Institutional investors in the United States have committed to buy $3.5 million-worth of Sunshine Heart Inc. (ASX: SHC) shares in a private placement — that is, if the company’s Australian shareholders agree.
The medical device company that started out in Sydney, Australia, and now is headquartered in Minneapolis, Minnesota, 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.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The company whose shares trade for a couple Australian cents on the Australian Securities Exchange received Food and 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.
This summer, the first minimally invasive surgery (pdf) to implant the C-Pulse system was done at 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.”
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Sunshine Heart would use proceeds from its private placement and rights offering to finish its feasibility trial and six-month patient follow-up, and apply to the FDA for a larger pivotal trial in the United States 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.
