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Mount Sinai Pioneers New Approach for Cardiac Arrhythmia Patients Using the EpiAccess® System

NEW YORK, NY, August 16, 2016 - The Mount Sinai Hospital is the first site in the New York metropolitan area to pioneer a new approach for the treatment of cardiac arrhythmias using the EpiAccess® system. Developed by medical device company EpiEP, Inc., the EpiAccess system is a specialized instrument that facilitates an epicardial approach for non-surgical procedures on the surface of the heart.

“We are pleased to be among the first facilities in the nation to offer the EpiAccess system,” said Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at The Mount Sinai Hospital and the Mount Sinai Health System. “By providing routine and safe access to the pericardial space, the device offers a new approach to treat arrhythmias from the outside of the heart, enabling enhanced safety in advanced procedures and opening a new frontier for treating our patients.”

Non-surgical epicardial access has traditionally been limited by the two-dimensional image of a needle guided by intermittent fluoroscopy, which makes it difficult to know the precise location of the needle tip when accessing this small space surrounding the heart. The EpiAccess needle’s fiber-optic tip provides real-time pressure frequency data and immediate confirmation to alert physicians about needle tip location during the procedure. It was designed to reduce the risk of complications such as pericardial effusions, procedure time, and exposure to radiation used during these types of procedures.

These first procedures with the EpiAccess system were performed by Srinivas Dukkipati, MD, Co-Director of Cardiac Arrhythmia Services at The Mount Sinai Hospital.

Dr. Reddy serves as an uncompensated consultant for EpiEp (manufacturer of the EpiAccess system). Dr. Reddy also owns equity in EpiEp (a privately traded company) in the form of stock options.

EpiEP, Inc. Appoints William E. (Gene) Sanders, Jr. MD MBA to Board of Directors

Electrophysiologist, former FDA medical officer, and medical device veteran joins EpiEP, Inc. board of directors

New Haven, Conn. - Jan. 11, 2016 - EpiEP Inc. (EpiEP), a medical device company that has developed an FDA-cleared and CE-marked epicardial access system, today announced that William E. (Gene) Sanders, Jr. MD, MBA a recent medical officer at the FDA’s Office of Device Evaluation, Cardiac Electrophysiology Device Branch, has joined the EpiEP, Inc. Board of Directors.

Dr. Sanders brings an extensive career as a practicing electrophysiologist, medical researcher, and FDA award-winning scientist to the EpiEP board position. Previously, Dr. Sanders was an Associate Professor of Medicine and Pathology at University of North Carolina at Chapel Hill, where he spent 15 years as the Director of Clinical Cardiac Electrophysiology and Pacing and Associate Director of Cardiovascular Diagnostic and Interventional Laboratories. He has been directly involved in the success of multiple start-up medical device companies, acting as a consultant and board member. He will offer a clinical perspective to the board as the company prepares for commercialization of its first product, the EpiAccess System™.

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Texas Cardiac Arrhythmia Institute at St. David's Medical Center First in US to Use EpiAccess™ System

AUSTIN, Texas, Aug. 17, 2015 /PRNewswire/ – The Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center recently became the first facility in the United States to use the EpiAccess™ System to access the pericardial cavity of the heart during an epicardial ablation. The procedure was performed by Andrea Natale, M.D., F.H.R.S., F.A.C.C., F.E.S.C., cardiac electrophysiologist and executive medical director of TCAI, and J. David Burkhardt, M.D., F.A.C.C., cardiac electrophysiologist at TCAI.

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EpiEP, Inc. Appoints Don Crawford to Board of Directors

Medical device veteran and executive joins EpiEP, Inc. board of directors

New Haven, Conn., May 11, 2015 – EpiEP Inc. (EpiEP), a medical device company that has developed an FDA-cleared and CE-marked epicardial access system, today announced that Don Crawford, president and chief executive officer of Analytics For Life (A4L), has joined the EpiEP, Inc. board of directors.

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EpiEP, Inc. Announces Completion of the EASe Post-Market Clinical Study

Medical device company reaches milestone for FDA-cleared and CE-marked epicardial access system

New Haven, Conn., May 4, 2015 – EpiEP Inc. (EpiEP), a medical device company that has developed an FDA-cleared and CE-marked epicardial access system, today announced the completion of the Post-Market Clinical Follow-up (PMCF) study for the EpiEP EpiAccess™ System (“EASe”), conducted at four sites in Europe.

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EpiEP, Inc. Receives FDA 510(k) Clearance for EpiAccess System™

Pressure-guided epicardial access system enables electrophysiologists to perform challenging procedures on the surface of the heart

New Haven, Conn. - Nov. 10, 2014 – EpiEP, Inc. (EpiEP), today announced that its EpiAccess™ system, a pressure-guided epicardial access system designed to help physicians perform procedures on the surface of the heart, has received 510(k) clearance from U.S. Food and Drug Administration (FDA), a step that will allow EpiEP to commercially distribute the device.

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Pamela Bunes: a Business New Haven Rising Star

October 6, 2011 Congratulations, Pamela Bunes, on being named a Business New Haven Rising Star for 2011! We are proud that New Haven-based EpiEP Inc., the company you founded and now lead, is a member of our Connecticut Innovations portfolio.

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U.Va. Start-Up EpiEP Receives $1.5 Million Investment

July 8, 2010 — EpiEP Inc., a medical device company spun out of the University of Virginia, has received $1.5 million in investments and commitments for the development of its novel EpiAccess system, which shows promise to improve and expand the treatment of cardiac arrhythmia and other heart conditions.

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