What You Should Know:
Fresenius Medical Care (FMC) today announced its plans to invest an additional $25 million in clinical-stage biotechnology platform company Humacyte following the extension of its collaboration in June. Fresenius Medical Care acquired a stake in Humacyte in 2018 for $150M as part of a strategic partnership.
Following the merger of Humacyte with a special purpose acquisition company (SPAC), FMC is increasing its position in the newly combined entity as the lead investor of a private investment in public equity (PIPE). The combined company, called Humacyte, is listed and trades on the Nasdaq exchange under HUMA.
Regenerative Innovations Harnessing the Body’s Own Ability to Heal
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 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.