The publication highlights PURE EP's broader dynamic range and sampling rate versus standard EP recording systems as well as the use of additional proprietary filtering and processing to improve recording of Purkinje potentials and other high-frequency signals in pre-clinical studies. The researchers highlighted PURE EP's ability to detect and visualize high-frequency signals in the presence of larger waveforms as well as its capability to display the same channel with different processing options to highlight specific features while still displaying the original electrogram signal. The authors further stated these features may improve mapping and ablation outcomes in arrhythmias dependent upon the Purkinje network. Purkinje dependent arrhythmias include a number of forms of ventricular tachycardia and ventricular fibrillation.
Greg Cash, President and Chief Executive of BioSig Technologies, stated, "Publication of these exciting findings in a peer reviewed journal such as JACC: Clinical Electrophysiology indicates the importance of these previously unavailable capabilities and their potential to advance the diagnosis and treatment of complex cardiac arrhythmias."
About BioSig Technologies
BioSig Technologies is a medical device company that is developing a proprietary technology platform designed to improve the $4 billion EP marketplace (1) (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 System.
The PURE EP(TM) System is a surface electrocardiogram and intracardiac multichannel signal acquisition and analysis system engineered to assist electrophysiologists in making clinical decisions in real-time by acquiring and displaying high-fidelity cardiac signal recordings and providing clarity of data which may be used to guide the electrophysiologists in identifying ablation targets - areas of tissue to treat that otherwise create a heart rhythm disturbance (arrhythmia).
Analysts forecast the global market for EP devices will grow at a 12.1 percent compound annual growth rate, from $2.5 billion in 2012 to $5.5 billion by 2019(1), making it one of the fastest growing medical device segments. Just in the US, the number of Atrial Fibrillation (AF) and Ventricular Tachycardia (VT) arrhythmia ablations is forecast to grow at 10.5 percent from 2012 to 2017(2).
BioSig has partnered with Minnetronix on technology development and is working toward a FDA 510(k) clearance for the PURE EP System. The Company has achieved proof of concept validation and tested its prototype at the University of California at Los Angeles (UCLA) Cardiac Arrhythmia Center; and, has performed pre-clinical studies at Mayo Clinic in Minnesota. Additionally, an Advanced Research Program at Mayo Clinic began in June 2016. The Company is also collaborating with other prestigious cardiac arrhythmia centers including Texas Cardiac Arrhythmia Institute, UH Case Medical Center in Cleveland, Ohio and Mount Sinai Medical Center in New York.
(1) Electrophysiology Devices Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 – 2019
(2) HRI 2013 "Global Opportunities in Medical Devices & Diagnostics" report; triangulation of multiple sources; AF includes left atrial tachycardia, left WPW, left atrial flutter.
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SOURCE BioSig Technologies, Inc.