Graham Bonnell
Sidoti Presentation 1 13 2021 Sidoti Winter 2021 Investor Conference
January 13th 14th, 2021
NASDAQ : BSGM
SYMBOL: BSGM
1
Disclaimer
This presentation contains forward-looking statements including statements that address activities, events or developments that 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 procedure projections, financing plans, and related documents. Forward-looking statements are based on BioSig's experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the 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 of products, BioSig's ability to develop and market new and enhanced products, the timing of and ability to obtain and maintain regulatory clearances and approvals for its products and the impact of failure to obtain such clearances and approvals on its ability to promote its products and train doctors and operators in the use of its products, the timing of and ability to obtain reimbursement if required of procedures utilizing BioSig's products and the potential impact of current healthcare reform initiatives thereon, competition from existing and new products and procedures or BioSig's ability to effectively react to 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, government regulation, 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 of new information, future events or otherwise.
SYMBOL: BSGM
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Who We Are NASDAQ: BSGM
· EP Tech Market 13.5% CAGR · Global EP Market Expected to be $12.2 Billion by 2026* · 31 Patents Issued · First Customer is #1 Center by Volume in U.S. · Razor & Blade Business Model · FDA Approved · Unblinding of clinical data in 2021
Data source: MarketWatch Global Electrophysiology Device Market Could Exceed $12.2 Billion By 2026
SYMBOL: BSGM
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PURE EPTM Developed Through Collaboration with Leading Centers
Relationships at leading, high-volume centers create traction for PURE EPTM in the market
2011
2013
2014
2014
2015
Concept developed with Texas Cardiac Arrhythmia Institute
Proof of concept test completed
at UCLA
Prototype test with UCLA
Initial pre-clinical planning
at Mayo Clinic
First pre-clinical trials at Mayo
Clinic
2016
Advanced research at Mayo Clinic,
trials at Mount Sinai
2016
Technology development partnership with Minnetronix
2017
Strategic collaboration with Mayo Clinic, first beta units, pre-FDA testing
2018
FDA 510(k) clearance
2019
First patient cases and first clinical trial
2020
Targeted commercial release of PURE EPTM
System
SYMBOL: BSGM
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Market Opportunity PURE EP TM
Global EP Procedures Growing Rapidly
Cardiac Ablation Procedures Are Key Hospital Revenue Drivers
Complex Cardiac Ablation:
13.5% Growth Rate
U.S.
3,425 EP labs
OUS:
3,915
EP labs
Total Global Addressable Market
$2.0 Billion
Published by Cardiovascular Rounds, Guggenheim Analyst Chris Pasquale Data source: 2018 MD&D report Advisory Board and BioSig Technologies, Inc. estimates.
SYMBOL: BSGM
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EP During COVID-19
EP procedures are clinically urgent
· Delaying procedure increases stroke risk and worsens outcomes
EP procedures are revenue generating
· CV surgery and invasive cardiology have the highest net annual revenue compared to all other service lines
Median Revenues Per Case For Ablation and Select EP Procedures
Inpatient Ablations
$55,825
$23,240
DRG 273 (ablations w/MCC)
$51,512
$19,460
DRG 274 (ablations w/o
MCC)
Outpatient Ablations
$33,417
N/A
APC 5213 (level 3 EP procedures)
Inpatient CV Comparators $20,520
N/A
All inpatient EP
$9,600 N/A
All inpatient CV
Reimbursement rates continue to increase
· From 2019 to 2020 ablations and LAAO (DRG 274) had a reimbursement rate increase of 8.8%
CMS Reimbursement Changes From FY 2019 to FY 2020
Procedure Inpatient All inpatient services Ablations and LAAO (DRG 274) Pacemaker implant (DRG 244) ICD implant (DRG 227) Outpatient All outpatient services Ablations (APC 5213) Pacemaker implant (APC 5223) ICD implant (APC 5232)
Reimbursement Rate Change
2.5% 8.8% 0.9% 0.9%
2.6% 6.3% 3.8% 5.3%
*Data Source: Advisory Board, Published by Cardiovascular Rounds
SYMBOL: BSGM
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PURE EPTM System Customer Installations
Hospital of the University of Pennsylvania
PURE EP TM
Texas Cardiac Arrhythmia Institute
SYMBOL: BSGM
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Challenges in EP For All Procedures
Physicians Can't Fix What They Can't See
Signal Quality
81% of physicians rated signal quality as "Critical"
Success Rate
20 - 40% of ablations are unsuccessful
Data source: PUBMED 11/2017 and Healthwise and the University of Michigan, 12/15/2019.
SYMBOL: BSGM
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Expanded Product Adoption, Experience, and a Growing Database
# PURE EP Procedures by Account
TCAI (TX)
228
Mayo JAX (FL)
91
Penn (PA)
57
MGH (MA)
10
Deborah (NJ)
37
Overland Park (KS) 20
EE 1 cases (4 ctrs) 29
TOTAL
472
*Data as of Jan. 8, 2020 w a lag in some reporting *COVID shutdown Mar 12 - May 3 *Diagnosis was not logged for all procedures
# Physician Users
TCAI
11
Mayo
3
Penn
8
MGH
1
Deborah
2
Overland Park 2
Other EE Ctrs 5
TOTAL
32
Diagnosis
Persistent AF
Paroxysmal AF
PVC Ischemic VT Nonischemic VT
Diagnosis
14 Atypical Flutter 10 3
15 Atrial Tachycardia 7 0
57 AVNRT
7
17 Typical Flutter
8
11 AVRT/WPW
3
2019
1 center 69 procedures
2020
7 centers 425 procedures
2021 >20 centers >1000 procedures
Our Recent PURE EPTM Study - ESC 2020
· A blinded, independent analysis confirmed that the PURE EPTM system's signals are preferred to conventional sources
· In 35.5% of samples, the reviewers selected PURE EPTM data because "more signal components were visible"
· PURE EPTM System produces reliable and high-quality signals when compared to the standard of care systems
More clinical data is expected to be unblinded this year
SYMBOL: BSGM
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Physician Testimonies
"The PURE EP System does provide innovative design with greater resolution and greater bandwidth, which should allow for safer and more efficacious ablations in the future." - K. Venkatachalam, M.D., Cardiac Electrophysiologist, Mayo Clinic
"The quality of the recording that we can get in the lab can make a big difference [during the procedure]. . . The PURE EP System
clearly gave us better quality of intracardiac recording [compared to conventional systems.]"
- Andrea Natale, M.D., Texas Cardiac Arrhythmia Institute
SYMBOL: BSGM
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1
Commercialization Regions and Centers of Excellence
Overland Park Med. Ctr. Kansas City, KS
Memorial Hospital South Bend, IN
Mass. General Hospital Boston, MA
Deborah Heart Center Browns Mills, NJ
University of Pennsylvania Philadelphia, PA
Texas Cardiac Arrhythmia Institute St David's Medical Center Austin, TX
Mayo Clinic Jacksonville, FL
Florida
120 EP Programs 240 Labs
Texas
220 EP Programs 440 Labs
Northeast
175 EP Programs 400 Labs
Source: Industry data and BioSig Technologies, Inc. estimates.
Revenue Potential
$286 Million
SYMBOL: BSGM
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Business Model
Data Sets Modules
Service Agreements
Data source: MarketWatch Global Electrophysiology Device Market Could Exceed $12.2 Billion By 2026
SYMBOL: BSGM
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Value Drivers
· Raised $41 million in 2020 · $32 million in cash on the balance sheet
and no debt · Achieved first commercial contract 4Q20 · Expect to triple the customer base in 2021 · CE mark approval / EU entry Q4 2021 · Sequential revenue growth in 2021
: BSGM
SYMBOL: BSGM
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Management Team
Kenneth L. Londoner, MBA
Founder, Chairman, CEO, Director J & W Seligman & Co.; Endicott Management Partners
Natasha Drapeau
Executive Vice President IG Group Plc
Todd Wiltshire
Senior Vice President, Corporate Development Fidelity Investments
John Kowalski
Vice President, Sales Biosense Webster (Johnson & Johnson)
Manasi Patwardhan
Director of Strategic Planning Medtronic; Boston Scientific; Verily Life Sciences
Steve Chaussy, CPA
CFO Penske Automotive;
Andy Ballou
Vice President, Investor Relations Janney Montgomery Scott; RBC Capital Markets
Barry Keenan, Ph.D, MBA, PMP
Vice President, Engineering Medtronic; Alfred Mann Institute for Biomedical Engineering
Julie Stephenson, BSN, MBA
Vice President, Clinical Affairs Medtronic; Boston Scientific
Olivier Chaudoir
Senior Director, Marketing Biosense Webster, DePuy Synthes (Johnson & Johnson)
SYMBOL: BSGM
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