Overview

Headquartered in Andover, Massachusetts, TransMedics™ is a medical device company founded in 1998 to address the unmet need for better, more effective organ transplant technologies. The Company has developed the first commercial, portable warm blood perfusion system that allows for a new type of organ transplant, called a living organ transplant. This technology, called an Organ Care System, or OCS, is designed to maintain organs in a warm, functioning state outside of the body during transport from organ donor to recipient. The OCS could potentially increase organ availability and improve outcomes for the growing population of patients with end stage organ failure in need of a transplant, bridging the widening gap between the number of organs available and the number of recipients awaiting transplants.

Mission

TransMedics’ mission is to enable more patients with end stage organ failure to benefit from the accepted medical standard of care — organ transplantation. TransMedics' Organ Care System is designed to deliver the healthiest organ, thereby potentially increasing the number of available organs, improving patient outcomes, and reducing recovery time, hospital stays and reliance on ongoing medical therapies.

The Organ Care System

Despite dramatic medical advances in the science of organ transplant, one key area has remained virtually unchanged for decades—the way that organs are preserved and transported from donor to recipient. To date, organs are removed from a donor and literally placed on ice in a cold, non-functioning state. This method creates severe time limitations while potentially causing injury to the organ and significant underutilization of the current pool of consented, donated organs.

TransMedics’ patented technology, the Organ Care System, maintains organs in a functioning state outside the body, pumping warm, oxygenated, nutrient-rich blood through the organ. The OCS is designed to help meet the need for healthy organs for transplant by potentially improving the health of the organ, allowing more time between donation and transplant, increasing the distance an organ can travel, and allowing surgeons the opportunity to assess the organ before transplant for better overall outcomes.

TransMedics received permission to affix the CE Mark to the OCS for use in heart transplants. We completed a clinical trial of the OCS for heart transplants in the European Union, called PROTECT-I, in February 2007. We are currently conducting a clinical feasibility study of the OCS for heart transplants in the United States, called PROCEED. We are also maintaining a registry of data from heart transplants performed in the European Union since February 2007 called PROTECT-II.

How Great is the Need for New Transplant Technologies?

The number of people requiring a life-saving transplant continues to rise faster than the number of available donors. Today, over 94,000 patients are waiting for an organ transplant in the US. Each day, 17 people die waiting for an organ and 116 people are added to the list. Three thousand people are waiting for a new heart and nearly half of them have been waiting for more than 2 years.

Globally, the list of patients waiting for a
life-saving organ transplant is expected to surpass 200,000 by the end of the decade.

Since 2003, there has been a 10 percent increase in the number of organ donors in the US. However, despite this progress, more than half of all hearts that have been consented for donation still go unused. The limitations of current cold preservation methods contribute to this problem.

New technologies like the TransMedics Organ Care System may play a vital role in helping to increase the utilization of available healthy organs from the pool that are presently going unused by lengthening time between organ donation and transplant, increasing the distance an organ can travel, allowing for better assessment of the organ by the physician, and potentially improving the health of organs for better overall outcomes.