BioVentrix Announces Successful First-In-Man, Catheter-Based Endovascular Clinical Procedure with Revivent-TC™ System for Heart Failure Treatment

SAN RAMON, Calif., and VILNIUS, Lithuania, May 16, 2016 — BioVentrix, a pioneer of technologies and procedures for less-invasive treatment of heart failure (HF), today announced the first-in-man use of its next generation Revivent-TC™ System with an endovascular catheter-based approach from within the left ventricle. The Less Invasive Ventricular Enhancement™ or the LIVE™ procedure, used to reshape and reduce the left ventricle (LV), now utilizes deployment of its micro-anchor technology to exclude scar tissue from within the vasculature and without opening the chest. The device was successfully implanted in a 64-year-old female patient suffering from heart failure symptoms as a result of a myocardial infarction. The procedure was performed by Dr. med. Giedrius Davidavicius, Interventional Cardiologist, and Dr. med. Gintaras Kalinauskas, Cardiothoracic Surgeon, at Vilnius University Hospital in Vilnius, Lithuania.

"We are very pleased with the results of the Revivent-TC™ endovascular delivery system and the immediate clinical benefit to the patient," said Dr. Davidavicius. "This new endovascular delivery system to exclude the scar from within the LV cavity reduces procedural risk, improves accuracy of anchor implant, and enables a more minimally invasive approach for patients suffering from this disease."

"For patients this fragile, they are often precluded from any meaningful intervention due to the risks and extended recovery," said Dr. Kalinauskas. "The new Revivent-TC™ endovascular approach has provided an opportunity for more patients who are suffering from ischemic cardiomyopathy to be treated; while the improved accuracy of anchor placement should lead to even better clinical outcomes for these patients," continued Dr. Kalinauskas.

"The success of this endovascular procedure shows our commitment to the development of the LIVETM procedure to reach a fully percutaneous left ventricular volume reduction system for ischemic heart failure patients," said Dr. Lon Annest, Chief Medical Officer for BioVentrix, Inc. "This is a significant milestone for not only the company, but for all heart failure patients who suffer from ischemic cardiomyopathy," continued Dr. Annest.

BioVentrix has shown that the exclusion of scar tissue from the LV cavity in patients suffering from ischemic cardiomyopathy heart failure results in substantial improvements in Quality of Life1. Additionally, previous studies reported in the surgical literature have shown that a significant LV volume reduction conveys a survival benefit for treated patients2.

About the Revivent-TC™ System and the LIVE Procedure
Placement of the Revivent-TC™ System via the LIVE™ procedure obviates the need for more invasive surgery. Instead, small titanium anchors are placed along the outer surface of the heart and along one of the interior walls via a closed-chest, endovascular approach. The anchors are then pulled toward one another, effectively excluding the scarred and non-functioning heart wall. Ventricular volume is immediately reduced as a result of the exclusion, by as much as 30-40 percent1.

About the LIVE Procedure: The World’s Only Reshaping Left Ventricle Therapy
The LIVE procedure is based upon a well-defined law of physics called the law of Laplace, which describes the relationship between the radius and pressure of the LV, and its resulting wall tension. Increased wall tension is the underlying cause of LV enlargement, worsening heart failure symptoms and ultimately patient death. Reducing wall tension is key to preventing further LV enlargement and treats the progression of the disease. The Revivent-TC™ System, placed via the LIVE procedure, is uniquely designed to directly reduce the LV radius, which in turn decreases wall tension and interrupts the ongoing, destructive process of heart failure.

1Wechsler, A. et al., Clinical benefits twelve months after less invasive ventricular restoration operations without ventriculotomy. Annual meeting of the European Society of Cardio-Thoracic Surgery, 07 Oct. 2013, Vienna, Austria.

2Michler R et al. Insights from the STICH trial: Change in left ventricular size after coronary artery bypass grafting with and without surgical ventricular reconstruction. J of Thoracic and Cardiovascular Surgery. 29 October 2012 (10.1016/j.jtcvs.2012.09.007).