Axonics® Submits Interim Clinical Data to U.S. Food & Drug Administration for its Sacral Neuromodulation System
Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, today announced the submission of interim clinical data from the ARTISAN-SNM pivotal clinical study to the U.S. Food & Drug Administration (“FDA”).
The ARTISAN-SNM study is a 129-patient single-arm, prospective, multi-center, unblinded pivotal clinical study, approved under an FDA Investigational Device Exemption (“IDE”) to evaluate the safety and efficacy of the Axonics r-SNM® System1 for urinary dysfunction.
This interim clinical data was submitted as a supplement to the Company’s previously filed “literature-based” premarket approval application (“PMA”). The interim analysis was conducted in accordance with a revised statistical analysis plan using an Intent to Treat (“ITT”) analysis of a partial cohort of all implanted subjects that have reached their six-month post-implant time point. The clinical study report, filed with FDA, provides safety and efficacy results from an early-look analysis in 60 implanted subjects, including 59 patients that have reached the six-month primary endpoint and one explanted patient.
Enrollment for the ARTISAN-SNM study was completed in June 2018 and all patients have now reached their six-month, post-implant primary endpoint.
Raymond W. Cohen, CEO of Axonics, commented, “On December 7, 2018, the FDA authorized an interim analysis of a partial ITT cohort from our ARTISAN-SNM pivotal study. Given that, we determined it was advantageous to enrich our current literature-based PMA currently under review by the FDA. We are in the process of analyzing the full ARTISAN-SNM cohort of patients and maintain the option to submit a traditional PMA in Q1 2019. Our strategy is intended to obtain PMA approval of our r-SNM System through the most expeditious route.”
Axonics filed the literature-based PMA on December 3, 2018. As is the case with a traditional PMA, the FDA has at least 180 days to review and decide whether or not to approve the PMA. Axonics anticipates that the FDA will complete a substantive review by early March 2019. Once management responds to any questions that may arise, the FDA will then have another 90 days to complete its review and issue a decision letter.
About Overactive Bladder and Sacral Neuromodulation
Overactive bladder (OAB) includes urinary urge incontinence and urinary frequency and affects an estimated 85 million adults in the U.S. and Europe. OAB is caused by a miscommunication between the bladder and the brain and significantly impacts quality of life. SNM therapy is a well-established treatment that has been widely employed to reduce symptoms and restore bladder function and is also employed to treat urinary retention and fecal incontinence. Reimbursement for SNM is well established in the United States and is a covered service in Europe, Canada and Australia.
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. The Axonics r-SNM System is the first rechargeable Sacral Neuromodulation system approved for sale in Europe, Canada and Australia. The r-SNM System offers a temporary disposable external trial system, a miniaturized and rechargeable long-lived stimulator that is qualified to function for at least 15 years. Also included is 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.
1 The Axonics r-SNM® System is an investigational medical device
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
Keio Plaza Hotel Hosts “Hina-matsuri (Girls’ Doll Festival)” Event – 6,800 Magnificent Hanging Art Ornaments and Tea Ceremony Culture16.1.2019 17:05 | Tiedote
Keio Plaza Hotel Tokyo (KPH), one of Japan’s most prestigious international hotels located in Shinjuku, Tokyo, will host an event entitled “Hina-matsuri through Tea Ceremony Culture and Hanging Art” to help guests celebrate Japan’s cultural event known as Girls’ Doll Festival or “Hina-matsuri” from February 1 (Friday) to March 28 (Thursday), 2019 with magnificent hanging art ornaments displayed in our lobby and special menu items served in our restaurants. In addition to the display of some 6,800 magnificent and ornate handmade dolls and other traditional decorations in this coming event, our Hotel will also display various traditional and historical art items used in traditional Japanese tea ceremony, which has long been a part of the cultural upbringing of Japanese women from the Meiji Period (1868 to 1912). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190116005191/en/ About 6,800 hanging decorative art ornaments meticul
Virgin Voyages Calling All RockStars to Sea16.1.2019 17:00 | Tiedote
Virgin Voyages, the new lifestyle brand set to disrupt the travel industry, today released several designs and images of their RockStar Suites. The new company is throwing out traditional clichés on luxury and formalities, and instead bringing Rebellious Luxe to life at sea with their RockStar Suites designed by Tom Dixon’s Design Research Studio as the pinnacle of that experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190116005444/en/ Massive Suite Living Room. (Photo: Business Wire) Highlights of the Massive Suite, the top suite aboard the Scarlet Lady, include its very own guitar-clad music room, views of the ocean from every corner of the suite, and a massive terrace complete with its own Peek-a-View outdoor shower, hot tub, hammocks and a runway outdoor dining table, where a staircase will help Sailors make their way on top of the table for dancing. “Virgin has always avoided stuffy formalities and brought a lo
Janssen announces European Commission approval of ERLEADA® (apalutamide) for non-metastatic castration-resistant prostate cancer patients who are at high risk of developing metastatic disease16.1.2019 16:24 | Tiedote
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission (EC) has granted marketing authorisation for ERLEADA® (apalutamide), a next generation oral androgen receptor inhibitor for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. The EC approval is based on data from the pivotal Phase 3 SPARTAN study, which was published in The New England Journal of Medicine. The study assessed the efficacy and safety of apalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in patients with nmCRPC who had a rapidly rising prostate specific antigen (PSA) level despite receiving continuous ADT. Findings from the study showed that apalutamide plus ADT, significantly reduced the risk of developing distant metastasis or death (metastasis free survival [MFS]) by 72 percent, compared to placebo in combination with ADT (HR = 0.28; 95% CI, 0
Jam City Announces $145 Million in Strategic Financing to Fuel Consolidation and Growth Initiatives16.1.2019 16:00 | Tiedote
Jam City, Inc., a leader in mobile entertainment, today announced $145 million in strategic financing jointly led by JPMorgan Chase Bank, N.A. and Bank of America Merrill Lynch, and a syndicate of lenders including Silicon Valley Bank, SunTrust Bank and CIT Bank, N.A. The financing will support Jam City’s acquisitions and global growth initiatives. Today’s announcement follows Jam City’s recent multi-year game development deal with Disney and expansion to Toronto. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190116005007/en/ Chris DeWolfe, Jam City CEO, and Josh Yguado, Jam City COO and President (left to right). Photo credit: Ethan Pines “In a global mobile games market that is consolidating, Jam City could not be more proud to be working with JPMorgan, Bank of America Merrill Lynch, Silicon Valley Bank, SunTrust Bank and CIT Bank to strategically support the financing of our acquisition and growth plans,” said Chris DeWo
VITEC Streamlines IPTV, Digital Signage, and Video Wall Workflows at ISE 201916.1.2019 16:00 | Tiedote
VITEC, a worldwide leader in advanced video encoding and streaming solutions, today announced it will showcase the latest capabilities for its award-winning EZ TV IPTV & Digital Signage Platform at ISE 2019 on Stand 14-M200. The chosen solution for sports and entertainment venues, enterprise, government, and military agencies in Europe and the U.S., EZ TV’s comprehensive feature set enables any organization to centrally manage and stream HD, low-latency, in-house feeds and TV channels, as well as create eye-catching digital signage and video walls for distribution to any displays through a facility. VITEC’s EZ TV IPTV & Digital Signage Platform is ideal for the ever-changing video, marketing, and sales requirements of today's sports venues as well as for the secure dissemination and content management of full-motion video streams and offline files for enterprise and mission-critical applications and government agencies. Designed to integrate seamlessly with any IT environment and run o
Moody’s Analytics IFRS 17 Solution Licensed by Manulife16.1.2019 16:00 | Tiedote
Moody’s Analytics, a global provider of financial intelligence, announced today that it is collaborating with Manulife to be the solution provider for its global implementation of IFRS 17. Moody’s Analytics solution for IFRS 17 includes AXIS™ IFRS 17 Link Modules and RiskIntegrity™ IFRS 17, helping insurers and reinsurers meet the financial reporting challenges under the new reporting standard. This solution has been designed to coordinate and facilitate the full suite of actuarial, accounting, and data management processes required for the reporting components for IFRS 17 statement preparation. ”We have been working on defining our needs for new solutions to meet IFRS 17 requirements and, after a preliminarily trial with Moody’s Analytics, we decided to continue to partner with Moody’s Analytics for their RiskIntegrity IFRS 17 solution and AXIS IFRS 17 Link Module to support us in implementing the new standard,” said Jon Bradbury, IFRS 17 Systems Delivery lead at Manulife. “We are con
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