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Fresenius Medical Care increases investment in Humacyte, accompanies human acellular vessel developer’s stock market launch

| Press release

Press release

Fresenius Medical Care, the world’s leading provider of products and services for individuals with renal diseases, is investing an additional USD 25 million in the U.S. medical company Humacyte, Inc. In connection with the merger of Humacyte with a special purpose acquisition company (SPAC), Fresenius Medical Care is increasing its position in the newly combined entity as the lead investor of a private investment in public equity (PIPE). Fresenius Medical Care acquired a stake in Humacyte in 2018 for USD 150 million and agreed then on a strategic partnership. The combined company, which will be called Humacyte, is listed and trades on the Nasdaq exchange under HUMA. Fresenius Medical Care’s original stake in Humacyte will be exchanged for shares in the combined company.

Humacyte is developing implantable human acellular vessels for multiple vascular repair, reconstruction and replacement. These vessels are biologically produced blood vessels made from banked human smooth muscle cells; they are manufactured to be non-immunogenic and are to be available “off the shelf” when needed by a patient. Among numerous applications, the product is now being investigated in a clinical study for use as a vascular access for hemodialysis patients, and may prove more effective than conventional synthetic grafts and fistulas in reducing infection as well as central venous catheter use. Other possible applications include reconstruction and repair from traumatic injury, and for implants for various vascular diseases.

“Humacyte's regenerative medicine technology has great potential in many areas of healthcare,” said Franklin W. Maddux, MD, Global Chief Medical Officer of Fresenius Medical Care. “We are committed to helping Humacyte achieve market approvals with this renewed investment, to bring their technology into the mainstream of health delivery. This will bring benefits worldwide in the care of patients needing repair or reconstruction of the human vasculature. In this way, Fresenius Medical Care is consistently pursuing our strategic goal of driving medical progress with innovative therapeutic approaches, recognizing the powerful advances this represents in bringing regenerative medicine to people in need.”

Humacyte and Fresenius Medical Care had already expanded their collaboration in June: In addition to the vascular access and peripheral arterial disease applications, Fresenius Medical Care was granted exclusive rights to market the human acellular vessel outside the United States, including enhancements and modifications for vascular trauma applications.

“Our partnership with Fresenius Medical Care has developed very positively over the last three years, and we are very pleased with the company’s renewed commitment to our shared goals,” said Laura Niklason, MD, PhD, the Chief Executive Officer of Humacyte. “Our two teams have worked well to prepare for the commercialization of our human acellular vessels globally since the formation of the partnership, and we look forward to collaborating further to benefit patients and care providers, as well as the growth of our two companies.”

The biotechnology-derived blood vessel is an investigational product and is currently subject to late-stage clinical trials in the United States and Europe. Humacyte plans to file for regulatory approval in both markets after their completion Fresenius Medical Care will support the approval processes and plans the introduction in other markets worldwide with Humacyte.

Fresenius Medical Care is the world's leading provider of products and services for individuals with renal diseases of which around 3.7 million patients worldwide regularly undergo dialysis treatment. Through its network of more than 4,100 dialysis clinics, Fresenius Medical Care provides dialysis treatments for approximately 346,000 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Along with its core business, the Renal Care Continuum, the company focuses on expanding in complementary areas and in the field of critical care. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME) and on the New York Stock Exchange (FMS).

This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to various factors, including, but not limited to, changes in business, economic and competitive conditions, legal changes, regulatory approvals, impacts related to the COVID-19 pandemic results of clinical studies, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.