Sanara MedTech Inc. and Biomimetic Innovations Provide Update on OsStic™
Rhea-AI Summary
Sanara MedTech (Nasdaq: SMTI) and Biomimetic Innovations provided a progress update on OsStic™, a synthetic injectable structural bio-adhesive targeted for U.S. commercial launch in Q1 2027, conditional on anticipated FDA clearance. OsStic received FDA Breakthrough Device Designation (Dec 2023) and a U.S. patent was granted in 2025 (U.S. Patent No. 12,251,490) covering compositions, adhesives, kits, and prefilled syringes. The release cites preclinical mechanical testing showing 40x stronger bonding versus traditional calcium phosphate bone cement and notes ongoing product development, clinical, regulatory, and medical education milestones in 2025.
Positive
- FDA Breakthrough Device Designation (Dec 2023)
- U.S. patent granted: No. 12,251,490 (2025)
- Planned U.S. commercial launch in Q1 2027 (conditional)
- Preclinical testing: 40x stronger bonding vs calcium phosphate cement
Negative
- U.S. market launch is contingent on FDA clearance
- Reported data are preclinical only; no human outcomes disclosed
Key Figures
Market Reality Check
Peers on Argus 2 Down
Momentum scanner shows 2 sector peers (e.g., STAA, STSS) moving down with median move about -6.1%, while SMTI is up 8.59%, indicating stock-specific strength against broader sector weakness.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 19 | Conference participation | Neutral | -8.8% | Announcement of participation in Piper Sandler healthcare conference and webcast access. |
| Nov 12 | Q3 2025 earnings | Neutral | -24.7% | Reported strong revenue and EBITDA growth but large noncash impairment from discontinued THP. |
| Nov 11 | Strategic realignment | Neutral | -0.4% | Decision to discontinue THP and refocus capital on core surgical operations. |
| Oct 01 | Earnings scheduling | Neutral | -2.9% | Scheduling Q3 2025 results release and investor call with access details. |
| Sep 02 | CEO transition | Positive | -3.2% | Appointment of Seth Yon as CEO highlighting strong past revenue growth under his leadership. |
Recent SMTI news, including earnings, strategic updates, and leadership changes, often saw negative price reactions even when fundamentals or strategy appeared constructive.
Over the last few months, Sanara MedTech has focused investors on its core surgical business and financial performance. It discontinued the Tissue Health Plus segment, recorded sizable impairment charges, and still delivered growing Q3 2025 revenue and improved adjusted EBITDA from continuing operations. Leadership also transitioned to CEO Seth Yon, supported by an investor presentation outlining 2026 priorities. Against this backdrop, today’s OsStic™ development and patent update reinforces the strategic pivot toward surgical innovation and bone-focused technologies.
Market Pulse Summary
This announcement highlights continued progress on OsStic™, including FDA Breakthrough Device Designation, a 2025 U.S. patent grant, and a targeted Q1 2027 U.S. launch. It reinforces Sanara’s strategy to focus on surgical innovations after discontinuing its THP segment. Investors may track future regulatory milestones, additional clinical data supporting the claim of “forty times stronger” bonding, and how OsStic fits into the company’s broader soft tissue and bone fusion portfolio.
Key Terms
breakthrough device designation regulatory
AI-generated analysis. Not financial advice.
Poised for U.S. market launch in Q1 2027 following the achievement of recent milestones and OsStic’s granted patent in 2025
FORT WORTH, TX, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Sanara MedTech Inc. (“Sanara,” the “Company,” “we,” “our” or “us”) (Nasdaq: SMTI), a medical technology company focused on developing and commercializing transformative technologies to improve clinical outcomes and reduce healthcare expenditures in the surgical market, together with Biomimetic Innovations Ltd (“BMI”), today provided an update on progress related to their strategic alliance. In addition, Sanara reaffirmed its plans to introduce OsStic™ Synthetic Injectable Structural Bio-Adhesive (“OsStic”) to the U.S. commercial market in the first quarter of 2027, following anticipated clearance by the U.S. Food and Drug Administration (“FDA”), to support reduction and provisional fixation treatment of the more than 100,000(1) peri-articular fractures occurring annually nationwide.
The FDA granted OsStic Breakthrough Device Designation in December 2023, recognizing its potential to provide more effective treatment for life-threatening or irreversibly debilitating conditions. If cleared for the target indication, we expect that OsStic will be the first bone bioadhesive available in the U.S. that utilizes phosphoserine, alpha-tricalcium phosphate (α-TCP), and calcium silicate as key ingredients to support bone healing and enhance structural and mechanical stability. OsStic is fast-setting in bone tissue, injectable, moldable, and remodels into bone—addressing critical limitations of current provisional fixation techniques. Preclinical mechanical testing demonstrates that OsStic provides forty times stronger bonding than traditional calcium phosphate bone cement.(2)
Highlighting the unmet clinical need in complex joint reconstruction, Dr. J. Tracy Watson, Professor of Orthopaedic Surgery and Chief of the Orthopaedic Trauma Service at Saint Louis University School of Medicine, said, “As a trauma surgeon, there is no greater challenge than reconstructing complex articular fractures. Current technologies often fall short in restoring joint congruency and stability, especially when faced with highly fragmented surfaces. OsStic represents a major paradigm shift—enabling us to achieve micro-stability and reconstruct joints that were previously considered non-repairable. This is the kind of innovation our field has been waiting for.”
Throughout 2025, BMI and Sanara have achieved key product development, clinical, regulatory, and medical education milestones related to both OsStic and a related hardware-agnostic adjunctive internal fixation technology. In addition, the U.S. Patent and Trademark Office affirmed the novelty and utility of OsStic by granting U.S. Patent No. 12,251,490, entitled “Composition of alpha-TCP, Silicate, and Phosphorylated Amino Acid.” The granted claims under the patent encompass aqueous compositions, bone fillers, and biological tissue adhesives covering the key ingredients of OsStic, as well as adhesion methods, kits, and prefilled syringes for forming the inventive composition. This patent augments BMI’s existing patent portfolio which protects the use of OsStic through 2037 in a variety of clinical applications, including U.S. Patent No. 11,964,072 for bonding soft tissues, as well as pending applications to further protect OsStic, additional adhesive compositions, and an adjunctive internal fixation technology beyond 2040.
Seth Yon, Sanara’s President and Chief Executive Officer, commented “OsStic exemplifies our commitment to bringing truly innovative solutions to the surgical market. By working closely with BMI, we’re expanding our portfolio through our License and Distribution Agreement with BMI to address critical unmet needs in orthopaedic care and strengthen our position as a leader in surgical innovation.”
Mark McMahan, Chief Commercial Officer of BMI, added “We’re excited to partner with Sanara MedTech to introduce OsStic to the U.S. market. This collaboration combines BMI’s technology leadership with Sanara’s commercial expertise, ensuring surgeons and patients have access to a new standard in bone bioadhesives.”
(1) National Library of Medicine; BMI and Sanara company estimates.(2) Data on file. Preclinical mechanical testing data.
About the Strategic Alliance Between Sanara and BMI
On January 21, 2025, Sanara announced the execution of an exclusive license and distribution agreement (the “License and Distribution Agreement”) with BMI, a privately-held medical device company headquartered in Shannon, Ireland. In 2025, Sanara contributed
Under the terms of the License and Distribution Agreement, Sanara acquired the exclusive U.S. marketing, sales, and distribution rights to OsStic, as well as a hardware agnostic adjunctive internal fixation technology featuring novel delivery to promote targeted application of OsStic, for use in fracture management. The License and Distribution Agreement is for an initial five-year period, with the option to automatically renew for successive two-year periods.
About Biomimetic Innovations Ltd and PBC Biomed
Biomimetic Innovations Ltd is an affiliate of PBC Biomed, a medical device company involved in design, development and manufacturing. PBC Biomed partners with medical device, biologic, pharmaceutical and combination product innovators to accelerate their technology through the product lifecycle stages. PBC Biomed offers regulatory, clinical, quality assurance and commercial support, and facilitates the design, development and validation of medical devices, biologics, and combination products. PBC Biomed’s ISO 13485 facilities and ISO 9001 certified processes enable the company to perform clean room manufacturing, packing and sterilization for a range of medical device products. PBC Biomed is headquartered in Shannon, Ireland, with offices in Memphis, Tennessee and Chamonix, France. PBC Biomed has a track record in developing and commercializing new technologies, bringing the N-Force Fixation/iN3 Cement to market through its affiliate company, CelgenTek Innovations (acquired by Zimmer Biomet in 2016), and more recently bringing ReFeel® to market as a nerve regeneration solution, with partner company Mochida Pharmaceuticals Ltd (Japan). For more information, please visit www.pbcbiomed.com and www.pbcbiomed.com/affiliates/biomimeticinnovations/.
About Sanara MedTech Inc.
Sanara MedTech Inc. is a medical technology company focused on developing and commercializing transformative technologies to improve clinical outcomes and reduce healthcare expenditures in the surgical market. The Company develops, markets, and distributes surgical products for use by physicians and clinicians in hospitals. Each of the Company’s products, services, and technologies are designed to achieve the goal of providing better clinical outcomes at a lower overall cost for patients. Sanara’s products are primarily sold in the North American surgical tissue repair markets. Sanara markets and distributes CellerateRX® Surgical Activated Collagen® Powder, BIASURGE® Advanced Surgical Solution, FORTIFY TRG® Tissue Repair Graft, FORTIFY FLOWABLE® Extracellular Matrix, as well as a portfolio of advanced biologic products including: ACTIGEN® Verified Inductive Bone Matrix, ALLOCYTE® Plus Advanced Viable Bone Matrix, BiFORM® Bioactive Moldable Matrix, and TEXAGEN® Amniotic Membrane Allograft to the surgical market. The Company believes it can drive its pipeline from concept to preclinical and clinical development while meeting quality and regulatory requirements. The Company strives to be one of the most innovative and comprehensive providers of effective surgical solutions and is continually seeking to expand its offerings for patients requiring treatments in the United States. For more information, please visit SanaraMedTech.com.
Information about Forward-Looking Statements
The statements in this press release that do not constitute historical facts are “forward-looking statements,” within the meaning of and subject to the safe harbor created by the Private Securities Litigation Reform Act of 1995. These statements may be identified by terms such as “aims,” “anticipates,” “believes,” contemplates,” “continue,” “could,” “estimates,” “expect,” “forecast,” “guidance,” “intends,” “may,” “plans,” “possible,” “potential,” “predicts,” “preliminary,” “projects,” “seeks,” “should,” “targets,” “will” or “would,” or the negatives of these terms, variations of these terms or other similar expressions. These forward-looking statements include, among others, statements regarding the Company’s arrangement with BMI and the integration of BMI’s OsStic and related technologies into the Company’s product and service offerings, the timing of 510(k) clearance and the introduction of OsStic and related technologies to the U.S. market, the efficacy and adoption of OsStic upon introduction to the U.S. commercial market, the Company’s business strategy and mission, the development of new products, the timing of commercialization of the Company’s products, the regulatory approval process and expansion of the Company’s business. These items involve risks, contingencies and uncertainties such as uncertainties associated with the development and process for obtaining regulatory approval, including 510(k) clearance from the FDA, for new products and OsStic and related technologies, the Company’s ability to build out its executive team, the Company’s ability to identify and effectively utilize the net proceeds of its term loan to support the Company’s growth initiatives, the extent of product demand, market and customer acceptance, the effect of economic conditions, competition, pricing, uncertainties associated with the development and process for obtaining regulatory approval for new products, the ability to consummate and integrate acquisitions, and other risks, contingencies and uncertainties detailed in the Company’s SEC filings, which could cause the Company’s actual operating results, performance or business plans or prospects to differ materially from those expressed in, or implied by these statements.
All forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to revise any of these statements to reflect the future circumstances or the occurrence of unanticipated events, except as required by applicable securities laws.
Investor Relations Contact:
Jack Powell or Mike Piccinino, CFA
ICR Healthcare
IR@sanaramedtech.com
FAQ
When does Sanara MedTech (SMTI) plan to launch OsStic in the U.S.?
What regulatory milestone does OsStic have for SMTI?
What patent protection does OsStic have for SMTI?
How strong is OsStic compared with traditional bone cement according to SMTI?
Is OsStic approved for use in the U.S. now (SMTI)?
