Business Wire03.07.17
Axonics Modulation Technologies Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM) system for the treatment of urinary and fecal dysfunction, has been awarded four U.S. patents from the United States Patent and Trademark Office relating to its implantable sacral neuromodulation technology.
“The diverse and rapid expansion of the Axonics U.S. patent portfolio demonstrates the level of innovation applied by our company in addressing the unmet needs of clinicians and patients relating to implantable Sacral Neuromodulation. With these four new U.S. patents, we now have 73 granted and 78 pending patent applications in our portfolio in various jurisdictions around the world,” said Raymond W. Cohen, Axonics CEO.
The Axonics patent portfolio represents technology internally developed by Axonics and under license from the Alfred Mann Foundation.
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 (including urinary urge incontinence and urinary urgency-frequency), urinary retention, and fecal incontinence.
The company has completed enrollment of its RELAX-OAB multi-center post-market clinical study for patients with overactive bladder in select centers in the Netherlands, Belgium, France, and the United Kingdom.
Axonics anticipates initiating a U.S. Food and Drug Administration (FDA) pivotal clinical study for overactive bladder patients in select centers in the United States, Canada, and Europe in the second half of 2017.
The Axonics neuromodulation platform includes, among other innovations, a miniaturized rechargeable implantable neuromodulation stimulator that is approximately one-fourth the size of the smallest currently marketed rechargeable neuromodulation devices and can be directed toward numerous clinical applications. The Axonics stimulator is qualified to last at least 15 years in the body and needs to be recharged once every week or two for approximately one hour via a charging system designed to optimize ease of use and patient comfort. In addition, the Axonics platform features a key-fob sized, patient-friendly remote control and an intuitive clinician programmer that will guide and support physician implanters throughout the clinical procedure, from lead placement to programming. Axonics’ initial clinical application for its technology is Sacral Neuromodulation (SNM) for the treatment of urinary and fecal dysfunction which affects more than 100 million adults in the United States and Europe. SNM is a reimbursed FDA-approved therapy that has proven to be an effective and durable treatment widely used in Europe and the United States for the past two decades with more than 200,000 patients having benefited from the therapy to date.
Axonics, based in Irvine, Calif., is a privately held company developing novel implantable neuromodulation technology directed toward a number of clinical indications. Investors include Edmond de Rothschild Investment Partners, Advent Life Sciences, NeoMed Management, Legend Capital, Cormorant Asset Management and The Alfred E. Mann Foundation.
- U.S. 9,555,246 and U.S. 9,561,372 relate to an integrated electromyography (EMG) technology that aids in accurate placement during the lead implantation procedure.
- U.S. 9,533,155 relates to an electrode recommendation engine simplifying the programming of stimulation therapy.
- U.S. 9,517,338 relates to a multichannel stimulation lead test clip improving ease of use during the lead implantation procedure.
“The diverse and rapid expansion of the Axonics U.S. patent portfolio demonstrates the level of innovation applied by our company in addressing the unmet needs of clinicians and patients relating to implantable Sacral Neuromodulation. With these four new U.S. patents, we now have 73 granted and 78 pending patent applications in our portfolio in various jurisdictions around the world,” said Raymond W. Cohen, Axonics CEO.
The Axonics patent portfolio represents technology internally developed by Axonics and under license from the Alfred Mann Foundation.
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 (including urinary urge incontinence and urinary urgency-frequency), urinary retention, and fecal incontinence.
The company has completed enrollment of its RELAX-OAB multi-center post-market clinical study for patients with overactive bladder in select centers in the Netherlands, Belgium, France, and the United Kingdom.
Axonics anticipates initiating a U.S. Food and Drug Administration (FDA) pivotal clinical study for overactive bladder patients in select centers in the United States, Canada, and Europe in the second half of 2017.
The Axonics neuromodulation platform includes, among other innovations, a miniaturized rechargeable implantable neuromodulation stimulator that is approximately one-fourth the size of the smallest currently marketed rechargeable neuromodulation devices and can be directed toward numerous clinical applications. The Axonics stimulator is qualified to last at least 15 years in the body and needs to be recharged once every week or two for approximately one hour via a charging system designed to optimize ease of use and patient comfort. In addition, the Axonics platform features a key-fob sized, patient-friendly remote control and an intuitive clinician programmer that will guide and support physician implanters throughout the clinical procedure, from lead placement to programming. Axonics’ initial clinical application for its technology is Sacral Neuromodulation (SNM) for the treatment of urinary and fecal dysfunction which affects more than 100 million adults in the United States and Europe. SNM is a reimbursed FDA-approved therapy that has proven to be an effective and durable treatment widely used in Europe and the United States for the past two decades with more than 200,000 patients having benefited from the therapy to date.
Axonics, based in Irvine, Calif., is a privately held company developing novel implantable neuromodulation technology directed toward a number of clinical indications. Investors include Edmond de Rothschild Investment Partners, Advent Life Sciences, NeoMed Management, Legend Capital, Cormorant Asset Management and The Alfred E. Mann Foundation.
