The medical device company — which started out in Sydney, Australia, and is now headquartered in Minneapolis — hopes to raise up to $10.3 million more through a complicated rights offering that could play out over four years, according to a press release.
Sunshine Heart is trying to commercialize the C-Pulse Heart Assist System — an implantable counter-pulsation system that does not contact the blood — to help heart failure patients. The system expands a cuff around the aorta during diastole — the relaxation part of the heartbeat — to move more blood through the body.
The company whose shares trade for a couple Australian cents on the Australian Securities Exchange received Food & Drug Administration approval to begin a 20-patient clinical feasibility trial in 2008 (PDF).
The first two moderate heart failure patients in the study were implanted at Ohio State University Medical Center in Columbus, Ohio, in April 2009 (PDF). The first severe heart failure patient in the study was implanted at Pennsylvania State University a year later (PDF).
This summer, the first minimally invasive surgery (PDF) to implant the C-Pulse system was done at the University of Louisville.
“These latest procedures accomplish our goal of successfully implanting the C-Pulse System through a mini-thoracotomy surgical method,” said Dave Rosa, Sunshine Heart’s chief executive, in an August release (PDF). “As we approach the end of our feasibility study, we are encouraged by the interest of our centers, and we remain dedicated to developing this minimally invasive, cost-effective treatment that is intended to relieve the symptoms of moderate heart failure.”
Sunshine Heart would use proceeds from its private placement and rights offering to finish its feasibility trial and six-month patient follow-up; to apply to the FDA for a larger U.S. pivotal trial; and to European authorities for CE Mark approval. The company also would use the investor money to develop its product, hire staff members for its new Minneapolis office and as working capital.
The company must file for a NASDAQ Stock Market listing as part of its private placement agreement with prospective U.S. investors.