BioSig Technologies (BSGM) is a development stage medical device company that is developing a proprietary technology platform designed to improve the rapidly growing $4B electrophysiology (EP) marketplace by minimizing noise and artifacts from cardiac recordings during EP studies and ablations. They are developing the PURE (Precise Uninterrupted Real-time evaluation of Electrograms) EP System, a surface electrocardiogram and intracardiac multichannel recording and analysis system that acquires, processes and displays electrocardiogram and electrograms required during electrophysiology studies and ablation procedures. These ablation procedures treat cardiac arrhythmias, which are broadly defined as a set of conditions in which the electrical activity of the heart is either irregular, faster or slower than normal. This type of heart disease afflicts ~14M Americans and two of the most prevalent and deadly types of arrhythmias consist of Atrial Fibrillation (AF) and Ventricular Tachycardia (VT).
BSGM will seek 510(k) clearance from the FDA, has achieved proof of concept through UCLA EP & Animal Labs and has performed preclinical studies at the Mayo Clinic in Minnesota. Collaborating with several of the nation’s most prestigious cardiac arrhythmia centers such as Texas Cardiac Arrhythmia Institute, UCLA Cardiac Arrhythmia Center, U.H. Case Medical Center in Cleveland, William Beaumont Hospital in Michigan, Mount Sinai Medical Center in NY and Mayo Clinic in Minnesota; and led by a proven management team and a veteran, independent Board of Directors, Minneapolis-based BioSig is preparing to commercialize its PURE EP System.