Here's more good news for Sunshine Heart ($SSH): After watching its shares jump 14% last month, the company snagged conditional FDA approval for its new C-Pulse Heart Assist implant.
And, predictably, Sunshine's stock leapt again, by 18% this time, according to The Wall Street Journal.
The new version of the C-Pulse tech is about half the size of the one currently on the market, and it's lighter and quieter, according to Sunshine. Conditional approval allows Sunshine to use its next-gen device in stateside clinical trials, and the implant is already on the market in Europe, picking up its CE mark in July.
The device is designed to treat moderate to severe heart failure, boosting patient comfort and performance through its outside-the-bloodstream ventricular assistance. Part of the tech's novelty--and perhaps why investors are so excited about its inventor--is that it requires little or no use of blood-thinning drugs like warfarin, cutting back on many of the risks associated with similar devices.
Next, the company plans to submit an investigational device exception later this year and, assuming it's approved by the FDA, begin a pivotal trial to get the new C-Pulse on shelves in the U.S.
- check out Sunshine's release
- read the WSJ story