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.
Axonics Modulation Technologies, Inc.
Dan Dearen, +1 949-396-6320
President & Chief Financial Officer
Investor & Media Contact
Matt Clawson, +1 949-370-8500
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Mary Kay Inc. Announces Two Executive Appointments in Supply Chain Operations24.1.2019 16:12 | Tiedote
Mary Kay Inc., celebrating its 55th anniversary as a top beauty brand and direct seller in nearly 40 markets, announces the appointments of Chaun Harper as Senior Vice President – Chief Manufacturing Officer and Dr. Lucy Gildea as Senior Vice President – Chief Scientific Officer. In their new roles, Harper and Gildea will join the global cosmetics company’s executive team. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190124005055/en/ In their new roles, Chaun Harper and Lucy Gildea will join the global cosmetics company's executive team. (Photo: Mary Kay Inc.) As Senior Vice President – Chief Manufacturing Officer, Chaun Harper will assume responsibility for global manufacturing operations, global inventory control, supply planning, transportation and global quality. Harper joined Mary Kay Inc. in 2014 as Director of Production Operations. During his tenure, Harper has been instrumental in creating a culture of continuous
nCipher Security Delivers Trust, Integrity and Control to Business Critical Information and Applications24.1.2019 16:00 | Tiedote
nCipher Security, the provider of trust, integrity and control for business critical information and applications, officially launched today creating a new leader in the general purpose hardware security module (HSM) marketplace. Today’s fast moving digital environment offers opportunities to enhance customer satisfaction, improve operational efficiency and gain competitive advantage, but in doing so also raises new security challenges. nCipher’s market-leading solutions and services allow organizations to keep pace with innovation while protecting their business critical assets from security breaches. The world’s leading organizations have depended on nCipher nShield HSMs for more than 20 years to provide a root of trust for their business critical applications and meet their cybersecurity needs. Our customers include 5 of the top 10 Fortune 100 and 10 of the top 20 FTSE 100 companies. Organizations are also now subject to an increasing number of strict compliance mandates such as the
FLIR Systems Awarded $39.6 Million Contract for Black Hornet Personal Reconnaissance Systems for U.S. Army Soldier Borne Sensor Program24.1.2019 16:00 | Tiedote
FLIR Systems, Inc. (NASDAQ: FLIR) has been awarded a $39.6 Million order to deliver FLIR Black Hornet Personal Reconnaissance Systems (PRS) in support of the United States (U.S.) Army. The highly capable nano-unmanned aerial vehicle (UAV) systems delivered under this contract will support platoon and small unit level surveillance and reconnaissance capabilities as part of the Soldier Borne Sensor (SBS) Program. The U.S. Army awarded in June 2018 the first SBS phase contract to FLIR for an initial batch of Black Hornet PRS. These systems are being delivered now to the U.S. Army for initial integration into the force. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190124005255/en/ FLIR Systems has been awarded a contract to deliver Black Hornet Personal Reconnaissance Systems for the United States Army's Soldier Borne Sensor program. The nano-unmanned aerial vehicle systems will support platoon and small unit level surveillanc
Smithers Viscient announces the appointment of Ian Siragher to the position of Managing Director24.1.2019 13:30 | Tiedote
Smithers Viscient, a global contract research organization (CRO), today announced the appointment of Ian Siragher to the position of Managing Director. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190124005031/en/ Ian Siragher, Managing Director, Smithers Viscient Europe (Photo: Business Wire) Siragher will assume operational responsibility for the Smithers Viscient European site in Harrogate, UK. His experience includes high technology start-ups, running SME business, sales, marketing and regulated industry programs within the analytical, pharmaceutical and drug delivery industries. He brings a wealth of entrepreneurial experience with proven strengths in scientific knowledge, operational and strategic planning, coupled with a strong client focus. “We are delighted to welcome Ian to our business,” said Susan Shepherd, President, Smithers Viscient. “Ian is an excellent appointment for us; he is a proven operational leader
HCL Technologies Honors Humanitarian Leaders at the 2019 World Economic Forum in Davos24.1.2019 13:22 | Tiedote
HCL Technologies, a global technology company, today announced its Goodwill Champions Awards Night to honor humanitarian leaders from around the world. The event will take place on January 24th, 2019, at the HCL Pavilion in Davos and will celebrate these heroic organizations committed to pursuing distinct noble causes, primarily focused on global education, youth development, and women empowerment. This is the first year the awards have been presented, and HCL Technologies plans to issue them each year in a global forum. The award recipients are Katja Iversen, CEO of Women Deliver, which advocates for global investments in gender equality and health; Olajumoke Adekege, Founder of Young Business Agency, which provides employability skills training and recruitment services to young job seekers globally; Chiara Tiles, Founder of We Do it Together – which produces films, documentaries, TV, and other forms of media, uniquely dedicated to the empowerment of women; Baillie Aaron, Founder and
P&G Joins TerraCycle’s Loop – an Environmentally Friendly and Convenient E-Shopping Platform – With 11 Household Brands24.1.2019 13:00 | Tiedote
The Procter & Gamble Company (NYSE:PG) today announced the introduction of reusable, refillable packaging on some of its most popular products as part of a new effort that aims to change the world’s reliance on single use packaging and disposable waste. Additionally, new “collect and recycle” circular solutions that help eliminate waste were also introduced as part of a partnership with LoopTM, a circular e-commerce platform developed by international recycling leader TerraCycle. Many of P&G’s largest global brands, including PanteneTM, TideTM, CascadeTM and Oral-BTM will participate in this innovative platform later this year. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190124005087/en/ Pantene is introducing a unique bottle made with lightweight, durable aluminum for its shampoo and conditioner. (Photo: Business Wire) Loop is a first of its kind global packaging and shopping circular solution which aims to improve the e
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme