Axonics® Sacral Neuromodulation System Receives Marketing Approval in Australia
Axonics Modulation Technologies, Inc. announced today that it received marketing approval from the Australian Department of Health, Therapeutic Goods Administration (TGA) for the first rechargeable Sacral Neuromodulation (r-SNM™) System® to treat Overactive Bladder (OAB), Fecal Incontinence and Urinary Retention.
This approval confirms that the Axonics r-SNM System meets all of the Australian Medical Devices Regulations for Active Implantable Medical Devices and enables commercialization throughout Australia.
“Australian TGA approval provides Axonics with another important marketing approval. Along with our European CE mark and Health Canada approval, this gives us the ability to sell our product in three significant international territories while we complete our U.S. pivotal study,” said Raymond W. Cohen, Chief Executive Officer of Axonics.
Over five million people, or approximately 20% of the Australian population, experience bladder or bowel control problems, many of which are not provided with a suitable therapeutic option. Urinary incontinence tops the list with up to 37% of women affected (Australian Institute of Health and Welfare report, 2006).
In the U.S. and Europe, OAB affects an estimated 85 million adults with another 40 million reported to suffer from fecal incontinence. SNM therapy is an effective and durable treatment that has been widely used and reimbursed for the past two decades accounting for an estimated $700 million in revenue in 2017. 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 a privately-held venture backed company that has developed a novel implantable neuromodulation technology for patients with urinary and bowel dysfunction and can be further directed towards other clinical indications. The Axonics r-SNM system includes a miniaturized rechargeable implantable stimulator qualified to function at least 15 years, a charging system optimized for reduced charge time without overheating, a patient-friendly remote control and an intuitive clinician programmer that facilitates the lead placement procedure and programming.
During 2016, the Axonics r-SNM system gained regulatory approval in Europe and Canada for the treatment of overactive bladder, urinary retention, and fecal incontinence. In November 2017, the U.S. Food & Drug Administration granted an Investigational Device Exemption to allow Axonics to conduct a pivotal study designed to gain FDA pre-market approval in the United States.
For more information, visit the Company’s website at www.axonicsmodulation.com
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6322
Chief Operating & Financial Officer
Investor & Media Contact
Matt Clawson, +1-949-370-8500
Information om Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco
Følg pressemeddelelser fra Business Wire
Skriv dig op her og modtag pressemeddelelser på mail. Indtast din mail, klik på abonner og følg instruktionerne i den udsendte mail.
Flere pressemeddelelser fra Business Wire
CA-RESMED20.5.2018 23:17 | pressemeddelelse
ResMed-sponsored Studies Show Combining Home Oxygen and Home Non-invasive Ventilation is a Cost Effective Treatment for COPD
INTL-WELL-BUILDING18.5.2018 16:49 | pressemeddelelse
WELL Building Standard Gaining Momentum in Europe
CA-UTIMACO18.5.2018 11:05 | pressemeddelelse
Utimaco Announces Intent to Acquire Atalla from Micro Focus
JANSSEN18.5.2018 09:02 | pressemeddelelse
Janssen to Present New Data in Urothelial, Haematologic and Prostate Cancers at ASCO 2018, including Best of ASCO Selections
FL-KARISMA-HOTELS18.5.2018 08:02 | pressemeddelelse
Karisma Hotels & Resorts to Open Allure Palazzi Kotor Bay Hotel by Karisma in June 2018
GLOBALTRADE18.5.2018 06:02 | pressemeddelelse
Siemens Financial Services Selects GTC’s @GlobalTrade Platform for Management of Export Documentary Credits
I vores nyhedsrum kan du læse alle vores pressemeddelelser, tilgå materiale i form af billeder og dokumenter, og finde vores kontaktoplysninger.Besøg vores nyhedsrum