Business Wire

Axonics® Files for Premarket Approval with U.S. Food & Drug Administration for its Sacral Neuromodulation System

Del

Axonics Modulation Technologies, Inc. (NASDAQ:AXNX), a medical technology company focused on the design, development and commercialization of rechargeable implantable Sacral Neuromodulation (“SNM”) solutions for the treatment of urinary and bowel dysfunction, today announced that on December 3, 2018, the Company submitted a premarket approval application (“PMA”) to the U.S. Food & Drug Administration (“FDA”) for the Axonics r-SNM® System, an investigational medical device.

This PMA filing submitted by Axonics is referred to as a “literature-based PMA”. While most PMAs are supported by original clinical investigations, in rare cases, literature-based evidence may be accepted as the sole basis for approval of a PMA to establish reasonable assurance of safety and effectiveness when the literature is sufficient, detailed, objective, and directly applicable to the subject device. In this PMA filing, Axonics has submitted existing literature reporting on InterStim II®, manufactured by Medtronic plc, the only currently approved SNM device.

In addition to the technical specifications, testing data and published literature, Axonics included one-year follow-up data from its 51-patient RELAX-OAB European Post-Market Clinical Follow-up study to support the PMA. This PMA filing incorporates all elements of the Axonics r-SNM implantable system as well as the External Trial System and related accessories.

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 the Company responds to any questions that may arise, the FDA will then have another 90 days to complete its review and issue a decision letter. Therefore, the earliest date a final determination is anticipated is June 2019.

Axonics is currently conducting a 129-patient pivotal clinical study, ARTISAN-SNM, under a U.S. Food & Drug Administration Investigational Device Exemption, for urinary dysfunction. On June 27, 2018, Axonics announced completion of the enrollment and implant phase. Axonics anticipates that substantially all patients will reach their 6-month post-implant endpoint on or about January 4, 2019.

Raymond W. Cohen, CEO of Axonics, commented, “This PMA filing gets Axonics on the review clock with the FDA. We believe the filing is robust and provides substantive responses to requests for additional information made by the FDA in May of this year. This filing also includes 1-year clinical follow up data from our European RELAX-OAB study. Given the FDA authorized an interim analysis of a partial cohort of 6-month post-implant safety and effectiveness data from our ongoing ARTISAN-SNM pivotal study for the same device, we have the option to submit this data to the FDA as part of this PMA. Moreover, we also retain the option to submit a traditional PMA in Q1 2019 once our full ARTISAN-SNM cohort reaches the 6-month primary endpoint. This strategy of filing both a literature-based PMA and conducting a pivotal clinical study in parallel provides Axonics with several pathways to ultimately obtain PMA approval of our r-SNM System.”

Axonics originally filed the literature-based PMA in January 2018, which underwent a substantive review by the FDA. On May 9, 2018, the FDA responded and requested that the Company submit additional information. In October of 2018, the Company withdrew the PMA in order to allow sufficient time to prepare a thorough response to the questions. The Company refiled the PMA on December 3, which included all of the information previously submitted, as well as the additional information addressing FDA’s questions in its May 9, 2018 correspondence. Axonics already underwent a pre-PMA audit by the FDA during 2018 which was completed without findings. Axonics continues to maintain a good working relationship with the FDA and will work interactively and expeditiously with the FDA during this process.

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 well-established treatment that has been widely used and reimbursed in Europe and the U.S. for the past two decades.

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.

Forward-Looking Statements

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.

Contact information

Axonics’ Contact
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
ir@axonics.com

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

Pioneering Project for Pharmaceutics – Vifor Pharma and the University of Basel are Jointly Establishing the World’s First Research Professorship for Nanopharmaceutical and Regulatory Science26.5.2019 07:00:00 CESTPressemelding

Nanopharmaceutics promises ground-breaking innovation in the development of medicines: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190526005014/en/ The Vifor Pharma Group is endowing two professorships for Nanopharmaceutical and Regulatory Science at the University of Basel The commitment by Vifor Pharma and the University of Basel is aimed at ensuring Switzerland has the specialist knowledge and equipment needed to compete globally in this important emerging area of life sciences With this decision, Vifor Pharma is demonstrating its commitment to Switzerland as a world-leading location for pharmaceutical research and development Nanomedicines are playing an increasingly important role in the development of innovative new medications. These drugs are able to overcome specific cellular barriers in the human body with a view to targeting their effect even more precisely. Nanopharmacy therefore promises to help advance medic

XINHUANET: Promotion Event of The Most Beautiful Shooting Location in China Held During Cannes Film Festival25.5.2019 18:20:00 CESTPressemelding

On May 16 (local time), an event was held at the 72nd Cannes Film Festival to recommend China’s most beautiful shooting locations on the theme of “Fascinating China.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190525005008/en/ The representative from Cannes Convention Bureau (1st L), Michel Chevillon (C), vice president of the French Riviera Chamber of Commerce and Industry and head of hotel association, and Adeline CHAUVEAU (3rd R), officer in charge of film and television projects from French Embassy to China, pose for a group photo with the representatives from the cities awarded for "The most beautiful shooting location in China." (Photo: Business Wire) In the event, the Yellow Sea National Forest Park in Dongtai, Jiangsu Province, the One Hundred Mile Azalea Forest in Bijie, Guizhou Province, Siming District of Xiamen, Fujian Province, and the Li Autonomous County in Lingshui, Hainan Province were on the list. The p

Knopp Biosciences Presents Positive Preclinical Data for Lead Neonatal Epilepsy Drug Candidate at 2019 Antiepileptic Drug and Device Trials XV Conference24.5.2019 14:00:00 CESTPressemelding

Knopp Biosciences LLC, a privately held drug discovery and development company focused on delivering breakthrough treatments for inflammatory and neurological diseases of high unmet need, today presented in vitro and in vivo data for the company’s lead molecule for the targeted treatment of KCNQ2-neonatal epileptic encephalopathy (KCNQ2-NEE) at the Antiepileptic Drug and Device Trials XV Conference in Miami, Florida. KCNQ2-NEE, a rare infant genetic epilepsy, results from mutations in genes encoding the Kv7.2/Kv7.3 ion channel, leading to frequent seizures and profound developmental delay. The preclinical data were presented by Steven Dworetzky, Ph.D., Knopp’s Chief Scientific Officer, a longtime Kv7 researcher who led the group that first cloned the Kv7.2 and Kv7.3 genes during his former tenure with the Bristol-Myers Squibb Co. Dr. Dworetzky presented results demonstrating the in vitro nanomolar activity of KB-3061 and its significant seizure protection in the maximal electroshock mo

Accelerate Your Business in South Korea Through 2019 K-Startup Grand Challenge24.5.2019 10:20:00 CESTPressemelding

Entrepreneurs from across the globe should set their sights on participating in the 2019 K-Startup Grand Challenge. Supported by the Ministry of SMEs and Startups and National IT Industry Promotion Agency (NIPA) of South Korea, the initiative provides invaluable support and comprehensive resources to early age startups. Applications for the K-Startup Grand Challenge are currently being accepted through June 14, 2019. In order to advance in the program, teams must pass a regional audition. A judging panel of startup ecosystem experts and Korean accelerators will select 40 teams to participate in an enriching 3.5 month-long acceleration program in Korea. The selected teams will have exclusive access to free office space at the Startup Campus in Pangyo Techno Valley, one-on-one mentoring, information sessions, coaching on Korean and Asian business culture and the chance to attend insightful seminars on accounting regulations to tax laws, patents and more. Opportunities for networking with

New Investigational Clinical Data for Ipsen’s Oncology Products in 11 Solid Tumor Types to Be Presented at 2019 ASCO Annual Meeting24.5.2019 05:00:00 CESTPressemelding

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced that new data from clinical studies on investigational uses of cancer medicines cabozantinib (Cabometyx®), liposomal irinotecan (Onivyde®), and lanreotide autogel (Somatuline®, marketed as Somatuline Depot® in the United States) will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting takes place in Chicago, Illinois, U.S., 31 May–4 June 2019; data featuring Ipsen medicines includes: New data from the Phase 3 CELESTIAL trial on the association of adverse events with efficacy outcomes for cabozantinib in patients with advanced hepatocellular carcinoma Overview of the Phase 3 COSMIC-312 trial of cabozantinib in combination with atezolizumab vs sorafenib in patients with advanced hepatocellular carcinoma who have not received previous systemic anticancer therapy First Phase 2 data from the CaboGIST study (trial 1317) from the European Organization for Research and Treatment of

The Posiflex Group Showcases an Ecosystem of Connected Solution Endpoints with IoT Remote Monitoring at Computex 201924.5.2019 01:00:00 CESTPressemelding

For the Computex 2019 show, The Posiflex Group is featuring leading solution technology from the family of brands as a fully Serviced IoT Ecosystem. Solution end points include: Connected Modular Kiosks, POS Terminals, and Digital Signage solutions from Posiflex and KIOSK Information Systems Smart Medical Displays with gesture controls from Portwell Connected Gaming Solutions with Player Tracking Technology from Portwell subsidiary, Ganlot The booth display is based on common field service endpoints represented in a European Manor Destination Resort setting. Field solutions for an array of vertical market applications include QSR ordering, cinema ticketing, fashion retail customer loyalty, interactive signage, hotel / medical center check-in and bill pay, as well as casino gaming technology. This year, in addition to their renowned POS product suite, Posiflex will be featuring newly introduced Modular Kiosk platforms (co-designed by KIOSK and Posiflex), which are configure-to-order sta