Theradaptive, Inc. has treated the first patient in its RESTORE International Phase I/II Feasibility Study. The study will evaluate the safety and performance of OsteoAdapt™ DE in promoting bone growth for dental reconstruction.
Advancing Bone Regeneration in Dentistry
The procedure was performed by Dr. Gal Avishai at Rabin Medical Center in Israel. Dr. Avishai noted the urgent need for better treatment options in dental and craniomaxillofacial repair. He stated that OsteoAdapt DE could be a significant step forward in patient care.
The Challenge of Alveolar Ridge Augmentation
Alveolar ridge augmentation is a surgical procedure to restore bone lost from tooth extraction, disease, or trauma.
This procedure is often necessary to ensure enough bone volume for successful dental implant placement.
Current methods using xenografts, allografts, or synthetics can be slow and may leave residual material, increasing complication risks.
OsteoAdapt™ DE and AMP2™ Technology
OsteoAdapt DE is designed to actively promote and speed up bone formation. It contains an osteoinductive component that uses AMP2™ technology. This is a proprietary, engineered variant of recombinant human bone morphogenetic protein-2 (BMP-2).
The technology enables targeted stem cell recruitment and controlled bone regeneration. This approach aims to shorten healing time, improve surgical outcomes, and allow for quicker implant readiness. The RESTORE trial will compare OsteoAdapt DE to a standard xenograft bone graft.
Military and Broader Applications
The study is supported by an Armed Forces Institute of Regenerative Medicine (AFIRM) award. The funding is aimed at advancing regenerative medicine for treating traumatic battlefield injuries, such as combat-related damage to the face and jaw.
Luis Alvarez, PhD, CEO and Founder of Theradaptive, said, “Regenerating bone with anatomical precision remains a critical challenge in clinical practice.” He added that the study is an important step for the technology, which could benefit a wide range of patients.
Theradaptive’s Clinical Pipeline
RESTORE is Theradaptive’s second clinical trial. The company’s first trial, OASIS, is for lumbar spinal fusion and is nearing completion of enrollment.
These programs highlight the potential of the OsteoAdapt platform across multiple therapeutic areas.
