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|HeartWare Announces Presentations at The International Society of Heart and Lung Transplantation Annual Meeting|
FRAMINGHAM, Mass. and SYDNEY, April 12, 2011 /PRNewswire via COMTEX/ -- 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 that the HeartWare(R) Ventricular Assist System will be the subject of presentations at The International Society of Heart and Lung Transplantation (ISHLT) 31st Annual Meeting and Scientific Sessions, April 13-16 in San Diego.
During ISHLT, multiple oral sessions, posters and presentations will detail experience with the HeartWare(R) Ventricular Assist System, which features the HVAD(R) pump. Most notably, at 4:00 pm Pacific (7:00 pm ET) on Friday, April 15, Principal Investigator for HeartWare's bridge-to-transplant study ADVANCE, Mark S. Slaughter, M.D., 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, will provide an update to clinical data from ADVANCE, as well as from the Continued Access Protocol for that study.
"For the past three years, the number of HVAD-related presentations at ISHLT has risen rapidly, reflecting broad and growing support among our international commercial sites and interest from our clinical trial sites in the U.S. The diversity of these presentations reflects the versatility of our device and, importantly, forums like ISHLT provide our customers with an excellent opportunity to share their global experiences with the HVAD. The growing interest and support is also evidenced by the fact that more than 1,000 advanced heart failure patients have now received the HVAD pump - an important milestone for our Company," explained Doug Godshall, President and Chief Executive Officer. "Today we have 54 international customers in 18 countries, as well as 41 U.S. clinical sites actively screening patients for our ENDURANCE destination therapy study."
Investor Breakout Session and Webcast
Following conclusion of presentations during the week at ISHLT, HeartWare management will host an investor breakout session, which will be available via audio webcast, at 7:00 pm Pacific (10:00 pm ET) on Friday, April 15, 2011. Management will be joined by Dr. Slaughter, as well as Professor Thomas Krabatsch, M.D., Ph.D., Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum Berlin.
The audio from the meeting will be available to the public via webcast through the Company's website at (http://www.heartware.com/) by selecting "ISHLT Investor Meeting" under the section titled "Corporate Presentations" on the home page. A replay of the audio webcast will be available through the above weblink shortly following completion of the investor meeting.
The audio for the meeting may also be accessed by dialing 1-877-941-2068 five minutes prior to the scheduled start time and referencing "HeartWare." For callers outside the United States, please dial +1-480-629-9712.
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(R) Ventricular Assist System features the HVAD(R) 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 and TGA approval in Australia. 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 http://www.heartware.com/.
HeartWare International, Inc. is a member of the Russell 2000(R) and its securities are publicly traded on The NASDAQ Stock Market and the Australian Securities Exchange.
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 timing and progress of, and presentation of data related to, clinical trials, expected timing of FDA regulatory filings, FDA acceptance of our filings and research and development activities. 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, the possibility the FDA does not accept our PMA application or approve the marketing of the HeartWare(R) Ventricular Assist System in the U.S., and 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, Form 8-K, or other current reports, as filed with the Securities and Exchange Commission.
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