Bioventus gets FDA clearance for two pain-management devices

Bioventus, a Durham-based health care company, has received regulatory permission to begin marketing two medical devices that treat chronic pain.

The U.S. Food and Drug Administration granted 510(k) clearance for both TalisMann and StimTrial, which provide Peripheral Nerve Stimulation (PNS) solutions for chronic pain management. The clearance allows both products to be sold immediately without additional clinical trials.

Bioventus said in a news release that it expects to begin a limited commercial release of both products in select U.S. markets during the third quarter of 2025, with a broader rollout planned for early 2026.

“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 of pain and restorative therapies at Bioventus. “It also creates an exciting growth opportunity for our business.”

The PNS market is estimated to be growing above 20 percent annually and is expected to exceed $500 million by 2029, according to a company SEC filing. 

TalisMann and StimTrial will help physicians to treat a broader spectrum of patients — from initial assessment to long-term therapy — with greater confidence and flexibility, the company said. The devices reinforce the company’s focus on delivering non-opioid, minimally invasive therapies.

TalisMann combines patented electric field conduction technology with an integrated pulse generator to potentially reach deeper, larger nerves. This combination is designed to provide long-term relief from chronic nerve pain for patients, potentially increasing the number of patients who respond to neuromodulation therapy.

StimTrial is a temporary thin wire lead that is placed near a targeted nerve. The trial lead gives physicians the ability to evaluate patient response to PNS therapy. The company said the product should facilitate physician adoption and payer reimbursement where trial assessments are required.

British spin-out

Bioventus was initially the biologics and clinical therapies unit of Smith & Nephew, a British medical technology company. In 2012, Smith & Nephew spun out Bioventus as a separate company with financial backing from healthcare investment firm Essex Woodlands.  Bioventus became a publicly traded company in 2021.

In addition to TalisMann and StimTrial, Bioventus’ marketed products include:

•    StimRouter, an implantable peripheral nerve stimulator for easing chronic pain.

•    Durolane, Gelsyn-3 and Supartz FX, injectable therapies for joint pain caused by osteoarthritis.

•    XCELL PRP, a benchtop device that processes whole blood to produce high-yield platelet-rich plasma (PRP) for therapeutic use.

•    Exogen, a device that uses ultrasound waves to stimulate the healing of fractured bones.

•    Osteoamp, an allograft that supports bone healing.

•    Signafuse, a bioactive bone graft that supports new bone formation.

•    Nexus, an ultrasonic surgical aspirator for hard and soft tissue removal.

•    BoneScalpel, an ultrasound instrument for osteotomy, a type of bone surgery.

•    SonaStar, an ultrasonic tool that helps surgeons remove soft tissue with precision, reducing surgery times.

Bioventus reported global revenues of $573.3 million in 2024. The company had about 930 employees as of December 2024, according to its latest annual report.