Canaccord’s healthcare analyst Jason Mills weighed in with an optimistic view on Sunshine Heart Inc (NASDAQ:SSH), following the news that the FDA responded to the company’s IDE supplement. Following supplement review, the FDA requested SSH to submit minor protocol changes to their COUNTER HF pivotal trial in order to receive approval to resume patient enrollment.
Mills noted, “We view this as a benign, modest delay, and would remain buyers as we think enrollment will accelerate upon recommencement of the study through 2016. We also note that the FDA’s response did not indicate any concerns regarding the device’s safety profile, and furthermore, the Data Safety Monitoring Board (DSMB) recommended continuation of the study. We think the latest guidance from FDA will help investigators target the most applicable patient population (i.e., INTERMACS 4-7) in whom we think C-Pulse has the highest probability of demonstrating positive outcomes, albeit will likely delay trial re-commencement until early May, in our estimation.”
Bottom line: “We continue to believe SSH offers investors the opportunity to participate in a nascent growth company that is commercializing potentially disruptive technology for the treatment of moderate heart failure. We remain positive regarding C-Pulse’s long-term potential for the treatment of Class III heart failure, which represents a very large target addressable patient population.”
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Jason Mills has a total average return of 4.9% and a 53.2% success rate. Mills has a -12.4% average return when recommending SSH, and is ranked #906 out of 3573 analysts.