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Company Links |
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Business Environment |
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End stage organ failure affects many people and arises from a variety of causes. According to estimates from the National Institutes of Health, or NIH, approximately 5,000,000 people in the United States suffer from heart failure, the leading causes of which include coronary artery disease, high blood pressure and diabetes. Each year, approximately 550,000 people are diagnosed with heart failure and approximately 300,000 people die from heart failure. NIH figures indicate that chronic obstructive pulmonary disease, which includes lung diseases such as emphysema and chronic bronchitis, affects approximately 12,100,000 adults in the United States and contributes to approximately 119,000 deaths each year.
NIH estimates that approximately 400,000 Americans have chronic liver disease, from causes such as viral infections and alcohol exposure, and approximately 27,000 people die of liver disease each year. The United States Renal Data System reports that each year since 1999, more than 100,000 people in the United States develop end stage kidney disease, which can result from chronic inflammation, diabetes, hypertension or other causes, and require either chronic dialysis or a kidney transplant.
According to the 2006 OPTN Report, the obstacle that most frequently prevents patients from benefiting from organ transplantation is the availability of suitable organs. During 2005, essentially all of the hearts and lungs, approximately 90% of the livers and almost 60% of the kidneys transplanted in the United States were retrieved from the limited pool of deceased donors whose brain functions had stopped, but whose hearts continued to beat.
Because of the specialized nature of transplantation, the organ transplant markets in the United States and Europe are highly concentrated. According to the OPTN, surgeons at the top 25 transplant centers in the United States performed 58% of all heart and lung transplants in 2005.
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Company Strategy |
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A medical device company focused on developing and commercializing a proprietary system to enable transplantation of beating hearts and other functioning organs.
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Product/Services Portfolio |
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The Company’s Organ Care System is the first commercial portable warm blood perfusion system for the maintenance, transport and evaluation of an organ between donor and recipient. The OCS is designed to maintain organs in a functioning state, perfused with warm, oxygenated, nutrient enriched blood between retrieval from the donor and transplant into the recipient. The Company is also developing the OCS for use in lung, liver and kidney transplants.
The OCS is comprised of two principal components: a portable platform and an organ specific disposable set, which includes a perfusion module, a solution set and accessories. The portable platform is designed to serve as a base for the organ specific disposable sets that hospitals will need to purchase for each organ transplant that is performed using the OCS. The Company has completed the development of the OCS, including a cardiac disposable set, for use in heart transplants and is developing the perfusion modules, solution sets and accessories for use in lung, liver and kidney transplants.
The wireless monitor displays information similar to the information typically displayed on an intensive care unit monitor for a transplant patient. The wireless monitor allows the physician to remotely monitor the organ and adjust various settings of the OCS, such as pump flow, temperature and gas delivery.
The Company completed a clinical trial of the OCS for heart transplants in the European Union, called PROTECT-I, in February 2007. The Company is currently conducting a clinical feasibility study of the OCS for heart transplants in the United States, called PROCEED. The Company is also maintaining a registry of data from heart transplants performed in the European Union since February 2007 using the OCS, called PROTECT-II.
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Investment Analysis |
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The Company did not recognize any revenue during the six months ended June 30, 2007 or the six months ended July 1, 2006.
Research and development expenses were $7.6 million for the six months ended June 30, 2007 compared to $6.2 million for the six months ended July 1, 2006.
Net interest income (expense) was $307,000 for the six months ended June 30, 2007 and $340,000 for the six months ended July 1, 2006.
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