Better Health for All

Orthofix's core products, such as orthobiologics, have favorable outcomes in approximately 70% of patients, leading to less pain and increased mobility.

The M6-C artificial cervical disc demonstrated a low subsequent intervention rate of 3.1% at five years post-operation, with a mean shoulder/arm pain VAS score of 0.5 compared to 2.1 in the ACDF control group. In 2023, the company reported 6 voluntary product recalls involving 646 units, and had two other recalls in 2018 for design and component issues. However, there were no product-related fatalities or FDA enforcement actions from 2020-2023. The company's products are priced based on market and regulatory factors, with pricing agreements reviewed by a Strategic Accounts team and special offers requiring approval. The TrueLok Elevate Transverse Bone Transport System addresses diabetic foot wounds, a condition impacting lower-income and minority communities. Orthofix publicly reports payments to healthcare professionals and organizations as required by laws like the U.S. Sunshine Act and Italian regulations, and has a comprehensive compliance program. The company's R&D expense was $15.815 million (8.2% of net sales) in Q1 2025 and $15.934 million in Q2 2025. Orthofix's Lewisville, Texas headquarters utilizes 100% sustainable energy, and the company offers a free recycling program for Bone Growth Stimulators, sending over 25,000 shipping labels to patients since February 2021. Orthofix supports charitable organizations and collaborates with clinical organizations such as Scottish Rite Hospital for Children. The company provides a comprehensive benefits package for employees, including an employee assistance program and a company wellness program focused on preventative care. Orthofix has robust cybersecurity programs based on the NIST Cybersecurity Framework, with mandatory employee training and encryption technologies. The company promotes Mental Health Awareness Month and offers a “Balancing Work and Family” virtual training. Orthofix has primary offices focused on surgeon and medical education and invests in investigational device exemption (IDE) studies to expand indications for use.

Fair Money & Economic Opportunity

Orthofix Medical Inc. is a medical device company, not a financial institution.

The company does not offer lending, insurance, or deposit services to consumers, nor does it provide consumer credit products. Therefore, KPIs related to financial products, services, and their impact on economic opportunity for underserved populations are not applicable to its core business model. While Orthofix has patient financial assistance programs, pricing policies for its medical devices, and various diversity and community involvement initiatives, these do not align with the specific definitions of the 'Fair Money & Economic Opportunity' KPIs, which are focused on financial services and products. No evidence was found in the provided articles to score any of the KPIs beyond 'Not applicable' (0).

Fair Pay & Worker Respect

Orthofix Medical Inc. reported an OSHA Incident Rate of 0.55 for 2024.

For Fiscal Year 2024, the CEO-to-median employee pay ratio was 126:1, based on a CEO compensation of $10,837,801 and a median employee pay of $86,095. In 2012, a subsidiary of Orthofix International NV (current parent Orthofix Medical) paid $30 million to settle allegations of illegal kickbacks to physicians.

Honest & Fair Business

Orthofix Medical Inc. provides a 24/7, toll-free, confidential, and anonymous compliance hotline (EthicsPoint) for reporting potential violations, as detailed in its Code of Conduct.

However, there is no evidence regarding the independence of the investigation processes for these reports. The company disclosed a material weakness in the design and operation of certain management review controls in its 2023 10-K, but this weakness did not result in any financial misstatements. Orthofix's Code of Conduct covers anti-bribery and anti-corruption, and the company complies with transparency laws like the US Sunshine Act and Italy's Confindustria Dispositivi Medici Code of Ethics. Despite this, there is no information on the frequency or effectiveness metrics of its anti-corruption training, nor is there evidence that the policy is customized for high-risk areas.

Kind to Animals

Orthofix conducts pre-clinical trials on animals for drug efficacy and mechanism of action research, including sponsored independent research at the Cleveland Clinic, New York University, and University of Medicine and Dentistry of New Jersey.

The company's policy states it conducts pre-clinical trials on animals, and animal studies were conducted at the Cleveland Clinic. There is no formal policy that prohibits or restricts animal testing, nor is there a commitment to reduction. The company does not provide data on the number of animals used in testing annually. Orthofix adheres to the AdvaMed Code of Ethics and MedTech Europe’s Code of Ethics, but there is no evidence of public engagement in animal welfare policy improvement or advocacy for higher standards. While MTF Biologics is mentioned as a global nonprofit dedicated to research, there is no evidence of Orthofix's participation in multi-stakeholder initiatives to develop industry-wide animal-free testing standards.

No War, No Weapons

Orthofix's 2023 Conflict Minerals Report indicates that while the company conducted Reasonable Country of Origin Inquiries (RCOIs) with suppliers for tin, tantalum, and tungsten (3TG), some suppliers lacked sufficient information to determine the country of origin.

The company relies on third-party audits of smelters/refiners, not direct supplier audits, and lacks sufficient data to definitively determine if its products are conflict-free. Orthofix plans to improve due diligence in the next reporting period.

Planet-Friendly Business

Orthofix reported Scope 1 emissions of 751 tCO2e and market-based Scope 2 emissions of 1,803 tCO2e for 2024.

The company is currently calculating Scope 3 emissions, which are not yet fully published. The Lewisville, Texas headquarters uses 100% sustainable energy, but the overall share of operational energy from renewables for the entire company was 14.9% in 2023. In 2024, 135 tons of non-hazardous waste were recycled out of 418 tons generated, resulting in a diversion rate of 32.3%. The company launched a nationwide recycling program for its Bone Growth Therapy devices in the U.S. in March 2021, and approximately 8,000 units were recycled in 2022. The company reported zero environmental compliance violations. Orthofix initiated a comprehensive climate risk assessment process in 2024. In 2024, 20.7 ML of water was withdrawn from water-stressed areas out of a total withdrawal of 28.6 ML, meaning 72.4% of water was sourced from stressed basins. The company reduced plastic strap consumption by 88% from 2016 to 2023 and is developing single-use sterile packed instrumentation to reduce carbon associated with repeated shipping and sterilization.

Respect for Cultures & Communities

No specific, concrete data points were found in the provided articles to assess Orthofix Medical Inc. against the defined KPIs for "Respect for Cultures & Communities." The articles did not contain information regarding formal partnerships with indigenous or local community groups, revenue reinvested in local community development, cultural appropriation incidents, cultural impact assessment protocols, local employment ratios, community grievance mechanisms, or cultural preservation investments.

Information about language accessibility in patient education materials was explicitly stated not to be about OFIX.US. Details regarding FCPA violations pertained to bribery and accounting irregularities, not cultural appropriation or incidents as defined by the value. Therefore, no KPIs could be scored.

Safe & Smart Tech

Orthofix has implemented security training programs for its employees.

The company also incorporates security into its product development lifecycle. Additionally, Orthofix's CISO provides monthly security reports to top management and holds quarterly meetings with a steering committee, and clinical research affairs staff proactively seeks security advice before clinical trials.

Zero Waste & Sustainable Products

In 2023, Orthofix recycled 244 tons of non-hazardous waste out of a total of 422 tons, resulting in a waste diversion rate of 57.82% for non-hazardous waste.

The company reported no waste disposal violations in the past year (2021). Orthofix generated 48 tons of hazardous waste in 2023 and has a sustainability policy that includes responsible hazardous waste protocols. The company has a free recycling program for Bone Growth Stimulators, which recycled approximately 9,100 units (7.29 metric tons) in 2023. This program also involves sending over 25,000 shipping labels to patients to facilitate recycling of these devices. The recycling and take-back programs are limited to Bone Growth Stimulators, indicating a narrow scope of product recyclability and take-back coverage. Orthofix expects suppliers to support environmental and animal welfare improvements, but specific waste requirements for suppliers are not detailed.