EDEN PRAIRIE, MN and SYDNEY, AUSTRALIA -- (Marketwire) -- 03/11/13 -- Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC) today announced financial results for the fourth quarter and year ended December 31, 2012 and provided an update on the progress of the C-Pulse® Heart Assist System.
Fourth Quarter Milestones:
•Unconditional IDE approval for U.S. FDA pivotal trial •Release of 1 year follow up data on C-Pulse feasibility trial •Existing C-Pulse patients converted to new single unit driver •Infrastructure in place for European post market and U.S. pivotal trials
Fourth Quarter Financial Highlights:
•SG&A expense totaled $1.9 million in the fourth quarter and $6.9 million for the full year 2012 compared to $2.1 million and $5.4 million in 2011, respectively •R&D expense totaled $2.2 million in the fourth quarter and $8.0 million for the full year 2012 compared to $3.3 million and $11.2 million in 2011, respectively •$14.2 million cash balance at December 31, 2012, up from $6.6 million at December 31, 2011
•$25 million equity line of credit; $1M investment by Aspire Capital Fund, LLC •Addition of U.S. board member •Conditional approval to delist from ASX •First U.S. pivotal trial site activated, enrollment process commenced •First European post-market trial site activated, enrollment process commenced •First U.S. pivotal site received CMS reimbursement approval •Additional patent filings for fully implantable system •Initiation of fully implantable pump design program with Cirtec Medical Systems
"After achieving several key regulatory milestones in 2012 and making significant progress toward initiating our U.S. and European trials, we entered 2013 by further fortifying the company's financial resources, continuing to transition the board composition to U.S. market expertise and activating initial trial sites in the U.S. and Europe. We remain confident that 22 centers will be initiated to participate in the U.S. pivotal trial and eight centers in Europe will be activated by the end of 2013," said Dave Rosa, Chief Executive Officer of Sunshine Heart
The Berlin Heart Center, located in Berlin Germany, one of the leading heart failure centers in the world, was recently initiated for the European post market trial. By the end of 2013, the Company expects to have centers located in Germany, Italy and the United Kingdom enrolling patients in the European post market trial. In addition, St. Luke's Medical Center in Kansas City, Missouri, the leading enroller in the U.S. feasibility trial, was recently initiated and has received confirmation from CMS that the C-Pulse procedures will be reimbursed.
On the product development front, the Company completed its contract with Cirtec Medical Systems, a firm with decades of expertise in the development of implantable mechanical circulatory support devices and expects to have a contract completed with a transcutaneous energy transfer (TET) manufacturer this quarter. Once an implantable product is developed, it will eliminate the driveline exiting the skin, thereby removing the risk of exit site infections. As part of this effort, additional intellectual property has been filed regarding the fully implantable program.
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