Axonics® Receives Health Canada Approval for its Sacral Neuromodulation External Trial System
Axonics Modulation Technologies, Inc., (NASDAQ: AXNX), developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and bowel dysfunction , announced today that it has received Health Canada approval (Homologation d'un instrument medical) to market its External Trial System.
Axonics previously received Health Canada approval for its miniaturized rechargeable implantable neurostimulator, tined lead, patient and clinician programmers, charger and related accessories.
The External Trial System is an additional element of the Axonics r-SNM system used to help identify responders to Sacral Neuromodulation therapy prior to a permanent implant. It is composed of a temporary, single-use disposable external stimulator that is connected to either a Tined Lead or a temporary Peripheral Nerve Evaluation (PNE) Lead, depending on the preferred trial method.
Raymond W. Cohen, Chief Executive Officer, said, “This approval comes at the right time, as we begin commercial activities in Canada. Whilst the Canadian SNM market has been limited historically, we believe that our small rechargeable neurostimulator, which features an expected in-body life of 15 years or more, will potentially spur market growth by bringing tangible benefits to patients and significant cost savings to the national health care system by eliminating the need to replace our competitor’s non-rechargeable device every three to five years.”
Axonics is currently conducting a 129-patient pivotal clinical study for urinary incontinence patients under a U.S. FDA Investigational Device Exemption. The enrollment and implant phase was completed in late June 2018. The Company anticipates filing a pre-market approval (PMA) application for FDA approval in the United States after the six-month post-implant endpoint has been reached.
On November 2, 2018, Axonics completed an IPO raising $120 million in gross proceeds from the offering. Common stock is now trading on The Nasdaq Global Select Market under the ticker symbol “AXNX”.
About Overactive Bladder and Sacral Neuromodulation
Overactive bladder (OAB) affects an estimated 85 million adults in the U.S. and Europe. Another approximately 40 million adults are reported to suffer from fecal incontinence. SNM therapy is an effective and durable treatment that has been widely used and reimbursed in Europe and the U.S. for the past two decades. It is estimated that well over 300,000 patients have benefited from the therapy to date. SNM is the only OAB treatment with proven clinical superiority to standard medical therapy and OAB patients who receive SNM report significantly higher quality of life than patients undergoing drug treatment.
About Axonics Modulation Technologies, Inc.
Axonics, based in Irvine, CA, is focused on development and commercialization of a novel implantable SNM system for patients with urinary and bowel dysfunction and disrupting the SNM market that is currently dominated by one large provider. The Axonics r-SNM system offers a temporary disposable external trial system, a minituarized and rechargeable long-lived stimulator that is qualified to function for at least 15 years and a tined lead, as well as patient-friendly accessories such as a charging system optimized for minimal charge time without overheating, a small, easy to use patient remote control and an intuitive clinician programmer that facilitates lead placement and programming. For more information, visit the Company’s website at www.axonicsmodulation.com .
Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov . Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.
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