Sanara MedTech Inc. and its partner Biomimetic Innovations Ltd. announced that the company is advancing its OsStic synthetic injectable structural bio‑adhesive toward a U.S. commercial launch scheduled for the first quarter of 2027. The announcement follows the U.S. Patent and Trademark Office’s grant of Patent No. 12,251,490 on the same day, securing protection for the key ingredients—alpha‑tricalcium phosphate, calcium silicate, and a phosphorylated amino acid—through 2037.
OsStic received FDA Breakthrough Device Designation in December 2023, a status that expedites regulatory review and signals strong clinical potential. Sanara holds exclusive U.S. marketing, sales, and distribution rights under its license with BMI, a partnership that was executed in January 2025. The product’s fast‑setting, injectable, moldable formulation can remodel into bone, offering a 40‑fold increase in bonding strength over traditional calcium phosphate cements according to pre‑clinical data. This advantage could reduce the need for hardware removal surgeries and improve patient outcomes in orthopaedic trauma and joint reconstruction.
The U.S. market for peri‑articular fractures exceeds 100,000 cases annually, creating a sizable addressable opportunity for a product that can provide structural support and adhesive bonding in minimally invasive procedures. By positioning OsStic as a first‑in‑class solution, Sanara aims to capture a share of this market and differentiate itself from larger, diversified competitors. The company’s dual‑pronged growth strategy balances its mature Sanara Surgical segment with the high‑potential Tissue Health Plus platform, although the latter has recently been discontinued to focus resources on core surgical business.
Financially, Sanara’s recent reports show revenue growth in the surgical segment, but the company continues to post net losses as it invests in product development and regulatory milestones. Management has emphasized cost discipline and strategic investments in high‑return verticals, signaling confidence in long‑term profitability while navigating the capital intensity of medical device development. The patent grant and FDA designation provide a strong foundation for future revenue generation and reinforce Sanara’s position as an innovator in surgical biomaterials.
Dr. J. Tracy Watson, a leading orthopedic surgeon, noted that OsStic’s unique properties could transform fracture care by offering a durable, injectable alternative to traditional hardware. The company’s leadership remains focused on scaling the product, securing regulatory approvals, and expanding market reach in the U.S. market.
The announcement marks a significant milestone in Sanara’s journey toward commercializing a disruptive bone‑fixation technology, underscoring the company’s commitment to advancing patient care and strengthening its competitive position in the orthopaedic device market.
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