IRVINE, Calif. - Axonics, Inc. (NASDAQ:AXNX), a medical technology company, has announced today that it received approval from Australia's Therapeutic Goods Administration (TGA) to market its Axonics F15™ sacral neuromodulation (SNM) system. The system is designed to treat adults with overactive bladder without the need for regular recharging.
The Axonics F15 SNM system features a recharge-free implantable neurostimulator, which is notably compact and thin. Its battery life is expected to exceed 15 years under typical use and potentially over 20 years at lower energy settings. The system provides constant current stimulation, which automatically adjusts to maintain therapeutic relief and requires minimal reprogramming. Additionally, the F15 is MRI compatible and comes with an intuitive, recharge-free patient remote control.
Urologist Dr. Ailsa Wilson Edwards from Calvary North Adelaide Hospital expressed enthusiasm for the new treatment option, highlighting the increased device longevity and ease of use compared to existing technologies.
Axonics has been active in the Australian market since March 2023, where it also offers Bulkamid®, a hydrogel for female stress urinary incontinence.
Raymond W. Cohen, CEO of Axonics, commented on the approval, underscoring the company's commitment to innovation and the promotion of its incontinence therapies in the United States, Europe, and Australia.
The company has recently been recognized for its rapid growth, ranking second on the 2023 Financial Times list of the fastest-growing companies in the Americas.
In the U.S., urinary incontinence affects an estimated 28 million women and fecal incontinence impacts around 19 million adults. Axonics' SNM systems aim to provide a long-lasting and user-friendly solution for these conditions.
This news is based on a press release statement from Axonics, Inc. and does not include any additional analysis or opinion.
InvestingPro Insights
As Axonics, Inc. (NASDAQ:AXNX) secures approval for its Axonics F15™ sacral neuromodulation (SNM) system in Australia, the company's financial metrics reflect a potent mix of growth and market confidence. With a market capitalization of approximately $3.45 billion USD, Axonics showcases a significant presence in the medical technology sector.
InvestingPro data indicates robust revenue growth for Axonics, with an impressive 30.82% increase in the last twelve months as of Q1 2024. This growth trajectory is further evidenced by a quarterly revenue growth of 29.38% in Q1 2024. The company's gross profit margin stands at a healthy 75.25%, suggesting efficient cost management relative to revenue.
An InvestingPro Tip worth noting is that Axonics holds more cash than debt on its balance sheet, which could provide financial flexibility and stability. Moreover, the company's liquid assets surpass short-term obligations, suggesting a strong liquidity position. These financial health indicators are particularly relevant as Axonics expands its product offerings and market reach.
While analysts do not anticipate the company will be profitable this year, and it is trading at a high EBITDA valuation multiple, the company's strategic advancements and market expansion could be key factors for potential investors to consider. For those interested in a deeper dive into Axonics' financials, InvestingPro offers additional insights, including 10 more InvestingPro Tips for AXNX at https://www.investing.com/pro/AXNX. For a more comprehensive analysis, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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