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Fresenius Medical Care gains global distribution rights for vascular access device
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Fresenius Medical Care is spending $150 million to obtain global distribution rights for Humacyl, an investigational vascular access device in clinical trials in the United States.
The agreement with Humacyte Inc. will put Fresenius Medical Care in charge of marketing, sales and distribution of the device and give the dialysis product and services company a 19% stake in Humacyte. The transaction is expected to close in July.
Humacyte’s bioengineered blood vessel for dialysis access is in phase 3 pivotal trials in the United States and Europe, and the company said it plans to seek regulatory approval in both regions upon completion of the trials.
“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,” Franklin Maddux, MD, chief medical officer for Fresenius Medical Care North America, said in a jointly issued press release about the partnership. “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 health care system.”
Humacyte noted that its new access product can be available for use in hemodialysis within weeks of being implanted in the patient and may have an overall higher rate of maturation. It also may offer a more durable, biologic alternative to synthetic grafts, the company noted.
“This is a transformational milestone for Humacyte, giving us the world’s strongest partner to help bring our product to more patients globally,” Carrie Cox, CEO and chairman of Humacyte, said in the release. “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.”
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