HeartWare and Dualis MedTech Announce Agreement to Develop Fully Implantable Ventricular Assist System

FRAMINGHAM, Mass. and SYDNEY, Jan. 9, 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, and Dualis MedTech GmbH, a subsidiary of AVRA Surgical, Inc., today announced an agreement to develop ventricular assist devices with wireless, transcutaneous energy transfer system (TETS) technology exclusively for HeartWare.

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Since mid-2011, a collaborative team of HeartWare and Dualis engineers has successfully demonstrated the feasibility of integrating Dualis' proprietary wireless energy transfer technology with the HeartWare® HVAD and MVAD systems.  Under terms of the agreement, HeartWare will fund a TETS development program for left ventricular assist devices (LVADs), as well as receive an option to fund programs to explore developments in bi-ventricular support and first rights to future developments outside the field of TETS and ventricular assist devices.

"What makes us most enthusiastic about this alliance is the expertise, passion and creativity of the people at Dualis.  Dualis was spun out of DLR, the German Aerospace research organization and we now have access to the talents and ideas of the team at Dualis, as well as the research powerhouse present at DLR," said Doug Godshall, CEO and President of HeartWare.  "Our internal TETS program has melded seamlessly with Dualis' and through this relationship we can accelerate our development timeline, as well as take advantage of the technology upgrade we have seen through the integration of the two programs.  We have augmented our capabilities via this relationship and foresee a meaningful expansion of our pipeline utilizing new technologies generated by our new European partners."

"At Dualis, our primary focus with this first initiative with HeartWare is to harness our proprietary and established energy transfer system to work with its HVAD and MVAD pumps," explained Dr. Thomas Schmid, CEO and Managing Director for Dualis MedTech.  "We have already conducted over a dozen animal studies of our TETS technology, which gives us great confidence in the integrity of our system.  We are delighted to now have an opportunity to marry our advanced system with the leading LVAD technology and look forward to a long and productive partnership with HeartWare as we pursue our mission of creating intelligent implants to treat poorly managed medical conditions."

The Dualis wireless energy transfer system for implantable devices is designed to allow patients to safely and efficiently provide power during normal daily activities.  By coupling an external "sender" coil with an implanted "receiver" coil, the TETS system is able to transfer electricity through the patient's skin, thereby eliminating the traditional power and transmitter cable utilized in ventricular assist devices today.

Additional terms of the agreement were not disclosed.

About Dualis

DUALIS is a young and highly innovative medical technology company that specializes in the area of active implants.  The company offers research and development services, as well as its own technologies developed in close collaboration with the German Aerospace Center.  For more information, please visit http://www.dualis-medtech.de/.  Dualis, a subsidiary of AVRA Surgical, is a spin-off from the German Aerospace Centre (DLR). 

DLR is Germany's national research center for aeronautics and space.  Its extensive research and development work in aeronautics, space, transportation and energy is integrated into national and international cooperative ventures.  DLR's research portfolio ranges from fundamental research to innovative development of the applications and products of tomorrow.  Innovations made by DLR in the fields of aeronautics and space have beneficially transferred to many organizations in industries including materials technology, medicine and software engineering.

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 and TGA approval in Australia.  The device is currently the subject of United States clinical trials for two indications: bridge-to-transplant and destination therapy.  More than 1,700 advance heart failure patients globally have received an implanted HeartWare System.  For additional information, please visit 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 timing and progress of, and presentation of data related to, clinical trials, expected timing of regulatory filings and approvals, research and development activities and changes in executive management. 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® 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, Current Reports on Form 8-K, or other filings with the Securities and Exchange Commission.

HeartWare International, Inc. is a member of the Russell 2000® and its securities are publicly traded on The NASDAQ Stock Market and the Australian Securities Exchange.

HEARTWARE, HVAD, MVAD and HeartWare logos are registered trademarks of HeartWare, Inc.

For additional HeartWare information:
Christopher Taylor
HeartWare International, Inc.
Email: [email protected]
Phone: +1 508 739 0864

SOURCE HeartWare International, Inc.