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

Oct 03, 2006, 01:00 ET from TransMedics, Inc.

    ANDOVER, Mass., Oct. 3 /PRNewswire/ -- 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
     "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.
     For more information, visit

SOURCE TransMedics, Inc.