Traumatic events (home or vehicle accidents, falls, or violent crimes) can cause life-threatening injuries to blood vessels. Surgeons treating these injuries need to urgently repair or replace the damaged blood vessels to help restore circulation quickly and save limbs. The HAV is designed to be immediately available, 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. The HAV for vascular trauma has been granted accelerated approval pathway from the U.S. FDA, and priority designation from the Department of the Defense, and is currently being evaluated in a Phase II/III clinical trial.

Arteriovenous access is essential for patients with end-stage renal disease (ESRD) to receive hemodialysis. There are currently three traditional methods for obtaining vascular access for hemodialysis: an AV fistula, a synthetic graft, and a catheter. Each of these vascular access methods has substantial limitations, and the HAV is intended to overcome many of these limitations. Clinical evidence suggests that it is non-immunogenetic, infection-resistant, and can become a durable living tissue. The HAV is being studied in a a Phase III trial in AV Access.

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 a patient’s own veins or arteries, particularly if the patient does not have any that can be harvested for the procedure.

We have modified the HAV production process to enable the embedding of a biocompatible medical-grade stent within the wall of the engineered vessel. Combining a non-degradable stent with the degradable polymer scaffold used for HAV production results in a composite scaffold that can be seeded with smooth muscle cells and grown in culture. After decellularization, the engineered trachea consists of the extracellular matrix contained in the HAV, along with an embedded stent that prevents the collapse of the engineered airway with inspiration or neck movements.

End-stage lung disease is the fourth leading cause of death in the U.S., and lung transplantation remains severely limited by donor organ shortages. Dr. Niklason’s laboratory at Yale University has pioneered the development of using decellularized native lungs, combined with targeted recellularization of the lung scaffolds within biomimetic bioreactors, to produce whole lungs that are capable of exchanging gas. Studies in rodents have demonstrated gas exchange for several hours. Efforts to scale-up the technology to human-sized organs are ongoing.

Esophageal cancers, congenital malformations, and traumatic injuries are difficult to treat and are life threatening; severely impacting patients ability to swallow or intake food.  Patients have limited reconstruction options available today for effective repair and management of these types of esophageal diseases.  Humacyte is exploring the ability to create readily available tissue replacements to restore esophagus anatomy and function for patients. 

Coronary artery bypass grafting (CABG) is a type of surgery that improves blood flow to the heart. It’s used for people who have severe coronary heart disease (CHD), also called coronary artery disease.

CHD is a condition in which a substance called plaque (plak) builds up inside the coronary arteries. These arteries supply oxygen-rich blood to your heart. Plaque is made up of fat, cholesterol, calcium, and other substances found in the blood.

The Biovascular Pancreas (“BVP”) is a modification of Humacyte’s HAV product, leveraging the HAV to deliver therapeutic cells to within close proximity of the patient’s bloodstream. We believe that the HAV extracellular matrix material is both highly biocompatible, as evidenced by adaptive cellular repopulation after implantation, and also highly angiogenic, as evidenced by extensive formation of micro-vessels surrounding the HAV in vivo. These attributes mean that the HAV may serve as a suitable conduit for delivering large numbers of therapeutic cells to a patient.

For patients suffering from bladder cancer or other diseases, diverting urine from the bladder to outside the body is critical.  Urinary diversions are used to create the new exit paths for urine.  At Humacyte, we are developing readily available tissues with our platform technology to provide a new, biologic urinary diversion opportunity for patients in need.

VASCULAR TRAUMA:
Traumatic events (home or vehicle accidents, falls, or violent crimes) can cause life-threatening injuries to blood vessels. Surgeons treating these injuries need to urgently repair or replace the damaged blood vessels to help restore circulation quickly and save limbs. The HAV is designed to be immediately available, 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. The HAV for vascular trauma has been granted accelerated approval pathway from the U.S. FDA, and priority designation from the Department of the Defense, and is currently being evaluated in a Phase II/III clinical trial.

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DIALYSIS AV ACCESS:
Arteriovenous access is essential for patients with end-stage renal disease (ESRD) to receive hemodialysis. There are currently three traditional methods for obtaining vascular access for hemodialysis: an AV fistula, a synthetic graft, and a catheter. Each of these vascular access methods has substantial limitations, and the HAV is intended to overcome many of these limitations. Clinical evidence suggests that it is non-immunogenetic, infection-resistant, and can become a durable living tissue. The HAV is being studied in a a Phase III trial in AV Access.

2 of 9

PERIPHERAL ARTERIAL DISEASE (PAD):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 a patient’s own veins or arteries, particularly if the patient does not have any that can be harvested for the procedure.

3 of 9

CABG:
Coronary artery bypass grafting (CABG) is a type of surgery that improves blood flow to the heart. It’s used for people who have severe coronary heart disease (CHD), also called coronary artery disease.

CHD is a condition in which a substance called plaque (plak) builds up inside the coronary arteries. These arteries supply oxygen-rich blood to your heart. Plaque is made up of fat, cholesterol, calcium, and other substances found in the blood.

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TRACHEA:
We have modified the HAV production process to enable the embedding of a biocompatible medical-grade stent within the wall of the engineered vessel. Combining a non-degradable stent with the degradable polymer scaffold used for HAV production results in a composite scaffold that can be seeded with smooth muscle cells and grown in culture. After decellularization, the engineered trachea consists of the extracellular matrix contained in the HAV, along with an embedded stent that prevents the collapse of the engineered airway with inspiration or neck movements.

5 of 9

LUNG:
End-stage lung disease is the fourth leading cause of death in the U.S., and lung transplantation remains severely limited by donor organ shortages. Dr. Niklason’s laboratory at Yale University has pioneered the development of using decellularized native lungs, combined with targeted recellularization of the lung scaffolds within biomimetic bioreactors, to produce whole lungs that are capable of exchanging gas. Studies in rodents have demonstrated gas exchange for several hours. Efforts to scale-up the technology to human-sized organs are ongoing.

6 of 9

PANCREAS:
The Biovascular Pancreas (“BVP”) is a modification of Humacyte’s HAV product, leveraging the HAV to deliver therapeutic cells to within close proximity of the patient’s bloodstream. We believe that the HAV extracellular matrix material is both highly biocompatible, as evidenced by adaptive cellular repopulation after implantation, and also highly angiogenic, as evidenced by extensive formation of micro-vessels surrounding the HAV in vivo. These attributes mean that the HAV may serve as a suitable conduit for delivering large numbers of therapeutic cells to a patient.

7 of 9

ESOPHAGUS:
Esophageal cancers, congenital malformations, and traumatic injuries are difficult to treat and are life threatening; severely impacting patients ability to swallow or intake food.  Patients have limited reconstruction options available today for effective repair and management of these types of esophageal diseases.  Humacyte is exploring the ability to create readily available tissue replacements to restore esophagus anatomy and function for patients. 

8 of 9

URINARY CONDUIT:

For patients suffering from bladder cancer or other diseases, diverting urine from the bladder to outside the body is critical.  Urinary diversions are used to create the new exit paths for urine.  At Humacyte, we are developing readily available tissues with our platform technology to provide a new, biologic urinary diversion opportunity for patients in need.

9 of 9
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