Sanara MedTech (SMTI) FDA Approvals $34.16 0.00 (0.00%) As of 09:39 AM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesOwnershipSEC FilingsShort InterestTrendsBuy This Stock Sanara MedTech's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Sanara MedTech (SMTI). Over the past two years, Sanara MedTech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CellerateRX. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. CellerateRX FDA Regulatory Events CellerateRX is a drug developed by Sanara MedTech for the following indication: Surgical Powder in the Management of Spine Surgery Wounds. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Publication - March 11,2026Publication Drug: CellerateRXAnnounced Date: March 11, 2026Indication: Surgical Powder in the Management of Spine Surgery WoundsAnnouncementSanara MedTech Inc. announced the publication of a peer-reviewed study evaluating the economic and clinical value of CellerateRX® Surgical Powder ("CellerateRX") in the Journal of Medical Economics.AI SummarySanara MedTech announced a peer‑reviewed study in the Journal of Medical Economics that evaluated the economic and clinical value of CellerateRX® Surgical Powder. Researchers used economic modeling to compare two groups of high‑comorbidity patients having complex spinal surgery: those who received CellerateRX as an adjunct to standard wound care and those who received standard care alone. The study tracked postoperative complications, hospital readmissions, and surgical revisions over one year. Clinical benefits were measured in quality‑adjusted life years (QALYs) and direct medical costs were expressed in 2025 U.S. dollars. The study found that adding CellerateRX led to both better health outcomes and overall cost savings versus standard care alone. Authors concluded CellerateRX can be a value‑enhancing part of the spine surgery care pathway, especially for patients who face higher risk of complications, by reducing complications, readmissions and costly revision procedures. Read Announcement Sanara MedTech FDA Events - Frequently Asked Questions Has Sanara MedTech received FDA approval? As of now, Sanara MedTech (SMTI) has not received any FDA approvals for its therapy in the last two years. What drugs has Sanara MedTech submitted to the FDA? In the past two years, Sanara MedTech (SMTI) has reported FDA regulatory activity for CellerateRX. What is the most recent FDA event for Sanara MedTech? The most recent FDA-related event for Sanara MedTech occurred on March 11, 2026, involving CellerateRX. The update was categorized as "Publication," with the company reporting: "Sanara MedTech Inc. announced the publication of a peer-reviewed study evaluating the economic and clinical value of CellerateRX® Surgical Powder ("CellerateRX") in the Journal of Medical Economics." What conditions do Sanara MedTech's current drugs treat? Currently, Sanara MedTech has one therapy (CellerateRX) targeting the following condition: Surgical Powder in the Management of Spine Surgery Wounds. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Agenus FDA EventsBiomea Fusion FDA EventsMiNK Therapeutics FDA EventsRigel Pharmaceuticals FDA EventsBristol Myers Squibb FDA EventsAligos Therapeutics FDA EventsAnnexon FDA EventsAlterity Therapeutics FDA EventsCullinan Therapeutics FDA EventsDefinium Therapeutics FDA EventsAthira Pharma FDA EventsNeurocrine Biosciences FDA EventsNeonc Technologies FDA EventsNatera FDA EventsScienture FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies QuidelOrtho FDA Events Align Technology FDA Events Merit Medical Systems FDA Events Alpha Tau Medical FDA Events PROCEPT BioRobotics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:SMTI last updated on 3/11/2026 by MarketBeat.com Staff. 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Publication - March 11,2026Publication Drug: CellerateRXAnnounced Date: March 11, 2026Indication: Surgical Powder in the Management of Spine Surgery WoundsAnnouncementSanara MedTech Inc. announced the publication of a peer-reviewed study evaluating the economic and clinical value of CellerateRX® Surgical Powder ("CellerateRX") in the Journal of Medical Economics.AI SummarySanara MedTech announced a peer‑reviewed study in the Journal of Medical Economics that evaluated the economic and clinical value of CellerateRX® Surgical Powder. Researchers used economic modeling to compare two groups of high‑comorbidity patients having complex spinal surgery: those who received CellerateRX as an adjunct to standard wound care and those who received standard care alone. The study tracked postoperative complications, hospital readmissions, and surgical revisions over one year. Clinical benefits were measured in quality‑adjusted life years (QALYs) and direct medical costs were expressed in 2025 U.S. dollars. The study found that adding CellerateRX led to both better health outcomes and overall cost savings versus standard care alone. Authors concluded CellerateRX can be a value‑enhancing part of the spine surgery care pathway, especially for patients who face higher risk of complications, by reducing complications, readmissions and costly revision procedures. Read Announcement
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