The Andover, Mass.-based organ transplant transportation technology developer revealed in a news release that it is offering $60 million in shares of common stock, plus a 30-day option to purchase additional shares that total up to 15% of the numbers of shares sold in the offering.
J.P. Morgan and Morgan Stanley are acting as joint lead book-running managers in the offering, while Canaccord Genuity is acting as lead manager.
TransMedics’ offering follows results from its OCS Liver Protect trial that achieved its primary clinical objectives by meeting primary and secondary effectiveness and safety endpoints.
The 300-patient trial randomized 153 patients for transplantation using the OCS liver and 147 patients in the control group with cold storage methods across 18 U.S. liver transplant centers.
The primary effectiveness endpoint of the study was the incidence of early allograft dysfunction (EAD) in the first seven days, while the primary safety endpoint was the average number of liver graft-related serious adverse events per patient measured over 30 days after the transplant.
Results from the pivotal trial showed that OCS Liver use resulted in a significantly lower incidence of EAD at 17.3% compared to 30.5% in the control. Use of the OCS Liver also resulted in a lower incidence of ischemic cholangiopathy complications at six months (1.4%) compared to the control (8.5%).
The average liver graft-related serious adverse events per patient were non-inferior to the control, coming in at 0.046 compared to 0.075 in the control. A total of 152 donor livers from 155 were successfully transplanted, resulting in a 98.1 utilization rate.
Massachusetts General Hospital chief of the division of transplant surgery and lead investigator Dr. James Markmann said in a news release that the results from the trial “set the stage for transformative changes” in liver transplantation and the investigators are set to submit the results for publication in a peer-reviewed journal soon.
“We are humbled and excited by these compelling top-line results from our OCS Liver Protect trial,” added TransMedics president & CEO Dr. Waleed Hassanein. “Data from the trial further support our belief that the OCS Liver system along with our OCS Lung and OCS Heart systems has the potential to meaningfully improve patient outcomes and increase the number of organ transplants to help end-stage organ failure patients.
“We are grateful for all the trial investigators, their teams and institutions for completing this seminal trial in liver transplantation.”