Sunshine Heart Inc (NASDAQ:SSH) announced an update on its next generation, fully implantable version of the Company’s flagship C-Pulse® technology. Sunshine Heart is pleased to report that it will commence a first-in-human study using the novel transcutaneous energy transmission (TET) system and a new smaller implantable pump in Q3 2016.
The study will initially enroll patients at hospitals outside the U.S., and will target patients suffering from advanced Class III/IV heart failure, similar to the patient population of Sunshine Heart’s current ongoing COUNTER HF™ Study. Feasibility of implant, safety and short term durability will be the primary objectives. Performance and efficacy data will be collected to evaluate patient quality of life, freedom from heart failure symptoms and other standard heart failure measures including the ability to bridge to other therapies.
Dr. William Cohn, Director of Center for Technology and Innovation, Texas Heart Institute, who has been involved since the inception of the program, will lead the study. Dr. Cohn commented that “the development of a completely implantable circulatory assist device that obviates the need for a driveline will be an important milestone in the evolution of heart failure therapies. The system will also be non-blood contacting and non-obligatory and may prove to be a real game changer for patients with intermediate stage heart failure.”
The development of a fully implantable system will eliminate the need to manage a driveline and will address the risk of exit site infections. Together with smaller and lighter wearable components, the system is designed to provide an improved quality of life for patients. The company believes this system will lead to increased market access to target all Class III HF patients, similar to CRM and neuromodulation devices. In addition, the unique ability to deliver chronic counterpulsation therapy and augment coronary blood flow, may afford a new market opportunity for the treatment of angina and ischemic heart disease where morbidity and mortality remain high in heart failure populations with reduced and preserved ejection fraction.*
The benefits of C-pulse and counterpulsation on the pulmonary circulation and the high prevalence of pulmonary hypertension in the latter population may also provide for a therapeutic opportunity with a fully implantable system in this large population with an unmet need. (Original Source)
Shares of Sunshine Heart Inc closed yesterday at $3.10. SSH has a 1-year high of $6.90 and a 1-year low of $2.41. The stock’s 50-day moving average is $3.57 and its 200-day moving average is $4.34.
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 represents a potential upside of 287.1% 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 $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 1.2% and 2.3% respectively. Lichtman has a success rate of 56.3% and is ranked #1728 out of 3718 analysts, while Mills has a success rate of 49.2% and is ranked #1350.
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.