BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing the PURE EP(TM) System, a proprietary platform designed to address an unmet technology need for the $4 billion electrophysiology (EP) marketplace, today provided a shareholder update and highlighted the company’s recent achievements it has reached during the first part of 2017.
BioSig Technologies issued a Shareholder Letter to its investors; a copy of which can be found here.
Highlights:
- As previously announced, BioSig signed a product development collaboration agreement with expert Mayo Clinic cardiac electrophysiologists.
- The Company secured a private placement with proceeds totaling nearly $5 million, with Laidlaw & Co (UK) Ltd. in New York serving as placement agent, and a separate funding with accredited investors.
- Management is currently engaged with regulatory agencies in the U.S. and in Europe to secure clearance to sell the PURE EP System, both internationally and domestically.
- The Company expressed its intent to enter the emerging field of bioelectric medicine.
“We are extremely pleased with the significant trajectory that we have experienced throughout the first quarter of this year,” stated Kenneth Londoner, Executive Chairman of BioSig Technologies Inc. “In addition to bolstering our relationship with Mayo Clinic expert physicians, we have also made significant strides towards commercialization of our unparalleled electrophysiology technology. BioSig’s PURE EP System, continues to generate excitement within the ever-growing electrophysiology marketplace. We anticipate receiving our FDA 510(k) clearance by the end of this year, and look forward to commercialization in 2018.”
Mr. Londoner continued, “Management feels that we are at an inflection point and that now was an ideal time to reach out to our loyal shareholder base. Going forward, we expect to forge additional relationships with industry leaders, actively target new customers and develop cutting-edge medical devices to capitalize on the evolving med tech space.”
About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary technology platform designed to improve the $4 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.
Data from the 2016 HRI Global Opportunities in Medical Devices & Diagnostics report shows the global Electrophysiology (EP) market revenues is expected to grow nearly 10% annually, from currently $4 billion to approximately $6 billion by 2020 with accompanying procedure growth close to 10% annually, from 865,000 patients in 2015 to 1,350,000 in 2020.
BioSig has partnered with Minnetronix on technology development and is working toward FDA 510(k) clearance and CE Mark for the PURE EP System.
Mayo Clinic has a financial interest in the technology referenced in this news release.
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) 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 web site 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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