US-based medical device company Bioventus has secured the US Food and Drug Administration (FDA) 510(k) clearance for its TalisMann and StimTrial products.
The products represent an advancement in Bioventus’ Peripheral Nerve Stimulation (PNS) solutions for chronic pain management.
The FDA clearances for TalisMann and StimTrial signify a substantial growth opportunity for Bioventus, enabling the company to offer a comprehensive PNS portfolio.
It allows the company to further penetrate the PNS market, which is anticipated to grow over 20% annually, reaching over $500m by 2029.
Bioventus pain and restorative therapies general manager Anthony Doyle said: “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.”
The TalisMann and StimTrial aim to empower physicians with enhanced tools for treating a wider range of patients, from initial assessment through to long-term therapy
Also, the products support non-opioid, minimally invasive treatment options.
TalisMann leverages patented electric field conduction technology with an integrated pulse generator, targeting deeper and larger nerves.
The design aims to provide long-term relief from chronic nerve pain, potentially increasing patient responsiveness to neuromodulation therapy.
Enhanced power facilitates easier lead placement and broadens the range of addressable nerves for physicians.
StimTrial allows physicians to evaluate patient response to PNS therapy.
The capability is expected to encourage physician adoption and support payer reimbursement in cases where trial assessments are necessary.
Bioventus plans a limited commercial release of TalisMann and StimTrial in select US markets during the third quarter, with a broader rollout slated for early 2026.
The company is committed to delivering clinically proven, cost-effective products that promote rapid and safe healing, supporting patients in resuming active lives.
Bioventus’ offerings include pain treatments, surgical solutions, and restorative therapies, underpinned by high-quality standards and evidence-based medicine.
