AUS
NZ
UK
CA
USA
IND
Axonics, Inc. (Nasdaq:AXNX) has reached a significant milestone with the Therapeutic Goods Administration's (TGA) recent approval to market its Axonics R20® rechargeable sacral neuromodulation (SNM) system in Australia. This innovative treatment option offers hope for adults struggling with overactive bladder and fecal incontinence, conditions that affect millions and can severely impact quality of life.
The Axonics R20 neurostimulator is a remarkable advancement in the field of neuromodulation, boasting a functional lifespan of at least 20 years within the body. Patients can now enjoy the convenience of recharging their implanted device only once every 6 to 10 months, with each recharge taking just one hour. This feature not only enhances patient comfort but also minimizes the hassle associated with frequent recharging—a significant improvement over older systems.
The R20 retains the compact 5cc form factor of its predecessor, the Axonics R15®, making it easy to implant and less invasive for patients. It utilizes the same proven tined lead and comes equipped with an intuitive patient remote control, allowing users to manage their therapy with ease. Furthermore, the R20 system offers enhanced programming capabilities and expanded MRI labeling, providing physicians with greater flexibility in treating their patients.
Dr. Janelle Brennan, a urologist at St. John of God Bendigo Hospital, expressed her enthusiasm for the new technology: “Approval of the Axonics R20 is welcome news for Australians with bladder and bowel dysfunction. I am excited to offer my patients a therapy that provides durable symptom relief with a small rechargeable neurostimulator that can last over 20 years in the body.” Her statement underscores the potential of the R20 to transform patient experiences and outcomes in a field often marked by limited options.
Axonics commenced its SNM commercial activities in Australia in March 2023, making rapid strides in addressing the needs of patients suffering from these challenging conditions. The company previously received TGA approval for its F15® recharge-free SNM system in May 2024 and also markets Bulkamid®, a unique hydrogel for female stress urinary incontinence. This range of innovative therapies highlights Axonics’ commitment to improving the lives of those affected by incontinence.
Raymond W. Cohen, CEO of Axonics, expressed his delight at the regulatory approval: “Our mission-driven team remains committed to innovating, supporting our dedicated physician customers and their patients, and raising awareness of our best-in-class incontinence therapies.” His comments reflect the company’s ongoing dedication to advancing treatment options in the realm of urology and neuromodulation.
The R20 is set to hit the Australian market in November, promising to make a significant impact on patient care and quality of life. As awareness of these advanced therapies grows, Axonics is poised to lead the way in providing effective solutions for bladder and bowel dysfunction. With the R20, patients can look forward to a future where their symptoms are managed more effectively, allowing them to regain control over their daily lives.
