Santa Monica, CA, Feb. 26, 2019 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the electrophysiology (EP) marketplace, today announced that the Company appointed a Senior R&D Engineer and is working on further senior biomedical engineering hires to support BioSig’s growing manufacturing processes and advanced R&D activities.
Mr. Fui Veavea brings to the Company over 29 years of manufacturing and engineering experience in a range of medical device sectors, including implantable class III devices, diabetes-monitoring and respiratory diagnostic systems. During his career Mr. Veavea acquired a wealth of knowledge in semiconductor, computer programming and validation and installation of sensors. He successfully led a number of product transfer and manufacturing processes and is highly experienced in regulatory matters, including quality design assurance and post-market surveillance. Mr. Veavea is a holder of various certifications, honors and awards, such as RAND Worldwide Certificate of Achievement to Pro-Engineer (2000).
“One of our internal goals for 2019 is the expansion of our engineering talents to augment the success and expansion we are seeing in other areas. Fui’s experience in a wide range of product development and quality control arenas is something that attracted BioSig. As we build on the primary goals with delivering high quality human data, we seek to increase internal talent to support our manufacturing processes during this important chapter in our Company’s development. We are confident that Fui will make a valuable addition to our team and look forward to his contributions,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies.
On February 20, 2019 the Company announced that it successfully conducted first patient cases using PURE EP(tm) System, its FDA approved proprietary signal acquisition and processing technology. The first commercial use of the System was completed at the Texas Cardiac Arrhythmia Institute (“TCAI”) in Austin, TX under the leadership of Andrea Natale, M.D., F.A.C.C., F.H.R.S., F.E.S.C., Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. Early results of the studies suggested improved cardiac signal detection and fidelity.
The Company released its Shareholder Letter earlier in February 2019, where it stated its intentions to present the results from the First-in-Human studies and the early feedback from the use of the PURE EP(tm) System to a larger community of physicians during the Heart Rhythm Society event in May 2019.
About BioSig Technologies
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosig.com). Led by a proven management team and a veteran Board of Directors, BioSig Technologies is preparing to commercialize its PURE EP™ System. The technology has been developed to address an unmet need in a large and growing market.
The Company’s first product, 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 potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and has received FDA 510(k) clearance for the PURE EP™ System in August 2018.
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 products and 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 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.