Business Wire

Axonics® Sacral Neuromodulation System Receives Marketing Approval in Australia

Jaa

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

Contact information

Company Contact
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6322
Chief Operating & Financial Officer
ddearen@axonicsmodulation.com
or
Investor & Media Contact
W2Opure
Matt Clawson, +1-949-370-8500
mclawson@W2Ogroup.com

Tietoja julkaisijasta

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 jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Tigo Releases State-of-the-art Wireless Technology – Mesh – as the New Solar Communication Architecture for the TS4 Platform18.7.2018 22:41Tiedote

Tigo®, pioneer of the smart modular Flex MLPE platform, today announced the release of its new Mesh communication architecture. This state-of-the-art wireless technology directly translates to customer benefits – including simplifying the solar design process and accelerating the commissioning steps. The complete Tigo solution uses a simple yet powerful data collection technology that covers the widest ranges of residential & commercial installations at the lowest cost. With Mesh and the recently announced Tigo Access Point (TAP), customers eliminate the need to address any roof obstruction or orientation constraint. To learn more about Mesh and TAP, register for Tigo’s free, online webinar “The Future of Solar is Wireless” on Wednesday July 25th, 2018 at 10am PDT. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180718005827/en/ Mesh is Tigo's proprietary software that allows each TS4 unit to act as a repeater, extending the

ViiV Healthcare Shares Data from Landmark 2-Drug Regimen Trials At AIDS 201818.7.2018 20:21Tiedote

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, will be presenting over 20 abstracts, including data from the landmark GEMINI 1 & 2 clinical trials, at the 22nd International AIDS Conference (AIDS 2018), 23-27 July 2018, in Amsterdam, The Netherlands. The data being presented this year has a strong focus on novel exploratory therapeutic options and innovative treatment strategies, as well as improving awareness and understanding of key issues that continue to affect the HIV community. John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented, “As we see advancements in the treatment options available to people living with HIV, our research efforts over the past few years have been focused on moving beyond viral load and addressing some of the unresolved issues that people living with HIV face, such as the potential long-term risks and toxicities that can be associated with li

Xilam: H1 2018 Revenue: +50%18.7.2018 19:00Tiedote

Regulatory News: The Xilam Group (Paris:XIL) posted consolidated H1 2018 revenue of EUR 13,866 thousand, an increase of 50%. This increase represents an excellent performance, as it follows on the heels of growth of 54% in H1 2017. Revenue for the first part of this financial year breaks down as follows. In thousands of euros 30.06.2018 (1) 30.06.2017 Change New productions 8,465 4,571 +85% Catalogue 5,385 4,652 +16% Other 16 16 +0% Revenue and subsidies 13,866 9,239 +50% (1) Unaudited data. Remarkable success for new releases +85% Excellent H1 growth was driven by the two main businesses, New Productions and Catalogue. In New Productions, H1 deliveries generated record revenue of EUR 8,465 thousand, an 85% increase compared with H1 2017, and confirmed Xilam’s position as a major European animation company. Catalogue revenue was up 16% compared with H1 2017, thanks again to traditional TV channels and digital platforms, in both France and abroad. A fast-paced delivery schedule Thanks t

Department for International Trade: Life Sciences at the Heart of UK Economy18.7.2018 15:38Tiedote

The Government will today (Wednesday 18 July) host the second in a series of roundtables with stakeholders from key life science businesses, demonstrating the importance of the sector to the UK economy. The Chancellor, International Trade Secretary, Business Secretary and Health and Social Care Secretary will be amongst those that meet with senior representatives from leading UK and international life sciences companies as the UK positions itself as the global home of health innovation, welcoming overseas investment and seeking to boost exports in the process. Discussions at the roundtable will focus on how the future of the Life Sciences sector will be supported by the delivery of our modern Industrial Strategy, ensuring that the UK is ‘open for business’ with a positive business environment, our ambitions for a comprehensive agreement with the EU on our future relationship and the development and implementation of our independent trade policy. To date, the government has engaged sign

Universal Laser Systems Expands Its Materials Database with 3M, Victrex and Dexmet Materials18.7.2018 15:05Tiedote

Universal Laser Systems (ULS) announces the addition of 3M™, Victrex® and Dexmet materials to its materials database, the most extensive repository of laser material processing parameters for materials in the range of 10 watts to 500 watts. The 3M, Victrex and Dexmet materials new to the ULS materials database were specifically added for laser processing with the ULTRA and XLS platforms, suited for high accuracy and precision laser cutting, laser ablation and laser surface modification. The materials include: 3M™ Extreme Sealing Tape 4412N 3M™ Thermally Conductive Silicone Interface Pad 5516 Victrex® APTIV® PEEK Film Dexmet PolyGrid® 8PTFE10-125ST Expanded PTFE Dexmet MicroGrid® AL 25 Expanded Aluminum Laser processing notes, describing the results of the laser-material interaction for these materials, are also available in the Materials Library on the ULS website to help potential customers explore the advantages of deploying laser technology within their manufacturing, research and d

Sterigenics Expands European Capacity With New State-of-the-Art Gamma Sterilization Facility in the UK18.7.2018 15:00Tiedote

Sterigenics, a Sotera Health company and leading global provider of mission-critical sterilization solutions and expert advisory services, announced today it is building a new facility in Markham Vale North in Chesterfield/Derbyshire, UK. The facility will significantly expand Sterigenics’ footprint in Europe to help meet the growing sterilization needs of its customers and support the company’s mission of Safeguarding Global HealthTM. Scheduled for completion in the fourth quarter, 2018, the facility will include the installation of a state-of-the-art Nordion JS10000 gamma irradiator with a research loop. The new 60,000-square-foot facility will add gamma sterilization capabilities in the UK to complement Sterigenics’ existing ethylene oxide (EtO) facility based in Somercotes/Derbyshire. “Sterigenics is committed to being the world’s leading provider of sterilization services and partnering with our customers to eliminate threats to human health,” said Philip Macnabb, President of Ste

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