This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration. Need a new registration confirmation email? Click here
EDEN PRAIRIE, Minn., May 14, 2013 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (Nasdaq:SSH) today announced corporate updates and financial results for the first quarter ended March 31, 2013.
First Quarter Corporate Highlights:
First site activated in U.S. C-Pulse ® System pivotal trial, COUNTER HF
Reimbursement approval granted by CMS for first U.S. pivotal trial site
First site activated in European multi-center C-Pulse ® System post-market trial, OPTIONS HF
Two additional Board members added
$25M equity line of credit established with Aspire Capital Fund, LLC
First Quarter Financial Highlights:
SG&A expense totaled $2.0M in 1Q13 vs. $1.9M in 1Q12
R&D expense totaled $2.4M in 1Q13 vs. $2.2M in 1Q12
Loss per share $(0.47) in 1Q13 vs. $(0.66) in 1Q12
Cash used in operations was $4.1M in 1Q13 vs. $4.8M in 1Q12
In the first quarter, Mid America Heart Institute-Saint Luke's Hospital was the first site to be activated in the U.S. COUNTER HF trial. Sunshine Heart has been notified by the site that CMS has already granted reimbursement eligibility for use of the C-Pulse System. Mid America Heart was the leading implanter for the Company's C-Pulse feasibility study. Three additional centers from the Company's feasibility study are currently in the activation process. Additionally, Sunshine Heart received word on May 9, 2013 that its second site, Minneapolis VA Medical Center, has been activated. The Company anticipates a range of enrollments, including control and C-Pulse implanted patients, to total 32 to 44 by year-end 2013.
Sunshine Heart has appointed Dr. Margarita Camacho, Surgical Director Cardiac Transplantation and Mechanical Device Program, Barnabas Health Heart Center at Newark Beth Israel Medical Center, as the National Surgical Principal Investigator (PI) for its COUNTER HF trial. Dr. Camacho was previously a member of the data and safety monitoring board that oversaw the feasibility trial. She joins Dr. William Abraham of the Ohio State University Medical Center, who was previously named as the National Cardiology Principal Investigator for the COUNTER HF trial.