Corporate Presentation June 2017 - Amazon S3 Corp… · This presentation contains forward-looking...

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Corporate Presentation June 2017 Symbol: BSGM

Transcript of Corporate Presentation June 2017 - Amazon S3 Corp… · This presentation contains forward-looking...

Page 1: Corporate Presentation June 2017 - Amazon S3 Corp… · This presentation contains forward-looking statementsincluding statementsthat addressactivities, ... competition from existing

Corporate Presentation June 2017

Symbol: BSGM

Page 2: Corporate Presentation June 2017 - Amazon S3 Corp… · This presentation contains forward-looking statementsincluding statementsthat addressactivities, ... competition from existing

Disclaimer

Symbol: BSGM 2

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 and operators in the use of its products, the timing of andability to obtain reimbursement if required of procedures utilizing BioSig’s products and the potential impact of currenthealthcare reform initiatives thereon, competition from existing and new products and procedures or BioSig’s ability toeffectively react to other risks and uncertainties described from time to time in BioSig’s SEC filings, such as fluctuation offinancial results, reliance on third party manufacturers and suppliers, litigation or other proceedings, 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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RhythmiaMedical

$272

m

illio

n

$275

m

illio

n

$331

mill

ion

$350

mill

ion

$410

mill

ion

CardioInsight

Bard

Endosense

ToperaMedical

Premiums for Electrophysiology (EP) Tech

BioSig & Mayo Clinic - 10 Year Collaboration Signed 3/15/17

Symbol: BSGM 3

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Upcoming Major Company Milestones

Symbol: BSGM4

2017 Q1 Q2 Q3 Q4

FDA 510(k)

UPLIST TO NASDAQ

PEER REVIEWED PUBLICATIONS

ON-GOING TRIALS

INDUSTRY SYMPOSIA

NEW PATENT APPLICATIONS

Engineering Journal – 1H 2017Cardiology Journal – 1H 2017

Mayo – Advanced Research InitiativeMount Sinai – VT Scar Model UCLA – Advanced VT Mapping

EHRA-CARDIOSTIM – June 18-21, 2017

Visualization Tools Recording EP Procedures

Submission3Q17

Clearance4Q17

Uplist to NASDAQ

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BioSig Investment Highlights

Symbol: BSGM 5

• $4B+ EP Market Growing 10% Annually

• Aggressive M&A Activity ⇒ High Growth Sector

• Plan to Uplist to NASDAQ; Potential Dual Listing in EU

• FDA 510(k) Submission 3Q17 ⇒ Expected FDA Clearance 4Q17

• World-Class Mgmt, Board of Directors, Scientific Advisory Board

• Long Term Collaboration with Mayo Clinic

Page 6: Corporate Presentation June 2017 - Amazon S3 Corp… · This presentation contains forward-looking statementsincluding statementsthat addressactivities, ... competition from existing

The Problem Unreliable Information

Symbol: BSGM 6

MRI CT Scan Robotic Surgical System

Equipment in EP Lab Making Noise

Ablation Generator

Electrical noiseobscures needed

information

EP Lab For Cardiac Ablation Procedures

Mapping System

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BioSig’s PURE EP™ System vs. Current Technology

Symbol: BSGM 7

Micro-ComponentsRevealed

Conventional Recorder in BluePURE EP™ System in Red

Noisy Signal Noisy

Signal

Low Amplitude Signals Revealed

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8

• Proprietary Hardware and Software

• New Information for the Physician

• Targeted Commercial Launch 2018

• European Commercial Launch 2019

• Potential Reduction in Costs for Hospitals

Symbol: BSGM

The Solution: BioSig’s Technology

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Need for Technological Innovation

Symbol: BSGM 9

The FDA at the Heart Rhythm Society 2017

This slide was presented by the head of the FDA for EP at a presentation led by Dr. Andrea Natale (BioSig’s Scientific Advisory Board Chairman):

Need for Technological Innovations in AF Ablation

• The growing burden of AF has far-reaching public health implications.

• Catheter ablation is being widely performed for the treatment of symptomatic drug refractory AF. However, the outcomes of AF ablation are still suboptimal.

• Technological innovations are warranted to improve safety, effectiveness and procedural efficiency.

www.fda.gov

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Driver: Ablation Becoming First Line of Therapy

Large & Fast Growing Market

Symbol: BSGM 10

EP Labs: Estimated 4,500 WW; 3,000 in US In US by 2020: Expected 422,000 Procedures; Over $3B in Revenues

EP Devices

$4.0

$6.0

$-

$2.0

$4.0

$6.0

$8.0

2016 2020

Current EP Market is >$4B Worldwide$

in B

illio

nsProcedure Growth

865,000

1,350,000

-

500,000

1,000,000

1,500,000

2015 2020

Proc

edur

es

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Current EP Recording Devices

Symbol: BSGM 11

~$1 BILLION Installed Base CardioLab

50%

Lab Systems Pro15%

EP Workmate35%

Today’s Technology Needs Improvement

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Symbol: BSGM 12

PURE EP System Testimonial"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 arealso 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."Samuel J. Asirvatham,

M.D. Mayo ClinicLink to MD&DI Article: Cutting Out the Noise to Target Arrhythmias

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PURE EP – Development Path Collaborating with Leading Centers

Symbol: BSGM 13

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

July 2016 -Present

Advanced Research Program

at Mayo Clinic

Other Collaborations

Brigham And Women’s Hospital in Boston

June 2016 -Present

Pre-Clinical Studies at Mt

Sinai in NY

UH Case Medical Center in Cleveland

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Presentations and Manuscripts from Pre-Clinical Studies

Symbol: BSGM 14

Enhanced Electrophysiology Recording Improves Signal Acquisition and Differentiation Presentation by the team from Mayo Clinic at the 13th Annual International Dead Sea Symposium (IDSS) in Tel-Aviv and

available online, March 2016

Enhanced Electrophysiology Recording System Poster presented at 38th Annual International Conference EMBC 2016, August 2016

Novel Electrophysiology Signal Recording System Enables Specific Visualization of the Purkinje Network and Other High-Frequency Signals

JACC: Clinical Electrophysiology, Volume 2, Issue 7, Page 850, December 2016

Use of Terminal Unipolar Electrogram Current of Injury as a Novel Marker to Estimate Contact: An Acute Canine StudyPoster Presentation at HRS 38th Annual Scientific Sessions May 2017 in Chicago

Initial Experience with the BioSig PURE EP™ Signal Recording System: An Animal Laboratory ExperiencePublication in The Journal of Innovations in Cardiac Rhythm Management, 8 (2017), 2690-2699 April 2017 issue

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Unique Collaboration with Mayo

Symbol: BSGM 15

• 10-Year Agreement • Technology & Clinical Development

• PURE EP Version 2.0 • PURE EP Version 3.0

• Joint Intellectual Property Filings• Licensing Opportunities• Investment

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Symbol: BSGM 16

World-Class Scientific Advisory Board

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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Symbol: BSGM 17

Board of DirectorsKenneth L. Londoner, MBA Founder, Executive Chairman, CEO, Director; Endicott Management Partners, J & W Seligman & Co

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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Proven Management Team

Symbol: BSGM 18

Kenneth L. Londoner, MBA

Founder, Executive Chairman, CEO, Director; Endicott Management Partners, LLC, J & W Seligman & Co

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

Natasha Russkina Managing Director, Europe; Founder: Augeous Consulting SPGeneva, Switzerland; Bus. Dev. Mngr: IG GROUP, Belarus & London

Lora Mikolaitis Co-Founder, Director of Administration; President: Miko Consulting Group, Inc.

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EP Sector M&A Activity

19

Company Proof ofConcept Prototype Clinical

DataCE

Mark FDA Sales Acquirer/Investor Valuation

HeartWare • • • • • • Medtronic $1.1 BillionJune 2016

St. Jude Medical • • • • • • Abbott $25 billionApril 2016

Hansen Medical • • • • • • Auris Surgical Robotics

$80 millionApril 2016

Kalila MedicalFormed 2010 • • • • • • Abbott Undisclosed

Feb 2016nContactFormed 2005 • • • • Atricure $149 million

Oct 2015CardioInsight Formed 2006 • • • • • • Medtronic $272 million

June 2015Topera MedicalFormed 2010 • • • • • Abbott $350 million

Dec 2014Endosense SAFormed 2003 • • • • • St. Jude $331 million

Aug 2013Bard EPDivision of CR Bard • • • • • • Boston Scientific $275 million

Nov 2013Rhythmia MedicalFormed 2004 • • • Boston Scientific $410 million

Oct 2012

Symbol: BSGM

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Symbol: BSGM 20

BioSig Technologies, Inc. (BSGM)

OTCQB: BSGMWWW.BIOSIGTECH.COM

Key Company Data (6/01/17)

Recent price: $1.36

52-week range: $1.05 - $2.00

Primary shares i/o: 25.22 million

Float: 12.2 million

Market cap: $34.3 million

Avg Volume (30 day): 48,327 shares

Page 21: Corporate Presentation June 2017 - Amazon S3 Corp… · This presentation contains forward-looking statementsincluding statementsthat addressactivities, ... competition from existing

BioSig Investment Highlights

Symbol: BSGM 21

• $4B+ EP Market Growing 10% Annually

• Aggressive M&A Activity ⇒ High Growth Sector

• Plan to Up List to NASDAQ; Potential Dual Listing in EU

• FDA 510(k) Submission 3Q17 ⇒ Expected FDA Clearance 4Q17

• World-Class Mgmt, Board of Directors, Scientific Advisory Board

• Long Term Collaboration with Mayo Clinic

Page 22: Corporate Presentation June 2017 - Amazon S3 Corp… · This presentation contains forward-looking statementsincluding statementsthat addressactivities, ... competition from existing

Contact BioSig

Symbol: BSGM 22

Ken LondonerFounder, Executive Chairman, CEO

(203) 644-5200 [email protected]

Lora MikolaitisCo-Founder, Director of Administration

(310) 948-7200 [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 this document asconstituting 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 information including important informationregarding 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.

Page 23: Corporate Presentation June 2017 - Amazon S3 Corp… · This presentation contains forward-looking statementsincluding statementsthat addressactivities, ... competition from existing

BioSig’s Goal: • Improve EP lab

throughput

• Reduce complexity, length & costs of procedures

• Improve outcomes & reduce need for repeated procedures

Symbol: BSGM 23

Catheter Ablation vs. Drug Therapy

Destroys arrhythmic tissue to cure

2-8 hours depending on clinician experience, disease

1-3 procedures typically

Low risk, minimally invasive

Suppresses symptoms, does not cure

Many drugs taken indefinitely

Possible detrimental side effects

Not tolerated by many patients

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Risk of Stroke 4- to 5-fold(5th leading cause of death)

Symbol: BSGM 24

BioSig’s Focus: Complex Arrhythmias

N o r m a l H e a r t R hy t h m At r i a l F i b r i l l a t i o n

Everyone over 40 has a 1 in 4 lifetime risk

Affects > 6M in US

Rapid/irregular heart rate

Expensive due to multiple ablation procedures needed

Sources: CDC, http://www.preventaf-strokecrisis.org/files/files/The%20AF%20Report%2014%20April%202012.pdf

Left AtriumRight Atrium

SA Node

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Improved signals should enable more precise treatments and less procedures

VT – Signals Difficult to Detect

Symbol: BSGM 25

N o r m a l H e a r t R hy t h m Ve n t r i c u l a rTa c hyc a rd i a ( V T )

≈ 450,000 Sudden cardiac deaths in the US annually

Rapid / irregular heartbeat in the ventricles of the heart

Rapidly fatal if not reversed

Can be treated with ablation

Left Ventricle

SA Node

Right Ventricle

Page 26: Corporate Presentation June 2017 - Amazon S3 Corp… · This presentation contains forward-looking statementsincluding statementsthat addressactivities, ... competition from existing

An Electrophysiology (EP) Study tests the electrical conduction system of the heart by recording ECG signals and intracardiac electrograms.

Catheter Ablation is a low-risk procedure to destroy small areas of heart tissue that cause rapid and irregular heartbeats to help restore the heart’s regular rhythm.

Symbol: BSGM 26

PURE EP™ System Pure Signals

For Successful EP Studies and Ablation Treatments…

…it is Critically Dependent on the Recording System to

Faithfully Acquire/Display Multiple, Low Amplitude Signals

Precise Uninterrupted Real-time Evaluations of Electrocardiograms (ECG) & Electrograms