Sunshine Heart to start C-Pulse Heart Assist trial in US

US Food and Drug Administration (FDA) conditional approval for an investigational device exemption (IDE) for Sunshine Heart’s (ASX:SHC) flagship C-Pulse Heart Assist System paves the way for the company to conduct a key clinical trial of the system to support its FDA application.

Sunshine Heart now plans to commence a 388 patient North American trial of the device in the fourth quarter. Half the patients will receive C-Pulse, with the other half receiving optimal clinical therapy.

The primary endpoint is a reduction in worsening heart failure events leading to hospitalisation or mortality. A one-year follow up is planned.

The company estimates that enrolment in the trial will take around two and a half years from its start date.

Based on the FDA's approval and Sunshine Heart's tentative timeline, financial services group Cowen and Company revealed in an analyst report that it expects US commercialisation for C-Pulse to be achieved in 2017.

Sunshine Heart expects receive revenue from sales of C-Pulse during the trial in areas where reimbursement is available. Cowen and Company expects sales from the US and from a post-market study in Europe – where it has CE Mark approval – to total $3 million in 2013. The firm restated its Outperform rating on Sunshine Heart shares, citing its belief in the market potential of the C-Pulse system, as well as recent positive data from earlier feasibility trials.

The C-Pulse system has potential safety advantages over other treatments for heart failure. The device sits outside of the bloodstream, reducing the risk of complications, and can be installed in a relatively simple procedure similar to the implantation of a pacemaker.

Sunshine Heart (ASX:SHC) shares were up 10% on last week’s close at 4.4c as of Wednesday morning.