Sunshine Heart (NSDQ:SSH) said today it is looking at therapeutic strategies focused on neuromodulation rather than counterpulsation, touting the shift as a more cost effective strategy with a faster path to commercialization for its C-Pulse system.
The C-Pulse system is designed to use intra-aortic balloon counter-pulsation to reduce the load on the left ventricle, using a cuff around the exterior of the aorta designed to inflate and deflate in sync with the heart’s pulsation to augment cardiac function.
The shift came based off data from a clinical trial in which the Eden Prairie, Minn.-based company said it discovered that the primary mechanism which was providing a clinical benefit was neuromodulatory, caused by the counterpulsation balloon’s placement on the ascending aorta, as the device is activating baroreceptors with each expansion.
Sunshine Heart said the change will result in a more cost-effective way to develop a fully-implantable system, a faster path to commercialization and broader access to the NYHA Class III heart failure market.
“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. Our approach targets easy to find anatomical structures which provide an immediate and measurable response. In addition, the mechanism of action is direct, simple and well understood,” CEO John Erb said in a press release.
With the shift, Sunshine Heart said it has 3 new primary objectives, including a physician-led 5-patient study of the C-Pulse device looking at sympathetic nerve activity with the device, a 1st-in-man acute 20-patient study evaluating the neuromodulation approach and the development of a fully implantable system.
The company said the physician-led trial is underway, with a planned 20-patient neuromod trial slated for the 4th quarter of this year and completion by the end of the year. The company hopes to launch a 30-patient trial of a fully-implantable system in 2017.
“We are excited to announce some initial details on our revised clinical strategy, and more information will be released once additional details are finalized,” CEO Erb said in prepared remarks.
In May, Sunshine Heart saw shares rise after the medical device company said today that it slashed its 1st-quarter losses, topping Wall Street’s expectation.
Sunshine, which has not commercialized its C-Pulse heart failure device yet, cut its losses by -32.1% to -$4.8 million, or -26¢ per share; adjusted to exclude 1-time items, earnings per share were -25¢, 6¢ ahead of the consensus expectation on The Street. The company said it cut its cash burn by 35% compared with Q1 2015 and still expects to seek investors this year.
Sunshine said it plans to launch the 1st-in-human trial for C-Pulse this year to measure its neuromodulation effects. The company said it also plans to submit the clinical protocol for a short-term study to the FDA, with an expected protocol approval and patient enrollment coming by early 2017.
