Humacyte Closes $75 Million Series C Financing
The funding is expected to support Humacyte’s ongoing HUMANITY study, the company’s pivotal Phase III study assessing the human acellular vessel (HAV), or HUMACYL®, as a conduit for hemodialysis in patients with end-stage renal disease who are not candidates for fistula placement. In September 2017, Humacyte announced the completion of enrollment of 350 evaluable subjects and expects 12-month post-implantation patient data from the study to be available during the third quarter of this year.
HUMACYL is an investigational product that has not yet been approved by the FDA. However, clinical trials to date suggest that HUMACYL has the potential to become a part of the body’s living tissue. These trials also suggest that HUMACYL may have the potential to last longer with fewer complications than existing synthetic alternatives used for hemodialysis access, possibly lowering healthcare costs by decreasing the number of surgical interventions.
Humacyte also intends to use the funds to complete the development, testing, and qualification of the proprietary bioprocessing system planned to manufacture HUMACYL. Earlier this year, Humacyte completed construction of its state-of-the-art, R&D and bioprocessing facility in Durham, North Carolina. Upon Phase III study completion and facility qualification, the company plans to file a biologics license application (BLA) to seek marketing authorization for HUMACYL. As previously announced, HUMACYL was granted the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA), which is expected to expedite its pathway through the FDA review process.
“The enthusiastic response from new and existing investors is a reflection of the remarkable opportunity Humacyte has to revolutionize vascular medicine, through our groundbreaking biomedical engineering platform,” said Carrie S. Cox, Chairman and Chief Executive Officer of Humacyte. “Completing the final stage of clinical testing for our first product candidate later this year will be a significant achievement for our organization and the overall regenerative medicine industry.”
The company also announced plans to complete the transition of its development teams and laboratories to the new facility by the third quarter of 2018. The new facility will also serve as Humacyte headquarters.