20 transplants completed worth a look

HeartWare announced today the completion of patient enrolment in the international clinical trial for the HVADTM left ventricular assist device. Please find attached the announcement released to the ASX.



Key Points:



The HVADTM pump has now been implanted in 20 patients across 5 hospitals. On a cumulative basis, these patients have been supported for over 3,000 days. The average duration of support exceeds 150 days per patient. So far eight patients have successfully passed the endpoint of the trial.
The completion of enrolment enables HeartWare to move forward with European regulatory submissions during the fourth quarter of this year, with an expectation of commercial launch early in 2008.
HeartWare remains on track with both its US and international regulatory timelines. Key short term milestones are as follows.


Ø Q4 2007 - Submission of Technical Dossier to Competent Authority in Europe

Ø Q4 2007 - Extension of International Trial to allow additional implants

Ø Q4 2007 - Submissions of IDE to US FDA

Ø Q1 2008 - CE Marking

Ø Q1 / Q2 2008 - First commercial revenue

Ø Q1 2008 - Commencement of US Trial

Ø Q1 2008 - First US revenue (reimbursement during the clinical trial)





About HeartWare

HeartWare is developing a family of proprietary circulatory assist devices to treat patients with heart failure. HeartWare’s lead device, the HVADTM, is currently progressing through an international clinical trial involving 20 patients. With a volume of 45cc, the HVADTM is the smallest “3rd generation” pump and the only full output device implantable routinely within the thoracic cavity.

HeartWare’s miniaturization platform enables the development of smaller devices, potentially implantable by minimally invasive surgical techniques. Pre-clinical studies are underway for HeartWare’s MVADTM, a pump one third the size of the HVADTM. HeartWare’s IV-VAD, a pump one tenth the size of the HVADTM, is at early prototype stage.



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Howard Leibman

HeartWare Limited

Level 57, MLC Centre | 19-29 Martin Place | Sydney NSW 2000

Tel. + 61 (2) 9238 2064

Fax. + 61 (2) 9238 2063

Mbl. + 61 402 440 644

Email. [email protected]