Corporate Presentation June 2017 - Amazon S3 Corp… · This presentation contains forward-looking...
Transcript of Corporate Presentation June 2017 - Amazon S3 Corp… · This presentation contains forward-looking...
Corporate Presentation June 2017
Symbol: BSGM
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.
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
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
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
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
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
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
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
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
Current EP Recording Devices
Symbol: BSGM 11
~$1 BILLION Installed Base CardioLab
50%
Lab Systems Pro15%
EP Workmate35%
Today’s Technology Needs Improvement
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
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
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
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
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
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.
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.
EP Sector M&A Activity
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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
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
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
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.
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
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
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
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