Bioventus receives FDA clearance for two pain management devices

Published 30/07/2025, 16:40
Bioventus receives FDA clearance for two pain management devices

DURHAM, N.C. - Bioventus Inc. (NASDAQ:BVS), a $452 million medical device company with annual revenues of $567 million and impressive gross margins of 67%, announced Wednesday it has received U.S. Food and Drug Administration 510(k) clearances for two new peripheral nerve stimulation (PNS) devices designed for chronic pain management.

The company received clearances for TalisMann, which combines electric field conduction technology with an integrated pulse generator to target deeper nerves, and StimTrial, a trial lead that allows physicians to evaluate patient response to PNS therapy.

These approvals expand Bioventus’s portfolio of non-opioid, minimally invasive pain management solutions and position the company to compete in the PNS market, which the company estimates is growing over 20 percent annually and expected to exceed $500 million by 2029. The company’s own revenue growth of 8.6% demonstrates its ability to capitalize on expanding markets. According to InvestingPro analysis, while currently unprofitable, analysts expect Bioventus to achieve profitability this year.

"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.

The company plans to begin limited commercial release of both devices in select U.S. markets during the third quarter of 2025, with a broader rollout planned for early 2026.

According to the press release, TalisMann’s increased power capabilities allow for easier lead placement and potentially broaden the range of treatable nerves, while StimTrial is expected to facilitate physician adoption and payer reimbursement where trial assessments are required.

Bioventus focuses on developing clinically proven products for pain treatments, surgical solutions, and restorative therapies. Wall Street analysts maintain a bullish outlook on the stock, and InvestingPro research indicates the stock is currently undervalued, with additional insights available in the comprehensive Pro Research Report covering this and 1,400+ other US equities.

In other recent news, Bioventus Inc. reported its first-quarter 2025 earnings, surpassing expectations with an earnings per share (EPS) of $0.06 compared to the projected $0.02. This performance highlights the company’s ability to exceed analyst forecasts despite facing broader market concerns. Additionally, Bioventus held its 2025 Annual Meeting of Stockholders, where several Class I directors were elected to the Board to serve until the 2026 meeting. The directors elected include Robert E. Claypoole, Philip G. Cowdy, and others, with a majority of votes in favor of their election.

In analyst updates, Cantor Fitzgerald initiated coverage on Bioventus with an Overweight rating and set a price target of $12.00. This positive outlook is based on Bioventus’s strong position in the market for pain treatments and surgical solutions. These developments reflect the ongoing strategic and financial activities within Bioventus. The company’s continued engagement with shareholders and positive analyst assessments suggest a focus on growth and market presence.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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