Humacyte

Humacyte's acellular tissue engineered vessel (ATEV) demonstrated superior functional patency compared to standard arteriovenous fistulas in high-risk hemodialysis patients with end-stage kidney disease.

• Humacyte's acellular tissue engineered vessel (ATEV) received FDA approval in December 2024 for extremity vascular trauma, marking a significant advancement in regenerative medicine. • The company is conducting late-stage clinical trials for additional applications including arteriovenous access for hemodialysis and peripheral artery disease, both having received FDA's Regenerative Medicine Advanced Therapy designation. • Humacyte's biotechnology platform aims to deliver universally implantable bioengineered human tissues, with preclinical development underway for coronary artery bypass grafts, pediatric heart surgery, and type 1 diabetes treatment.

• Trestle Biotherapeutics and Humacyte have announced a research collaboration to explore technology integration for bioengineering vascularized organs for transplantation. • The partnership aims to combine Trestle's biofabricated kidney tissues with Humacyte's FDA-approved acellular tissue engineered vessels (ATEV™) to develop human bioengineered kidneys with vascular perfusion. • This collaboration addresses a critical need in kidney disease treatment, potentially offering alternatives for the 600,000 U.S. patients dependent on dialysis and the 100,000 waiting for kidney transplants.

• Humacyte's lab-grown blood vessels receive FDA approval, marking a significant advancement in regenerative medicine and offering new hope for vascular repair. • The technology, developed over two decades, provides an innovative solution for patients with limited options for vascular reconstruction. • This approval underscores the potential of tissue engineering to address critical medical needs and improve patient outcomes in vascular disease. • The bioengineered vessels offer a promising alternative to synthetic grafts, potentially reducing complications and improving long-term patency.

• Humacyte's shares experienced a 38% surge following the FDA's full approval of Symvess for adult patients, indicating strong market confidence. • Symvess is approved as a vascular conduit for extremity arterial injuries when urgent blood flow restoration is needed to prevent limb loss. • The approval is specific to cases where vein grafts are not feasible, offering a new option for complex vascular repairs in trauma cases. • Symvess has been utilized in various traumatic injuries, including those from car accidents, gunshot wounds, and industrial incidents.

The FDA has approved SYMVESS, Humacyte's acellular tissue-engineered vessel, for treating extremity arterial injuries in adults when urgent revascularization is needed.

A class action lawsuit has been filed against Humacyte, Inc. for allegedly misleading investors regarding its manufacturing practices and the FDA review of its Biologic License Application (BLA).

• Humacyte's acellular tissue-engineered vessel (ATEV) demonstrated superior patency compared to synthetic grafts in repairing arterial injuries in trauma patients. • The ATEV system showed a 91.5% 30-day secondary patency rate in extremity patients, outperforming the 78.9% historically reported for synthetic grafts. • The engineered tissue offers an off-the-shelf solution, reducing critical surgical time compared to harvesting a vein from the patient. • Humacyte is seeking FDA approval for ATEV, potentially revolutionizing vascular trauma care and improving patient outcomes in extreme injury scenarios.

• Humacyte's acellular tissue engineered vessel (ATEV) was evaluated against autologous AV fistulas in end-stage renal disease (ESRD) patients requiring hemodialysis access. • The Phase 3 trial assessed the efficacy and safety of ATEV compared to the current standard of care, autologous AV fistulas. • Results from the study were presented at the 51st Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITH).

• Humacyte presented Phase 3 clinical trial results of its acellular tissue engineered vessel (ATEV) compared to autologous AV fistulas for hemodialysis access in end-stage renal disease patients. • The study evaluated the efficacy and safety of Humacyte's ATEV in vascular access for patients undergoing hemodialysis. • Humacyte's ATEV has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA, highlighting its potential in addressing unmet needs in vascular access. • The ATEV is currently under FDA review for vascular trauma repair, with ongoing preclinical development for various other applications.