Bioventus Gets FDA OK for 2 Next-Gen Peripheral Nerve Stim Devices

Bioventus has received U.S. Food and Drug Administration (FDA) 510(k) clearances for TalisMann and StimTrial, bolstering its portfolio of peripheral nerve stimulation (PNS) devices for chronic pain management.

TalisMann combines the company’s electric field conduction technology with an integrated pulse generator to potentially reach deeper, larger nerves. The combination provides long-term relief from chronic nerve pain, potentially growing the number of patients who respond to neuromodulation therapy. The increase in power also allows easier lead placement and can broaden addressable nerves.

StimTrial is the company’s first trial lead and offers the ability to evaluate patient response to PNS therapy. Bioventus believes this will facilitate physician adoption and payer reimbursement where trial assessments are required.

Now that these two devices are FDA-cleared, the company’s PNS portfolio can be used to potentially treat a broader patient spectrum, from initial assessment to long-term therapy.

“The FDA clearance of both TalisMann and StimTrial represents a significant step forward in our PNS business, providing patients with innovative technologies,” said Anthony Doyle, General Manager, Pain and Restorative Therapies, Bioventus. “It also creates an exciting growth opportunity for our business.”

The company is planning for a limited commercial release of both TalisMann and StimTrial in select U.S. markets during Q3, with broader rollout planned for early 2026.

Last year, the company sold its Advanced Rehabilitation business to Accelmed partners for up to $45 million.