Humacyte is a biotechnology company specializing in the development of bioengineered human tissues, notably universally implantable, lab-grown blood vessels, aimed at transforming vascular medicine and improving patient outcomes.
Can you provide an overview of the key highlights and changes at Humacyte since last year?
Since our last discussion in December 2023, we have seen significant progress. At that time, we had just submitted a Biologics License Application (BLA) to the FDA for our engineered blood vessel, the Acellular Tissue Engineered Vessel (ATEV), for the treatment of vascular trauma. Our BLA was accepted and granted priority review with a PDUFA decision date originally set for August 10, 2024. During the process, the FDA conducted a thorough review, including inspections and discussions about manufacturing, data, labeling, and post-approval commitments. However, just before the decision date, the FDA requested additional time to review our file. As of now, we are still awaiting their final decision, but we remain confident based on our long-term data and the product's performance.
In the meantime, we have made strides with our pivotal Phase 3 clinical trial studying the ATEV to help patients with kidney failure on dialysis. The results showed that our vessels outperformed the current standard of care, improving usability, function, and patency for dialysis access. These findings were presented at the American Society of Nephrology’s Kidney Week conference recently. Additionally, we are engaging with the FDA to pursue a second indication for our vessels in dialysis access for patients with kidney failure.
If the FDA grants approval, when do you expect patients to benefit from your product?
While I cannot predict when the FDA will deliver its decision, we are ready to move quickly upon approval. Our commercialization and manufacturing readiness are already in place, ensuring a smooth transition post-approval.
What are your market estimates for engineered blood vessels?
We project significant demand over time. For the U.S. trauma market alone, which believe there are approximately 26,000 arterial repair cases annually. While uptake rates are hard to predict, our modeling supports us capturing a meaningful portion of that market. .
Do you manufacture the vessels in-house?
We handle all manufacturing in-house. While we initially worked with a contract research organization for smaller-scale production during early Phase 3 trials, we brought manufacturing entirely in-house in 2019.
Growing human arteries from scratch is a highly specialized process, so we have scaled our capabilities for commercial production. Our current facility can produce about 8,000 vessels annually, with potential expansion to 40,000 vessels as demand increases.
Beyond trauma and dialysis, what other potential applications are in your pipeline?
We are exploring multiple indications, including peripheral artery disease, heart bypass, pediatric heart surgery, and type 1 diabetes. If approved, these applications could fundamentally change how vascular diseases and injuries are treated. The concept of repairing arterial injuries without causing additional harm to the patient—by using engineered vessels rather than harvesting veins—is transformative. It could significantly improve patient outcomes and surgical approaches over time.
Have you considered licensing your bioengineering platform for broader applications?
Our platform has immense potential, and while we have primarily focused on internal development, partnering with companies specializing in specific disease areas could make sense. For instance, we have already demonstrated the ability to create other tubular tissues, like tracheas, that function in primates. Potential applications in the urinary and digestive tracts could also emerge. Collaborating with established players in areas like diabetes or gastrointestinal diseases could accelerate clinical trials and product commercialization.
Are you still working with Ukraine on humanitarian efforts?
Our humanitarian program with Ukraine ran from June 2022 to June 2023 as mandated by the Ukrainian government. While we no longer have an active program, we continue to follow up with the treated patients. In August 2024, we presented long-term data from this initiative at a military medical meeting in Florida. Just last month, JAMA Surgery, an American Medical Association peer-reviewed journal, published results from the humanitarian program and from our Phase II/ III clinical studies in a study detailing the performance of the ATEV for the repair of vascular injuries in civilian life and on the battlefield.
Looking ahead, what progress do you hope to share next year?
By next year, I hope to report that our vessel has received its first FDA approval for trauma and that sales are ramping up. I also aim to share news about filing for a second indication in dialysis access and the initiation of a Phase 3 clinical study for peripheral artery disease. This progress would reflect our dedication to transforming vascular medicine and improving patient care.
