Saturday, August 8, 2020

Transmedics initiates offering following successful trial showing reduction in liver transplant complications | 2020-05-26

Transplant News Sharing // News from Source

Transmedics Group Inc. reported a proposed public offering of $60 million of its shares of common stock (NASDAQ:TMDX). The Andover, Mass.-based company expects to grant underwriters a 30-day purchase option for additional shares of its common stock up to 15% of the number of shares sold in the offering. J.P. Morgan and Morgan Stanley are jointly managing the proposed offering with Canaccord Genuity acting as lead manager.

The news comes one day after the company reported that the pivotal PROTECT trial showed its Organ Care System (OCS) Liver reduced the most common severe complication following liver transplantation, early allograft dysfunction. The system also resulted in significantly lower incidence of ischemic cholangiopathy complications, a leading cause of late graft failure. The trial met all primary and secondary endpoints.

The Transmedics OCS is a portable unit that enables preservation and assessment of organs to be used for transplantation. The system facilitates extracorporeal warm perfusion of organs and mirrors human physiology, keeping organs in optimal condition. Transmedics received FDA approval to market its OCS Lung in May 2019 and its OCS Heart is currently under FDA review.

The timing for a public offering could work well for the company.

Transmedics “has numerous other growth drivers in its three organ programs that should gain traction in 2020-21,” said Joshua Jennings of Cowen Equity Research in a company update. “Near-term catalysts include submission of a U.S. PMA for liver and FDA advisory panel and potential approval in heart.”

“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,” said Transmedic President and CEO Waleed Hassanein.

The PROTECT trial

The prospective, randomized controlled trial enrolled 300 patients across 18 liver transplant centers in the U.S. The researchers randomized 153 patients to transplantation with livers maintained using the OCS Liver, while 147 patients in the control group received livers preserved and transported using cold storage methods.

The primary endpoint was reduction in early allograft dysfunction (EAD) in the first seven days post-transplant. EAD may indicate damage to the donor liver and is associated with increased ICU and hospital stays.

The trial showed OCS Liver nearly halved the incidence of EAD, 17.3% vs 30.5% in controls, across livers obtained both after donor brain death and after donor circulatory death. Use of OCS Liver also sharply reduced the incidence of ischemic cholangiopathy at six months after transplantation to 1.4% compared to 8.5% for controls.

In addition, the trial demonstrated that the OCS Liver maintained donor livers in near physiologic functioning state. Patient survival 30 days after the transplant was the same in the OCS Liver group and in the control group at 99.3%. Both groups had low rates of average graft-related serious adverse events per patient observed, 0.046 for OCS vs 0.075 for controls.

For the study, the researchers instrumented 155 donor livers on the OCS Liver. Of those 152 were successfully transplanted, for a utilization rate of 98.1%.

The company will be submitting the results to a peer-reviewed journal for publication.

“To our knowledge, these results from the OCS Liver PROTECT trial represent the first time a new technology or therapy has had a positive impact on both EAD and ischemic cholangiopathy in liver transplantation,” said Malcolm MacConmara, director of the Organ Research Lab at the University of Texas Southwestern Medical Center and a co-investigator of the OCS Liver PROTECT Trial. “If approved, this would safely expand the utilization of donor livers and significantly increase the number of livers available for life-saving transplantation.”

Company outlook

Transmedics is also conducting the first U.S. trial of donor (circulator death) hearts (DCD) using its OCS Heart. The company had enrolled 20 patients as of the end of February. The company ended the first quarter with 25 DCD heart transplants, according to Jennings.

That trial has as its endpoint noninferiority of six month posttransplant survival compared to patients who receive hearts preserved with cold storage, after adjustment for risk factors.

While transplants declined from mid-March to mid-April, they are “essential and nonelective procedures,” said Hassanein in a group earnings call in early May 2020.

While disruptions caused by the pandemic caused the company to pull its guidance for 2020, “we are uniquely advantaged in terms of durability of our business by the nature of transplantation,” Hassanein said, with “a well-established pent-up demand for organ transplant procedures represented by the transplant waiting list, which have continued grow even throughout this pandemic.”

COVID testing is now part of standard pre-operative preparation for donors and “we believe organ transplantation will be amongst the first procedures to resume as hospitals begin to shift from dedicating all their available resources to the COVID-19 crisis,” he added.

As a result, Hassanein expected to see incremental improvement on a quarterly basis starting in the third quarter with potential normalization by late 2020 or early 2021.

Transmedics raised more than $105 million from its IPO in May 2019.

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