Tenon Medical's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Tenon Medical (TNON).
Over the past two years, Tenon Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
MAINSAIL™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
MAINSAIL™ FDA Regulatory Events
MAINSAIL™ is a drug developed by Tenon Medical for the following indication: Catamaran(R) SI Joint Fusion System.
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:
- MAINSAIL™
- Announced Date:
- September 4, 2024
- Indication:
- Catamaran(R) SI Joint Fusion System
Announcement
Tenon Medical, Inc. announced the first publication of the Catamaran SI Joint Fusion System® MAINSAIL™ study.
AI Summary
Tenon Medical, Inc. announced the first publication of its Catamaran SI Joint Fusion System® MAINSAIL study. This ongoing post-market study is testing a minimally invasive surgical treatment for patients with SI joint disruptions or degenerative sacroiliitis. The study followed 33 patients across six U.S. clinical sites and showed significant improvements in pain and disability scores at six months. Patients experienced a notable decrease in pain intensity and reported a reduction in disability. Early results also revealed high patient satisfaction and a robust safety profile, with no serious adverse events recorded.
Additionally, among the few patients who reached the 12-month follow-up, CT scans showed clear signs of joint fusion in most cases. The study supports the Catamaran system’s potential to be a safe and effective option in reducing pain and improving quality of life for patients with SI joint dysfunction.
Read Announcement
Tenon Medical FDA Events - Frequently Asked Questions
As of now, Tenon Medical (TNON) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Tenon Medical (TNON) has reported FDA regulatory activity for MAINSAIL™.
The most recent FDA-related event for Tenon Medical occurred on September 4, 2024, involving MAINSAIL™. The update was categorized as "Publication," with the company reporting: "Tenon Medical, Inc. announced the first publication of the Catamaran SI Joint Fusion System® MAINSAIL™ study."
Currently, Tenon Medical has one therapy (MAINSAIL™) targeting the following condition: Catamaran(R) SI Joint Fusion System.
More FDA Event Resources from MarketBeat
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
This page (NASDAQ:TNON) was last updated on 7/21/2025 by MarketBeat.com Staff
Free TNON Stock Alerts