Biodynamik Receives FDA IDE Approval for Pivotal U.S. Trial of XT3 System in Diabetic Foot Ulcers

Foothill Ranch, CA — April 2026 — Biodynamik, Inc., a medical device company advancing orthopedic-driven regenerative technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application to initiate a pivotal clinical study evaluating the company’s XT3 System for the treatment of chronic diabetic foot ulcers (DFUs). […]