NASDAQ: BSGM

BioSig Technologies, Inc. (NASDAQ: BSGM) is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace. With the global EP market projected to reach $16B in 2028 with a 11.2% growth rate, BioSig has commenced a targeted commercial release of its PURE EP™ System, generating its first commercial sale in December 2020. The Company's first product The PURE EP System is an FDA 510(k) cleared non-invasive class II device that aims to enhance physician workflow and increase procedural efficiency and efficacy in cardiac electrophysiology. To date, physicians have completed more than 2,500 patient cases with the PURE EP System.

The PURE EP™ System received FDA 510(k) clearance in August 2018. Systems are installed at multiple locations, including Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Mayo Clinic's Florida, Minnesota and Arizona campuses, and

more recently at Cleveland Clinic.

Global Market Insights Inc. March 08, 2022.

PURE EP™ System

Key Growth Drivers

  1. Advanced Technology - The non-invasive PURE EP™ System is a novel signal processing and acquisition platform designed to extract advanced diagnostic and therapeutic data that enhances physician workflow and increases throughput. PURE EP™ is a computerized delivers superior intracardiac signals for real-time clinical analysis during a catheter ablation- the minimally invasive procedure that treats cardiac arrhythmia. The technology was engineered to address the limitations of existing electrophysiology (EP) technologies by empowering physicians with superior signals and actionable insights.
  2. Market Opportunity - global electrophysiology market is expected to exceed more than US $16 billion by 2028 and is growing at a compound annual growth rate (CAGR) of 11.2%. The Company also operates within the rapidly emerging field of bioelectronic medicine, estimated at $25.11 billion in 2020 with projected annual growth of 10.27%.
  3. KOL Support - PURE EP has been used and valued by many of the industry's leading electrophysiology physicians, including Dr. Andrea Natale of Texas Cardiac Arrhythmia Institute, and Dr. G. Joseph Gallinghouse. The Company achieved proof of concept validation through UCLA, and has performed numerous pre-clinical studies at Mayo Clinic, MN under the leadership of Samuel J. Asirvatham, M.D., Mayo Clinic's Vice-Chair of Innovation and Medical Director, Electrophysiology Laboratory.

Market Snapshot

NASDAQ: BSGM

Price

$0.70

(10/12/22)

Average

Volume

322,903

(30 day)

52-Wk. Range

$0.50-

$4.10

Float

40.3M

Shares

44.9M

Outstanding

Market Cap

$31.4 M

Recent Highlights

  • Signed Purchase Agreement with San Antonio Methodist Hospital
  • Signed Purchase Agreement with Kansas City Rhythm Institute at Overland Park Medical Center
  • Signed Master Agreement with Hospital Corporation of America (HCA)
  • Announced Evaluation Agreement with Cleveland Clinic
  • Surpassed 2,500 procedures
  • Announced 49 allowed/ issued design and utility patents
  • Appointed Gray Fleming as Chief Commercial Officer & John Sieckhaus as Chief Operating Officer
  • Clinical data acquired by PURE EP™ published in the Journal of Cardiovascular Electrophysiology
  • Commenced Physician-Initiated Research Protocol at Kansas City Heart Rhythm Institute
  • Selected Plexus Corp. as its manufacturing partner

BioSig Technologies, Inc.

Contact:

Kenneth L. Londoner, CEO

Phone: (203) 409-5444 x119 klondoner@biosigtech.com

Investor Relations

Andrew Ballou

Phone: (203) 409-5444, x133 aballou@biosigtech.com

NASDAQ: BSGM

PURE EP System

Proprietary Hardware and Software with Advanced Signal Processing Capabilities:

  • To Improve Signal Clarity Through Reduction of 'Noise' and Artifacts
  • To Minimize Need for Repeat Procedures
  • To Preserve Important Clinical Information
  • To Improve Workflow
  • To Increase Confidence in Performing
    Complex Ablations
  • Customizable user control interface for a better understanding of ECG and intracardiac signals

Projected Global EP Market-11.2% Growth reaching $16B by 2028

  • Global Ablation Procedure Growth: 8.4% growth rate, from 973,220 in 2017 to 1.45 projected million in 2022.
  • Complex Ablation Procedures: 440,629 in 2017 to 830,390 in 2022; 13.5% projected growth rate
  • Estimated 3,425 EP rooms in US; 3,915 EP rooms OUS

Collaborating with Leading EPs from:

Investment Catalysts

Proven Team

BioSig is operated by a proven management team and a premier Board of Directors with high levels of inside equity ownership.

BioSig brought together leading physicians, executives and engineering experts from leading medical centers of excellence, healthcare programs, Fortune 500 Companies and elite educational institutions for its Advisory Board including Mayo Clinic, Mount Sinai Medical Center, UCLA, Johnson & Johnson, Nasdaq and Prudential Securities.

Kenneth L. Londoner, Chairman & CEO, has a wealth of knowledge and experience that spans many decades and includes founding, running, and serving as Director to a number of life science companies. Mr. Londoner began his career with J. & W. Seligman & Co., Inc., a leading institutional money management firm where he rose from research analyst to managing $3.5 billion in mutual funds, pension funds, and international assets.

Steve Chaussy, CFO has acted as a consultant for small publicly traded entities with a special emphasis towards SEC reporting and compliance; and served as CFO for a large private distribution and wholesaling company, where he gained international experience.

Investment Highlights

  • World class commercial team
  • Achieved first revenues
  • Conducted First Clinical Trial with PURE EP™
    System
  • Significant Insider Ownership
  • 10-yearStrategic Collaboration with Mayo Clinic
  • IP Strategy Led by Sherpa Technology Group and Sterne Kessler Goldstein & Fox. - 49 allowed/issued design and utility patents
  • FDA clearance achieved
  • Proven Management Team and Board of Directors
  • Global and Growing Addressable Market
  • Operates Within Rapidly Emerging Field of
    Bioelectronic Medicine
  • High-GrowthSector Earns Innovation
    Premium, Aggressive M&A

Current Cardiac Arrhythmia Epidemic (1 in 18 or 14.4M Americans)

Two of the most prevalent , complex and potentially deadly types of arrhythmias today are Atrial Fibrillation (AF) and Ventricular Tachycardia (VT). Ventricular arrhythmias account for

approximately 300,000 sudden deaths per year

in the United States alone. Catheter ablation is fast becoming a first line therapy, driving demand for improved technologies. AF is the most common arrhythmia affecting 33.5 million people worldwide, with as many as 6.1 million people in the U.S. now and expected 8-12 million by 2050. AF increases the risk of stroke 4x to 5x and contributes to ~750,000 hospitalizations per year. The direct cost of AF is approximately $6B annually; adding other indirect costs brings

AF total cost to $26B.

Management and Past Experience

Directors

Kenneth L. Londoner, MBA, Founder,

Donald E. Foley, Director - Former CEO & Chair: Wilmington Trust; Sr VP, Treas & Dir:

ITT Corp; Asst Treas: International Paper Co.

Chairman, Chief Executive Officer, Director

David Weild IV, MBA, Director - Current Chairman & CEO; Weild & Co.; Former Vice

Endicott Management Partners; J & W Seligman & Co; Director: Alliqua

Chairman: NASDAQ; Former Head of Corporate Finance & Equity Markets: Prudential Securities

Steve Chaussy, CPA, Chief Financial Officer

Patrick J. Gallagher, MBA, Director - Mg Dir: Laidlaw & Co.; Kinex Pharmaceuticals;

Liberski Inc; Anna & Co; Penske Truck Leasing, Ford, Hogg & Cobbe

Director: Cingulate Therapeutics, BDR Research Group, GC Capital Partners, Kidder Peabody

Gray Fleming, Chief Commercial Officer

Frederick D. Hrkac, Director - 30+ years of industry experience including Europe, Middle

East & Africa President of Boston Scientific; Executive: Johnson & Johnson, Biosense Webster

St. Jude Medical; Abbott Laboratories

James Klein, Director - Former President of Infrastructure and Defense Products, Qorvo,

John Sieckhaus, Chief Operating Officer

where he was focused on bringing innovative RF technology to the medical testing market

St. Jude Medical; Abbott Laboratories

James J. Barry, Director - Principal Owner; Convergent Biomedical Group LLC; former

Andrew Ballou, VP, Investor Relations

President and CEO; InspireMD, Inc.; former SVP of Corporate Technology at Boston Scientific

Janney Montgomery Scott LLC., RBC Capital Markets

Analyst Coverage: Laidlaw & Co (UK) Ltd., Trickle Research,

Brenda Castrodad, VP, Human Resources

Intro-act and Noble Capital Markets., Taglich Brothers

TissueTech, Inc., HeartWare Inc.

Katie Freshwater, VP, Marketing

Disclaimer: This Corporate Summary Sheet includes forward-looking statements. Statements contained in this

release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that

Cardinal Health, Medtronic, Kimberly-Clark Healthcare

forward-looking statements are inherently uncertain. Actual performance and results may differ materially from

Olivier Chaudoir, Sr. Director of Marketing

that projected or suggested herein due to certain risks and uncertainties including, without limitation, ability to

obtain financing, regulatory approvals, competition and marketplace demand. More information, and BioSig risk

Biosense Webster, DePuy Synthes

factors, are set forth in its filings with the SEC. BioSig assumes no obligation to publicly update or revise its

forward-looking statements. Data Sources: 2018 MD&D report, Worldwide Epidemiology of Atrial Fibrillation in

Zachary Koch, CCDS, CEPS, Clinical Director

the journal Circulation, 2013; CDC Fact Sheet on Atrial Fibrillation; American Heart Association; Ventricular

Abbott, St. Jude Medical

Tachycardia in Medscape, December 2017; "Healthcare Costs Drop Sharply after Successful Ablation," Marlene

Busko, Medscape, May 4, 2016 , and Biolelectronic Medicine 2019-2029. IDTechEx Research. *As reported in

the 09/30/21 form 10Q filed on November 15th, 2021.

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Disclaimer

Biosig Technologies Inc. published this content on 14 October 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 November 2022 09:46:07 UTC.