Core Insights - Sanara MedTech Inc. plans to launch OsStic Synthetic Injectable Structural Bio-Adhesive in the U.S. market in Q1 2027, following FDA clearance [1][2] - OsStic has received Breakthrough Device Designation from the FDA, indicating its potential to improve treatment for serious conditions [2] - The product is expected to be the first bone bioadhesive in the U.S. utilizing phosphoserine, α-TCP, and calcium silicate, offering significant advantages over traditional methods [2][3] Product Development and Regulatory Milestones - Sanara and Biomimetic Innovations Ltd (BMI) have achieved significant milestones in product development, clinical trials, and regulatory processes throughout 2025 [3] - The U.S. Patent and Trademark Office granted a patent for OsStic, ensuring protection of its key ingredients and applications until at least 2037 [3][6] - The partnership between Sanara and BMI includes an exclusive license and distribution agreement, enhancing Sanara's market position in orthopedic care [5][6] Market Need and Innovation - OsStic addresses critical limitations in current provisional fixation techniques, providing forty times stronger bonding than traditional calcium phosphate bone cement [2][3] - The product aims to meet the unmet clinical needs in complex joint reconstruction, offering a paradigm shift in treating previously non-repairable fractures [3] - Sanara's commitment to innovation is reflected in its collaboration with BMI to introduce OsStic as a new standard in bone bioadhesives [4]