BioSig Technologies Announces Results of Independent Product Assessment Study for PURE EP System
Data will be used in commercial strategy and planning for 2018 launch
Minneapolis, MN, Oct. 26, 2017 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing a proprietary platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company has concluded a key part of the strategic planning project launched earlier this year in collaboration with Health Research International (HRI).
Project goals included understanding and presenting the clinical relevance of BioSig’s technology, pricing strategies, and envisioning optimal applications of BioSig’s platform technology beyond EP.
As part of the study, HRI conducted a detailed survey of U.S. electrophysiologists primarily based in New York, Texas, Massachusetts, Florida, Pennsylvania, and North Carolina. Among the factors interfering with effective ablations, the inability to record high quality unipolar signals and difficulty detecting small intracardiac signals were consistently reported.
Survey respondents rated all six features listed of the PURE EP System as being ‘Very Helpful’ for their ablations, emphasizing overall noise reduction and improved signal clarity/accuracy as key benefits. Most respondents see signal clarity as paramount to the success of ablations and indicated interest in a technology that reduces ‘noise’.
PURE EP System’s ability to shorten procedure time - including the ability to perform more complex ablations - was listed as its definitive economic benefit. These expected time savings were largely responsible for the attractive pricing recommended for PURE EP System.
“The two key factors impacting the successful adoption of a new technology are that it address an unmet need, and that its ability to fill that need is fairly easily understood. According to our survey results, PURE EP System meets both criteria. The unmet need is interference with the signals that drive complex EP ablation procedures; the solution is PURE EP’s ability to eliminate most ‘noise’ and waveform interference, thereby enhancing signal breadth and clarity, and reducing the time required to perform these procedures,” commented Suzanne Ratzloff, President of Health Research International, about the survey results.
“We are pleased with the results this study has delivered. Having seen the impact that Health Research International has had on product launches for many established companies in our sector, we knew we were working with a gold standard in strategic planning and market forecasting. We have seen a consistent response amongst the EP community, which has confirmed our expectations for the clinical relevance of PURE EP System. Furthermore, we have seen that the assessment of PURE EP features increased with the size of the respondent’s complex ablations caseload, suggesting a greater appreciation of PURE EP among busier EP labs. This is an excellent outcome during this pivotal point in our Company’s business development,” said Kenneth Londoner, Chairman & Chief Executive Officer of BioSig Technologies, Inc.
Health Research International is a “boutique” medical market research and business development firm with more than 30 years of experience addressing the needs of companies ranging from small start-ups to the largest medical device companies in the world. HRI’s custom consulting services include comprehensive market analyses and forecasts, focus groups, end user surveys and interviews, regulatory and reimbursement analyses, competitive analyses of products and companies, pricing sensitivity studies and econometric market modeling.
About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary technology platform designed to improve the $4.6 billion electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Minneapolis-based BioSig Technologies is preparing to commercialize its PURE EP(TM) System. The technology has been developed to address an unmet need in a large and growing market.
The PURE EP System is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and is working toward FDA 510(k) clearance for the PURE EP System.
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) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our 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.
Contact: Natasha Russkina BioSig Technologies, Inc. VP Business Development & Corporate Finance firstname.lastname@example.org +41 (0) 76 823 7527
Released October 26, 2017