Bioventus receives FDA 510(k) clearances for TalisMann and StimTrial PNS products

Bioventus Inc.

FDA granted 510(k) clearance for TalisMann PNS system with integrated pulse generator for deeper/larger nerves.
StimTrial is a trial lead to evaluate patient response, expected to aid physician adoption and payer reimbursement.
Limited commercial release in select U.S. markets in Q3 2025; broader rollout planned for early 2026.
PNS market growing >20% annually, expected to exceed $500M by 2029, representing a growth opportunity.
Company offers comprehensive PNS portfolio for chronic pain management with non-opioid, minimally invasive therapies.

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