Sunshine Heart Announces Second Quarter 2015 Results And Provides Corporate Update

EDEN PRAIRIE, Minn., Aug. 4, 2015 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (NASDAQ:SSH) announced today its financial results and provided a corporate update for the second quarter of 2015. The Company will host a conference call and webcast at 9:00 AM ET today to discuss its financial results and provide an update on its ongoing clinical studies.

To access the live webcast, please visit the Investors page of the Sunshine Heart website at http://ir.sunshineheart.com. Alternatively, the live conference call can be accessed by dialing (877) 303-9826 (U.S.) or (224) 357-2194 (international) and using conference ID 88546172. An audio archive of the webcast will be available following the call at http://ir.sunshineheart.com.

"The past quarter was clearly a critical one for the Company, highlighted by the resumption of enrollment in the COUNTER HF™ pivotal study. We are pleased we were able to resolve this matter with the FDA in an expeditious manner and are especially encouraged with the speed in which we are reactivating centers. In addition, we are making substantial progress in other initiatives in both the research and product development areas," commented Dave Rosa, President and Chief Executive Officer of Sunshine Heart.

Second Quarter Corporate Highlights:

• Resumption of enrollment in COUNTER HF US pivotal study
• Conducted investigator meeting with 25 participating centers
• 7 sites activated during the second quarter after receiving Investigational Review Board (IRB) approval. To date, a total of 15 of 27 sites have been activated
• The 15th OPTIONS HF EU patient was implanted
• Completed pre-clinical study plans investigating the effect of C-Pulse® with respect to pulmonary artery hypertension with Dr. Mark Slaughter of Jewish Hospital in Louisville Kentucky
• 3 scientific papers were presented covering improved driveline infection rate, C-Pulse efficacy in CRT patients and pre-clinical results from CPII. 2 additional papers have been submitted to AHA on improved hospitalization rates and clinical hemodynamic data demonstrating novel mechanism of action.

Second Quarter Financial Highlights:

• Cash used in operations was $12.8 million in the first six months of 2015 vs. $11.9 million in the first six months of 2014
• Additional $2.0 million term loan from Silicon Valley Bank funded based on FDA approval for interim analysis
• Cash and cash equivalents on hand at June 30, 2015 was $33.4 million vs. $31.3 million at year-end 2014

As previously reported, the COUNTER HF study was temporarily paused this past March after Sunshine Heart communicated to the FDA four deaths in the treatment arm of the study. The deaths were independently adjudicated as not being device or therapy related and, on May 26^th, the Company announced that the FDA had approved resumption of patient enrollment into the study. Upon receiving the FDA's approval, the Company immediately provided participating sites all of the required documentation for IRB submission. To date, 15 of 27 sites have received IRB approval and are activated. Sunshine Heart currently expects the remaining 12 sites to receive approval by the end of August. Also, the Company is pleased to report that the first 3 patients have been enrolled in COUNTER HF shortly after sites were activated for a total of 51 enrollments in the study to date. The Company has a growing pipeline of patients that are being evaluated for enrollment in the third quarter of 2015. In addition, Sunshine Heart's newly formed Physician Subject Selection Committee met to review the profiles of these initial patients and the process was both efficient and expeditious.

A COUNTER HF study investigator meeting was held on May 7-8, 2015 to prepare the study sites for resumption of enrollment. The Company is pleased to report that while the study remained in pause during this timeframe, 25 centers attended. There was a high level of enthusiasm among attending physicians and clinicians and the Company plans to post a video on its website from sessions held at the meeting.

The European based OPTIONS HF study implanted its 15th patient, which was the first referred by Professor Hüseyin Ince. Professor Ince is head of the cardiology department at the Vivantes clinic Friedrichshain and Vivantes clinic Urban in Berlin.

A key development during the second quarter was the Company's continued work around exploring the breadth and potential of the C-Pulse technology platform. Clinical data was recently obtained from OPTIONS HF patients, in collaboration with Prof. Segers' lab at University of Ghent, Belgium, to quantify the effects of C-Pulse on arterial stiffness. This is a first of its kind study, employing noninvasive measurements of pressure and flow in the ascending aorta to quantify the unloading effects of C-Pulse which may be mediated by relaxing the muscle in the walls of blood vessels in the peripheral circulation. These unique observations may be due to neuromodulation effects of C-Pulse where compression of the ascending aorta may lead to signals being sent to the brain resulting in alteration of sympathetic nerve activity to the blood vessels, kidney and heart. Additionally, physician initiated studies are being planned and the Company is providing technical support for these studies where the physicians are obtaining clinical data to directly measure sympathetic nerve activity during device ON/OFF phases. Pre-clinical studies evaluating the effects of C-Pulse for pulmonary artery hypertension are also planned to begin in the third quarter at The University of Louisville. Initial observations have indicated counterpulsation of the pulmonary artery may lead to relaxation of the pulmonary blood vessels. Based on physician feedback, this may be possibly related to release of nitric oxide. The studies will be designed to measure hemodynamic and hormonal mechanisms.