Investigational HAV products.
Imagine lifesaving vascular access or replacement of segments of a patient’s blood vessels without requiring any cells or tissue from the patient. At Humacyte, this vision may become a reality thanks to our proprietary technology and process for developing HAV products that are currently being investigated in the clinic.
Our Technology Platform
Located in our state-of-the-art facility, our technology platform isolates and grows stable, immediately available investigational HAV replacements which, if approved, could be tailored to pre-designed clinical and commercial specifications for vascular and non-vascular surgery applications.
By growing these investigational vessels in vitro from banked vascular smooth muscle cells and then decellularizing the final HAV product, we may be able to significantly increase the durability of the vascular access and reduce the risk of infection. The result? An end product that can be ready on a hospital storage shelf for any patient — at any time — in need of a new or replacement vascular access.
Following further development and regulatory approval, our goal is to design and create a manufacturing process to produce commercial quantities of our investigational HAVs in a scalable, cost-effective manner. In our ongoing research, we see vast opportunities for products with life-saving potential.
Designed for significant unmet clinical needs.
HAVs: breakthrough in the world of vascular access and tissue replacement.
A new surgical option.
The benefits of investigational HAVs mean potentially better efficacy, safety, and outcomes for patients.
LOWER RATE OF FAILURE
The failure rate for current plastic dialysis grafts is high, with complications that include infection, thrombosis, and neo-intimal hyperplasia. Investigational HAVs are found to be more resistant to these failure modes in initial investigational trials.
Using investigational HAVs means that other surrogate blood vessels, e.g., saphenous vein from the leg, won’t have to be removed from the patient. This approach saves the patient’s vein and the patient from additional operations.
Investigational HAVs have the potential to be grown, stored and immediately available for vascular access or as a peripheral conduit throughout the body.
Surgical creation of vascular accesses may be costly, and complications often arise. The more durable, investigational HAVs have the potential to avoid complications and more surgeries, yielding potentially significant health care cost savings.
How investigational HAVs could change lives.
The use of investigational HAVs could lead to more positive, long-term clinical outcomes for End-Stage Renal Disease.
Humacyte’s Target Application
A target goal at Humacyte has been to create lifesaving and long-lasting vascular access or replacement for patients with End-Stage Renal Disease. Humacyte’s technology platform is designed to create products that can be stored for at least one year, and available for any suitable patient candidate, making biologic vessels and other human tissues readily available for surgeons and patients at the time of need.
More than 465,000 people in the U.S. with End-Stage Renal Disease (ESRD) undergo hemodialysis treatment.
Current vascular access options have poor durability or functional patency, and ultimately fail.
Humacyte’s HAV (our investigational HAVs) could serve as a potential alternative to synthetic fluoropolymers (plastic grafts) in these patients.
In clinical trials, HAV has shown the potential to resist inflammatory and immune responses from the recipient. These attributes make HAV a great alternative and confer potential remarkable advantages vs. other potentially competing and largely synthetic products.
At Humacyte, we see endless potential for better patient outcomes. We anticipate a continued evolution of products for clinical needs. Future elements include pilot-scale operations in our current Humacyte cGMP manufacturing space as well as plans to transition to large-scale, campaign production. Potential new applications include:
We have started a phase II clinical trial of HAV as a bypass conduit in patients with peripheral arterial disease (PAD). This trial will assess the vessel’s performance in the arterial bypass position, and gauge usability and suitability for repairing peripheral human arterial blood vessels in patients with peripheral arterial disease (PAD) in the US.
Utilizing recent funding from the National Institute of Health and the U.S. Department of Defense, to explore applications for bypass and reconstruction in patients with peripheral vascular trauma, Humacyte will begin clinical trials that focus on patients with vascular trauma (potentially civilians and soldiers) with penetrating wound injuries or peripheral blast trauma.
We believe that our ongoing research and development may ultimately lead to additional groundbreaking applications of Humacyte’s technology, including vascular reconstruction and Coronary Artery Bypass Grafting (CABG).
Our clinical trials have led to positive results.
AV: arteriovenous, in our case, a surgery performed that directly connects or transposes a vein and an artery PAD: Peripheral Arterial Disease Vascular Trauma: injury to a blood vessel; in our case, bypass of arterial trauma either due to motor vehicle accident (MVA), or due to a penetrating trauma such as knife or gunshot wounds Small Caliber: small size structure; in our case, less than 6mm diameter