Sanara MedTech's Drug in the FDA Approval Process
This 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.
- Drug:
- CellerateRX
- Announced Date:
- March 11, 2026
- Indication:
- Surgical Powder in the Management of Spine Surgery Wounds
Announcement
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.
AI Summary
Sanara 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.
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Sanara MedTech FDA Events - Frequently Asked Questions
As of now, Sanara MedTech (SMTI) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Sanara MedTech (SMTI) has reported FDA regulatory activity for CellerateRX.
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."
Currently, Sanara MedTech has one therapy (CellerateRX) targeting the following condition: Surgical Powder in the Management of Spine Surgery Wounds.
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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
FDA progress for NASDAQ:SMTI last updated on 3/11/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
