Fresenius Medical Care (NYSE:FMS; ETR:FRE) said today it inked a $150 million strategic partnership deal with Humacyte through which Fresenius will gain exclusive rights to commercialize Humacyte’s Humacyl bioengineered blood vessel technology.
Research Triangle Park, N.C.-based Humacyte is exploring the use of its Humacyl human acellular vessel as a conduit for hemodialysis in patients with end-stage renal disease who cannot have fistula placement.
Fresenius Medical will now be responsible for the marketing, sales and distribution of Humacyl following appropriate regulatory approval, the companies said. Fresenius will also make a $150 million equity investment to obtain a 19% fully diluted ownership stake in Humacyte, with the deal expected to close next month.
“By partnering with Humacyte, Fresenius Medical Care has an opportunity to offer a dialysis vascular access option with the potential for significant clinical efficacy and safety improvements, including the potential to minimize catheter contact time to the benefit of our patients. Our exclusive rights to distribute this innovative technology to dialysis patients worldwide may have significant benefits not only to patients, but health systems as well. With the potential for fewer anticipated complications and interventions compared to synthetic grafts, we may see increased safety for patients and reduced medical and economic burdens to the healthcare system,” Fresenius Medical Care North America chief medical officer Dr. Franklin Maddux said in a prepared statement.
Humacyl vessels are currently being studied in a Phase III pivotal trial in the US and Europe, with Humacyte planning on seeking regulatory clearances in both regions upon completion.
“This is a transformational milestone for Humacyte, giving us the world’s strongest partner to help bring our product to more patients globally. Our partnership will allow Humacyte to focus on advancing the potential for Humacyl as a substantial breakthrough in the science of regenerative medicine, and to continue our development of an exciting future pipeline,” Humacyte CEO Carrie Cox said in a press release.
In early May, Fresenius saw shares fall slightly after the dialysis-focused medical group missed expectations on Wall Street and saw sales and profits shrink in their first quarter earnings report.