HeartWare Limited (HTW) has received conditional approval from...

HeartWare Limited (HTW) has received conditional approval from the United States Food and Drug Administration ("FDA") of an Investigational Device Exemption ("IDE") for its lead product, the HeartWare Left Ventricular Assist System (LVAS). The company said the granting of conditional IDE approval by the FDA enables the company to immediately commence its US clinical trial for the HeartWare LVAS for use as a bridge to cardiac transplant in patients suffering from end-stage heart failure.

Sunshine Heart Inc (SHC) has announced the terms of an underwritten non-renounceable rights issue to raise $5.4 million. Under the rights issue, eligible shareholders will be invited to subscribe for four new shares for every eleven shares held at the record date at an offer price of 7c per share. The price represents a 23% discount to the volume weighted average price of Sunshine Heart’s shares over the previous month. Sunshine Heart said the funds raised would be used to support the company’s ongoing activities and the proposed US clinical trial of C-Pulse. The rights issue has been fully underwritten by Sunshine Heart’s major shareholders GBS Venture Partners and CM Capital. CEO Donald Rohrbaugh said that the equity raising would strengthen the company’s balance sheet ahead of the forthcoming United States clinical trial and provide some financial flexibility.