Orthofix Medical Inc.

Orthofix Medical Inc. is a medical device company specializing in orthopedic and spine products. The development and regulatory approval of such medical devices, particularly those involving biologics, bone grafts, or implantable materials, typically requires animal testing to demonstrate safety and efficacy. This testing is a standard, and often mandatory, component of the pre-clinical research phase for new medical devices submitted to agencies like the U.S. Food and Drug Administration.

The company's product pipeline and clinical trial activities, as documented in its public filings and industry databases, imply ongoing research and development efforts. These efforts inherently involve animal testing to meet regulatory compliance standards before human clinical trials can commence. While Orthofix may outsource this testing to contract research organizations (CROs), funding and requiring such testing constitutes involvement under the exclusion criteria.