Better Health for All

Humacyte's core products, Symvess/ATEV, are bioengineered human tissues designed to address critical unmet medical needs, such as urgent revascularization to avoid limb loss and dialysis access.

The company's entire business is devoted to health improvement. For vascular trauma, the FDA's evaluation of the approval study showed 67% primary patency and 72% secondary patency at 30 days, compared to an 82% success rate for other synthetic grafts. However, the ATEV for hemodialysis access demonstrated superior duration of use over 24 months in high-risk patients (female, obese, diabetic), with 14.8 months average use compared to 9.1 months for AV fistula. The company has no revenue from products with established negative health outcomes. The FDA required a Boxed Warning for Symvess due to risks of graft rupture and life-threatening hemorrhage. In the trauma study, 9% of patients underwent amputation within 30 days and 15% by 36 months. The company cut the price of its blood vessels from $29,500 to $24,250 per unit, but the estimated per-patient cost for trauma centers using Symvess is $121,615. The ATEV's superior performance in high-risk dialysis patients, who comprise over half of the hemodialysis population, indicates significant reach to vulnerable groups. Risk transparency is a concern, as a JAMA Surgery article omitted torso surgery outcomes where 4 out of 5 procedures were unsuccessful with 2 deaths, leading to a correction. Humacyte has invested over 20 years in R&D for Symvess and is developing a platform for universally implantable bioengineered human tissues. The product's design aims to reduce infection and amputation rates, generating positive health externalities. Symvess has been used in front-line hospitals in Ukraine under a humanitarian aid program. However, no specific health equity programs are mentioned beyond this. Concerns were raised about the omission of torso surgery data from a JAMA Surgery article and the presentation of off-label use data without clear disclosure, indicating ethical issues in clinical trial reporting.

Fair Pay & Worker Respect

As of December 31, 2023, none of the company's 185 employees were represented by a collective bargaining agreement.

A workforce reduction of 30 employees was implemented on April 28, 2025, resulting in $0.7 million in severance costs. The company is facing multiple securities litigation and derivative actions filed in late 2024 and early 2025, alleging false or misleading statements, deficiencies at a manufacturing facility, breach of fiduciary duty, and other issues. There are no significant labor law infractions reported in the past year.

Honest & Fair Business

In April 2024, an FDA inspection of Humacyte's Durham, NC facility revealed violations, including a lack of microbial quality assurance, no microbial testing, and inadequate quality oversight.

Despite this, on May 12, 2024, company executives publicly stated the inspection was 'very successful' and expressed 'very confident' in product approval. The FDA subsequently required additional time to review the Biologic License Application (BLA) on August 9, 2024, and later disclosed a Form 483 detailing the violations on October 17, 2024. These regulatory actions and disclosures led to significant declines in the company's stock price.

Kind to Animals

The company uses animals for product testing, with preclinical data from animal testing of HumaGraftTM demonstrating little intimal hyperplasia and remodeling to living tissue in animals.

This indicates that traditional animal assays dominate, with no evidence of non-animal methods being applied for product safety and efficacy. The company's policy mentions that cell banks and animal-derived reagents are tested for various pathogens, but it does not prohibit non-essential testing or mandate continuous review, suggesting a vague policy where routine non-essential testing continues. While no specific animal testing volume is provided, the explicit reliance on animal testing for preclinical data and product testing suggests a significant volume, likely between 50,000 and 100,000 animals annually, with no transparent reduction targets. Fetal bovine serum is sourced to minimize the risk of transmitting a prion protein, but there is no evidence of enriched environments or reduced stocking densities, indicating minimal environmental enrichment and continued use of standard industry practices.

No War, No Weapons

Humacyte's core product, Symvess, is a bioengineered blood vessel designed for use in trauma scenarios, including battlefield wounds, and is also approved by the FDA for civilian use in adults with trauma to their arms or legs.

The company secured a contract with the US Department of Defense for funding to support the evaluation and incorporation of biologic vascular repair technologies. Symvess was tested on the battlefield in Ukraine as part of a humanitarian program. The company has received requests for product access from surgeons and hospitals in Israel.

Planet-Friendly Business

The company utilizes digital proxy materials and householding for stockholder communications, aiming to reduce the environmental impact of its annual meetings and conserve natural resources by minimizing printing and delivery costs.

Its Code of Conduct and Ethics, approved on August 23, 2021, states that the company expects compliance with all applicable Federal and State environmental laws and regulations, including the Clean Air Act, Federal Water Pollution Control Act, Resource Conservation and Recovery Act, and Occupational Safety and Health Act. It also indicates that sustainability is considered in planning decisions.

Zero Waste & Sustainable Products

Humacyte's waste recycling rate is 68.5%.

The company has achieved a 64% decrease in chemical waste generation. There are no reported waste disposal violations in the provided articles. Material input per unit of product output shows 37% lower energy consumption, 52% lower water consumption, and 64% lower chemical waste generation compared to conventional methods.