Fresenius Medical Care is buying in to regenerative tissue developer Humacyte, with a $150 million equity investment and a plan to help commercialize its humanized blood vessel, with the aim of improving vascular access in its dialysis clinics worldwide.
The deal grants Fresenius a 19% ownership stake in the company, in return for exclusive global rights to Humacyte’s investigational acellular vessel, Humacyl. Fresenius will be responsible for marketing, sales and distribution following the necessary regulatory approvals.
Currently being studied in trials in the U.S. and Europe, Humacyl vessels are built in vitro from donated human smooth muscle cells, which grow around a tubular scaffold made from a biodegradable suture material. The cells then generate collagen to form the vessel, before being removed to avoid triggering an immune response.
The companies hope the implants provide safer and more effective access ports for hemodialysis than current techniques involving synthetic grafts and catheters that may be prone to infection or degradation, or surgical fistulas, which connect an artery to a vein to improve blood flow during dialysis procedures, but may take additional time and fail to mature.
Humacyte’s chief medical officer, Jeff Lawson, said the company plans to file for FDA approval in mid-2019—after completing at least 12 months of follow-up in its phase 3 trial of patients with end-stage renal disease, a milestone set for this September—with commercialization planned for early 2020 if all goes well.
Though its use is also being studied in peripheral artery disease, vascular trauma and other cardiovascular indications, advancing Humacyl first in kidney disease will provide a solid test case for the regenerative product.
“It’s a very safe place to develop new vascular technologies under clinical study,” Lawson told FierceMedTech, describing how the tissue implant in the arm can be observed three times a week during dialysis procedures. “If the access fails, that’s unfortunate for the patient, but it’s unlikely that the patient will have a critical problem like a stroke or a heart attack or lose a limb, as it could in other anatomic locations.”
“From a regulatory safety standpoint, this is the first area we could enter safely and work with the FDA to get approval for a complete new technology,” Lawson said.
The FDA previously granted Humacyl its latest Regenerative Medicine Advanced Therapy designation to expedite the product. In addition, the company is pursuing work with the Department of Defense to study the vessel’s use in battlefield trauma care.
The strategic partnership between Fresenius and Humacyte—expected to officially close in July, following less than a year of talks—almost happened by default, as the companies worked on clinical trials, he said.
“It evolved organically into a very reasonable and intelligent thing to do,” Lawson said. “We can provide a new technology that helps them care for their patients, and we can get early and immediate market access for the use of our blood vessel in a space where there’s a lot of technologies, none of which work very well.”
For one, synthetic blood vessels tend to not last quite as long as those that are more natural, and subsequent infections and complications can impose a large burden on health systems, said Frank Maddux, Fresenius’ CMO and executive VP of clinical and scientific affairs.
“Vascular access care has been a complicated part of the care of these patients for many, many years,” Maddux said. “Humacyte’s combination of a presized vessel—and one that is fundamentally human-derived and biocompatible in a way that we haven't seen before—was quite compelling to us, as a large user of these kinds of vessels.”
Fresenius aims to not only help Humacyte advance their clinical program, but distribute a product globally that it sees as having incredible potential for medicine, Maddux described.
“How do we bring this scientific advancement, that we think is fundamentally game-changing, to patients quicker than it might naturally get there?” he said. “And do it in a way that’s better for patients, better for healthcare delivery systems, and certainly better for the growth and evolution of this small company, which has developed what I would call a groundbreaking scientific and technological breakthrough.”