|Organ Care System--Courtesy of TransMedics|
TransMedics hopes to transform the way human organs are preserved when they are transported for donor transplantation. Its Organ Care System is a portable, ex vivo organ perfusion system designed to preserve a donor heart in a near-normothermic and beating state from retrieval to transplantation. The current approach in the U.S. is to rapidly cool organs upon removal and keep them in cold storage until surgery.
The expectation is that, as compared to cold storage, the TransMedics OCS Heart system minimizes ischemia, optimizes organ condition and enables continuous monitoring and assessment of the heart outside the body. This is anticipated to make more hearts available for transplantation and to improve patient outcomes.
Now, the Andover, MA startup has secured a major cash infusion to match its large ambitions. It's gotten a $51.2 million round from investors including the Cambridge-based Fayerweather Fund as well as Russian pharma company Pharmstandard International.
"We are ... supported by a world-class syndicate of new and existing life science investors. This financing strongly positions TransMedics to capitalize on the significant market opportunity in front of us," said TransMedics President and CEO Dr. Waleed Hassanein in a statement.
Pharmastandard is represented in the investment by a trio of firms: InBio Ventures, Ervington Investments, and BioStar Ventures. Existing investors Abrams Capital, Lung Biotechnology PBC, Flagship Ventures and KPCB also participated.
TransMedics' OCS Heart and OCS Lung systems are CE marked and in use in leading transplant centers in Europe, Australia and Canada. The OCS Heart, OCS Lung and OCS Liver systems are currently in clinical testing in the U.S.
The OCS Heart System was slated for an FDA advisory committee meeting last November, but it was canceled after the agency determined to be no longer needed. No further word has been released on the PMA submission review.
TransMedics did recently win a positive recommendation from the difficult-to-please UK agency National Institute for Health and Care Excellence (NICE), which gave its most positive recommendation for the OCS Heart technology in March.
"Prolonged cold storage times may result in ischaemic and reperfusion injuries that can impair heart function after transplantation," summed up the NICE guidance. "Normothermic extracorporeal preservation aims to keep the donor's heart beating outside the body, using a perfusion machine that delivers warm oxygenated blood supplemented with catecholamine, nutrients and electrolytes."