Traditionally, donor organs are rapidly cooled and kept in cold, ischemic storage until surgery.
Waleed Hassanein

CEO: Dr. Waleed Hassanein
Based: Andover, Massachusetts
Founded: 1998
Company website

The scoop 

With its Organ Care System, TransMedics is delivering an alternative to ice-filled picnic coolers as the standard means to transport donor organs in the U.S. The system—which keeps organs close to body temperature and delivers nutrients to the organs—is already available in the EU and Australia for the transportation of hearts and lungs.

Traditionally, donor organs are rapidly cooled and kept in cold, ischemic storage until surgery. While cold storage lessens the damage an organ may otherwise sustain during transport, it causes some problems of its own. By definition, an ischemically stored organ has no blood circulation, which eventually causes damage and makes it impossible to check if it functions properly while in storage.

The Organ Care System (OCS) comprises a portable platform, a perfusion module, a transparent, sterile chamber that protects the organ and keeps it at the right temperature, and a solution set, designed to deliver nutrients to the organ. The platform houses the whole operation and includes oxygen supply and a pump that maintains a flow of warm, nutrient-rich blood to the organ, as well as a monitor, which physicians may use to assess the state of the organ.

What makes TransMedics fierce 

Many have tried to develop alternatives for organ transport, but none have landed on a method that has clinically outperformed cold storage on a consistent basis, according to the company. By keeping the organ in a warm, “living” state outside the body, TransMedics’ system not only tamps down on potential damage associated with cold storage, but could also reduce the number of donor organs that go to waste.

The longer an organ spends in cold storage, the greater the extent of tissue damage; eventually, the organ becomes unusable. The OCS is expected to extend the amount of time organs may be kept outside the body, enabling them to travel a greater distance to where they’re needed and ultimately, cutting down on wasted organs.

“The device could keep a heart functioning for up to 11 hours, nearly triple the time with cold storage,” reported The Seattle Times in 2015.

TransMedics picked up $51.2 million in an equity round led by Fayerweather Fund and Pharmstandard International, with participation from existing backers, including Lung Biotechnology PBC, Flagship Ventures, Abrams Capital and KPCB. "This financing strongly positions TransMedics to capitalize on the significant market opportunity in front of us,” said CEO Hassanein at the time. In July, the company added another $13 million to the haul.

What to look for 

The OCS Heart system snagged a positive recommendation from the U.K.’s National Institute for Health and Care Excellence, citing evidence that normothermic, ex vivo preservation of hearts is effective and safe enough for doctors to consider the method for their patients. Additionally, the FDA canceled a November 2015 advisory committee meeting surrounding the PMA submission of the device, saying it was no longer required.

TransMedics’ OCS Heart is in clinical testing in the U.S., while trials for its OCS Lung and OCS Liver are enrolling. Last February, the company announced the first patient in its pivotal trial to receive a liver transplant using the OCS Liver.

"This is a significant milestone for TransMedics, as it represents the introduction of our third product platform ... and significantly expands our overall addressable market potential,” said Hassanein at the time. “It solidifies our market leadership position given that OCS is the only multi-organ platform in the market worldwide.” — Amirah Al Idrus, @FierceBiotech


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