Bioventus' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Bioventus (BVS).
Over the past two years, Bioventus has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TalisMann. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TalisMann FDA Regulatory Events
TalisMann is a drug developed by Bioventus for the following indication: For chronic pain management.
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:
- TalisMann
- Announced Date:
- July 30, 2025
- Indication:
- For chronic pain management.
Announcement
Bioventus Inc announced today a significant milestone with the U.S. Food and Drug Administration (FDA) 510(k) clearances for both TalisMann™ and StimTrial™, expanding the Company's innovative portfolio of Peripheral Nerve Stimulation (PNS) solutions for chronic pain management.
AI Summary
Bioventus Inc. announced that the U.S. Food and Drug Administration granted 510(k) clearances for TalisMann™ and StimTrial™, marking an expansion of its Peripheral Nerve Stimulation (PNS) portfolio. These non-opioid, minimally invasive devices target chronic pain by supporting assessment and long-term therapy.
The PNS market is growing over 20% annually and is projected to exceed $500 million by 2029. With these clearances, Bioventus provides physicians with new tools to treat more patients and reinforce confidence in neuromodulation therapies.
TalisMann™ uses patented electric field conduction and an integrated pulse generator to reach deeper, larger nerves and simplify lead placement. StimTrial™ is the company’s first trial lead, enabling doctors to evaluate patient response to PNS and streamline reimbursement processes.
A limited U.S. launch is planned for the third quarter of 2025, with broad availability expected in early 2026, reflecting Bioventus’s commitment to innovation and active healing.
Read Announcement
Bioventus FDA Events - Frequently Asked Questions
As of now, Bioventus (BVS) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Bioventus (BVS) has reported FDA regulatory activity for TalisMann.
The most recent FDA-related event for Bioventus occurred on July 30, 2025, involving TalisMann. The update was categorized as "Provided Update," with the company reporting: "Bioventus Inc announced today a significant milestone with the U.S. Food and Drug Administration (FDA) 510(k) clearances for both TalisMann™ and StimTrial™, expanding the Company's innovative portfolio of Peripheral Nerve Stimulation (PNS) solutions for chronic pain management."
Currently, Bioventus has one therapy (TalisMann) targeting the following condition: For chronic pain management..
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:BVS) was last updated on 8/22/2025 by MarketBeat.com Staff
MarketBeat All Access