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Clinical Data Published in the Journal of Cardiovascular Electrophysiology Could Be Important for This Stock


Benzinga | Oct 13, 2021 01:38PM EDT

Clinical Data Published in the Journal of Cardiovascular Electrophysiology Could Be Important for This Stock

BioSig Technologies, Inc. (NASDAQ:BSGM) announced that an article titled "Evaluation of a Novel Cardiac Signal Processing System for Electrophysiology Procedures: The PURE EP 2.0 Study" has been published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access as of September 23, 2021, via the Wiley Online Library.

The PURE EP 2.0 study was conducted at three U.S. hospitals: Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital.

Intracardiac signal data of clinical interest was collected during 51 cardiac ablation procedures using the PURE EP(tm) System, the signal recording system, and the 3D mapping system at the same time stamps. The samples were randomized and subjected to blinded, head-to-head evaluation by 3 independent electrophysiologists to determine the overall quality and clinical utility of PURE EP(tm) signals when compared to conventional sources. Each reviewer responded to the same 235 signal comparisons using a 10-point rating scale.

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 the signals from conventional sources.

"In order for any new medical technology to be widely adopted and accepted, strong, prospective clinical study results are necessary. The results from the PURE EP 2.0 study clearly validate the clinical importance of our technology and position the company for continued growth and success. We are grateful for the many physician investigators and research staff who participated in this study and look forward to continuing our clinical work to advance the field of electrophysiology and bioelectronic medicine," commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.

To date, over 60 physicians have completed more than 1,400 patient cases with the PURE EP(tm) System across 13 clinical sites.

Through the use of electromedical devices like the PURE EP(tm), bioelectronic medicine explores how targeted electrical signals in the body can help to diagnose and treat a wide range of diseases, from diabetes to depression. Companies such as Abbott Laboratories (NYSE:ABT) and IRIDEX (NASDAQ:IRIX) join BioSig Technologies in a global market that reached $41.3 billion in 2018 and should reach $58.5 billion by 2023.







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