BioVentrix Announces 30th Clinical Case Milestone for Revivent-TC™ Technology

Adoption of revolutionary, less invasive procedure spreads across Europe

San Ramon, Calif., and Prague, Czech Republic, Dec. 14, 2015 — BioVentrix a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today announced the successful completion of the 30th clinical case using the closed-chest Revivent-TC Ventricular Enhancement System. The hybrid procedure was performed by Prof. Petr Neuzil (interventional cardiologist) and Dr. Ivo Skalsky (cardiothoracic surgeon) on a 38-year-old female patient at the Na Holmoce Hospital in Prague, Czech Republic.

The Less Invasive Ventricular Enhancement™ or the LIVE™ procedure, utilizing this new TransCatheter approach, is in clinical trials throughout Europe. This case comes on the heels of other successful Revivent-TC cases performed recently in Spain, Italy, France, and Germany.

"Before the LIVE procedure, this patient’s quality of life was severely impacted by her heart failure to the point where she could no longer walk even short distances without discomfort. The Revivent-TC system allows treatment of patients with worsening heart failure and those that are already very ill without opening the chest," said Prof. Neuzil. "The adoption of the Revivent-TC system allows us to treat the underlying cause of heart failure by reshaping the left ventricle to improve pumping efficiency and reduce wall stress," added Dr. Skalsky.

"The LIVE procedure with the Revivent-TC System has gained adoption in Europe, because it is the only technology that stops the destructive, ongoing process of heart failure,” said David Schickling, Vice President of Sales and Marketing at BioVentrix. “Recent analysis has shown that 76 percent of patients with Mitral Regurgitation that were treated with the Revivent technology had an added benefit of improvement in mitral valve functionality1. We are gratified that our technology is immediately impacting the lives of ischemic heart failure patients who have few remaining therapeutic options."

BioVentrix has reported an average reduction of 31% in Left Ventricular volume and a 14% improvement in Ejection Fraction (EF) at 1-year post-op follow-up2. The data continues to show the same volume reduction and ejection fraction increase with this hybrid approach as was demonstrated with the previous surgical technique.

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, TransCatheter 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.

1,2Revivent data on file.