Sunshine Heart Inc (NASDAQ:SSH) is pleased to announce the US Food and Drug Administration (FDA) has approved an amendment to the stopping rule criteria for the Company’s COUNTER HF™ pivotal study for its C-Pulse Heart Assist System®. The Agency has agreed to change this protocol from “all cause” deaths to specifically, mortality associated with device, procedure or therapy.
“Redefining COUNTER HF’s stoppage rule to be focused purely on C-Pulse related events is an important study protocol amendment as it greatly reduces our risk of having to pause the trial again due to unrelated C-Pulse mortality events,” commented Dave Rosa, President and Chief Executive Officer of Sunshine Heart.
Sunshine Heart previously announced on March 6, 2015 a temporary enrollment pause in accordance with the study’s original “stopping rule.” This particular protocol indicated that, in the event more than three of the first twenty subjects pass away for any reason, including non-device related deaths, the Company would work with the FDA to establish a plan before resuming enrollment. An independent Clinical Events Committee (CEC) determined that all four of the reported deaths were adjudicated as being non-device related and, on May 26th, the Company announced the FDA’sapproval to resume enrollment in the COUNTER HF study.
Moving forward, the “stopping rule” has been amended such that COUNTER HF will be halted if more than seven of the first twenty implanted subjects pass away during device support within twelve months of implant. Importantly, in order for a study pause to occur, each mortality event will have to be adjudicated as possibly or definitely related to the procedure, therapy or device. (Original Source)
Shares of Sunshine Heart opened today at $2.8 and are currently trading up at $2.89. SSH has a 1-year high of $6.90 and a 1-year low of $1.99. The stock’s 50-day moving average is $2.95 and its 200-day moving average is $3.98.
On the ratings front, Sunshine Heart has been the subject of a number of recent research reports. In a report issued on August 4, Oppenheimer analyst Steven Lichtman maintained a Buy rating on SSH, with a price target of $10, which represents a potential upside of 257.1% from where the stock is currently trading. Separately, on the same day, Canaccord Genuity’s Jason Mills reiterated a Buy rating on the stock and has a price target of $5.
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 -4.6% and 1.9% respectively. Lichtman has a success rate of 49.2% and is ranked #3508 out of 3743 analysts, while Mills has a success rate of 49.5% and is ranked #1303.
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.