP™ System
4
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
![Page 6: PURE EP™ System...Sources: 1. Electrophysiology Devices Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 – 2019 2. HRI 2013 “Global Opportunities](https://reader034.vdocument.in/reader034/viewer/2022042219/5ec4c2ff7c87645d1d4ce379/html5/thumbnails/6.jpg)
Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
Large & Fast Growing MarketAblation becoming First Line of Therapy
5
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
EP Devices: 12.1% CAGR is One of the Fastest Growing Medical Device Segments1
$2.5
$5.5
$- $1.0 $2.0 $3.0 $4.0 $5.0 $6.0
2012 2019
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
Current EP Market is <$4 B worldwide
$ in
Bill
ions
U.S. AF & VT Complex CatheterAblation Procedures2
97,250
160,000
-
50,000
100,000
150,000
200,000
2012 2017
Forecasted to grow 10.5% annually through 2017
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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
EP Recorder Competitive Landscape$750 MILLION - $1 BILLION Global Market
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CardioLab50%
Lab Systems Pro15%
EP Workmate35%
Installed Global Unit Market Share
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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
Shortcomings of Existing Treatments
7
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
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
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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
Proven Management Team
8
Kenneth L. Londoner, MBA
Founder, Executive Chairman, Director; Endicott Management Partners, LLC, J & W Seligman & Co
Gregory D. CashPresident, CEO and Director; Pres: Argent International, NeuroTherm, HeartsineTech, 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.
Asher Holzer, PhD. Chief Scientific Officer; Director/Pres/Chairman, InspireMD, Inc., Co-founder/Pres/Chairman, InspireMD Ltd., Founder/CEO, Adar Medical Ltd.
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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
Board of Directors
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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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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
World-Class Scientific Advisory Board Top authorities in electrophysiology
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Andrea Natale, MD, Chairman Executive Medical Director, Texas Cardiac Arrhythmia Institute, St. David’s Medical Center
Samuel Asirvatham, MD Professor 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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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
PURE EP – Novel Information System Collaborating with Leading Centers
11
June 2011
Concept Developed with Texas Cardiac
Arrhythmia Institute
June 2013
PURE EP System Proof of Concept
(POC) Test at UCLA
September 2014
PURE EP System Prototype Test at
UCLA
December 2014
Visit to Mayo Clinic to plan Pre-
Clinical Studies
March, June &November 2015
Pre-Clinical Studies at Mayo
Clinic
October 2015
Pre-Clinical Studies at UCLA
Other Collaborations
William Beaumont Hospital in MichiganUH Case Medical
Center in Cleveland
Mount SinaiMedical Center
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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
PURE EP: A Few Key Advantagesas stated by Dr. Samuel Asirvatham, Mayo Clinic
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MDDI - http://www.mddionline.com/article/cutting-out-noise-target-arrhythmias-07-08-15
"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 improved resolution may translate to better
ability to pick up specific signals and relate them to specific structure and
substrate.”
"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."
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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
PURE EPTM System: Path to Market
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
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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
PURE EPTM System: Path to Market
14
2016 2017Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Phase 1Design Requirements
Design Plan Risk Reduction
Phase 2Detailed Design
Engineering Confidence Testing
& Alpha Build
Phase 3Design
Refinements Beta Design
Phase 4Beta Build
Verification Testing Pre-production
activities
FDA Review
Launch Prep & Production Builds
MARKET INTRODUCTIONLaunch Ver. 1.0
Mayo Manuscript
IEEE Manuscript
AF SYMPOSIUM HRS Meeting AF SYMPOSIUM HRS Meeting
Submit Abstracts
510 (k) Clearance
Market Launch Preparation
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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
EP Sector M&A Activity
15
CompanyProof ofConcept Prototype
Clinical Data CE Mark FDA Sales
Acquirer/Investor Valuation
nContactFormed 2005 • • • • Atricure $149 million
Oct 2015CardioInsightFormed 2006 • • • • • • Medtronic $272 million
June 2015Topera MedicalFormed 2010 • • • • • Abbott $350 million
Dec 2014Bard EPDivision of CR Bard • • • • • • Boston Scientific $275 million
Nov 2013Rhythmia MedicalFormed 2004 • • • Boston Scientific $410 million
Oct 2012Ablation FrontiersFormed 2004 • • • • Medtronic $465 million
Feb 2009EP MedsystemsFormed 1993 • • • • • St. Jude $92.1 million
July 2008CryocathFormed 1995 • • • • • Medtronic $380 million
Nov 2008Endocardial SolutionsFormed 1992 • • • St. Jude $272 million
Jan 2005Prucka EngineeringFormed 1988 • • • • • GE Undisclosed
Nov 1999
Each acquired company was sold for an average of $296 million and a mean of $275 million. BioSig which has a better technology and is further in development then many of the acquired companies is currently undervalued at ~18 million.
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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
Catalysts for Shareholder Value
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PRE-CLINICAL DATA Mayo Clinic
Peer Review Cardiology JournalQ2 2016 Engineering Journal
Feb 2016 Heart Rhythm Society
May 2016 UCLA
2H 2016
UPLIST TO NASDAQ Q2 2016 Sell Side Research/Conferences
BUSINESS DEVELOPMENT Technology Partnerships International Distribution
FDA 510(k) CLEARANCE Q4 2016/Q1 2017
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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
BioSig Investment Highlights
Large & Growing Cardiac Arrhythmia Patient Population ⇒Ablations Increasing 10%+ Annually
$4B 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
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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
Contact BioSig
18
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 this document as constituting either an offer to sell or solicitation of anoffer to buy any securities in the Company. A prospective subscriber must rely solely on the terms of and disclosure of information including important information regarding risks and conflicts of interest contained in the Company's final offering memorandum andrelated documents, the only basis on which subscriptions may be made.
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]
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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
Deficiencies In Present Ablation
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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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Symbol: BSGM © 2016 BioSig Technologies, Inc. All rights reserved. The contents of this document are proprietary and confidential.
BioSig Technologies, Inc. (BSGM)
20
OTCQB: BSGMWWW.BIOSIGTECH.COM
KEY COMPANY DATA (03/07/16)
Recent price: $1.30
52-week range: $0.90 - $4.80
Primary shares i/o: 17.02 million
Market cap: $22.1 million
Headquarters: Minneapolis, MN