Theradaptive’s RESTORE Trial Initiation for OsteoAdapt™ DE
Published on November 4, 2025
Supported by MTEC and funded through the DHA AFIRM FY24 Clinical Trial Award, Theradaptive’s RESTORE Phase I/II trial targets combat-related craniofacial injuries, advancing regenerative medicine for military and civilian patients. The study evaluates OsteoAdapt™ DE, a next-generation bioactive graft using the AMP2™ platform, designed to accelerate bone healing and improve precision over traditional grafts.
Project Highlight
Theradaptive, a clinical-stage biotech innovator, has treated the first patient in its RESTORE Phase I/II feasibility study evaluating OsteoAdapt™ DE for alveolar ridge augmentation. Their AMP2™-based platform is advancing targeted and efficient bone healing, offering a powerful alternative to traditional, passive grafts.
Musculoskeletal and craniomaxillofacial trauma—particularly volumetric bone loss in cranial, facial and jaw areas—is a critical concern in both civilian and military medicine. Current bone graft materials often suffer from slow integration, residual material retention, and unpredictable results, which can hinder readiness and recovery in forward-deployed or resource-constrained environments.
To overcome this, Theradaptive’s OsteoAdapt™ DE employs AMP2™, a proprietary engineered BMP-2 protein variant that actively stimulates stem cell recruitment and accelerates bone formation while minimizing leftover graft material. Unlike passive grafts, this next-generation bioactive graft is designed for precision, speed, and improved healing outcomes.
The RESTORE trial has enrolled its first of 45 patients under a randomized, controlled, blinded design to assess both safety and performance of OsteoAdapt™ DE versus standard grafts in patients requiring alveolar ridge augmentation. This initiative follows Theradaptive’s prior advances in spinal fusion with their 80 patient Phase I/II OASIS trial for lumbar spine fusion and reinforces its growing regenerative medicine pipeline.
Funded by a Defense Health Agency AFIRM FY24 Clinical Trial Award through MTEC with support from WFIRM, this study targets combat-related craniofacial injuries—underscoring its military relevance in accelerating rehabilitation and return-to-duty for injured service members. Theradaptive’s parallel efforts include ongoing trial execution in spine repair, expansion into extremity repair, orthopedic and sports medicine applications, and preparing for broader clinical translation.
Source: prnewswire.com
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Theradaptive
Theradaptive is dedicated to developing innovative therapeutics through advanced protein engineering, aiming to improve the delivery and efficacy of treatments for patients suffering from debilitating conditions related to tissue damage. Their mission is to create safer and more effective therapeutics that address unmet medical needs, particularly in the fields of vascular, soft tissue, and orthopedic repair.
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