Miromatrix Applauds the FDA for Its Continued Commitment to the Field of Organ Transplant
Miromatrix Medical Inc. (NASDAQ: MIRO) recently commended the FDA for its two-day public advisory committee meeting focused on organ transplantation, especially xenotransplantation. The FDA acknowledged the critical shortage of human organs for transplant and the need for innovative solutions. Miromatrix shared its proprietary decellularization and recellularization technology, which aims to create transplantable organs without classifying as xenotransplantation. This technology may potentially reduce organ rejection risks by replacing pig cells with human cells, addressing historical challenges in organ transplantation.
- FDA recognizes the urgent need for innovative organ transplantation solutions.
- Miromatrix's proprietary technology may improve organ transplant success rates.
- The technology is not classified as xenotransplantation, potentially easing regulatory challenges.
- None.
EDEN PRAIRIE, Minn., July 05, 2022 (GLOBE NEWSWIRE) -- Miromatrix Medical Inc. (NASDAQ: MIRO), a life sciences company pioneering a novel technology for bioengineering fully transplantable organs to help save and improve patients' lives, applauds the U.S. Food and Drug Administration (FDA) for hosting a two-day public advisory committee meeting to discuss scientific and regulatory topics relating to the field of organ transplant, specifically xenotransplantation. Opening remarks from the FDA highlighted the limited availability of human organs for transplant and recognized the tremendous unmet need for new treatments for patients with end-stage organ failure.
"We are appreciative of the FDA's significant commitment of time and resources to discuss topics that may ultimately help address the extensive shortage of organs available for transplant. We are also excited by the possibility that our proprietary decellularization and recellularization technology may provide an additional treatment alternative for organ transplant patients," said Jeff Ross Ph.D., Miromatrix's CEO. "Our proprietary decellularization and recellularization technology platform was designed in such a manner that we believe it is not classified as xenotransplantation, and it may address some of the challenges that have historically faced xenotransplantation technologies, including gene editing technologies."
Scott Nyberg M.D., Ph.D., a Mayo Clinic transplant surgeon and Miromatrix collaborator, added that "Miromatrix's two-step method of decellularization and recellularization is designed to remove the porcine cells from the organs obtained from pigs and replace them with unmodified human cells to reduce the risk of organ rejection amongst other potential benefits."
The FDA published its original guidance for the xenotransplantation industry in 2003 and updated that guidance in 2016. The FDA noted that the updated guidance addresses many of the topics discussed during the two-day meeting and that the science is changing rapidly.
About Miromatrix
Miromatrix Medical Inc. is a life sciences company pioneering a novel technology for bioengineering fully transplantable human organs to help save and improve patients' lives. The Company has developed a proprietary perfusion technology platform for bioengineering organs that it believes will efficiently scale to address the shortage of available human organs. The Company's initial development focus is on human livers and kidneys. For more information, visit miromatrix.com.
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