BioSig Advances its PURE™ System Commercial Launch to Medical Centers Nationwide

Rhea-AI Summary

BioSig Technologies (NASDAQ: BSGM) announced its national commercial launch of the PURE EP™ System, set for July 1, 2022. The company has over 30 advanced leads at Medical Centers of Excellence and has streamlined product evaluations from 180-360 days to just 60 days. The PURE EP™ System, a non-invasive class II device, enhances cardiac electrophysiology with significant clinical backing: over 2,200 patient cases and a 75% improvement in signal quality. BioSig's efforts are led by Chief Commercial Officer Gray Fleming, with a partnership established to facilitate financing options for prospective buyers.

Positive

• Over 30 advanced leads at Medical Centers of Excellence.
• Streamlined product evaluations from 180-360 days to 60 days.
• More than 2,200 patient cases completed with PURE EP™ System.
• Study shows 93% consensus on improved intracardiac signal quality.

Negative

• None.

Westport, CT, May 26, 2022 (GLOBE NEWSWIRE) --

• Commercial pipeline to include 30 advanced leads at Medical Centers of Excellence

• Company’s development and operational infrastructure will be on track to support anticipated sales growth following commercial rollout on July 1, 2022

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company advancing electrophysiology workflow by delivering greater intracardiac signal fidelity through its proprietary signal processing platform, today announced the rollout of the Company’s national commercial launch campaign.

Under the leadership of its Chief Commercial Officer Gray Fleming, BioSig has implemented several important initiatives to accelerate the transition from its limited market release to a national launch of its PURE EP(TM) System. The Company currently has over 30 qualified leads ahead of its official commercial kick-off, expected to commence on July 1, 2022. The PURE EP(TM) is an FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. To date, more than 73 physicians have completed over 2,200 patient cases with the PURE EP(TM) System.

Commercial strategy highlights include:

• Business agreement with Summit Blue Capital to implement a leasing and finance program for the PURE EP(TM) System. The agreement aims to expedite the pathway to purchase and increase the of scope PURE EP(TM) adopters across the U.S.

• Streamlined product evaluations from 180-360 days to 60 days with a succinct clinical and economic value proposition that showcases the advantages of the technology and accelerates adoption.   

• Strengthened management, commercial, clinical, and marketing teams under the leadership of Gray Fleming, Chief Commercial Officer, who spent 18 years with St. Jude Medical/Abbott.

• Restructured clinical support and installation teams in preparation for increased commercial activity. The Company’s new commercial structure includes national account directors covering five regions in the United States to support product evaluations and the rapid transformation of qualified leads into sales.

• Implemented an effective CRM system and pipeline management system to support sales opportunities and streamline data and customer engagements.

• Company to implement new brand strategy and marketing programs to reflect business growth and evolution. These efforts include an updated website and new visual content and branding.

“As a Company we have worked tirelessly to reach this point to commercially roll out our PURE(TM) System nationwide. We have put the right people in place and have executed on a strategy to see this come to fruition. We believe July 2022 will be a major milestone for our Company and we look forward to collaborating with our new medical centers that recognize the invaluable benefits of Pure EP(TM) for their patients,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

Clinical data acquired by the PURE EP(TM) System in a multi-center study at centers of excellence including Texas Cardiac Arrhythmia Institute at St. David’s Medical Center and Mayo Clinic was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP™ signals over conventional sources.

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, PURE EP™ System, is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing 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.

FAQ

What is the significance of the BioSig Technologies press release dated May 26, 2022?

The press release marks the announcement of the national commercial launch of the PURE EP™ System on July 1, 2022.

How many patient cases have been completed with the PURE EP™ System?

Over 2,200 patient cases have been completed with the PURE EP™ System.

What improvements were noted in the clinical study of the PURE EP™ System?

The study showed a 75% overall improvement in intracardiac signal quality.

Who is leading the commercial strategy for BioSig Technologies?

Gray Fleming, the Chief Commercial Officer, is leading the commercial strategy.

What is the expected impact of the partnership with Summit Blue Capital?

The partnership aims to implement a leasing and finance program to expedite purchasing of the PURE EP™ System.