BioSig Completes 1000 Patient Cases with its Signal Processing System for Electrophysiology

Rhea-AI Summary

BioSig Technologies, Inc. (NASDAQ: BSGM) has surpassed its initial target of conducting 1000 patient cases with its PURE EP™ System, achieving this milestone at nine installation sites. The Company has raised its procedural volume goal to at least 1500 by the end of 2021, driven by increased technology adoption in electrophysiology. BioSig's expansion includes enhancing its commercial team and targeting key regions: the Northeast, Texas, and Florida. The ongoing rise in technology use signals a recovery from pandemic-related challenges, potentially positioning BioSig for strong performance in the latter half of 2021.

Positive

• Surpassed initial target of 1000 patient cases with the PURE EP System.
• Increased procedural volume goal to at least 1500 by end of 2021.
• Expansion of the commercial team to enhance regional sales efforts.
• Growth in technology usage indicates recovery post-pandemic.

Negative

• None.

Westport, CT, June 30, 2021 (GLOBE NEWSWIRE) --

• The Company recently increased its procedural volume targets due to accelerated technology usage
• BioSig expands its commercial team to target technology adoption across three strategic regions

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that physicians have completed 1000 patient cases with its technology across nine installation sites.

BioSig’s non-invasive computerized technology, the PURE EP(tm) System, aims to drive procedural efficiency and efficacy in electrophysiology. The system provides essential diagnostic signals with high clinical value in all cardiac ablations that treat irregular heartbeats or arrhythmias.

Previously the Company increased the patient case goal from 1000 to at least 1500 procedures by the end of 2021, having delivered 425 procedures at the end of 2020. The Company is currently conducting patient cases in nine medical centers across the country. Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, TX, Mayo Clinic Florida Campus, the Company’s first commercial customers, and the University of Pennsylvania count among the most prominent technology users with over 600 patient cases conducted to date¹.

“We are thrilled to cross the 1000-case milestone, a figure that was our initial target for the entire 2021. Most importantly, this case growth allows us to collect vast amounts of clinical data daily, providing us with immense intelligence that is vital for our clinical and commercial strategy. Increased technology usage in elective procedures is a much-awaited sign of the steady pandemic recovery in our country, and we are looking forward to a strong second half of 2021,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

The Company is in the targeted commercial launch phase, focusing on expanding its clinical footprint across the Northeast, Texas, and Florida, the three regions that account for the largest electrophysiology programs in the country. The Company recently expanded its commercial team by appointing Mr. Walt Quinn to lead regional sales in Florida. Mr. Quinn brings to the Company over 25 years of medical device and capital equipment sales experience in some of the leading companies in the field, including Ethicon (a Johnson&Johnson company), Medtronic, Topera (an Abbott company), and CardioFocus.

The Company will be exhibiting at the annual Heart Rhythm 2021 convention on July 28-31, 2021, at the Boston Convention and Exhibition Center in Boston, MA. BioSig’s executive leadership, clinical, commercial, and engineering teams will host a series of presentations that will showcase the latest clinical data and demonstrate the newest software features of its PURE EP(tm) System.

One in 18 Americans suffers from cardiac arrhythmia. Atrial fibrillation is the most common arrhythmia type, affecting over 33 million people worldwide, including over 6 million in the U.S. The number of people suffering from atrial fibrillation is expected to reach 8-12 million by 2050.² According to the Centers for Disease Control and Prevention (CDC), atrial fibrillation causes more than 750,000 hospitalizations in the U.S. each year, resulting in approximately $6 billion in healthcare spending annually³.

About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, the PURE EP(tm) System, is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 

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¹ Data as of June 24, 2021.

² Top 10 Things You should Know About Heart Rhythm; Scripps Health.

³ Managing Atrial Fibrillation; Lisa Eramom MA, Medical Economics Journal, February 25, 2019, Volume 96, Issue 4

FAQ

What recent milestone did BioSig Technologies achieve regarding its PURE EP System?

BioSig Technologies recently surpassed its initial target of 1000 patient cases, reaching this milestone with its PURE EP System.

What is BioSig's new procedural volume target for 2021?

BioSig has increased its procedural volume target to at least 1500 cases by the end of 2021.

Which regions is BioSig focusing on for commercial expansion?

BioSig is targeting the Northeast, Texas, and Florida for its commercial expansion efforts.

How many procedures has BioSig conducted as of now?

BioSig has conducted over 1000 patient cases with its technology.

Who has BioSig appointed to lead regional sales in Florida?

BioSig appointed Walt Quinn to lead its regional sales efforts in Florida.