BioVentrix announces completion of enrollment in PliCath HF human clinical trial

BioVentrix, developer of the PliCath HF™ System, today announced the achievement of a significant milestone - completion of enrollment in its pilot human clinical trial. PliCath HF is a novel device which enables Epicardial Catheter-based Ventricular Restoration (ECVR). The PliCath HF system is designed to treat the most common type of heart failure (HF) by restoring a more normal geometry to an enlarged, scarred heart. This effect is accomplished by exclusion from the left ventricle (LV) of non-contracting scar tissue, which typically results from a previous heart attack. Numerous studies have shown that enlarged hearts not only function poorly, but also continue to deteriorate, eventually leading to death. PliCath HF reduces ventricular volume, thus enabling the heart to pump more efficiently and maintain adequate perfusion to the body without excessive stress on the muscle of the heart wall.

“This device will extend effective treatment to a large group of patients where no other option is currently available. We are excited to move forward into our next clinical phase, which will soon include a completely closed chest, minimally invasive therapy for these patients.”

BioVentrix medical advisor and cardiothoracic surgeon, Dr. Andrew Wechsler of Drexel University, participated in the conduct of the trial and has firsthand experience with the benefits of the technology. "The PliCath HF device enables significant LV volume reduction, resulting in restoration of cardiac function without the risk of cutting into the heart or the need for cardiopulmonary bypass. Most of these patients have attempted other therapies, were extremely ill, and could not have tolerated a fully invasive surgical approach requiring entry into the ventricle. These patients have demonstrated impressive improvement in all categories of assessment. This product has the potential to benefit a large number of patients with congestive heart failure."

The 26-patient study was conducted at five leading centers in Europe, and to date, 12 patients have reached 90-day follow up or greater. The patients have shown an average indexed left ventricular end systolic volume (LVESVI) reduction of 31% with a significant improvement in ejection fraction (the percentage of cardiac volume ejected with each heart beat). Importantly, these clinical findings were matched by drastic improvements in the patient's functional status and quality-of-life (QOL) assessments.

HF afflicts a large population, has no cure, and is progressively disabling. Over a million hospital admissions in the US are due to HF, resulting in an annual cost of nearly $40 billion. An additional 670,000 new diagnoses and 250,000 HF deaths are estimated each year. Currently, "open heart procedures" are applied sparingly among such debilitated patients due to its invasiveness and substantial cost.

"Heart failure remains a problem of epidemic proportions," said Kenneth Miller, President & CEO of BioVentrix. "This device will extend effective treatment to a large group of patients where no other option is currently available. We are excited to move forward into our next clinical phase, which will soon include a completely closed chest, minimally invasive therapy for these patients."