Sunshine Heart, Inc. (NASDAQ:SSH) announced an update on its COUNTER HF™ US pivotal study for the C-Pulse Heart Assist System. COUNTER HF is a prospective, randomized, multi-center, controlled study evaluating the safety and efficacy of the C-Pulse system for the treatment of NYHA Class III and ambulatory Class IV heart failure. The study was temporarily paused this past March after the Company notified the FDA of four deaths in the treatment arm of the study. The deaths were adjudicated as not device or therapy related and as previously announced on May 26th, the FDA approved resumption of patient enrollment in the study.
“I’m pleased with the enthusiasm and speed at which sites are being reactivated. We witnessed genuine excitement for the study at our recent investigator meeting and are strongly encouraged by the momentum generated at many of our sites,” commented Dave Rosa, President and Chief Executive Officer of Sunshine Heart.
Immediately following the FDA’s decision to approve enrollment to continue the COUNTER HF’s study, Sunshine Heart distributed material to all sites with the necessary documentation in order to achieve site Investigational Review Board (IRB) approvals. Currently, 12 sites have been reactivated which is approximately half of all previously activated sites. Sunshine Heart expects the majority of sites to be reactivated by the end August. In addition, the Company is pleased to announce the enrollment of its first two patients since the resumption of the COUNTER HF study. One of these patients was already reviewed by Sunshine Heart’s newly formed Physician Subject Selection Committee. This process was handled efficiently and led to the first implant being scheduled for this morning. (Original Source)
Shares of Sunshine Heart closed yesterday at $3.19. SSH has a 1-year high of $6.90 and a 1-year low of $3.11. The stock’s 50-day moving average is $3.74 and its 200-day moving average is $4.40.
On the ratings front, Sunshine Heart has been the subject of a number of recent research reports. In a report issued on May 5, Oppenheimer analyst Steven Lichtman reiterated a Buy rating on SSH, with a price target of $12, which implies an upside of 276.2% from current levels. Separately, on the same day, Canaccord Genuity’s Jason Mills reiterated a Buy rating on the stock and has a price target of $7.50.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Steven Lichtman and Jason Mills have a total average return of 1.8% and 4.8% respectively. Lichtman has a success rate of 57.6% and is ranked #1534 out of 3713 analysts, while Mills has a success rate of 51.5% and is ranked #863.
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.