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SEC Filings

10-12G/A
HEARTWARE INTERNATIONAL, INC. filed this Form 10-12G/A on 07/13/2007
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Table of Contents

Research and development
     From the date of our inception through March 31, 2007, we have incurred approximately $25.5 million on research and development of our LVAD technologies. For the quarter ended March 31, 2007 and each of the years ended December 31, 2006 and 2005, we incurred research and development expenses of $3.1 million, $11.7 million and $10.7 million, respectively. Research and development costs include activities related to the research, development, design, testing, and manufacturing of prototypes of our products. It also includes clinical activities and regulatory costs. Research and development costs also include cost associated with certain HeartWare employees engaged in research and development activities, as well as external consultants and contractors that we may engage from time to time. We expect our research and development expenses to increase significantly as we continue the development of our HVAD pump, initiate commercialization activities, research the application of, and develop our miniaturized heart pump technology, conduct additional clinical trials and hire additional employees.
Manufacturing
     Our products are currently being utilized only in connection with clinical trials. Our manufacturing activities to date, and for the foreseeable future, will continue to consist primarily of process development, component assembly, quality control testing and research and development activities.
     A number of critical components of our HVAD, including the center post, pump housing and impeller, are provided by outside suppliers and then assembled and tested by us in-house. We do not presently have supply agreements in place with our suppliers, other than a production services agreement with Minnextronix, Inc., which is described elsewhere herein. We have identified second source suppliers for all of our critical components, except for Minnetronix, Inc.
Employees
     As of May 31, 2007, we had 70 employees, 13 of whom hold masters or doctorate degrees. Approximately 54 employees are engaged in research and development including manufacturing and operations, 4 in clinical and 12 in finance, legal and other administrative functions. None of our employees are represented by a labor union or covered by a collective bargaining agreement. We consider our relations with our employees to be good.
Medical Advisory Board
     HeartWare maintains a six-person Medical Advisory Board (“Advisory Board”) which guides the Company in both clinical and product development strategies. Our Advisory Board is comprised of a group of cardiac surgeons and cardiologists. Their compensation is on a per diem basis to the extent their services are requested by the Company. The following are biographical summaries of the members of our Medical Advisory Board.
     O. Howard “Bud” Frazier, MD, Chairman & Chief Transplant Services, Director Cardiovascular Research, Texas Heart Institute. Dr. Frazier has been a pioneer in the surgical treatment of severe heart failure. He has been director of cardiopulmonary

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