28 April 2026

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Theradaptive Completes Enrollment in RESTORE Study

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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.

Study enrollment completion marks critical milestone in advancing bone regeneration for dental reconstruction using Theradaptive’s targeted therapeutic platform

Theradaptive, Inc., a clinical-stage biotechnology company pioneering targeted protein therapeutics for tissue regeneration, recently announced the successful treatment of the 45th and final patient 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.

“Completing enrollment in the RESTORE study is a major achievement that validates the growing clinical interest in our platform,” said Dr. Luis Alvarez, Founder and CEO of Theradaptive. “We are grateful to the investigators, clinical teams, patients, and partners whose dedication made this milestone possible. This achievement strengthens our growing body of clinical evidence and brings us closer to delivering meaningful new treatments for patients with limited options.”

“Participating in the RESTORE study has provided valuable clinical insight into the potential of OsteoAdapt DE as an innovative approach to bone regeneration,” said Dr. Ariel Hirschhorn, Principal Investigator at Sheba Medical Center, a participating site in the multicenter trial. “We are encouraged by its potential to address more complex craniomaxillofacial procedures and are proud to contribute to this important advancement in regenerative medicine.”

OsteoAdapt DE uses AMP2™, Theradaptive’s engineered human bone morphogenetic protein-2 (BMP-2) variant. Unlike traditional graft materials that primarily rely on passive osteoconduction and can be slow to incorporate, OsteoAdapt DE is designed to promote active bone formation while minimizing residual material at the time of implant placement. This novel approach aims to accelerate healing and improve surgical outcomes. The RESTORE trial is evaluating the safety and performance of OsteoAdapt DE against standard xenograft bone grafts.

Note: OsteoAdapt® DE is an investigational device and is not approved for commercial sale. Limited by U.S. federal law to investigational use only.

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.

The RESTORE trial represents Theradaptive’s second clinical trial and reflects the continued expansion of its clinical pipeline. Enrollment has also been completed in the OASIS Phase I/II Trial evaluating OsteoAdapt SP, a product under clinical investigation for spinal fusion. Together, these programs highlight the broad potential of the OsteoAdapt platform across multiple therapeutic areas.

Note: OsteoAdapt® SP is an investigational device and is not approved for commercial sale. Limited by U.S. federal law to investigational use only.

Theradaptive is a privately held, clinical-stage biologics company developing protein therapeutics for spine, orthopedics, dental , and soft tissue repair, as well as 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 .

Note: Both OsteoAdapt® DE and OsteoAdapt® SP are investigational devices and are not approved for commercial sale. Limited by U.S. federal law to investigational use only.

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.

Source: https://clinicaltrials.gov/study/NCT07078331