Encouraging News: Sunshine Heart Provides Corporate Update
BY GlobeNewswire
— 5:30 AM ET 01/12/2015
EDEN PRAIRIE, Minn., Jan. 12, 2015 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. ( SSH ) today provided an update on the Company's U.S. Counter HF™ and European OPTIONS HF studies along with progress on its next generation, fully implantable C-Pulse® Heart Assist System.
The U.S. Counter HF study concluded 2014 with 40 enrollments, 21 activated centers, and 12 additional centers committed to participate. The Company is pleased to report 13 patients were enrolled in the fourth quarter, which was much higher than projected. In addition, despite challenges during the quarter presented by seasonality, the company continued to experience strong site enthusiasm in identifying potential patients. 15 of the 21 activated centers have enrolled patients with 2 new centers enrolling their first patient. Moving forward, Sunshine Heart ( SSH ) is expecting to experience continued growth in enrollment throughout 2015 due to the following: Addition of 2 development therapy specialists (5 total) to accelerate patient enrollment, increased site proficiency in identifying appropriate patients, continued site activations.
Furthermore, the Company expects a decision from the FDA on its request to conduct an interim analysis before the end of the first quarter of 2015.
If successful in demonstrating efficacy at the time of interim analysis, the Company will be in a position to discuss early PMA submission with FDA. Data was also obtained during device optimization using pulse wave analysis by the AtCor Medical Sphygmograph. Key metrics typically used to determine the impact on left ventricular load are: left ventricular (LV) wall stress, LV stroke volume, Wasted Energy (WE), Tension-Time Index (TTI). Sunshine Heart ( SSH ) has published data on the positive effects of C-Pulse on LV stroke volume and wall stress. Recent evaluation of this data demonstrated improvements in reduction of Wasted Energy and Tension-Time index, two key metrics in evaluating myocardial oxygen consumption. These measurements were taken with the C-Pulse system turned-off and then measured once it had been reactivated. These metrics have also been used to assess cardiac resynchronization therapy success.
With respect to the European OPTIONS HF study, Sunshine Heart ( SSH ) finished 2014 with 14 implants performed of which two implants were completed in the fourth quarter at newly activated sites in Germany and Austria. The Company expects to see continued growth in European implants in the first quarter of 2015 and beyond and expects to release study results in mid-2016. A response from the German authorities regarding Sunshine Heart's ( SSH) New Diagnostic and Methods (NUB) submission for reimbursement for the C-Pulse System is expected in February. Given that the Company has not built any revenue in its 2015 plan for EU reimbursement, an approval would represent financial upside to internal guidance. The Company currently has direct representation in Europe to provide clinical and future sales support for the OPTIONS HF trial and commercial purposes.
"We are particularly pleased with progress achieved during the fourth quarter with both of the COUNTER HF™ and OPTIONS HF trials. The pace of enrollment in both studies seems to be gaining sustainable momentum and we will continue to provide updates along the way when appropriate," commented Dave Rosa, Chief Executive Officer of Sunshine Heart ( SSH).
On the research and development front, the next generation, fully implantable C-Pulse System continues to experience exciting progress. During the course of 2014, Sunshine Heart ( SSH) successfully completed both acute and chronic animal trials and has already developed its next, smaller iteration which the Company's physician advisors are confident can be placed via a minimally invasive procedure. Sunshine Heart ( SSH) has also built in-house expertise in the software and hardware components of the C-Pulse System through additional personnel hires to complement independent partners helping with the development of the C-Pulse pump and TETS (Transcutaneous Energy Transfer System). With continued progress, the Company believes it is well positioned to be the first current mechanical assist company to complete its first in man clinical evaluation.
The Company is currently scheduled to meet with the FDA to discuss the fully implantable system on January 15, 2015.
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