Mardil Medical Announces First Human Implants of the VenTouch® Triad Targeted Ventricular Reshaping System

MINNEAPOLIS, March 14, 2018 — Mardil Medical, Inc., today announced the first human implants of its VenTouch® Triad device. Designed as a combination therapy to simultaneously treat the dilated ventricle and the resulting distorted valve in patients suffering from Type IIIb Functional Mitral Valve Regurgitation (FMR), VenTouch is a less-invasive treatment for a condition that can, if left untreated, accelerate and worsen heart failure. Over 500,000 patients in the United States are afflicted annually with Type IIIb FMR, one of the most difficult and expensive patient populations in cardiology to manage.

The VenTouch Triad device was implanted in two patients with severe Type IIIb FMR. Both patients presented several challenges due to severe FMR combined with significant heart dilation and poor left ventricular function. In both patients, the FMR was reduced to only mild or trace amounts.

The surgeries were performed on February 12-13 at Sanitorio Italiano in Asunción, Paraguay by a heart team of four US cardiac surgeons and imaging specialists directed by Mardil Medical chief medical officer Dr. Spencer Kubo and site investigator Dr. Adrian Ebner.

"After implantation of the VenTouch Triad device, mitral valve regurgitation was markedly reduced," said Dr. George Gellert, an imaging specialist and prominent trainer of cardiologists on the latest in echocardiography for structural heart procedures. "Our heart team was impressed by the ease of placement and the immediate and significant benefit demonstrated with both the ventricular function and the valve anatomy itself in this difficult-to-treat patient population."

The current standard of care treatment for FMR is an open-chest and open-heart surgical procedure on bypass pump which can be difficult to perform and risky for sicker patients. Unfortunately, less invasive, often catheter-based treatment options being studied currently, including interventional or minimally invasive replacement or repair therapies, have been only capable of reaching and addressing the otherwise healthy valve apparatus in the Type IIIb FMR patients. Unlike those treatments, the VenTouch combination therapy delivers the three necessary mechanism adjustments in the specifically targeted Carpentier Type IIIb FMR patient population: correction of the displaced papillary muscles, reduction of diastolic wall stresses encouraging accelerated reverse remodeling, and return of leaflet coaptation. No other implantable device offers more than just one of these benefits.

"The VenTouch Triad system is unique because it is the only technology that directly addresses the fundamental mechanisms of FMR, namely ventricular enlargement, annular dilation and displacement of the papillary muscles," said heart failure cardiologist Dr. Spencer Kubo.

"Having now successfully treated patients with the VenTouch Triad System, Mardil has taken an important step towards our goal of introducing this ground-breaking therapy and giving Type IIIb FMR patients a mechanism-focused and minimally invasive treatment option," said Jim Buck, President and CEO of Mardil Medical. "With the recent new financing, Mardil is poised to start Canadian and US trials later this year."