BioVentrix announces the 1st Revivent TC™ TransCatheter Ventricular Enhancement procedure in Germany after receiving CE-Mark Certification

San Ramon, Calif., and Hamburg, Germany, December 19, 2016 — BioVentrix, Inc. a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today announced the first closed-chest Revivent TCTM TransCatheter Ventricular Enhancement System procedure in Germany since receiving CE mark certification. The Less Invasive Ventricular EnhancementTM or LIVETM procedure was performed by interventional cardiologists Dr. Christian Frerker, MD and Dr. Tobias Schmidt, MD and by cardiothoracic surgeon Dr. Ralf Bader, MD at Asklepios Klinik St. Georg in Hamburg, Germany. The St. Georg Heart team is led by Prof. Dr. Karl-Heinz Kuck, who is also the Chairman of the Department of Cardiology and Electrophysiology.

The physicians implanted 2 anchor pairs and achieved a left ventricular volume reduction of 24%, which is a significant improvement for a patient suffering from ischemic heart failure. Left Ventricular volume reduction is a common measure of cardiac performance that significantly impacts the short and long-term survival rates. By remodeling the LV to a more normal shape and size, the implant improves pumping efficiency, decreases wall stress, and immediately reverses patient symptoms.

“We are pleased to be the first center in Germany to perform the Revivent TC procedure after CE mark certification,” said Dr. Frerker. “The Revivent TC procedure continues to show significant clinical benefits to patients who suffer from ischemic cardiomyopathy post-myocardial infarction. It’s a viable solution when guideline directed medical therapy (GDMT) is not suitable,” continued Dr. Frerker.

“The 24% volume reduction should directly impact the heart’s pumping efficiency, which is a positive outcome for ischemic patients. That will result in an improvement in the patient’s quality of life,” added Dr. Schmidt. “This is the only minimally invasive technology which enables plication of scar tissue resulting in complete exclusion outside the LV cavity,” continued Dr. Schmidt.

“The Revivent TC procedure alleviates wall stress by the reshaping of the left ventricle and allowing for the heart to operate as it was intended to going forward. The immediate impact the Revivent TC procedure has on a patient is life- changing,” added Dr. Bader.

About BioVentrix and the Revivent TC System
BioVentrix, a privately held medical technology company headquartered in San Ramon, Calif., is focused on developing and commercializing minimally invasive therapies for treating HF. The company recently received CE mark certification for its closed-chest Revivent TC TransCatheter Ventricular Enhancement System for plication of scar tissue in post-MI, ischemic cardiomyopathy patients. 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 catheter-based approach. The anchors are then pulled towards 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.

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.