HeartWare Announces Publication of Results From U.S. Bridge-to-Transplant Clinical Trial

FRAMINGHAM, Mass. and SYDNEY, May 23, 2012 /PRNewswire/ -- HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced the publication of results from ADVANCE, the Company's U.S. clinical trial evaluating the use of the HeartWare® Ventricular Assist System as a bridge to heart transplantation in patients with advanced heart failure. The detailed findings from this study are published in the American Heart Association's journal Circulation, and demonstrate the potential utility of the HVAD® Pump to improve treatment outcomes for end-stage heart failure patients. The paper appears online as an "Ahead of Print" article of Circulation dated May 22, 2012.(1)

"With the publication of the ADVANCE trial in Circulation, cardiologists and cardiac surgeons treating advanced heart failure will now have the opportunity to thoroughly review the excellent results our investigators obtained using the HVAD® Pump to bridge their patients to transplant," noted co-principal investigator Keith Aaronson, M.D. M.S., Professor in the Division of Cardiovascular Medicine and Medical Director of the Heart Transplant Program and Center for Circulatory Support at the University of Michigan, on behalf of the ADVANCE investigators, including Mark Slaughter, M.D., co-principal investigator for ADVANCE, and Professor and Chief in the Division of Thoracic and Cardiovascular Surgery and Director of the Mechanical Assist Device and Heart Transplant Program at the University of Louisville.

The publication describes results from the ADVANCE study of 140 patients from 30 U.S. hospitals who received the HeartWare investigational device. The authors noted high rates of 180-day success and survival and improvements in quality of life and functional capacity for patients with end-stage heart failure that were similar to those seen with cardiac transplantation. Success was achieved for the primary endpoint by establishing non-inferiority between the investigational device and comparator arm of the study, which was derived from contemporaneous patients from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) [p<0.0001]. Success on the primary endpoint occurred in 92.0% of the investigational device patients in the per protocol study population, 90.7% of the investigational device patients in the safety study population and 90.1% of INTERMACS control patients. The most common adverse events were typical of those previously reported for an axial design, continuous-flow pump, and included bleeding, infections, stroke and perioperative right heart failure.

"The high rates of success and survival, as well as improvements in quality of life and functional capacity detailed in the publication, support our belief that, if approved, the HVAD would offer patients with advanced heart failure a valuable new treatment option," said Doug Godshall, President and Chief Executive Officer of HeartWare. "We are working closely with the FDA as they complete their review of our PMA application for the HeartWare® Ventricular Assist System as a bridge to heart transplant and look forward to their decision."

"As we showed at our FDA panel meeting last month, some of the more challenging adverse events we observed in this initial study cohort have improved measurably in our continued access cohort by refining post-operative management techniques and by introducing sintered inflow cannulas which appear to be contributing to decreased thromboembolic complications, added Mr. Godshall. "We never stop seeking ways to improve outcomes for our patients and believe that continued analysis, as well as our ongoing commitment to enhancing the performance of our system, will lead to a further reduction in certain adverse events."

The HeartWare Ventricular Assist System is under FDA review for a Bridge-to-Transplant indication. On April 25, 2012, the FDA's Circulatory System Devices Advisory Committee voted 9 to 2 that the benefits outweigh the risks for the use of the HeartWare Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure. The Advisory Committee's recommendation, while not binding, will be considered by the FDA in its review of the Premarket Approval (PMA) application submitted for the HeartWare Ventricular Assist System in December 2010.

About HeartWare International
HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV patients suffering from advanced heart failure. The HeartWare® Ventricular Assist System features the HVAD® pump, a small full-output circulatory support device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. HeartWare has received CE Marking for the HeartWare System in the European Union. The device is currently the subject of United States clinical trials for two indications: bridge-to-transplant under a continued access protocol and destination therapy. For additional information, please visit the company's website at www.heartware.com.

Forward-Looking Statements
This announcement contains forward-looking statements that are based on management's beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to the progress of clinical trials. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. HeartWare does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. HeartWare may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation those described in "Item 1A. Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission. We may update our risk factors from time to time in "Part II, Item 1A. Risk Factors" in our Quarterly Reports on Form 10-Q, or other current reports, as filed with the Securities and Exchange Commission.

For further information:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartwareinc.com
Phone: +1 508 739 0864

(1) Keith D Aaronson, MD, MS; Mark S Slaughter, MD, et al. Use of an Intrapericardial, Continuous Flow, Centrifugal Pump in Patients Awaiting Heart Transplantation. Circulation. Published electronically Ahead of Print. 22 May 2012. 10.1161/CIRCULATIONAHA.111.058412

Link: http://circ.ahajournals.org/cgi/content/abstract/CIRCULATIONAHA.111.058412v1?papetoc

SOURCE HeartWare International, Inc.