Biodynamik Receives ISO 13485 Certification and Completes MDSAP Audit
Lake Forest, CA — September 2025 — Biodynamik, Inc. has achieved a major milestone with the successful completion of its Medical Device Single Audit Program (MDSAP) audit and attainment of ISO 13485:2016 certification. These accomplishments demonstrate the company’s commitment to the highest international standards of quality, safety, and regulatory compliance for medical devices. ISO 13485 […]
Biodynamik Strengthens Innovation with U.S. Issued Patents for Tissue Distraction and Automation Systems
Lake Forest, CA — October 2025 — The United States Patent and Trademark Office (USPTO) has officially granted patents covering Biodynamik’s breakthrough technologies for tissue distraction and automation. This milestone underscores Biodynamik’s commitment to advancing regenerative limb salvage through innovative, patented technologies. These newly issued patents secure Biodynamik’s exclusive rights to its core systems that […]
Biodynamik Named Finalist in American Diabetes Association’s 2025 Innovation Challenge
Lake Forest, CA — June 2025 Biodynamik was selected as one of the Top 5 finalists in the American Diabetes Association’s (ADA) 2025 Innovation Challenge, gaining the opportunity to present its mission and breakthrough technology during the ADA’s prestigious scientific competition at the 85th Scientific Sessions. The Innovation Challenge highlights the most promising startups addressing […]
Biodynamik Named One of Southern California’s “Cool Companies” for 2025
Lake Forest, CA – Biodynamik Inc., a pioneer in regenerative medical technology for limb salvage and chronic wound repair, has been selected as one of Southern California’s “Cool Companies” for 2025 by Connect, a leading capital platform that highlights high-growth startups poised to transform their industries. Chosen from hundreds of applicants across the tech, life […]
Biodynamik Receives U.S. FDA Approval for XT3 System®
Lake Forest, CA – 2024- Biodynamik Inc., an innovative engineering-focused company specializing in advanced orthopedic procedures and medical technologies, proudly announces FDA 510(k) clearance for its XT3 System. The XT3 System is specifically designed to perform transverse bone transport in the tibia, representing meaningful progress in advancing the Transverse Tibial Transport (TTT) procedure in the […]
Biodynamik receives grant from National Science Foundation
Lake Forest, CA – December 11, 2024 – Biodynamik Inc. is excited to announce its receipt of a prestigious grant from the National Science Foundation (NSF), a milestone achievement that underscores the company’s commitment to advancing groundbreaking research and innovation. “NSF accelerates the translation of emerging technologies into transformative new products and services,” said Erwin […]
Biodynamik Leadership Completes Training in Transverse Tibial Bone Transport Under Renowned Dr. Qikai Hua
Lake Forest, CA – November 11, 2024 – Biodynamik Inc. is proud to announce that Johnny Chen (CEO) and Shanbao Cheng (CTO) recently traveled to the People’s Republic of China (PRC) to study under the world-renowned expert Dr. Qikai Hua, Professor and Chief Physician at The First Affiliated Hospital of Guangxi Medical University. Dr. Hua […]