TransMedics said yesterday that it added $12.5 million to the $51.2 million equity round it closed in May, taking its total raise to more than $63.7 million.
Andover, Mass.-based TransMedics developed the Organ Care System, which is designed to perfuse donor organs with warm, oxygenated blood and monitor its status until transplantation.
“We are thankful and excited to be 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,” CEO Dr. Waleed Hassanein said back in May, when the company announced the funding.
The round was co-led by the Fayerweather Fund and Pharmstandard International S.A., represented by InBio Ventures, Ervington Investments and BioStar ventures, Transmedics reported.
Existing investors Abrams Capital, Lung Biotechnology PBC, Flagship Ventures and KPCB joined the round. A total of 20 investors joined the round, according to a July 11 SEC filing.
In February, TransMedics said it launched a pivotal study of its OCS Liver device, which is designed to keep donated human liver warm and perfused until transplantation.
TransMedics said the 1st liver transplantation using OCS Liver was performed at Mass. General Hospital by Dr. James Markmann, a lead investigator for the 300-patient OCS Liver Protect trial and chairman of its steering committee.
Last November, the FDA told MassDevice.com that it decided it didn’t need to hold an advisory panel meeting to review the TransMedics heart preservation device. TransMedics is seeking an indication for “a portable, ex vivo organ perfusion system intended to preserve a donor heart in a near-normothermic and beating state from retrieval until the eventual transplantation into a suitable recipient,” according to the FDA.
In April 2015, The Lancet published results from the Proceed II study of 130 heart transplant patients, who were randomized to receiving hearts preserved with the OCS or via cold static storage. The TransMedics device came up non-inferior for the trial’s primary endpoint of 30 day patient and graft survival compared with traditional cold storage (94% vs. 97%).
In a Lancet editorial, the authors pointed out that 5 donor hearts in the Proceed II OCS arm were found unacceptable for transplant and discarded, meaning they were also excluded from the recipient outcome-focused study – which could cut both ways.
“The investigators suggest that the Organ Care System was able to identify pathologically abnormal hearts, and that potential recipients of these hearts were spared exposure to suboptimum organs,” they wrote, noting that the OCS would be considered inferior if the endpoint were adequacy of myocardial protection and donor heart utilization “because hearts that were initially deemed acceptable for transplantation were ultimately not implanted.”
“Importantly, the pathological abnormalities identified in these hearts do not necessarily represent non-viability,” they wrote. “Therefore, if these hearts had been allocated to patients in the cold static storage group, they might well have been transplanted with a successful outcome.”
TransMedics raised $20 million last year for the OCS device.
