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Bioventus Receives FDA 510(k) Clearances for two Next-Generation Peripheral Nerve Stimulation Products
Globenewswire· 2025-07-30 11:30
Core Insights - Bioventus Inc. has received FDA 510(k) clearances for TalisMann™ and StimTrial™, enhancing its Peripheral Nerve Stimulation (PNS) solutions for chronic pain management [1][2][3] Company Developments - The FDA clearances represent a significant growth opportunity for Bioventus in the PNS market, which is projected to grow over 20% annually and exceed $500 million by 2029 [2] - Bioventus plans to initiate a limited commercial release of TalisMann™ and StimTrial™ in select U.S. markets in Q3 2025, with a broader rollout expected in early 2026 [5] Product Highlights - TalisMann™ utilizes patented electric field conduction technology combined with an integrated pulse generator, aimed at providing long-term relief from chronic nerve pain and improving physician lead placement [8] - StimTrial™ is designed as a trial lead to help physicians assess patient responses to PNS therapy, potentially facilitating adoption and reimbursement [8]