Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced the acquisition of a lead placement solution from Radian, LLC that complements Axonics’ existing sacral neuromodulation (SNM) offering.

Physicians determine a patient’s eligibility for long-term SNM therapy by performing an external trial or peripheral nerve evaluation (PNE). The temporary lead that is placed during a PNE is often done in the office setting without real-time imaging (i.e., fluoroscopy). Due to anatomic variability between patients, locating the appropriate sacral foramen (closest to the desired root of the sacral nerve) can be challenging without fluoroscopy and can hinder physicians’ confidence in the procedure. The acquired technology addresses this challenge with an elegant solution comprising a software application and a hardware tool that makes PNE lead placement easier, faster, and more accurate.

The technology has the potential to reduce procedure time and facilitate a more accurate placement which, in turn, can increase physicians’ confidence in the SNM procedure and drive increased therapy adoption, utilization and permanent implant conversion rates. With a standard x-ray image of a patient’s pelvis, a physician can leverage the software to determine the optimal location for needle entry and lead placement based on the patient’s specific anatomy. The technology can readily be implemented into existing clinical workflows as it takes only minutes to use and requires minimal training.

Axonics has acquired the assets of Radian, LLC from Intermed Labs for undisclosed terms. Axonics expects the product to receive FDA clearance and be available on a commercial basis in mid-2024.

“Since Axonics’ founding, our SNM development efforts have focused on enhancing the physician and patient experience,” said Raymond W. Cohen, chief executive officer of Axonics. “We expect the Radian technology will improve patient comfort, increase physician confidence and SNM access, simplify the learning curve for physicians new to SNM, and increase PNE trial success rates, which should ultimately result in more adults being treated with our life-changing SNM therapy. We are confident that empowering physicians with innovative technology and tools has the potential to drive significant SNM market expansion in the years ahead.”

About Intermed Labs

Intermed Labs is an award-winning innovation lab and startup studio that advances technological breakthroughs in health technology. Intermed Labs works with talented physicians, companies, and health systems to conceive, launch, and scale new innovations to improve patient care. For more information, visit www.intermedlabs.com.

About Axonics

Axonics is a global medical technology company that is developing and commercializing novel products for adults with bladder and bowel dysfunction. Axonics recently ranked No. 2 on the 2023 Financial Times ranking of the fastest growing companies in the Americas and No. 4 on the 2022 Deloitte Technology Fast 500.

Axonics^® sacral neuromodulation systems provide adults with overactive bladder and/or fecal incontinence with long-lived, easy to use, safe, clinically effective therapy. In addition, the company’s best-in-class urethral bulking hydrogel, Bulkamid^®, provides safe and durable symptom relief to women with stress urinary incontinence. In the U.S., moderate to severe urinary incontinence affects an estimated 28 million women and fecal incontinence affects an estimated 19 million adults. Axonics’ clinically proven products are offered at hundreds of medical centers across the U.S. and abroad. Reimbursement coverage is well established in the U.S. and is a covered service in most European countries. For more information, visit www.axonics.com.

Forward-Looking Statements

Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “plans,” “expects,” “believes,” “anticipates,” “designs,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics' filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

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"We are confident that empowering physicians with innovative technology and tools has the potential to drive significant SNM market expansion in the years ahead."