Baxter links up with Miromatrix to test bioengineered liver replacement therapy

Baxter has teamed up with the xenotransplant developer Miromatrix Medical to help advance bioengineered replacement organs for patients suffering from acute liver failure.

The medtech signed on while Miromatrix’s work is currently in a holding pattern. The company is awaiting a green light from the FDA to launch a phase 1 human study after the agency delivered a clinical hold and requested additional data before participants could be treated.

After first disclosing it had received the FDA’s directive to pause the trial last December, Miromatrix provided a public update on the same day as the announcement of its collaboration with Baxter: In addition to seeking extra non-clinical and clinical information, the FDA also provided “valuable insights relating to certain chemistry, manufacturing and control,” as well as “clinical protocol topics unrelated to the clinical hold,” the company said.

“Having evaluated the matters identified in the clinical hold letter, we plan to submit our response to the FDA in the second half of 2023 and initiate a first-in-human clinical trial shortly after IND clearance,” Miromatrix CEO Jeff Ross said in a release.

Miromatrix, which went public through a $43 million IPO in June 2021, aims to convert pig organs into safe-to-use transplants for humans, with the goal of shortening the immense backlog for transplant requests. 

Starting with livers and kidneys, Miromatrix’s technology clears out all pig cells from the organ, leaving the architecture and blood vessels intact. That scaffolding is then refilled with living human cells harvested from other organ donors. 

The company estimates that more than 110,000 people in the U.S. are on the transplant list, while an average of 20 people die each day waiting for a compatible organ to become available. That includes more than 50,000 people in the U.S. dying from liver failure each year.

Baxter, which previously backed Miromatrix’s series C funding round, will now collaborate with Miromatrix to explore additional treatment options for patients with acute liver failure that are in need of organ support therapies. 

Miromatrix’s liver replacement therapy, called miroliverELAP, combines bioengineered tissue with Baxter’s PrisMax system—hardware for intensive care units that can provide continuous renal replacement therapy and blood exchange treatments.

According to the company, the liver can regenerate itself under certain circumstances, making therapy to support the native liver relevant to Miromatrix’s goals. By connecting the bioengineered organ to Baxter’s ICU hardware, miroliverELAP is designed to provide external support as a bridge-to-transplant, or even as a bridge-to-recovery, by replicating the functions of the patient’s own liver.

As the subject of the currently paused phase 1 trial, the first-in-human study of miroliverELAP will serve as the foundation for exploring clinical evidence that the combination of a device and replacement tissue can support patients with acute organ failure.

The liver-focused team-up also comes as Baxter plots the exit of its kidney care division. The company laid out plans early last month to spin off its $5 billion portfolio of dialysis machines, supplies, services and organ support hardware.

Scheduled to drop in the next 12 to 18 months, the remaining Baxter business will include its drug delivery division, monitors, ventilators, smart patient beds, advanced surgery devices and nutrition support products.