Business Wire

Axonics® Announces Publication of Clinical Articles about Its Sacral Neuromodulation System in the Journal of Neurourology and Urodynamics

Del

Axonics Modulation Technologies, Inc. announced today that three clinical articles relating to its miniaturized, rechargeable Sacral Neuromodulation system (Axonics r-SNM™ System) have been published in a special edition of the Journal of Neurourology and Urodynamics (NUU).

The Axonics r-SNM System is the first rechargeable Sacral Neuromodulation system for the treatment of bladder and bowel dysfunction. It is currently approved for sale in Europe, Canada and Australia.

The NUU publication includes three articles which describe the characteristics of the Axonics system and summarize the clinical results from a multi-center European clinical trial:

  • “The novel Axonics® rechargeable sacral neuromodulation system: Procedural and technical impressions from an initial North American experience” (Elterman, 2018), describes the Axonics system and implant technique
  • “Three-month clinical results with a rechargeable sacral neuromodulation system for the treatment of overactive bladder” (Blok et al., 2018), reports the 3-month safety and efficacy results of the RELAX-OAB study conducted in 51 patients suffering from Overactive Bladder
  • “Programming settings and recharge interval in a prospective study of a rechargeable sacral neuromodulation system for the treatment of overactive bladder” (Blok et al., 2018), reports the 3-month RELAX-OAB data on patient programming settings and charging experience

The publication of this special edition by NUU is reflective of the expanding interest for a miniaturized, rechargeable implant dedicated to SNM, as well as to the growing amount of clinical evidence supporting the use of the Axonics r-SNM System.

Last month, Axonics announced the first patient implants in the ARTISAN-SNM pivotal study were performed. This study is being conducted under an Investigational Device Exemption granted by the U.S. Food & Drug Administration and is designed to gain FDA Premarket Approval in the United States.

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.

For more information, visit the Company’s website at www.axonicsmodulation.com.

Contact information

Company Contact
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
Chief Operating & Financial Officer
ddearen@axonicsmodulation.com
or
Investor & Media Contact
W2Opure
Matt Clawson, +1-949-370-8500
mclawson@W2Ogroup.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Price f(x) Files Petitions with US Patent and Trademark Office to Invalidate Vendavo’s Patents and Launches a Counter Lawsuit17.12.2018 07:08Pressemelding

Price f(x), the global leader in cloud pricing software, has filed petitions for “Covered Business Method (“CBM”) Review” of four Vendavo patents, and will imminently file a fifth, which together will cover challenges to all of the patent claims that Vendavo has asserted in litigation between the parties. In Price f(x)’s view, each of Vendavo’s patents qualifies for the specialized CBM procedure created by US Congress to “crackdown on low-quality business method patents.” Price f(x)’s petitions challenge Vendavo’s patents on a variety of grounds, including in all cases that the claims are directed to patent-ineligible abstract ideas (e.g., math for pricing of products), and in many cases that Vendavo simply tried to claim more than it actually invented. The petitions are now pending in the U.S. Patent Office, which should make an initial ruling on Price f(x)’s petitions in approximately six months. Price f(x) is concurrently moving to stay the patent portion of the parties’ litigation

ABB: Shaping a leader focused in digital industries17.12.2018 06:16Pressemelding

Fundamental actions to focus, simplify and lead in digital industries for enhanced customer value and shareholder returns Focus of portfolio on digital industries through divestment of Power Grids Divestment of Power Grids to Hitachi expands existing partnership and strengthens Power Grids as a global infrastructure leader with enhanced access to markets and financing Enterprise Value of $11 billion for 100% of Power Grids, equivalent to an EV/op. EBITA multiple of 11.2x1 Crystallizing value from the transformation of Power Grids including doubling operational EBITA margin since 20142 ABB initially to retain 19.9 percent in the equity of carved-out Power Grids to ensure transition; pre-defined exit option on 19.9 percent equity at fair market value with floor price at 90 percent of agreed Enterprise Value, exercisable by ABB three years after closing Closing expected by first half of 20203 ABB intends to return 100% of the estimated net cash proceeds of $7.6-7.8 billion4 from the 80.1%

AURAK Gains SACSCOC Accreditation15.12.2018 10:49Pressemelding

The Southern Association of Colleges and Schools Commission on Colleges (SACSCOC) officially announced the accreditation of the American University of Ras Al Khaimah (AURAK) at its 2018 Annual Meeting which was held in New Orleans, Louisiana, in the United States of America. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181215005017/en/ AURAK delegation during the SACSCOC conference in New Orleans” (Photo: AETOSWire) SACSCOC, the regional body for the accreditation of degree-granting higher education institutions in the Southern United States, has a membership of more than 800 institutions in the Southern states and other international sites approved by SACSCOC that award associate, baccalaureate, master’s, and/or doctoral degrees. SACSCOC also awards accreditation to other international institutions of higher education that satisfy all its requirements and demonstrate compliance with its accreditation standards. AURAK now

Lehman Brothers Treasury Announces Plans for Partial Wind-Down14.12.2018 17:41Pressemelding

Lehman Brothers Treasury Co. B.V. in liquidation (“LBT”) today, through its U.S. counsel Kramer Levin Naftalis & Frankel LLP, announced that LBT is planning a final cash distribution to its creditors. Professional holders of eligible notes will have the option to retain their investment by electing to receive substitute notes of one (or a few) series. Such election shall take place through a solicitation process. As a consequence, LBT will be able to reduce the number of series of notes outstanding from more than 3,700 to one or a few. Noteholders electing to receive substitute notes will be afforded the same economic entitlement to distributions received by LBT from Lehman Brothers Holdings Inc. (“LBHI”) through the substitute notes. The substitute notes will be denominated in U.S. dollars and future distributions will be made in U.S. dollars only. Noteholders who are not professional investors, or hold notes that are not eligible for substitution, or do not elect to receive substitut

Takeda Receives Positive CHMP Opinion for ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma in Combination with AVD14.12.2018 17:00Pressemelding

Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the extension of the marketing authorization of ADCETRIS (brentuximab vedotin) and recommended its approval in combination with AVD in adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma. ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma. ADCETRIS is currently not approved as a therapy for previously untreated Hodgkin lymphoma in Europe. “For a large number of previously untreated Hodgkin lymphoma patients diagnosed with Stage IV disease, progression will occur with current treatments, highlighting a true unmet need in this population,” said Anna Sureda, M.D., Ph.D., Head of the Hematology Department and Hematopoietic Stem Cell Transplant Programme, Institut Català d'Oncologia - Hospital Duran i Reynals. “In the ECHELON-1 cl

Diamond CBD, POTN Subsidiary, Enters the $46 Billion Coffee Market With the Release of Premium Line of CBD-Infused Coffee & Tea K-Kup Capsules14.12.2018 15:42Pressemelding

Diamond CBD Inc., wholly owned subsidiary of PotNetwork Holdings, Inc. (OTC Pink: POTN), a leader in hemp extraction and innovative CBD products for the wellness market, enters the Coffee segment, an industry expected to reach revenues of $46 Billion in 2018. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181214005308/en/ Experience a cup of Chill (Photo: Business Wire) Produced in accordance with a universal K-Cup design, these pods fit in almost all modern single cup coffee makers, making it an easily integrated enhancement to any environment, delivering 25mgs of CBD in a tasty favorite beverage at less than $5 per cup. This new line of premium Chill Coffee Capsules was recently added to the Company’s broad range of cannabinoid and natural hemp products. Each box comes with 4 individual capsules in original chill coffee, decaf chill coffee, chill black tea, and chill green tea flavors. The unit price for each box is $10.00