Bioventus (Nasdaq:BVS) announced today that it received FDA 510(k) clearance for both its TalisMann and StimTrial offerings.
The FDA clearances expand the company’s portfolio of peripheral nerve stimulation (PNS) solutions for chronic pain management. Durham, North Carolina-based Bioventus said they mark an important step forward and a significant growth opportunity in the PNS market.
TalisMann and StimTrial add to a comprehensive portfolio that enables physicians to treat a broader spectrum of patients. It also reinforces the company’s commitment to delivering non-opioid, minimally invasive therapies for addressing real-world clinical needs.
Bioventus designed TalisMann to combine patented electric field conduction technology with an integrated pulse generator. It aims to potentially reach deeper, larger nerves to provide long-term relief from chronic nerve pain for patients. The company says its increase in power could allow for easier lead placement and potentially broaden addressable nerves.
StimTrial, meanwhile, provides physicians the ability to evaluate patient response to PNS therapy. Bioventus expects this to facilitate physician adoption and payer reimbursement where trial assessments are required.
The company expects to begin a limited commercial release of TalisMann and StimTrial in select U.S. markets during the third quarter. It plans for a broader rollout in early 2026.
“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, GM, Pain and Restorative Therapies at Bioventus.
