An official statement was made public regarding a collaborative research agreement between Miromatrix Medical and Baxter International to promote bioengineered replacement organs for patients with acute liver failure. These efforts were made to bring in more treatment options for patients who require organ support medications.
As part of the agreement, Miromatrix developed the miroliverELAP liver treatment, which combines a single-use bioengineered liver with Baxter’s PrisMax system. It is considered to be the first Investigative new medication for a bioengineered organ since Miromatrix filed its first application for miroliverELAP to the FDA in November last year.
While Miromatrix’s work is now on hold, Baxter joined hands with the company. After issuing a clinical hold and requesting more information before subjects could be treated, the FDA has given the firm the all-clear to begin phase 1 human research.
After the FDA approved the trial’s continuation, Miromatrix plans to start the Phase I clinical trial of miroliverELAP to treat individuals with Acute liver failure. Baxter is closely involved with Micromatrix and has part ownership in the company as well.
Micromatrix publicly released a statement regarding the closure of the project in December last year. According to the company, the FDA gave reasons which were not related to the hold of the project.
The CEO of Micromatrix Jeff Ross said in a release:
“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.”
Micromatrix raised $43 million from its IPO in 2021 to reduce the enormous backlog of transplant requests by transforming pig organs into human transplants that are safe to use. The method developed by Miromatrix first removes all pig cells from livers and kidneys while maintaining the organ’s structure and blood arteries. After that, live human cells obtained from other organ donors are used to replenish the scaffolding.
According to the firm, there are over 110,000 Americans waiting for organ transplants, and 20 individuals die on average every day while they are on the transplant waiting list. Included in this are the more than 50,000 Americans who pass away from liver failure each year.
Baxter’s PrisMax system, equipment for critical care units that can deliver continuous renal replacement therapy and blood exchange therapies, is used in conjunction with bioengineered tissue in Miromatrix’s liver replacement therapy, known as miroliverELAP.
The liver can repair itself, according to the business, thus, therapy to maintain the native liver is vital to Miromatrix’s objectives. The miroliverELAP is meant to give external support for transplant or recovery, by imitating the functions of the patient’s own liver by attaching the bioengineered organ to Baxter’s ICU hardware.
The first-in-human research of miroliverELAP, which is the focus of the presently delayed phase 1 trial, will act as the cornerstone for investigating clinical evidence that the combination of a device and replacement tissue may sustain patients with acute organ failure.
Baxter prepares to wind down its renal care business. Early last month, the business announced intentions to spin off its $5 billion portfolio of dialysis equipment, consumables, services, and hardware for organ support.
The remaining Baxter company will consist of its drug delivery division, monitors, ventilators, smart patient beds, sophisticated surgery equipment, and nutrition support products, and is expected to cease operations in the upcoming 12 to 18 months.