Lake Forest, CA — April 2026 — Biodynamik, Inc., a medical device company advancing orthopedic 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 the first FDA IDE-approved pivotal U.S. randomized trial of transverse tibial transport (TTT) for 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 diabetic foot ulcers in a controlled clinical study.”

 

“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. SMILE-TTT will evaluate the safety and effectiveness of TTT with the XT3 System for this use. 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.”

 

About Biodynamik

Biodynamik, Inc. develops orthopedic external fixation systems. The XT3® System is FDA 510(k) cleared for fracture fixation, nonunion, transverse bone transport of the tibia, and the correction of bony or soft tissue defects and deformities in adult patients. Biodynamik is sponsoring the SMILE-TTT study (IDE G260049) of transverse tibial transport in patients with diabetic foot ulcers; this use is investigational.

 

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding clinical development, regulatory pathways, and potential therapeutic benefits. These statements are subject to risks and uncertainties, and actual results may differ materially.