biosig technologies corporate presentation - may 2015

23

Upload: greg-cash

Post on 13-Aug-2015

77 views

Category:

Documents


2 download

TRANSCRIPT

Page 1: BioSig Technologies Corporate Presentation - May 2015
Page 2: BioSig Technologies Corporate Presentation - May 2015

2

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

Page 3: BioSig Technologies Corporate Presentation - May 2015

3

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

Page 4: BioSig Technologies Corporate Presentation - May 2015

4

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

Page 5: BioSig Technologies Corporate Presentation - May 2015

5

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

Page 6: BioSig Technologies Corporate Presentation - May 2015

6

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

Page 7: BioSig Technologies Corporate Presentation - May 2015

7

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.

Page 8: BioSig Technologies Corporate Presentation - May 2015

8

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

Page 9: BioSig Technologies Corporate Presentation - May 2015

9

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

Page 10: BioSig Technologies Corporate Presentation - May 2015

10

Current PURE EP System Prototype

PURE EP System Prototype connected to an ECG/IC Simulator

Page 11: BioSig Technologies Corporate Presentation - May 2015

11

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

Page 12: BioSig Technologies Corporate Presentation - May 2015

12

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

Page 13: BioSig Technologies Corporate Presentation - May 2015

13

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

Page 14: BioSig Technologies Corporate Presentation - May 2015

14

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

Page 15: BioSig Technologies Corporate Presentation - May 2015

15

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 • • •

Page 16: BioSig Technologies Corporate Presentation - May 2015

16

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

Page 17: BioSig Technologies Corporate Presentation - May 2015

17

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

Page 18: BioSig Technologies Corporate Presentation - May 2015

18

Milestones & Timelines

Page 19: BioSig Technologies Corporate Presentation - May 2015

19

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

Page 20: BioSig Technologies Corporate Presentation - May 2015

20

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

Page 21: BioSig Technologies Corporate Presentation - May 2015

21

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

Page 22: BioSig Technologies Corporate Presentation - May 2015

22

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.

Page 23: BioSig Technologies Corporate Presentation - May 2015

23

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