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Home » FDA clears Axonics’ recharge-free sacral neuromodulation system

FDA clears Axonics’ recharge-free sacral neuromodulation system

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AxonicsAxonics Modulation Technologies (Nasdaq:AXNX) announced today that it received FDA approval for its new implantable neurostimulator.

Irvine, California–based Axonics designed the Axonics F15 recharge-free sacral-neuromodulation (SNM) system with a functional life span of over 15 years at typical stimulation parameters and more than 2 decades at lower-energy settings.

The system’s size totals 10 cubic centimeters, making it 20% smaller than the market’s other non-rechargeable SNM device, Axonics said in a news release. In addition, its constant current automatically adjusts stimulation output, while it also offers intuitive, recharge-free key fob control featuring SmartMRI technology.

Axonics’ recharge-free SNM system has MRI compatibility for full-body MRI with 1.5T and 3.0T whole-body scanners, as well as a proprietary algorithm that recommends optimal stimulation parameters based on intraoperative responses.

Axonics CEO Raymond W. Cohen said last month, when discussing the company’s fourth-quarter earnings, that the company plans to begin shipping the recharge-free SNM in the second quarter of 2022 following FDA approval. Cohen reiterated that stance today by confirming the company’s plans to start shipping the Axonics F15 system in April.

“Axonics is keenly focused on developing innovative, best-in-class, patient-centric SNM solutions as well as expanding awareness and access to this life-changing therapy,” Cohen said in today’s news release. “The new Axonics F15 recharge-free SNM system is similarly groundbreaking – a small and thin INS with an expected life in the body of well over a decade that does not require any element of the system to be recharged – and sets a new standard for what is possible in this category.

Said Needham & Co. analyst Mike Matson about the approval: “We believe that the F15 approval closes a portfolio gap and could drive the next leg of SNM market share gains for AXNX.”

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