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Miromatrix Announces Key Strategic Investors to Advance the Development of Bioengineered Livers and Kidneys

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Miromatrix Medical (NASDAQ: MIRO), a biotechnology firm, announced significant funding from a Series C financing round led by Baxter, CareDx, and DaVita. The raised capital will expedite clinical trials for their bioengineered organ technology, specifically targeting liver and kidney programs. Miromatrix aims to launch a trial for its External Liver Assist Product in late 2022, addressing the critical shortage of transplantable organs in the U.S., where over 114,000 people await organ transplants.

Positive
  • Successful Series C financing led by strategic investors including Baxter, CareDx, and DaVita.
  • Funding will accelerate the clinical trial of the External Liver Assist Product, targeting human trials in late 2022.
  • Addressing a significant market need; over 114,000 individuals are on transplant waiting lists in the U.S.
Negative
  • The upcoming trial's initiation is still pending, which could imply delays in bringing the product to market.
  • The company continues to face challenges related to the urgent need for organ transplants, highlighting inherent market risks.

The biotechnology company working to eliminate the organ transplant waitlist outlines expansion of its clinical work, supported by IPO funds and Series C round, led by Baxter, CareDx, and DaVita

EDEN PRAIRIE, Minn., Aug. 11, 2021 (GLOBE NEWSWIRE) -- Miromatrix Medical Inc. (NASDAQ: MIRO), a life sciences company pioneering a novel technology for bioengineering fully transplantable organs to help save patients' lives and improve quality of life around the world, announced strategic investors involved in its Series C financing, which was followed by its June 24th IPO.

The Company outlined clinical initiatives and operational expansions as part of its investment plan for 2021 and 2022 focused on their liver and kidney programs. The additional funding will help accelerate Miromatrix' progress towards initiating a clinical trial of its External Liver Assist Product. The trial, which is expected to begin in the second half of 2022, will assess the function of a bioengineered liver in humans via an external application. It will serve as an important milestone in the ongoing research efforts to develop fully transplantable livers and kidneys, addressing the enormous unmet need for thousands of patients in the U.S. each year.

The Series C round was led by the venture capital investment arm of Baxter (NYSE: BAX), with participation by CareDx (NASDAQ: CDNA) and DaVita (NYSE: DVA) as strategic investors in the Company. DaVita originally invested in Miromatrix in 2018, leading its Series B-2 round, and it also provided bridge financing for the Series C round.

"We are excited to have strategic support from Baxter, DaVita, and CareDx, all of whom recognize the potential in our bioengineered organ technology and want to change the future of transplantation," said Jeff Ross, Ph.D., CEO of Miromatrix. "Their support, alongside our recent public offering, brings us closer to our goal of saving and improving patients' lives and ultimately eliminating the organ transplant waitlist."

According to data from the American Transplant Foundation, an estimated 114,000 people in the U.S. are waiting for a life-saving organ transplant, and more than half will die due to a lack of available organs. Miromatrix is currently focused on developing bioengineered livers and kidneys but plans to apply its patented perfusion decellularization and recellularization technology to bioengineer lungs, hearts, pancreases, and other vital organs for patients in need.

"Innovation is at the forefront of our mission to save and sustain the lives of patients with kidney disease across their care journey, which includes chronic kidney disease management through dialysis and to transplant," said Lee Ann Schuette, general manager of peritoneal dialysis, Baxter's Renal Care business. "By investing in potentially transformative kidney care options, we aim to accelerate the growth of innovations that address the unmet needs of kidney patients, so they can live their best lives."

Over 100,000 patients are diagnosed with end-stage renal disease (ESRD) each year in the U.S., with approximately 550,000 patients requiring chronic dialysis or a kidney transplant to survive. In addition, according to the Journal of the American Society of Nephrologists, more than 40,000 Americans die waiting for a kidney transplant each year due to the chronic shortage of kidneys. Miromatrix, Baxter, DaVita, and CareDx share a similar mission of providing patients with life-saving and sustaining therapies.

"Establishing partnerships with innovative health care companies seeking to improve the lives of patients with kidney failure is core to our work at DaVita," said Javier Rodriguez, CEO of DaVita. "We're energized to be deepening our collaboration with Miromatrix at this critical juncture for the company and shaping the future of kidney care together."

"Increasing organ availability through innovation aligns with our mission to improve long-term outcomes for patients across the transplant journey," said Reg Seeto, President and CEO of CareDx. "This collaboration with Miromatrix is perfectly in line with CareDx's vision to be the leading partner in the transplant ecosystem."

Miromatrix is a 2019 KidneyX Redesign Dialysis Phase I award recipient from the U.S. Department of Health and Human Services and the American Society of Nephrology to further the development of innovative solutions that can prevent, diagnose, and/or treat kidney diseases. The Company was also awarded a 2019 grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health to advance the development of a bioengineered transplantable liver to address the chronic shortage of transplantable livers.

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.

About Baxter
Every day, millions of patients and caregivers rely on Baxter's leading portfolio of critical care, nutrition, renal, hospital and surgical products. For 90 years, we've been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies, and therapies available in more than 100 countries, Baxter's employees worldwide are now building upon the company's rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on TwitterLinkedIn, and Facebook.

About CareDx
CareDx, Inc., headquartered in South San Francisco, California, is a leading precision medicine solutions company focused on the discovery, development and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. For more information, visit CareDx.com.

About DaVita
DaVita is a health care provider focused on transforming care delivery to improve quality of life for patients globally. The company is one of the largest providers of kidney care services in the U.S. and has been a leader in clinical quality and innovation for more than 20 years. DaVita cares for patients at every stage and setting along their kidney health journey—from slowing the progression of kidney disease to helping to support transplantation, from acute hospital care to dialysis at home. As of June 30, 2021, DaVita served 204,300 patients at 2,828 outpatient dialysis centers in the United States. The company also operated 331 outpatient dialysis centers in ten countries worldwide. DaVita has reduced hospitalizations, improved mortality, and worked collaboratively to propel the kidney care industry to adopt an equitable and high-quality standard of care for all patients, everywhere. To learn more, visit DaVita.com/About.

Investor Contact
Greg Chodaczek
347-620-7010
ir@miromatrix.com

Media Contact:
press@miromatrix.com 


FAQ

What recent funding did Miromatrix Medical (MIRO) secure?

Miromatrix Medical secured Series C funding led by Baxter, CareDx, and DaVita.

When is Miromatrix planning to start its clinical trial for the External Liver Assist Product?

The clinical trial is expected to begin in the second half of 2022.

How many people are on the organ transplant waiting list in the U.S.?

Over 114,000 people are currently waiting for life-saving organ transplants in the U.S.

Who are the strategic investors in Miromatrix's Series C financing?

The strategic investors include Baxter, CareDx, and DaVita.

Miromatrix Medical Inc.

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