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March 2, 2022

US FDA grants 510(k) clearance for Bioventus’ Neuromodulation System

StimRouter Neuromodulation System is designed to treat chronic pain of peripheral nerve origin, excluding craniofacial pain.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Bioventus’ StimRouter Neuromodulation System.

The next-generation pain treatment device is designed to treat chronic pain of peripheral nerve origin, excluding craniofacial pain.

StimRouter is a minimally invasive device, which comprises a thin, implanted lead with a conductive electrode, StimRouter Plus Mobile Application and external electric field conductor (E-EFC).

It transmits the electrical signals transcutaneously from the E-EFC and guides to the targeted nerve by the implanted lead. 

Bioventus chief commercial officer John Nosenzo said: “The impact of chronic, debilitating pain is more than just managing the impacted anatomy, it is also about helping return the individual back to a life pre-pain.

“The emotional and psychological damage from living with pain is horrific and we are pleased to support all the physicians who are committed to improving patient lives, in particular with alternatives to opioids when possible.

“The next generation StimRouter will support patients and physicians to meet their pain treatment goals as the previous generation of peripheral nerve stimulation has done for many years.”

The new version of the StimRouter system offers similar clinically proven, long-term pain relief and also significantly improves the control of the patient as well as the user experience.

It includes a smartphone application along with an advanced E-EFC.

Last August, Bioventus agreed to make a $50m escrow payment pursuant to its option and equity purchase agreement to acquire Israel-headquartered CartiHeal.

CartiHeal developed the Agili-C implant to treat cartilage and osteochondral defects in the knee joints of patients without severe osteoarthritis.

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