Shares of Sunshine Heart (SSH) are on the move in morning trading upon receiving conditional approval from the U.S. Food and Drug Administration for an Investigational Device Exemption, or IDE, for its C-Pulse® Heart Assist System.
Operating outside the patient’s bloodstream, the C-Pulse System utilizes the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. The C-Pulse System has the potential to stabilize – or even reverse – the heart failure process, which could result in a decreased chance of patients’ requiring additional, more severe therapies like transplants, artificial hearts or left ventricular assist devices.
With the conditional approval, Sunshine Heart now intends to move forward to initiate a pivotal clinical trial in the fourth quarter. The early-stage biotech says that the North American trial will take about 2-1/2 years for enrollment, consist of about 400 patients, span 30 to 40 clinical sites and include its next-generation C-Pulse driver. The new C-Pulse driver, a smaller, quieter version of its predecessor, received FDA approval in August for clinical trial use.
The primary endpoint of the trial will be reduction in worsening heart failure events leading to hospitalization, advanced heart failure therapies and heart failure related mortality, according to the company.
“We are thrilled to receive conditional approval from the FDA to move forward into a pivotal trial for C-Pulse,” said Dave Rosa, CEO of Sunshine Heart. Rosa also noted that the company has been hitting its timelines with receiving its CE Mark to market itsin Europe and other CE Mark-recognizing countries and now U.S. IDE approval. Sunshine Heart received its CE Mark in July for the C-Pulse System as a treatment for Class IV heart failure.
Shares of SSH debuted publicly in February at $12 per share and after a brief rise tumbled all the way to hit $2.50 at the end of June. Trading has been volatile since, including hitting a high of $17.25 and lows of $6.35 in August. Shares rose as high as $9.80 in early trading today and are currently holding around $9 each one hour into the trading day.