CareDx and Miromatrix Announce Exclusive Partnership to Advance Research Using Bioengineered Organs for Human Transplantation

CareDx Exclusive Provider of dd-cfDNA Testing Services for Use in Miromatrix Clinical Trials

Companies at Forefront of Alternative Organ Supply Research to Address Organ Shortage

CareDx, Inc. (Nasdaq: CDNA) and Miromatrix Medical Inc. (“Miromatrix”) (Nasdaq: MIRO) – today announced an exclusive partnership aimed at advancing the next wave of innovation using fully transplantable human bioengineered organs.

CareDx will develop an innovative testing solution for Miromatrix to use in pre-clinical animal models and will be the exclusive provider of donor-derived cell-free DNA (dd-cfDNA) testing services for use in human clinical studies to non-invasively assess acute allograft rejection in Miromatrix’s pipeline of human bioengineered organs.

“We are committed to being at the forefront of driving the next wave of innovation to address the organ supply shortage in transplantation through this collaboration with Miromatrix. We hope one day that bioengineered organs will become a reality for the thousands of patients waiting for a life-saving organ,” said Reg Seeto, CEO and President of CareDx. “We are proud to partner with Miromatrix, a leader at the forefront of human bioengineered organ development as they apply our expertise to advance their clinical pipeline.”

“CareDx is at the leading edge of transplant innovation and has been instrumental in driving paradigm shifts in clinical practice through their non-invasive testing services which are widely used by leading organ transplant centers across the U.S.,” said Jeff Ross, Ph.D., CEO of Miromatrix. “Our partnership with CareDx allows us to tap into their expertise in ways that may help us accelerate our momentum as we drive the next wave of innovation with bioengineered alternatives for use in human organ transplants.”

It is estimated that more than 100,000 people in the U.S. are waiting for an organ transplant,¹ but only slightly more than half of them are expected to receive an organ within five years.² It is estimated that 17 people die each day waiting for an organ transplant.¹

About CareDx – The Transplant Company

CareDx, Inc., headquartered in Brisbane, 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, please visit: caredx.com.

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. Miromatrix has developed a proprietary perfusion technology platform for bioengineering organs that it believes will efficiently scale to address the shortage of available human organs. Miromatrix’s initial development focus is on human livers and kidneys. For more information, visit: miromatrix.com.

CareDx Forward Looking Statements

This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the potential benefits and results that may be achieved with CareDx’s partnership with Miromatrix to advance research using human bioengineered organs (the “Partnership”). These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of the Partnership; risks that CareDx fails to develop the innovative testing solution in pre-clinical animal models or become the exclusive provider of dd-cfDNA testing services in human clinical studies for Miromatrix as planned; general economic and market factors; and other risks discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed by CareDx with the SEC on February 27, 2023 and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

Miromatrix Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding the testing solutions that will be used in pre-clinical animal models and the DNA testing services for use in human clinical studies. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "outlook," "guidance," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.

The forward-looking statements in this press release are only predictions and are based largely on our current business plans, expectations, and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our history of significant losses, which we expect to continue; our limited history operating as a commercial company; our expectations with respect to the regulatory pathway of our product candidates, our ability to obtain regulatory approvals for such product candidates, and the anticipated effect of delays in obtaining any such regulatory approvals; our expectations with respect to preclinical and clinical trial plans for our product candidates, the results of such activities and the safety and efficacy of our product candidates; our ability to commercialize our product candidates; our ability to compete successfully with larger competitors in our highly competitive industry; our ability to achieve and maintain adequate levels of coverage or reimbursement for any future products we may seek to commercialize; our expectations regarding our manufacturing capabilities; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide, including the outbreak of the novel strain of coronavirus, COVID-19; product liability claims; our ability to establish and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others; our ability to attract and retain senior management and key scientific personnel; and other important factors that could cause actual results, performance or achievements to differ materially from those expected or projected. For information identifying important factors that could cause actual results to differ materially from those anticipated in the forward-looking statements, please refer to the Risk Factors section of Miromatrix's 10-K filed with the U.S. Securities and Exchange Commission and any additional risks presented in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Except as expressly required by applicable securities law, Miromatrix disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

References

1. Health Resources and Services Administration: Organ Donation Statistics.
2. United Network for Organ Sharing: Waiting for your transplant

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