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).
The approved study, SMILE-TTT (Surgical MIcrovascularization of Lower Extremities for Diabetic Foot Ulcers – Transverse Tibial Transport Study), will enroll up to 200 patients across multiple U.S. clinical sites to evaluate the safety and effectiveness of Biodynamik’s XT3 System.
Notably, this study represents a landmark in the evolution of distraction-based therapies for limb salvage, as it is expected to be the first randomized controlled trial conducted outside of China evaluating transverse tibial transport (TTT) and related techniques for the treatment of diabetic foot ulcers. While prior studies have demonstrated promising clinical outcomes, this trial is designed to generate rigorous, prospective evidence under FDA oversight to support broader adoption.
“This is a major milestone for Biodynamik and for the field of limb salvage,” said Johnny Chen, Founder and Chief Executive Officer of Biodynamik. “FDA IDE approval enables us to formally evaluate a novel, orthopedic-based approach to treating diabetic foot ulcers by activating the body’s natural healing mechanisms. Our goal is to provide a new option for patients facing amputation.”
“Patients with diabetic foot ulcers and poor perfusion remain among the most challenging cases we treat, with limited options once revascularization is no longer feasible,” said John Lantis II, MD, Chief of Surgery, Mount Sinai West. “The SMILE-TTT study is an important step in evaluating a novel approach to restoring microvascular circulation and supporting wound healing. Randomized data will be key to validating this approach and supporting clinical adoption.”
Diabetic foot ulcers affect millions of patients globally and are a leading cause of lower extremity amputation. Current treatment options often fail to address the underlying issue of poor perfusion in ischemic tissue. Biodynamik’s XT3 System is designed to address this gap by leveraging principles of distraction angiogenesis to promote neovascularization and improve tissue healing.
The SMILE-TTT study is designed as a prospective, multi-center clinical trial and is intended to support future regulatory submissions to the FDA. Study endpoints will include complete wound healing and measures of perfusion improvement.
“Advancing to a U.S. pivotal study represents a significant step forward,” added Chen. “We are excited to work closely and collaboratively with the FDA, alongside leading clinical partners, to generate high-quality evidence that can support broader adoption of this therapy.”