(MENAFN - ProactiveInvestors - Australia) Sunshine Heart (ASX: SHC) has received unconditional approval from the U.S. Food and Drug Administration (FDA) to begin a pivotal U.S. trial of its flagship C-Pulse Heart Assist System.
The system is an implantable, non-blood contacting, heart assist therapy for the treatment of moderate to severe heart failure.
Importantly, Sunshine Heart is well funded with A17.4 million in cash at the end of September, following a recent underwritten capital raising.
The trial is on track to begin in the December quarter of 2012, with a number of leading heart failure centres in the U.S. interested in participating in the trial.
The primary endpoint of the proposed 388 patient pivotal trial is the reduction of events such as re-hospitalisation due to worsening heart failure and heart failure-related mortality.
Half of the patients will be implanted with the C-Pulse System, while the other half will receive optimal medical therapy across 30 to 40 clinical sites.
Sunshine Heart expects to receive revenues from trial sites for device implants, as the FDA has granted CMS Category B3 status.
Because of this designation, it is also anticipated that participating trial centres will be reimbursed by CMS and most private insurance providers.
The trial will utilise Sunshine Heart's next-generation single unit C-Pulse driver, which received approval for clinical trial use from the FDA in August 2012, and has been in use in Canadian and U.S. patients.
The new driver features a single unit that is lighter, quieter, about half the size of its predecessor, and also includes numerous software updates.
Sunshine Heart estimates enrolment for the event-driven pivotal trial will take around two and a half years. A one year safety follow-up is expected.
The company has achieved its regulatory and clinical objectives by receiving both the CE Mark and U.S. Investigational Device Exemption approval this year.
In July Sunshine Heart announced positive 12-month extended follow-up data from its preliminary feasibility study of the C-Pulse Heart Assist System.
Also in July, the company achieved CE Mark certification, allowing commercialisation of the device in Europe.
Sunshine Heart is targeting leading left ventricle assist device and transplant centres in Europe, specifically in Germany and Italy " two countries that, when combined, are believed to have the highest number of hospital bed days per year for heart failure in Europe.