Investigational HAV Products
Humacyte is pioneering the development and manufacture of off-the-shelf, universally available, immediately implantable, bioengineered human tissue. Our Human Acellular Vessel (HAV) is being explored as an innovative, regenerative vascular prosthesis to support repair, reconstruction, and replacement of blood vessels across multiple indications.
Our Technology Platform
Our proprietary technology platform deposits cryopreserved primary human aortic vascular cells, isolated from donor tissues, onto a biodegradable polymer mesh within a single-use bioreactor bag. Over weeks, the cells proliferate and build extracellular matrix while the polymer mesh degrades. The resulting bioengineered vessel is then decellularized to create the HAV: a vessel that retains the biomechanical properties of the vessel but cleansed of cellular components that could induce an immune response. The HAV in the bioreactor bag can be shipped, refrigerated, and immediately used when needed.
Potential Benefits Of Investigational HAVs
HAVs have broad applicability across the human body and the ability to address existing unmet needs.
HAVs are designed to be stored on-site at hospitals, trauma centers, and outpatient surgical centers.
HAVs are designed to be available for immediate use by simply opening and removing the HAV from its original flexible bioreactor bag.
Because they are acellular, HAVs have the potential to be universally implantable and durable across patients. In clinical trials, the HAVs have not generated foreign body or immune responses.
Low Infection Susceptibility
HAVs have reduced rates of infection compared to synthetic grafts, potentially allowing use in contaminated wounds with fewer complications.
Uniform and Predictable Size, Structure, and Quality
Harvested veins vary in size, structure, and quality by donor. Due to our proprietary manufacturing platform, HAVs are fabricated to precise specifications and under controlled quality standards.
HAVs have the potential to repopulate with the patient’s own vascular cells, creating a living vascular tissue with the associated long-term benefits of self-healing and infection resistance.
Designed For Significant Unmet Clinical Needs
Humacyte is developing the HAVs for broad applicability across the human body to address existing unmet needs.
Traumatic events (home or vehicle accidents, falls, or violent crime) can cause life-threatening injuries to blood vessels. Surgeons treating these injuries need to rapidly harvest the patient’s own veins or use a product to repair or replace the damage blood vessels. For vascular trauma, Humacyte is designing the HAVs to be immediately available off-the-shelf, infection-resistant, and durable, allowing the surgeon to preserve the native vessel of the patient, potentially minimizing surgical time, and reducing infection risk as compared to synthetic grafts.
Arteriovenous Access for Hemodialysis
Arteriovenous access is essential for patients with end-stage renal disease (ESRD) to receive hemodialysis. Currently, patients will either have an access created from their own arteries and veins (an arteriovenous fistula) or have a synthetic graft placed. These are associated with important limitations: some arteriovenous fistulas will never become usable for dialysis, and synthetic grafts are prone to potentially life-threatening infection. When used for dialysis access, our HAVs, with properties of native vessels, may be able to decrease infection risk and dialysis access failures, which would improve patient outcomes and lower the burden of dialysis costs on the healthcare system.
Peripheral Arterial Disease
Peripheral arterial disease, or PAD, is a cardiovascular disease caused by plaque buildup in arteries that supply the head, organs, and limbs. In PAD, the HAV can be used as a bypass conduit and may offer a durable alternative to synthetic grafts and to the patient’s own veins or arteries, particularly if the patient does not have any that can be harvested for the procedure.
In addition to our current indications, the HAV has exciting potential in other areas of disease.
Small Diameter HAV
Using our proprietary platform, we are actively developing smaller diameter HAV for use as Blalock-Thomas-Taussig shunt, or BT shunt, in pediatric heart surgery and coronary artery bypass surgery (CABG).
Complex Bioengineered Tissues
We are also exploring our bioengineered human tissue as a “Biovascular pancreas”, a cell delivery system for the treatment of Type 1 diabetes where our current 6 mm HAV could be modified with pancreatic islet cells to replicate the function of the endocrine pancreas.
Our clinical development program encompasses a number of studies across vascular trauma, vascular access for hemodialysis, and bypass for peripheral arterial disease. Read more about those studies here.
- In vascular trauma, our ongoing Phase 3 study (V005) is exploring the ability for HAVs to meet an increasingly urgent need for immediately-available novel materials for permanent vascular repair for both civilians and the military.
- In hemodialysis, our ongoing Phase 3 studies are comparing the HAVs to current standard of care, ePTFE (Study V006) and arteriovenous fistulas (Study V007). Our early Phase 1/2 studies of patients using the HAV for hemodialysis (V001 and V002) have supported its long term durability, and patients remain in long term follow up.
- In peripheral arterial disease, our ongoing Phase 2 study (V004) is exploring the HAVs in patients with PAD. Early results have shown excellent proof-of-concept for future development of the HAV for this indication.
- The HAV has potential in many other indications, and products for these indications are in development.
Our goal in development of the HAV is to create a regenerative vascular biologic that has the benefits and characteristics of native human blood vessels, manufactured on an innovative, scalable platform. With broad potential across many therapeutic areas, the product has the potential to improve patient’s quality of life, reduce the burden of disease, and save lives.