30.5.2017 22:02 | Business Wire
Positive Initial Results of the Axonics® RELAX-OAB Clinical Study Presented at the International Neuromodulation Society World Congress
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 .
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