The Organ Care System provides a complete support environment for hearts en route to transplant recipients. With the TransMedics' approach, hearts are perfused with warm, oxygenated, nutrient-rich blood and maintained in a beating, functioning state to travel further and arrive healthier. We completed a clinical trial for heart transplants in the European Union, called PROTECT-I, in February 2007. TransMedics received permission to affix the CE Mark to the OCS for use in heart transplants.

TransMedics is currently conducting a
multi-center clinical feasibility study of the OCS
in the United States, called PROCEED.

In February 2007, the FDA approved our application for a clinical feasibility study of the OCS for heart transplants, called PROCEED. In April 2007, we commenced the PROCEED trial in the United States to evaluate the safety and performance of the OCS for the preservation of donor hearts during transplant. In addition, we are maintaining a registry of data from heart transplants performed in the European Union since February 2007 using the OCS, called PROTECT-II.

Technology Overview

Traditional heart transplant surgery requires the transplant center to utilize an arrested donor heart that has been rushed to the recipient in a non-functioning cold ischemic state. It is well documented that the length of cold ischemic time has a direct and significant negative effect on the health of the organ and recipient survival. The impact of the highly urgent nature of this approach limits the utilization of existing donor hearts, and is also recognized as negative from both a cost and outcomes perspective.

This non-beating approach has greatly reduced the number of organs available for transplant and has constrained the implementation of improved matching strategies. The limitations of this current approach result in increased costs for maintaining potential recipients on the waitlist, unnecessary waitlist deaths, lengthy recovery times and extended hospital stays.

TRANSMEDICS' APPROACH TO HEART TRANSPLANTS

TransMedics enables living organ transplants for the first time. With a living organ transplant organs are maintained in a functioning state to reduce damage to the organ and to allow the surgeon the opportunity to assess and potentially improve its function prior to transplant.

• More organs - Lower waitlist cost and fewer waitlist deaths.
• Healthier organs - Better outcomes and reduced medical costs.
• Better matching - Better outcomes and better post transplant quality of life.
• Less urgent - Better outcomes and reduced medical costs.