The C-Pulse system is designed to use intra-aortic balloon counter-pulsation to reduce the load on the left ventricle. Today the company said it’s stopping enrollment in its Counter-HF trial and Options-HF post-market surveillance study to focus on the C-Pulse study and a faster path to the U.S. market.
Although C-Pulse has been on the market in the European Union since 2012, when it won CE Mark approval, Sunshine Heart report no revenues for the 3 months ended Dec. 31, 2015, compared with $177,000 during Q4 2014. Losses were -$6.6 million, or -36¢ per share, flat compared with -$6.7 million or -40¢ per share during the same period in 2014.
The FDA approved the 388-patient Counter-HF trial back in August 2012. Last March the company halted enrollment after 4 patients died, but resumed the next month after the FDA approved minor protocol changes. Today Sunshine Heart said data from Options-HF showed “clinically meaningful improvement” in mean left ventricular ejection fraction and “strong trends on improvement of functional capacity.”
“These results support belief that the C-Pulse mechanism of action may be both hemodynamic and neuromodulatory,” the company said.
“I am excited at the opportunity to lead Sunshine Heart, especially at this critical time for the company,” Erb said in prepared remarks. “I am also excited about executing a strategy that realizes the full potential of C-Pulse therapy. In that regard, today we are announcing the need to change our previous clinical and product development strategies. These changes are necessary in order for us to focus our resources on driving a strategy that allows us to capture the sizeable opportunity to serve heart failure patients. The company has learned a great deal so far and we are going to leverage that knowledge. I am confident that we have the talent and know-how necessary to develop and execute a much more effective and efficient strategy.”
SSH shares plunged -15.7% to 70¢ apiece today in early trading.