EpiEP

About EpiEP

EpiEP Inc. is a medical device company established in 2008, operating in the surgical and electrophysiology device market. The company is focused on developing instruments for minimally invasive procedures on the surface of the heart, an approach considered a significant advancement in electrophysiology. EpiEP's core business revolves around the sale of its proprietary EpiAccess™ System to healthcare facilities. This system is designed for use by physicians performing epicardial access procedures to treat conditions like ventricular tachycardia (VT) and atrial fibrillation (AF).

The company was founded by George T. Gillies, Ph.D., and Dr. Srijoy Mahapatra. Pamela Bunes, the current Chief Executive Officer, brings 24 years of experience in the medical device industry, with significant tenures at Johnson & Johnson's Ethicon Endo-Surgery and Biosense Webster. Her background includes managing new product launches, securing FDA and CE Mark approvals, and raising capital, with a recent decade focused specifically on cardiology and electrophysiology.

The company's flagship product, the EpiAccess™ System, provides a safer and more precise method for accessing the pericardial space surrounding the heart. The system consists of a disposable, single-use Tuohy-style needle with an integrated fiber optic pressure sensor at its tip, and a reusable control unit with a display monitor. A key feature is the pressure-guided needle that provides real-time data to alert physicians of the needle tip's exact location, a critical factor in avoiding unintended punctures of the heart muscle. This technology is designed to work in conjunction with standard fluoroscopy, offering adjunctive data to confirm when the needle has entered the pericardial cavity. The system received CE Mark approval in March 2014 and FDA 510(k) clearance in October 2014.