Healthcare Industry News:  Organ Care System 

Devices Regulatory

 News Release - October 3, 2006

TransMedics Receives European Union CE Marking Designation for its Organ Care System

ANDOVER, Mass., Oct. 3 (HSMN NewsFeed) -- TransMedics, Inc., announced today that it has received CE Marking approval for its Organ Care System, the first and only system that allows human donor organs to be maintained in their normal functioning state outside the human body. This designation assures physicians and patients that the Organ Care System is compliant with EU health and safety requirements, allowing TransMedics to market and distribute the system within the European Union, as well as many other countries throughout Asia and the Middle East.

TransMedics' Organ Care System maintains organs in a physiologic functioning state outside the human body to optimize their health and to allow real time ex-vivo clinical evaluation of donor organs for the first time ever. Warm, oxygenated, nutrient-rich blood is perfused through the organ from the time of removal until it is implanted, maintaining organs in a warm, functioning state outside the body until it is ready for implantation. As compared to current cold storage or cold perfusion techniques, the Organ Care System may allow the organ to withstand longer periods of time outside of the body and experience less damage resulting from lack of blood supply to the organ during transportation to the recipient.

"The Organ Care System addresses the vital need for a solution to the global shortage of organs available for end-stage organ failure patients. This designation is an important commercialization milestone for us and an essential step toward providing European physicians and patients with improved options for organ transplant," said Dr. Waleed Hassanein, founder, president and CEO of TransMedics, Inc.

In addition to increasing the number of transplantable organs and decreasing the risk of post-surgical complications, the Organ Care System is also aimed at providing significant cost benefits to the healthcare system. This technology is designed to: reduce the period of time patients need to be maintained on costly bridge therapies while waiting for a donor organ, ensure more rapid recovery and reduced hospital stays following transplantation, as well as reduce both the need for medical therapy to treat complications and the need for re-transplantation.

The Growing Need for New Transplant Technologies

The number of people requiring a life-saving transplant continues to rise faster than the number of available donors. Of the 12,000 people in Germany currently waiting for a donor organ, only a third will receive a transplant. Nearly 1,000 transplant candidates die each year. While there has been some progress in increasing donation rates in the last year, the demand for donor organs is increasing as well. In the UK today, there are 6,000 patients waiting for an organ transplant. However, fewer than 3,000 transplants are carried out annually; thus the transplant list continues to get longer. Unfortunately, more than half of all hearts that have been consented for donation still go unused. The limits of current cold preservation methods contribute to this problem. The situation is equally serious in the United States. Of the 89,000 people in the U.S. currently waiting for a donor organ, only a third will receive a transplant, while nearly 7,000 will die each year while waiting for an organ. This means approximately 17 transplant candidates die each day while waiting to receive a donor organ.

About TransMedics, Inc.

Headquartered in Andover, Massachusetts, TransMedics is a privately held medical device company founded in 1998 to address the unmet need for better, more effective organ transplant technologies. The Company has developed the first and only system that allows a new type of organ transplant, called a living organ transplant. This breakthrough, investigational technology, called an Organ Care System, is designed to maintain organs in a warm functioning state outside of the body during transport from organ donor to recipient. In Europe, TransMedics offers the Organ Care System under CE Marking. The goal of TransMedics' technology is to improve outcomes and increase organ availability for the growing population of patients with end-stage organ failure in need of a transplant, reduce recovery time, hospital stays and reliance on ongoing medical therapies, and ultimately bridge the ever-widening gap between the number of organs approved for donation and the number of recipients awaiting transplants.

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Source: TransMedics

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