Bioventus Receives FDA 510(k) Clearances for two Next-Generation Peripheral Nerve Stimulation Products
Bioventus (Nasdaq: BVS) has received FDA 510(k) clearances for two new Peripheral Nerve Stimulation (PNS) products: TalisMann™ and StimTrial™. These innovative solutions target the rapidly growing PNS market, which is projected to exceed $500 million by 2029 with over 20% annual growth.
TalisMann™ combines electric field conduction technology with an integrated pulse generator for treating chronic nerve pain, while StimTrial™ enables physicians to evaluate patient response to PNS therapy. The company plans a limited commercial release in Q3 2025, followed by a broader rollout in early 2026.
Bioventus (Nasdaq: BVS) ha ottenuto le approvazioni FDA 510(k) per due nuovi prodotti di Stimolazione del Nervo Periferico (PNS): TalisMann™ e StimTrial™. Queste soluzioni innovative sono destinate al mercato PNS in rapida crescita, che si prevede supererà i 500 milioni di dollari entro il 2029 con una crescita annua superiore al 20%.
TalisMann™ combina la tecnologia di conduzione del campo elettrico con un generatore di impulsi integrato per il trattamento del dolore cronico ai nervi, mentre StimTrial™ permette ai medici di valutare la risposta del paziente alla terapia PNS. L'azienda prevede un rilascio commerciale limitato nel terzo trimestre del 2025, seguito da un lancio più ampio all'inizio del 2026.
Bioventus (Nasdaq: BVS) ha recibido las aprobaciones FDA 510(k) para dos nuevos productos de Estimulación del Nervio Periférico (PNS): TalisMann™ y StimTrial™. Estas soluciones innovadoras están dirigidas al mercado de PNS en rápido crecimiento, que se proyecta superará los 500 millones de dólares para 2029 con un crecimiento anual superior al 20%.
TalisMann™ combina tecnología de conducción de campo eléctrico con un generador de pulsos integrado para tratar el dolor nervioso crónico, mientras que StimTrial™ permite a los médicos evaluar la respuesta del paciente a la terapia PNS. La compañía planea un lanzamiento comercial limitado en el tercer trimestre de 2025, seguido por un despliegue más amplio a principios de 2026.
Bioventus (Nasdaq: BVS)는 두 가지 새로운 말초신경자극(PNS) 제품인 TalisMann™과 StimTrial™에 대해 FDA 510(k) 승인을 받았습니다. 이 혁신적인 솔루션들은 연평균 20% 이상의 성장률로 2029년까지 5억 달러를 초과할 것으로 예상되는 빠르게 성장하는 PNS 시장을 목표로 합니다.
TalisMann™은 만성 신경통 치료를 위해 전기장 전도 기술과 통합 펄스 발생기를 결합하였으며, StimTrial™은 의사들이 PNS 치료에 대한 환자의 반응을 평가할 수 있도록 합니다. 회사는 2025년 3분기에 제한적 상업 출시를 계획하고 있으며, 2026년 초에는 보다 광범위한 출시를 진행할 예정입니다.
Bioventus (Nasdaq : BVS) a obtenu les autorisations FDA 510(k) pour deux nouveaux produits de stimulation nerveuse périphérique (PNS) : TalisMann™ et StimTrial™. Ces solutions innovantes ciblent le marché en forte croissance de la PNS, qui devrait dépasser les 500 millions de dollars d'ici 2029 avec une croissance annuelle de plus de 20 %.
TalisMann™ combine la technologie de conduction de champ électrique avec un générateur d'impulsions intégré pour traiter la douleur nerveuse chronique, tandis que StimTrial™ permet aux médecins d'évaluer la réponse des patients à la thérapie PNS. La société prévoit un lancement commercial limité au troisième trimestre 2025, suivi d'un déploiement plus large début 2026.
Bioventus (Nasdaq: BVS) hat die FDA 510(k)-Freigaben für zwei neue Produkte zur peripheren Nervenstimulation (PNS) erhalten: TalisMann™ und StimTrial™. Diese innovativen Lösungen richten sich an den schnell wachsenden PNS-Markt, der voraussichtlich bis 2029 über 500 Millionen US-Dollar erreichen wird, mit einem jährlichen Wachstum von über 20%.
TalisMann™ kombiniert die Technologie der elektrischen Feldleitung mit einem integrierten Pulsgenerator zur Behandlung chronischer Nervenschmerzen, während StimTrial™ Ärzten ermöglicht, die Reaktion der Patienten auf die PNS-Therapie zu bewerten. Das Unternehmen plant eine begrenzte Markteinführung im dritten Quartal 2025, gefolgt von einer breiteren Einführung Anfang 2026.
- FDA 510(k) clearances received for two new PNS products
- Entry into PNS market growing over 20% annually with $500M+ potential by 2029
- TalisMann technology enables treatment of deeper, larger nerves, expanding patient reach
- StimTrial product expected to facilitate physician adoption and payer reimbursement
- Limited initial commercial release suggests cautious market approach
- Full market rollout delayed until 2026
Insights
Bioventus's FDA clearances for TalisMann and StimTrial strengthen its position in the fast-growing PNS market for chronic pain management.
Bioventus has secured critical FDA 510(k) clearances for two new peripheral nerve stimulation (PNS) products, positioning the company to capture share in a market growing over
The technical innovations in these products are significant. TalisMann combines electric field conduction with an integrated pulse generator designed to reach deeper nerves more effectively. This advancement could meaningfully expand the patient population that responds to neuromodulation therapy. The increased power output simplifies lead placement for physicians and potentially allows treatment of a wider range of nerve targets.
StimTrial addresses a critical market need as Bioventus' first trial lead system. This enables physicians to evaluate patient response before permanent implantation – a capability that should accelerate physician adoption while satisfying payer requirements where trial periods are mandated for reimbursement approval.
The commercial strategy appears well-conceived, with limited release in Q3 2025 followed by broader rollout in early 2026, allowing for controlled market introduction and physician training. These clearances substantially enhance Bioventus's competitive positioning in the rapidly expanding PNS market segment, providing a complete portfolio that spans from trial assessment to long-term therapy.
DURHAM, N.C., July 30, 2025 (GLOBE NEWSWIRE) -- Bioventus Inc. (Nasdaq: BVS), a global leader in innovations for active healing, 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.
These two clearances mark an important step forward for Bioventus and represent a substantial growth opportunity as the Company looks to expand in the PNS market, which is currently estimated to be growing above 20 percent annually and expected to exceed
“The FDA clearance of both TalisMann™ and StimTrial™ represents a significant step forward in our PNS business, providing patients with innovative technologies. It also creates an exciting growth opportunity for our business”, said Anthony Doyle, General Manager, Pain and Restorative Therapies of Bioventus.
Portfolio Highlights:
- TalisMann™: Combines our patented electric field conduction technology with an integrated pulse generator to potentially reach deeper, larger nerves. This combination is designed to provide long-term relief from chronic nerve pain for patients, potentially increasing the number of patients who respond to neuromodulation therapy. From a physician's perspective, the increase in power allows for easier lead placement and potentially broadens addressable nerves.
- StimTrial™: Bioventus’ first trial lead provides physicians the ability to evaluate patient response to PNS therapy, which we expect will facilitate physician adoption and payer reimbursement where trial assessments are required.
Commercial Launch:
Bioventus expects to begin a limited commercial release of both TalisMann™ and StimTrial™ in select U.S. markets during this third quarter, with a broader rollout planned for early 2026.
About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for Pain Treatments, Surgical Solutions and Restorative Therapies. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.
Forward-Looking Statements
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Media Contact:
Dave Crawford
Bioventus
investor.relations@bioventus.com
FAQ
What FDA clearances did Bioventus (BVS) receive in July 2025?
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When will Bioventus launch TalisMann and StimTrial commercially?
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How does StimTrial benefit physicians and payers?
