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Axonics Modulation Hits Another High

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Axonics Modulation Technologies Inc. (AXNX) closed at a new high of $31.44 on Tuesday, an impressive 110 percent increase year-to-date. The stock was trading around $14 when we alerted readers to it on January 7, 2019 (Report titled "Axonics Ready To Charge Up?").

Axonics Modulation is a medical technology company whose rechargeable sacral neuromodulation (SNM) device, Axonics r-SNM System, has secured marketing approvals in Europe, Canada, and Australia. The implantable r-SNM device is indicated for patients with urinary and bowel dysfunction.

Sacral neuromodulation therapy is a reversible treatment that delivers electrical impulses to sacral nerve, the nerve that controls voiding function in the lower spine, to improve bladder and bowel function, and modulate pelvic pain.

In February of this year, Axonics r-SNM System received CE Mark for expanded use with full-body MRI scans. Without this labeling, any patient requiring an MRI scan on any body part below the head must have their r-SNM System surgically explanted prior to the MRI scan, resulting in an additional surgery for the patient and additional costs to patients and the healthcare system.

In the U.S., Axonics r-SNM System is currently under review by the FDA. The Company is confident of securing FDA approval for its r-SNM System during the second half of 2019. Currently, Medtronic's InterStim and InterStim II are the only FDA-approved SNM devices in the U.S.

In the first quarter ended March 31, 2019, net sales of the Axonics r-SNM System from international markets totaled $1.1 million compared to $0.5 million in the fourth quarter of 2018 and nil revenue in the first quarter of 2018.

The Company ended March 31, 2019, with cash, cash equivalents and short-term investments of $144.2 million.

Given the fact there is an important regulatory catalyst related to r-SNM System coming its way, it is worth keeping an eye on AXNX.

Axonics Modulation Technologies made its debut on the Nasdaq Global Select Market on October 31, 2018, offering its shares at a price of $15 each. The stock has thus far hit a low of $11.90 and a high of $32.90.

Related Reading

Axonics Ready To Charge Up?

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