Positive Initial Results of the Axonics® RELAX-OAB Clinical Study Presented at the International Neuromodulation Society World Congress
30.5.2017 20:00 | Business Wire
Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and fecal dysfunction, today announced the presentation of positive initial results from its prospective, multicenter clinical study at the 2017 International Neuromodulation Society (INS) World Congress in Edinburgh, Scotland.
The presentation, entitled “A rechargeable sacral neuromodulation system for the treatment of overactive bladder: interim results of a prospective, multicenter clinical study (RELAX-OAB study),” was delivered by Professor Philip Van Kerrebroeck, M.D., PhD, Chair of the Dept. of Urology, Maastricht University Medical Centre, The Netherlands.
The results presented included outcomes for 33 subjects who have reached their three-month primary endpoint and provided significant evidence that the Axonics r-SNM system is safe and efficacious.
A total of 51 overactive bladder patients with symptoms of urinary urgency incontinence and urgency frequency were enrolled and implanted in the RELAX-OAB study. All subjects were implanted with an Axonics miniaturized rechargeable neurostimulator and did not undergo an external test stimulation typically used to screen patients. At one month, 71% of subjects were initial responders to therapy, defined as a 50% or greater reduction in incontinence or urgency frequency symptoms, or a reduction to less than eight voids per day in urgency frequency subjects.
Data at three months post-implant demonstrated:
- 91% of initial responders continued to respond to therapy
- Initial responders reported clinically meaningful improvements in quality of life, underscored by significant improvements from baseline in the ICIQ-OABqol HRQL score of 31.0 points (+/- 4.4, SE, n=23)
- Over 90% of initial responders were satisfied with SNM therapy provided by the Axonics r-SNM System
- There were no serious adverse device effects or unanticipated adverse device effects reported
- Two subjects (4%) required surgical intervention
“As anticipated, the Axonics r-SNM system is delivering safe and effective symptom relief to patients,” said Raymond W. Cohen, Chief Executive Officer of Axonics. “The three-month study endpoint will be reached for all subjects in June and we expect the full dataset to confirm these clinically significant results. Axonics is grateful to Professor Van Kerrebroeck and the other investigators for participating in this study and congratulate them on the outstanding results.”
Bertil Blok, M.D., PhD, of Erasmus University Medical Center in Rotterdam, Netherlands, will present the complete study results on behalf of the investigators at the International Continence Society annual meeting in September in Florence, Italy.
The Axonics r-SNM System received European CE Mark approval in June 2016 and Health Canada approval in December 2016 for the treatment of overactive bladder, urinary retention, and fecal incontinence. These conditions affect over 100 million adults in the U.S. and Europe. SNM is a reimbursed and FDA-approved therapy that has proven to be an effective and durable treatment widely used in Europe and the U.S. for the past two decades with more than 250,000 patients having benefited from the therapy to date.
Axonics anticipates initiating a U.S. FDA pivotal clinical study for OAB patients in select centers in the U.S., Canada and Europe in the second half of 2017.
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 fecal dysfunction and can be further directed towards several clinical indications. The Axonics r-SNM System includes a miniaturized rechargeable stimulator qualified to function at least 15 years, an optimized charging system for limited charge time and reduced heating, a patient-friendly remote control and an intuitive clinician programmer that support the procedure from lead placement to programming. For more information, visit the Company’s website at www.axonicsmodulation.com.
Pure Communications, Inc.
Matt Clawson, +1-949-370-8500
Om Business Wire
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
IBC’s Big Screen to Explore the Future of Camera and Display Technologies and the Business Behind Cinema22.8.2017 16:58 | Pressemelding
IBC today announced the details of its Big Screen programme, taking place in a specially built auditorium designed to IBC’s specifications and featuring the very latest in cinema technology. With the latest Dolby Vision dramatic imaging and Dolby Atmos immersive audio sound installation, the four-day programme examines and demonstrates the hottest topics, themes, and insights surrounding the art, science, and business of cinema - from capture through to exhibition. As well as being the home of the Big Screen programme, the auditorium will screen in Dolby Vision and Dolby Atmos, Baby Driver, the acclaimed Edgar Wright feature from 2017. The programme for 2017, which has been shaped by a committee of global industry professionals, is an insightful examination of the future of cinema. From virtual reality in cinema to laser and camera assessments, visitors will get up to speed
Digi Communications N.V. Announces the Publishing of an Update to the Investigation by the Romanian National Anti-Corruption Directorate22.8.2017 16:38 | Pressemelding
In connection with the investigation triggered by the Romanian National Anti-Corruption Directorate (“DNA”), which we have previously disclosed to the market and to our investors in the initial public offering prospectus dated 26 April 2017, in the supplemental prospectus dated 8 May 2017 (together, the “Prospectus”), as well as in the subsequent public reports, we inform you that, based on the public release no 832/VIII/3 issued on 22 August 2017, the DNA sent to court under the judiciary control Mr. Ioan Bendei (Vice-president of the Board of Directors of RCS & RDS S.A. – the Company’s subsidiary („RCS&RDS”)) in connection with the offences of bribery and accessory to money laundering, as well as RCS&RDS in connection with the offences of bribery and money laundering, INTEGRASOFT S.R.L. (one of RCS&RDS’s subsidiaries in Romania) in connection with the offence of accessory to mon
SailPoint Named a Leader in Cloud-based Identity Governance22.8.2017 14:00 | Pressemelding
SailPoint, the leader in enterprise identity management, was recently named the overall market leader in KuppingerCole’s 2017 “Leadership Compass: Identity as a Service: Cloud-based Provisioning, Access Governance and Federation.” In addition to being named a leader in every category of the report, SailPoint received superior rankings in four of the five evaluation criteria: security, functionality, interoperability and usability. KuppingerCole is an international and independent analyst organization with a strong focus on Information Security and Identity and Access Management. KuppingerCole’s Leadership Compass reports provide an in-depth analysis of the main players in the market, defining each as a follower, challenger or leader. The Leadership Compass Report for IDaaS evaluates leaders in innovation, product features, and market reach for identity-as-a-service offerings tar
Meggitt Training Systems to Exhibit at DSEI 201722.8.2017 14:00 | Pressemelding
Meggitt Training Systems, the leading provider of integrated live-fire and virtual weapons training products and services for armed forces and law enforcement, will participate at Defence and Security Equipment International (DSEI) through the Georgia Department of Economic Development. The military and security industry event will be held September 12-15, 2017 at ExCeL in London, England. “Today’s threats necessitate maximum realism, despite stretched budgets, and that’s what Meggitt provides to government and commercial customers globally,” said Mark Mears, managing director at Meggitt Training Systems, Ltd. “Although proudly based in Georgia, Meggitt Training Systems is part of Meggitt PLC, a UK-headquartered corporation. As such, we particularly look forward to engaging with current and prospective customers at DSEI, the UK’s largest defense and security trade show.” On
Camelbay Real Estate Management NL B.V. Selects Yardi Voyager22.8.2017 13:58 | Pressemelding
Camelbay Real Estate Management NL B.V. will utilise Yardi Voyager® 7S, a browser-agnostic, fully mobile Software-as-a-Service platform, as its accounting and property management platform. Camelbay will use Yardi Voyager to streamline its property management, leasing and accounting processes for its Dutch real estate portfolio, which is predominantly comprised of commercial office assets. “The automation, transparency and fully integrated accounting and property management that Voyager provides will help us manage our daily financial and operational activities more efficiently and enhance our competitive position within the Dutch office market,” said Alon Levy, Director of Camelbay Real Estate Management NL B.V. “We are very pleased to welcome Camelbay as our latest client in the Netherlands,” said Neal Gemassmer, Vice President of International for Yardi.
Laser Design CyberGage®360, Automated 3D Scanning & Inspection System Adopted by Proto Labs in their State-of-the-Art Metrology Lab22.8.2017 13:44 | Pressemelding
Laser Design, Inc., a subsidiary of CyberOptics (NASDAQ:CYBE), and premier provider of ultra-precise 3D scanning systems and services, announces the adoption of the CyberGage360 3D Scanning and Inspection system by Proto Labs, the world’s fastest digital manufacturing source for custom prototypes and low-volume production parts providing unprecedented speed-to-market value for designers and engineers. “At Proto Labs, we strive to challenge the traditional rules of manufacturing in order to deliver custom manufactured components at unprecedented speeds,” said Dylan Lundberg, Senior Manufacturing Engineer of Protoworks, Proto Labs’ R&D lab. “Everything we do revolves around reducing our customers’ time to market and we do that by digitalizing the entire manufacturing process. From our front-end services to our proprietary processes on the manufacturing floor, you will find thr
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom