Axonics Ready To Charge Up?

(RTTNews) - Axonics Modulation Technologies Inc. (AXNX), which recently made its debut on the NASDAQ, is down nearly 2% so far this month while the iShares Nasdaq Biotechnology ETF index (IBB) has gained nearly 8% for the same period.

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. In the U.S., Medtronic's InterStim and InterStim II are the only approved SNM devices.

Sacral neuromodulation therapy is primarily used to treat patients with overactive bladder ("OAB"), fecal incontinence ("FI") and urinary retention ("UR").

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.

The Axonics r-SNM System is the first rechargeable Sacral Neuromodulation system, qualified to function at least 15 years whereas Medtronic's InterStim is non-rechargeable, and according to reports, its battery life is 5 to 7 years after which it has to be replaced. Axonics r-SNM System is also said to be 60% smaller than Medtronic's InterStim.

Axonics' 129-patient single-arm, pivotal clinical study, approved under an FDA Investigational Device Exemption, evaluating the safety and efficacy of the Axonics r-SNM System for urinary dysfunction, dubbed ARTISAN-SNM, is underway.

On January 2, 2019, the Company submitted interim clinical data from the ARTISAN-SNM study, involving 60 implanted subjects, including 59 patients that have reached the six-month primary endpoint and 1 explanted patient, to the FDA. This interim clinical data was submitted as a supplement to the Company's previously filed "literature-based" premarket approval application.

The "literature-based" premarket approval application, which included existing literature on Medtronic's InterStim II SNM device, was submitted by Axonics on December 4, 2018.

Although a traditional premarket approval (PMA) application, supported by original clinical investigations, is usually the norm, in rare cases, literature-based evidence may be accepted as the sole basis for approval of a PMA.

As is the case with a traditional premarket approval, the FDA has at least 180 days to review and decide whether or not to approve the PMA. The Company expects the FDA to complete a substantive review by early March 2019, and announce a final decision in June 2019.

The Company is in the process of analyzing the full ARTISAN-SNM cohort of patients and is also mulling the option of submitting a traditional PMA this quarter (Q1, 2019).

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.

On December 11, 2018, Axonics announced its financial results for the third quarter ended September 30, 2018 - the first earnings report as a public company.

Net loss for the recent third quarter was $7.6 million or $2.67 per share on revenue of $201 thousand. This compared with a net loss of $4.5 million or $1.67 per share, and revenue of $128 thousand in the prior-year quarter.

The Company ended September 30, 2018, with cash of $31.2 million, and total debt of $9.06 million.

Shares of Axonics Modulation have thus far hit a low of $11.95 and a high of $17.00. The stock closed Friday's (Jan.4) trading at $14.73, up 8.95%.