Sunshine Heart, Inc. (NASDAQ:SSH) is pleased to announce that the US Food and Drug Administration (FDA) has approved the resumption of patient enrollment in its COUNTER HF US pivotal study for the C-Pulse Heart Assist System. As such, the Company has already begun the process to provide all pivotal study centers with the information required for their Investigational Review Board to approve the continuation of study enrollment.
“Resuming enrollment in COUNTER HF has been our top priority and was accomplished within the timelines originally announced. The proposed protocol modifications have enhanced an already robust protocol, and should increase the likelihood of success. We are encouraged by our investigators’ enthusiasm as witnessed by the high site representation at our recent investigator meeting,” commented Dave Rosa, President and Chief Executive Officer of Sunshine Heart.
Earlier in February 2015 the FDA unconditionally approved an interim analysis for the COUNTER HF study, as a means to potentially reduce the approval timeline for the C-Pulse therapy. FDA approval to resume study enrollment will now allow the Company to progress expeditiously towards that goal. (Original Source)
Shares of Sunshine Heart closed last Friday at $4.28 . SSH has a 1-year high of $6.90 and a 1-year low of $3.49. The stock’s 50-day moving average is $4.36 and its 200-day moving average is $4.56.
On the ratings front, Sunshine Heart has been the subject of a number of recent research reports. In a report issued on May 5, Canaccord Genuity analyst Jason Mills reiterated a Buy rating on SSH, with a price target of $7.50, which represents a potential upside of 75.2% from where the stock is currently trading. Separately, on the same day, Oppenheimer’s Steven Lichtman reiterated a Buy rating on the stock and has a price target of $12.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Mills and Steven Lichtman have a total average return of 0.5% and -1.8% respectively. Mills has a success rate of 46.0% and is ranked #2144 out of 3608 analysts, while Lichtman has a success rate of 56.3% and is ranked #3148.
Sunshine Heart Inc is an early stage medical device company. It is engaged in developing, manufacturing and commercializing its C-Pulse Heart System for treatment of Class III and ambulatory Class IV heart failure.