Axonics Modulation Technologies, Inc. AXNX has presented a favorable outcome of its detailed one-year ARTISAN-SNM pivotal study at the joint scientific meeting of the American Urogynecologic Society (AUGS) and the International Urogynecological Association (IUGA). This came on the heels of the FDA approval of the Axonics r-SNM System1 in September 2019.
In the session, it showcased the Axonics r-SNM System and received first-hand impressions of various medical practitioners that attended. The company also received feedback on post-implant patients from physician implanters who took part in the study.
With the positive study results, the company aims to strengthen foothold in the implantable Sacral Neuromodulation (“SNM”) devices market.
Few Words on SNM
Approximately, 87 million adults in the United States and Europe suffer from urinary and bowel dysfunction. Another estimated 40 million adults reportedly suffer from fecal incontinence/accidental bowel leakage.
SNM therapy takes care of the problem by reducing and restoring pelvic floor function.
A Closer Look at the Study
The presentation (titled ‘Treatment of urinary urgency incontinence with the Axonics miniaturized, rechargeable SNM system: Clinical outcomes of the ARTISAN-SNM pivotal study’) shows results of the clinical study over 12 months. It highlights the important advancements observed in patients with respect to urinary urgency incontinence symptoms and quality of life after implanted with Axonics r-SNM System.
The study of ARTISAN-SNM is approved under the FDA Investigational Device Exemption to assess the safety and efficiency of the Axonics r-SNM System for urinary dysfunction.
Why is the Study a Breakthrough?
The study results were quite impressive as it proved that there were no serious device-related negative impacts after the implants. Also, there was a significant improvement in urgency incontinence episodes in most of the patients, contrary to earlier treatment options.
Per a report by Reports And Data, the global SNM market was valued at $2189.1 million in 2018 and is expected to reach $3153.4 million by 2026, seeing a CAGR of 4.94%. Key factors driving the market are the rising demand for minimally invasive therapy, increasing incidents of urinary bladder diseases and various technological advancements.
Axonics signed an agreement with Adult Pediatric Urology and Urogynecology (“ADPU”) in October 2019 to supply its product, Axonics r-SNM System. ADPU is a pioneer in the SNM treatment of urinary and bowel dysfunction, and its physicians have been successful in implanting SNM devices for quite a long time. Axonics received the FDA clearance for the product in September 2019.
In June 2019, the company received the FDA nod for the use of full-body MRI, using 1.5 Tesla MRI scanners for patients implanted with the Axonics System as part of its clinical study.
Comparison With Peers
In the SNM care space, a number of bigwigs are actively looking to tap bountiful opportunities. Medtronic plc MDT recently received the FDA approval for the InterStim(TM) smart programmer to be used with the InterStim system.
Abbott Laboratories ABT announced results of a new study, which confirmed that higher levels of a protein measured, with Abbott's blood test under development, could help detect mild traumatic brain injuries (“TBI”s), even when a CT scan failed to detect it.
Nuvectra Corporation NVTR has announced that its Virtis SNM system is currently under the FDA review. The company is closely working with the FDA to complete its pre-market approval (PMA) application for the Virtis platform.
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