We are a medical device company that is developing a proprietary technology platform for cardiac electrophysiology procedures.
The PURE EP™ System, our first product under development, is a novel cardiac EP recording and analysis system.
PURE EP is designed to improve the clarity of clinical signals available for EP studies and cardiac catheter ablation. It is a surface electrocardiogram (ECG) and intracardiac multichannel recording and analysis system designed 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 EP’s in identifying ablation targets – areas of tissue to treat that otherwise create a heart rhythm disturbance (arrhythmia). BioSig believes this information is not always easily obtained, if at all, from any other EP equipment in the market today.
These ablation procedures treat cardiac arrhythmias, which are broadly defined as a set of conditions in which the electrical activity of the heart is irregular, or faster or slower than normal. This type of heart disease afflicts 14.4 million Americans, or one in 18. Two of the most prevalent and deadly types of arrhythmias today are Atrial Fibrillation (AF) and Ventricular Tachycardia (VT).
According to the American Heart Association, AF increases an individual’s risk of stroke (fourth leading cause of death in the U.S.) four to five-fold. AF is the most common arrhythmia with 2.7 million cases in 2010 in the U.S., forecast to grow to 5.6 million cases by 2050. In the U.S. alone, AF leads to about 600,000 hospitalizations/year with a direct cost of about $6 billion annually and, adding indirect costs, brings the AF total cost to $26 billion.
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 – making it one of the fastest growing medical device segments. Just in the U.S., the number of AF and VT ablations is forecast to grow at 10.5 percent from 2012 to 2017.
BioSig will seek FDA 510(k) clearance for its PURE EP System. The Company has achieved proof of concept through UCLA EP & Animal Labs and has performed preclinical studies at the Mayo Clinic in Minnesota. BioSig is collaborating with several of the nation’s most prestigious cardiac arrhythmia centers to develop, refine and, ultimately, commercialize the PURE EP System, including:
- 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
- Mayo Clinic in Minnesota
Conventional Electrophysiology Reading (Top) versus the PURE EP System’s Reading (Bottom).