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Our platform is
a game-changer.

Humacyte’s technology is designed to create novel, bioengineered human acellular vessels (HAVs) that have the potential to significantly improve treatment outcomes.

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.

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.

LIFESAVING POTENTIAL

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.

LIFESAVING POTENTIAL

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.

The power of
vascular innovation.

Imagine a readily available, “off the shelf ” bioengineered human acellular vessel (HAV)
that could replace a patient's own blood vessel or create new vascular access
for patients who require dialysis, without requiring cells or tissue from the patient.

Humacyte is making that happen.

 
 

Designed for
significant unmet
clinical needs.

HAVs: breakthrough in the world of vascular access and tissue replacement.

HAVs are created from donated human smooth muscle cells placed on a tubular scaffold made of biodegradable suture material to form a HAV.
The tissue cells grow in vitro to form a biologic 3D scaffold matrix.
Cells on the scaffold generate collagen matrix during culture in a closed bioreactor system.
Cells, which can trigger an immune response, are then removed from the HAV matrix.
Once implanted, the HAV may be remodeled by the host (patient) to create a vascular structure more similar to native, adjacent vascular tissue.

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.

FEWER OPERATIONS

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.

IMMEDIATELY AVAILABLE

Investigational HAVs have the potential to be grown, stored and immediately available for vascular access or as a peripheral conduit throughout the body.

LESS COST

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.

FUTURE APPLICATIONS

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:

PAD (Peripheral Arterial Disease)

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.

Vascular Trauma

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.

Additional Future Applications

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 PROGRESS

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