Humacyte reports Q4 EPS (16c), consensus (25c)

“The past year has been a landmark time for Humacyte (HUMA), highlighted by the FDA’s approval of Symvess for the treatment of extremity vascular trauma,” said Laura Niklason, CEO. “Symvess is a biologic product that went through more than 20 years of research and development, and we believe that this first-in-class approval marks an important new era in vascular surgery. We are thrilled to deliver this transformative innovation to surgeons and patients in need of a new option to save limbs and lives. Results from our clinical studies suggest that there are patients walking on their own legs today who would not be doing so if Symvess were not available. Our commercial launch of Symvess is proceeding at full speed and we are excited by the response to date from hospitals and healthcare providers. So far the market has responded well, and 34 hospitals have already initiated the Value Analysis Committee approval process. We are also excited that just 16 days after having the commercial inventory availability, we made our first shipments of Symvess. The potential health economic benefits of Symvess are supported by our Budget Impact Model that was just published in the Journal of Medical Economics, which concludes that the avoidance of vascular infections and amputations drive cost reduction with the use of Symvess in traumatic injury. Our commercial team will continue to work closely with health care providers to make Symvess available to patients in need nationwide.”