Better Health for All

Axogen's core business is dedicated to restoring nerve function and quality of life for patients with peripheral nerve injuries

, with products like Avance Nerve Graft being FDA-approved and clinically proven to provide substantial health benefits, including statistical superiority in sensory function recovery over alternatives . The company's products are indicated for adult and pediatric patients aged one month or older , and it supports humanitarian efforts and product donations for indigent care . Axogen aims to reduce the use of pharmacologic solutions, including opioids , and offers products like Axoguard Nerve Cap to prevent symptomatic neuroma . In 2022, the company spent approximately $24.2 million on research and development . Axogen trained over three-quarters of hand and microsurgery surgeon fellows in the U.S. in 2022 and provides online educational tools . The company registers clinical studies on clinicaltrials.gov and adheres to ethical conduct standards, including informed consent . However, in 2024, one adverse event was reported for an Axoguard HA+ Nerve Protector , where a patient experienced severe pain, sweating, and nausea, leading to explantation . The most common adverse reactions for Avance were procedural pain (4%) and hyperesthesia (3%). While Axogen's quality systems were compliant with 21 CFR Part 1271 in 2022 , a separate audit resulted in two Form 483 observations on general procedures for its Medical Device Quality System, which were subsequently corrected . The company's products, made from human donor tissue, carry a risk of transmitting infectious agents , though no viral disease transmissions have been identified for Avance . The COVID-19 pandemic negatively impacted hospital staffing and surgical procedure volumes, affecting revenue and causing a pause in clinical study enrollment in 2020 .

Honest & Fair Business

Axogen has a comprehensive whistleblower policy, updated on January 6, 2021, which applies to employees and directors.

It encourages speaking up without fear of retaliation, with disciplinary action for retaliation. Anonymous reports are permitted via a third-party maintained hotline (844-989-2990) and website (axogeninc.ethicspoint.com). All calls are received and maintained by a third-party group, which submits reports to the General Counsel, Chief Compliance Officer, and the Chair of the Audit Committee. Summary reports are provided to the Board on a quarterly basis. When a concern is received, the company acknowledges it, indicates how it proposes to deal with the matter, provides an estimated response time, and informs whether initial inquiries or further investigations will take place. The company had one instance of an inadvertently untimley reported purchase of 2,525 shares by a director in 2024, which was subsequently reported on Form 5. Axogen prohibits giving anything of value to foreign officials to obtain or retain business, in accordance with the U.S. Foreign Corrupt Practices Act, and has an Anti-Fraud Policy. Nominal facilitating payments may be allowed in limited circumstances after discussion with local management and the CEO or Controller. The company also expects Business Partners to comply with anti-corruption laws and not engage in bribery or kickbacks.

Kind to Animals

Axogen, Inc. utilizes animal-derived materials in its products, specifically porcine (pig) small intestine submucosa (SIS) for products like Axoguard Nerve Protector and Axoguard Nerve Cap, and bovine collagen type I for other products.

The company also conducts pre-clinical studies involving animals to compare product performance and assess efficacy. However, the provided articles do not contain any specific, concrete data points or policies related to humane certifications, animal testing volumes, alternative testing methods, ethical input substitution percentages, supplier audits, cage-free sourcing, R&D investment in animal-free technologies, or public policy engagement on animal welfare. Therefore, no KPIs can be scored based on the available evidence.

No War, No Weapons

Axogen's core business is peripheral nerve repair,

and there is no evidence of revenue from arms or defense contracts, nor any dual-use products developed or sold. The company received a $350,000 grant from the U.S. Department of Defense in 2013 for nerve regeneration research, which is a medical application and not considered an arms or defense contract. There is no evidence of sales to embargoed regimes, peacebuilding investments, or conflict divestment policies. The company conducts human-rights due diligence by reviewing employees and business partners monthly for exclusion screening, and performs additional third-party due diligence screening for critical suppliers and foreign third-parties. Axogen's Business Partners Code of Conduct requires business partners and their subcontractors to not use conflict minerals and to meet conflict reporting requirements as mandated by the Dodd-Frank Wall Street Reform and Consumer Protection Act and the Securities and Exchange Commission, but no percentage of the supply chain certified conflict-free is provided. In 2021, Axogen had zero monetary losses related to legal proceedings associated with bribery, corruption, or false marketing claims, indicating 100% compliance with ethical standards in core business operations.

Planet-Friendly Business

No quantitative or specific qualitative evidence was found across the provided articles for any of the Planet-Friendly Business KPIs. The articles primarily announce the publication of an inaugural ESG report but do not contain the report's content or specific data points for environmental performance metrics, targets, or initiatives.

While some articles mention Scope 1 and 2 emissions, the reporting completeness (lack of Scope 3) combined with the specific quantitative thresholds and qualitative conditions of the rubric means no exact match could be made for any tier.

Safe & Smart Tech

Axogen's privacy policy, last updated in October 2021, states that the company will not sell, rent, license, or trade personal identifiable information (PII) to third parties for their direct marketing use without express consent.

There are no documented incidents of unauthorized data use. The company collects PII such as names, addresses, email, phone numbers, company name, and health information, both voluntarily provided and automatically through web server logs, cookies, and web beacons. The policy indicates that users can contact a Data Privacy Officer via mail, phone, or email to exercise their rights, but it does not detail specific user control options, privacy settings, or mechanisms for data portability or deletion. For users outside the U.S., personal information is transferred to the U.S., and for EU users, measures are in place to ensure suitable safeguards for such transfers. Third parties engaged by Axogen only process PII on the company's instructions and are required to use data only as necessary to perform their contract.