Eden Prairie, Minn.-based 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 device uses 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 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.
“After my first 2 months as CEO, I continue to be excited by the significant opportunity in front us at Sunshine Heart,” chairman & CEO John Erb said in prepared remarks. “The entire organization is focused on pursuing a business and clinical strategy that will allow us to realize the full potential of C-Pulse therapy in helping heart failure patients. We have learned a great deal about the treatment of heart failure patients and we are leveraging that knowledge. In that regard, I am pleased with the clinical progress we are making. We intend to submit our protocol for a short-term clinical study to the FDA by the end of the 3rd quarter. This will allow us to collect additional clinical evidence to support the development of our fully implantable system.”
The post Sunshine Heart pares losses, preps for 1st-in-human trial for C-Pulse heart failure device appeared first on MassDevice.
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