Theradaptive Treats First Patient in RESTORE Feasibility Study Evaluating OsteoAdapt™ DE in Dental Procedures

Study aims to advance bone regeneration for dental reconstruction using Theradaptive's targeted therapeutic platform

FREDERICK, Md., Aug. 26, 2025 /PRNewswire/ -- Theradaptive, Inc., a clinical-stage biotechnology company pioneering targeted protein therapeutics for tissue regeneration, today announced that the first patient has been successfully treated in the RESTORE International Phase I/II Feasibility Study. This prospective, blinded, randomized, controlled study is designed to evaluate the safety and performance of OsteoAdapt™ DE, a next-generation regenerative product developed to promote bone growth in alveolar ridge augmentation, a surgical dental reconstruction procedure.

The procedure was successfully performed by Dr. Gal Avishai at Rabin Medical Center in Petach Tikva, Israel. "There is an urgent need for advanced treatment options in dental and craniomaxillofacial repair," said Dr. Avishai. "OsteoAdapt DE's potential to deliver predictable, robust bone regeneration could represent a major step forward in patient care. We anticipate this technology will be especially valuable for jaw restoration following fractures or oncology resections. We're proud to be part of a study that could redefine what is possible in regenerative care."

Alveolar Ridge Augmentation and Clinical Need
Alveolar ridge augmentation is a surgical procedure used to preserve bone that has been lost due to tooth extraction, disease, or trauma, and is often critical to achieving sufficient bone volume for successful dental implant placement. Clinicians typically use materials (such as xenografts, allografts, or synthetics), which primarily rely on passive osteoconduction to support new bone growth. While widely adopted, these materials can be slow to incorporate and often leave significant residual graft material at the time of implant placement, increasing the risk of complications.

OsteoAdapt™ DE and AMP2™ Technology
Unlike traditional grafts, OsteoAdapt DE contains an osteoinductive component designed to actively promote and accelerate bone formation while minimizing residual material at the time of dental implant placement. The product utilizes AMP2™, Theradaptive's proprietary, engineered variant of recombinant human bone morphogenetic protein-2 (BMP-2), enabling targeted stem cell recruitment and controlled bone regeneration. This approach is intended to reduce healing time, improve surgical outcomes, and offer a quicker path to implant readiness. The RESTORE trial will assess the safety and performance of OsteoAdapt DE in comparison to a standard xenograft bone graft.

Support from AFIRM and Military Relevance
The study is supported by an Armed Forces Institute of Regenerative Medicine (AFIRM) Fiscal Year 2024 Clinical Trial Award, granted to Theradaptive through the Wake Forest Institute for Regenerative Medicine (WFIRM), and funded by the Defense Health Agency Research and Engineering Directorate, Department of Defense. This funding is specifically aimed at advancing regenerative medicine technologies for the treatment of traumatic battlefield injuries that are of critical concern to the military. These include combat-related damage to the face and jaw, areas where OsteoAdapt DE may offer significant clinical benefit.

"Regenerating bone with anatomical precision remains a critical challenge in clinical practice," said Luis Alvarez, PhD, CEO and Founder of Theradaptive. "Advancing this study with support from AFIRM is an important step forward for the technology we've developed, as we work to deliver a solution that benefits a broad range of patients, from those recovering from traumatic injuries to those undergoing advanced dental care, particularly in forward areas. This work also builds momentum for our broader bone regeneration program which has drawn strong interest from strategic partners in spine, orthopedics, and sports medicine, all areas where robust bone regeneration is key to improving patient outcomes."

About Theradaptive's Clinical Pipeline
RESTORE represents Theradaptive's second clinical trial. The company's initial trial, OASIS, is approaching completion of enrollment for lumbar spinal fusion indications, where OsteoAdapt SP is being evaluated under an FDA-approved Investigational Device Exemption (IDE). Together, these programs highlight the broad potential of the OsteoAdapt platform across multiple therapeutic areas, demonstrating its versatility and effectiveness in promoting targeted, reliable bone regeneration.

About Theradaptive
Theradaptive is a privately held, clinical-stage biologics company developing protein therapeutics for spine, orthopedics, dental, and soft tissue repair and targeted therapeutics in diverse areas such as immuno-oncology. The company leverages its therapeutic delivery platform to deliver recombinant biologics to targeted areas in the body with high precision and persistence to address unmet medical needs. For more information about Theradaptive and its clinical development program, visit www.theradaptive.com and follow the company on LinkedIn. Both OsteoAdapt™ DE and OsteoAdapt™ SP are Investigational Devices. Limited by U.S. Federal law to investigational use. This effort is being sponsored by the Government under Other Transaction Number W81XWH-15-9-0001. The views and conclusions herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government.

Media Contact:
Serena Santiago - serena.santiago@theradaptive.com

Investor Contact:
Dan Wolf - daniel.wolf@theradaptive.com

SOURCE Theradaptive