Sunshine Heart's Clinical Strategy to Benefit Patients With Heart Failure and Other Conditions

July 11, 2016–Sunshine Heart, Inc. announced an update to its clinical strategy that has the potential to benefit a currently underserved population of patients with class III heart failure and other related conditions.

After months of collecting data and researching a strategic path forward, Sunshine Heart Inc. is advancing a therapeutic strategy focused on neuromodulation rather than counterpulsation. In the feasibility trial, Sunshine Heart Inc.'s counterpulsation therapy provided greater benefits to patients than would have been expected through the hemodynamic action of the aortic cuff alone. 

Sunshine Heart Inc. has discovered that the primary mechanism of action providing the clinical benefit was a neuromodulatory effect due to the counterpulsation balloon’s placement on the ascending aorta and its activation of the aortic baroreceptors with each expansion. Compared to its prior clinical strategy, Sunshine Heart Inc. believes this new focus will provide a more cost effective way to develop a fully-implantable system, a faster path to commercialization, and broader access to the New York Health Association class III heart failure market.

John Erb, Sunshine Heart Inc.’s Chairman and CEO said, “We are confident that we are on the right track. A neuromodulation-based therapy will provide greater benefits to patients, physicians, and the market than our original C-Pulse System. Furthermore, we believe that the development and ultimate approval of a fully-implantable neuromodulation device can be achieved in half the time and at half the cost of our original system.”

Sunshine Heart, Inc. is an early-stage medical device company focused on developing a product portfolio to treat moderate to severe heart failure and related conditions.