Bioventus (BVS) FDA Approvals $10.68 +0.51 (+5.01%) Closing price 04:00 PM EasternExtended Trading$10.66 -0.02 (-0.22%) As of 06:23 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock Bioventus' Drug in the FDA Approval ProcessThis 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. Provided Update - July 30,2025Provided Update Drug: TalisMannAnnounced Date: July 30, 2025Indication: For chronic pain management.AnnouncementBioventus 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 SummaryBioventus 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 Has Bioventus received FDA approval? As of now, Bioventus (BVS) has not received any FDA approvals for its therapy in the last two years. What drugs has Bioventus submitted to the FDA? In the past two years, Bioventus (BVS) has reported FDA regulatory activity for TalisMann. What is the most recent FDA event for Bioventus? 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." What conditions do Bioventus' current drugs treat? Currently, Bioventus has one therapy (TalisMann) targeting the following condition: For chronic pain management.. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Allarity Therapeutics FDA EventsAvalo Therapeutics FDA EventsBridgeBio Pharma FDA EventsCellectar Biosciences FDA EventsCytokinetics FDA EventsEupraxia Pharmaceuticals FDA EventsFate Therapeutics FDA EventsHoth Therapeutics FDA EventsKymera Therapeutics FDA EventsPalisade Bio FDA EventsRelmada Therapeutics FDA EventsSensei Biotherapeutics FDA EventsVerrica Pharmaceuticals FDA EventsViridian Therapeutics FDA EventsZentalis Pharmaceuticals 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 Soleno Therapeutics FDA Events AxoGen FDA Events NovoCure FDA Events Artivion FDA Events Inspire Medical Systems FDA Events Pulse Biosciences FDA Events PROCEPT BioRobotics FDA Events iRadimed FDA Events SS Innovations International FDA Events Spyglass Pharma FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:BVS last updated on 7/30/2025 by MarketBeat.com Staff. 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Provided Update - July 30,2025Provided Update Drug: TalisMannAnnounced Date: July 30, 2025Indication: For chronic pain management.AnnouncementBioventus 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 SummaryBioventus 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
