TransMedics last week registered for an initial public offering worth more than $86 million for the organ transplant transportation system it developed.
The Organ Care System is designed to keep donated hearts, lungs and livers in near-living condition until transplantation; the company touts it as the only such system designed for more than one organ.
In Europe, the OCS Heart and OCS Lung devices are already on the market. A year ago the Andover, Mass.-based company won pre-market approval from the FDA for its OCS Lung transplant device for standard double-lung transplantation procedures.
In an April 5 regulatory filing TransMedics said it aims to raise as much as $86.3 million in the IPO, but didn’t detail the number of shares it plans to float or their potential price. It plans trade the stock on the NASDAQ exchange under the “TMDX” symbol.
TransMedics said it expects the FDA action over the next 18 months on the other PMAs it’s submitted, including one filed last August for unused donor lungs and another filed in December 2018 for currently utilized and un-utilized hearts donated after brain death.
In the U.S. the OCS devices are reimbursed using existing billing codes, with Medicare and private payors covering their use in pivotal trials of all three organs and for OCS Lung after last year’s approval.
“We believe these established channels will continue to facilitate commercial reimbursement for the OCS Lung and, if they are approved by the FDA, for the OCS Heart and OCS Liver. We are also in the process of seeking long-term reimbursement for our products outside of the United States,” TransMedics said in the filing.
The company said it put up sales of $13.0 million last year, up 68.8% compared with 2017.
In a separate release, TransMedics issued final results from its OCS Heart Expand study of already-donated hearts that might go unused. Presented last week at the annual meeting of the International Society for Heart & Lung Transplantation, the study showed a successful transplant rate of 81% and a patient survival rate of 95% at 30 days.
“We used donor hearts that would often have been wasted because of the inability to assess their viability using conventional cold storage. The OCS Heart also enabled investigators to travel longer distances to retrieve donor hearts to help more of our patients on the waiting list for a heart transplant,” said Dr. Jacob Schroder, of the Duke University Hospital, who presented the trial results, said in prepared remarks.
“These results have the potential to significantly expand the number of viable donor hearts for transplantation to help patients in need,” added TransMedics CEO Dr. Waleed Hassanein. “We are grateful for the dedication and commitment of the OCS Heart Expand trial investigators and, most importantly, we would like to thank the heart transplant patients who participated in the trial.”