biosig technologies corporate presentation - may 2015
TRANSCRIPT
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This presentation 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 financialperformance, approvals and launches by BioSig of new products, market acceptance of BioSig’s products, marketand procedure projections, financing plans, and related documents. Forward-looking statements are based onBioSig’s experience and perception of current conditions, trends, expected future developments and other factorsit believes are appropriate under the circumstances and are subject to numerous risks and uncertainties, many ofwhich 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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Proven Management Team & Board of Directors
World-Class Medical Advisory Board
EP Devices: $3B Total Addressable Market, 12.1% CAGR
Large Cardiac Arrhythmia Patient Population; Ablations Grow 10%+
Increasing Demand for New EP Technologies to Address:
Complex Ablation Treatments
High Costs, with Higher Patient Throughput, Shorter Procedure Times
Unacceptably High Recurrence Rates (31% - 46%)
High-Growth Sector Earns Innovation Premium, Aggressive M&A
BioSig Investment Highlights
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Cardiac Arrhythmias 1 in 18 (14.4M) Americans Suffer
Increases individual’s risk of Stroke 4- to 5-fold* - 5th Leading Cause of Death in the US
Most Common Arrhythmia: U.S. = 2.7M 2010; 5.6M by 2050* (7M - 12M Worldwide)
≈600,000 hospitalizations/year*
Direct cost = $6B annually; adding other indirect costs brings AF total cost to $26B*
Ventricular tachycardia (VT) and ventricular fibrillation (VF) arerapidly fatal if not reversed
Ventricular arrhythmias account for >350,000 Sudden Cardiac Deaths annually*
* American Heart Association data
ATRIAL FIBRILLATION (AF) VENTRICULAR TACHYCARDIA
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Cardiac EP: Large & Growing Market
EP Labs: Estimated 4,000 WW; 2,800 in the U.S. In 2012: 260,000 U.S. catheter ablation procedures; 600,000 WW Average ablation procedure price (USD): $6,000 - $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 Cardio Medical Device Segments1
$ Billions
97,250
160,000
-
50,000
100,000
150,000
200,000
2012 2017
U.S. AF and VT Catheter Ablations2
Forecasted to grow 10.5% annually through 2017 (VT 13.9% CAGR and AF 10.1% CAGR)Current EP Market is ~$3B worldwide
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BioSig’s Technology Addresses Critical Issues
High ablation recurrence rates: 31% for paroxysmal AF; 46% for persistent/permanent AF
Long procedure times: from 2-8 hours depending on case, clinician experience
Outdated technology: EP recording systems use core technology from the 1990s
Strong market demand for clear, accurate and real-time diagnostic data
Artifacts and noise generated by other EP lab equipment may compromise signal quality
Anti-arrhythmic drug therapies have limited effectiveness, driving demand for catheter ablation
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PURE EP proof of concept system during UCLA validation studies
PURE EP™ System
BioSig Technologies, Inc. has developeda novel Electrophysiology (EP) informationplatform – PURE EP™ System
The PURE EP System acquires and displays highfidelity intracardiac (IC) & electrocardiogram (ECG)signals.
PURE EP assists electrophysiologists in makingclinical decisions during cardiac catheter ablation inreal-time by providing information that we believe isnot always obtainable from any other equipmentpresently used in EP labs.
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System dedicated to improving cardiac signal recordings - fundamental for accurate diagnoses and treatments of cardiac arrhythmias
Preserves morphology of the patient’s cardiac signalsCLEAR ECG & IC SIGNALS
Visualize crucial information in real-time REAL-TIME ANALYSIS
Aide in optimizing procedure time and decision makingIN ORDER TO
PURE EP™ System
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Electrograms & ECG signals – important for diagnoses and treatments
Inadequate signal quality may lead to poorer outcomes, clinical and economic inefficiencies
PURE EP System is designed to preserve morphology of ECG & IC signals to ensure optimal clinical decision making
Signals may become degraded by environmental noise and signal processing
PURE EP System Value Proposition
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Current PURE EP System Prototype
PURE EP System Prototype connected to an ECG/IC Simulator
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PURE EP System Development to Date
Jan 2009 - Jan 2011 – Research activities
Understanding EP Lab environment/workflow and concepts of “Electroanatomy” vs. “Electrophysiology”
Defining architecture of the new system
June 2011 – Visit to TCAI
PURE EP System concept discussions w/Drs. Natale & Di Biase
June 2013 – PURE EP System Proof of Concept (POC)
Testing at UCLA’s EP & Animal Labs
September 2014 – PURE EP System Prototype
Test at UCLA Animal Lab
December 2014 – Visit to Mayo Clinic
PURE EP System presentation and planning Animal Studies with Drs. Asirvatham and Venkatachalam
March 2015 – Animal Study at Mayo Clinic
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Validation of PURE EP System
Testing of the PURE EP System is underway in EP and animal labs at UCLA and Mayo Clinic
BioSig is collaborating with leading Cardiac Centers:
Texas Cardiac Arrhythmia Institute UCLA Cardiac Arrhythmia Center U.H. Case Medical Center in Cleveland William Beaumont Hospital in Michigan Mount Sinai Medical Center in NY Mayo Clinic in Minnesota
BioSig has developed an ECG/IC simulator to objectively measure/compare PURE EP’s performance vs. existing EP systems
PURE EP proof of concept system during UCLA validation studies
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World-Class Scientific Advisory Board Leading 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, MDAssistant 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, MDDirector, Cardiac Arrhythmia Service and a Helmsley Trust Professor of Medicine, Mount Sinai Medical Center in New York
Luigi Di Biase, MD, PhDSenior Researcher at Texas Cardiac Arrhythmia Institute; Associate Professor, Albert Einstein College of Medicine, Adjunct Professor at the UT Austin
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EP Market: Intense Competition & Rapid Technological Advances
4 large companies share the majority of EP recording market share
They produce the following EP recording systems @~$250,000/unit:
Bard’s LabSystem PRO EP Recording System, originally designed in the late
1980s; acquired by Boston Scientific in 2013
Siemens developed the Axiom Sensis XP in 2002
GE’s CardioLab Recording System developed early ‘90s by Prucka Engineering;
acquired by GE 1999
St. Jude Medical’s EP-WorkMate Recording System was acquired from EP
MedSystems in 2008, received FDA approval in 2003
EP Competitive Landscape
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EP Sector M&A Activity
Company Pro
of
of
Co
nce
pt
Pro
toty
pe
Clin
ical
Dat
a
CE
Mar
k
FDA
Sale
s Acquirer/
Investor Valuation
Abbott/Topera
(Closing Q4-14 )• • • • • Abbott
$250M+ milestone $$
Q4-14 Deal
Bard EPDivision of CR Bard • • • • • • Boston Scientific
$275M2013 Deal
Rhythmia MedicalFormed 2004 • • • Boston Scientific
$265M2012 Deal
Ablation FrontiersFormed 2004 • • • • Medtronic
$225M+2009 Deal
EP MedsystemsFormed 1993 • • • • • St. Jude
$92.1M2008 Deal
CryocathFormed 1995 • • • • • Medtronic
$380M2008 Deal
Endocardial SolutionsFormed 1992 • • • St. Jude
$272M2005 Deal
Prucka EngineeringFormed 1988 • • • • • GE
Undisclosed1999
BioSig TechnologiesFormed 2009 • • •
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Proven Management Team & Board
Gregory D. CashPresident, CEO and Director
Former Pres: Argent International, NeuroTherm, Heartsine Tech, Vasomedical, Datascope, Eminent Tech; Mgmt: U.S. Surgical, Boston Scientific, Medtronic
Kenneth L. Londoner, MBACo-Founder, Executive Chairman/Director
Principal: Endicott Mgmt Partners, J & W Seligman & Co; Director: Alliqua, Red Coat Capital Management
Steve Chaussy, CPAChief Financial Officer
CFO; Liberski Inc, Anna & Co, Penske Truck Leasing, Ford Hogg and Cobbe
Jay O. Millerhagen, MS, MBAVP, 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 McLaughlinVP Corporate Finance, Investor Relations
President & COO: Ridgeback Capital,; Head of Trading: Sigma Capital; Front Office Capital Market Positions: SAC Capital & theinvestment bank, JP Morgan & Co.
Michele Chin-Purcell, PhDVP Quality & Regulatory Affairs
Sr. Dir RA: Spinal Modulation; Sr. Dir RA: St Jude Medical: Guidant/Boston Scientific: QA/RA/Compliance
Outside Directors:Roy T. Tanaka
Former Pres: J&J; Dir: TomoTherapy, Volcano Corp, Advanced Cardiac Therapeutics, VytronUS, Coherex Medical
Jerome B. Zeldis, MD, PhD Current CEO of Celgene Global Health & Chief Medical Officer of Celgene Corporation
Asher Holzer, PhD Founder: InspireMD; Mgr: CARTO System, Biosense
Jonathan Steinhouse VP Sales: Oracle, Sandlot Solutions, Orange MZI Healthcare currently
Patrick J. Gallagher Mg Dir: Laidlaw; Kinex Pharma; Dir: Cingulate Therapeutics, BDR Research Group, GC Capital Partners, Kidder Peabody
Jeffrey F. O’Donnell, Sr.Current CEO, Chair: Trice Medical; Current Chair: Mela Sciences; Founder: Embrella Cardiovascular (sold to Edwards Lifesciences); CEO: PhotoMedex, Radiance Medical (Cardiovascular Dynamics), Kensey Nash; Sales/Mktg Mngt: Boston Scientific, Guidant, J&J; Former Director: Cardiac Science, Endologix
Seth H. Z. Fischer Current CEO & Dir: Vivus, Inc; Former WW Chairman: J&J, Cardiovascular
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Animal Studies at Mayo Clinic and UCLA Cardiac Arrhythmia Center
Commence Additional Research Studies
Submit FDA 510(k) Application Q4-15
Continue to Build Intellectual Property Portfolio
Uplist to National Exchange in 2015
Prepare for Commercialization
BioSig’s Key 12-Month Milestones
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Milestones & Timelines
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Financing History
Founders: 2009-2010
Friends & Family: Mar 2011 $150K $7M PMV*
Series A Preferred: June 2011 $1M $15M PMV
Series B Preferred: April 2012 $1M $17.5M PMV
Series C Preferred: July 2013 $2.78M $20M PMV
Common: April 2014 $1.37M $36 - $38M PMV
Common: Sept 2014 $1M $51M PMV
Common: Mar 2015 $4M $60M PMV
No Debt
Consistent Management & Board Participation in Financings
*PMV = Pre-Money Valuation
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Proven Management Team & Board of Directors
World-Class Medical Advisory Board
EP Devices: $3B Total Addressable Market, 12.1% CAGR
Large Cardiac Arrhythmia Patient Population; Ablations Grow 10%+
Increasing Demand for New EP Technologies to Address:
Complex Ablation Treatments
High Costs, with Higher Patient Throughput, Shorter Procedure Times
Unacceptably High Recurrence Rates (31% - 46%)
High-Growth Sector Earns Innovation Premium, Aggressive M&A
BioSig Investment Highlights
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Gregory CashPresident & Chief Executive Officer
(612) [email protected]
Ken LondonerCo-Founder, Executive Chairman
(203) 644-5200 [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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PURE EP proof of concept system during UCLA validation studies.
BioSig Technologies Profile
BioSig Technologies, Inc. has developeda next-generation Electrophysiology (EP)Information System – PURE EP™ System.
The PURE EP System acquires and displays highfidelity intracardiac (IC) & electrocardiogram (ECG)signals.
PURE EP assists electrophysiologists in makingclinical decisions during cardiac catheter ablation inreal-time by providing information that BioSigbelieves is not always obtainable from any otherequipment presently used in EP labs.
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Why are EP Signals Critical?
Quality Cardiac Signal Recordings ⇒
Assist in Better Clinical Decision Making
Strong demand for clear, accurate and real-time diagnostic data
Signal noise in EP labs may lead to inefficient procedures
Certain arrhythmia ablation procedures currently performed by only limited number of centers due to complexities
During EP procedures, catheters are placed on cardiac tissue to record signals and apply energy to
destroy abnormal electrical pathways