AXNX - Axonics Notches FDA Approval for SNM System

Axonics Modulation Technologies (NASDAQ:AXNX) revealed on Monday (September 9) that the US Food and Drug Administration has given the company seal of approval for its rechargeable sacral neuromodulation (SNM) device.

Called the Axonics r-SNM® System, the rechargeable device has been approved to treat bowel incontinence in the United States.

According to the press release, the SNM system is the first rechargeable device of its kind to be commercially approved in the US, Europe, Canada and Australia.

In addition to treating bowel dysfunction, the company’s device is currently being reviewed by the FDA in a premarket filing for overreactive bladder and urinary retention.

Monday’s approval has been designated a 15 year shelf life in patients with bowel incontinence without having to remove it during MRI procedures.

“We believe the number of patients seeking SNM treatment will expand dramatically over the next few years given our fuss-free, long-lived, full-body MRI-compatible device,” Raymond Cohen, CEO of Axonics, said in a press release.

The US National Library of Medicine indicates that SNM treatment options have increased in popularity for conditions such as overactive bladder.

According to the agency, this method has the capability to decrease incidents and boost bladder capacity. In terms of bowel incontinence, the agency says that SNM has begun showing an improvement in patients’ quality of life who have this condition and who have been evaluated before and after implementation.

Approximately 87 million adults split between the US and Europe area affected with overbladder while 40 million adults are impacted by bowel incontinence.

A research report on global incontinence care products and devices estimates that during the forecast period 2015 to 2019, SNM devices grew significantly at an 18.7 percent compound annual growth rate (CAGR). Similarly, a report called Sacral Nerve Stimulation Market projects the market valuation for this industry will be worth  over US$2.3 billion by 2026, growing at a CAGR of 12.1 percent between now and then.

Fueling that growth will be a rising demand for more minimally invasive therapies and an increase in urinary bladder diseases, to name a few. The report suggests, however, that enough awareness and the costs of these products could hinder the market’s projected growth.

Axonics says that it plans to start shipping out its device across the US to doctors and hospitals by Q4 of this year subject to the FDA’s requirements.

Despite the FDA’s approval on Monday, shares of the company dropped 6.92 percent to close the trading session at US$33.24. Year-to-date, Axonics’ share price has increased more than 150 percent.

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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.