AlloSource, a non-profit provider of skin, bone and soft tissue allografts and a processor of cellular bone allografts, and Humacyte, Inc., a provider of regenerative medicine pursuing development of investigational bioengineered blood vessels, announced that they have entered into a long-term strategic manufacturing partnership.
In a release on Oct. 10, the Company said that according to the agreement, AlloSource will become the sole manufacturing partner to create Humacyte's investigational bioengineered blood vessels being developed for hemodialysis applications.
"AlloSource's cellular allograft expertise, as well as advanced tissue processing and manufacturing techniques, perfectly positions us to collaborate with Humacyte in continuing the pioneering R&D on their exciting technology," said Thomas Cycyota, president and chief executive officer, AlloSource. "We look forward to working together to honor the gift of tissue donation by using it in a new way to create something that could have the potential to become a progressive, life-saving product for patients in need."
The first investigational bioengineered vessel is being developed with the goal of approval for use in patients with chronic kidney disease.
"Through this collaboration with AlloSource, we believe we can build upon Humacyte's leadership position in vascular tissue engineering with the future market introduction of this innovative, investigational bioengineered blood vessel technology following completion of clinical development and receipt of regulatory approval," said Carrie Cox, chairman and chief executive officer, Humacyte. "AlloSource has a pre-eminent reputation as a leading provider and supplier of allografts and, together, we are joining forces to further establish a solid foundation with this technology for addressing the broad and diverse needs of patients and physicians."
Separately, a human pilot study is underway in Poland to initially evaluate the safety and performance of investigational bioengineered vessels for dialysis access. Future clinical trials, in support of marketing applications in both the U.S. and Europe, are planned after the completion of these initial studies. Subject to the successful completion of clinical development, commercialization of the hemodialysis graft currently is targeted for 2017 contingent upon FDA review and approval.
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