The Belgian academic Stefan De Wachter is seeking patent protection for methods of ensuring pelvic health and treating a disease or disorder characterized by a dysfunctional autonomic nervous system using neuromodulation and applying a burst stimulation pattern of electric pulses of high frequencies from electrodes located in the proximity of the sacral plexus and/or pelvic plexus.
Dr. Pfleger Arzneimittel GmbH is seeking patent protection for a system and a corresponding computer program product for assisting in alleviating overactive bladder syndrome and incontinence symptoms, particularly reduction of micturitions and reduction of urine loss. The system is particularly suited for being implemented and distributed as a smartphone app which may be operated by the user.
Stimvia s.r.o. (previously Tesla Medical s.r.o.) is in the process of securing $10 million in investment in a series A financing round that will allow the company to conduct a pivotal clinical study addressing overactive bladder, using Uris, its neuromodulation system, CEO Lukas Doskocil told BioWorld.
The U.S. FDA granted the de novo marketing request for Bluewind Medical Ltd.’s Revi system for the treatment of urgency incontinence with or without urinary urgency, the company reported on August 17. Unlike other neuromodulation devices approved in recent years, Revi stimulates the tibial nerve instead of the sacral nerves.
General Stim Inc.’s implanted sacral nerve stimulation (SNS) system was approved in China to treat individuals with certain bladder and bowel conditions. Hangzhou-based General Stim’s SNS system consists of a sacral nerve stimulator, an extension lead and an electrode.
Elidah Inc. expanded its line of U.S. FDA-cleared, over-the-counter devices to reduce or eliminate urinary incontinence in women with the launch of Elitone Urge for urge incontinence. The device is a muscle stimulator that can be worn under clothes as the user goes about her day and rebuilds muscle tone.
Uromems SAS reported the successful completion of the first-in-human implant of a smart, automated artificial urinary sphincter (AUS) device for treating stress urinary incontinence (SUI). This initial pilot study recently saw the first male patient implanted with the Uroactive System at Paris’s La Pitié-Salpêtrière University Hospital and is considered by the company to be a key milestone in the technology’s development.
Sumitovant Biopharma Ltd. subsidiary Urovant Sciences GmbH is out-licensing overactive bladder (OAB) treatment vibegron to Pierre Fabre Médicament to register and commercialize the drug in the EU, U,K, and Switzerland. Under the terms of the deal, Basel, Switzerland-based Urovant will receive up to $75 million in up-front payments, regulatory and sales milestones and royalties, while Urovant will retain full commercialization rights to vibegron in the U.S. and certain other markets.
Sumitovant Biopharma Ltd. subsidiary Urovant Sciences GmbH is out-licensing overactive bladder (OAB) treatment vibegron to Pierre Fabre Médicament to register and commercialize the drug in the EU, U,K, and Switzerland. Under the terms of the deal, Basel, Switzerland-based Urovant will receive up to $75 million in up-front payments, regulatory and sales milestones and royalties, while Urovant will retain full commercialization rights to vibegron in the U.S. and certain other markets.
Medtronic plc reported its tibial neuromodulation device was implanted in the first patient with overactive bladder as part of its Titan 2 pivotal study. The device stimulates the posterior tibial nerve near the ankle to assist in regulation of bladder function. Medtronic expects to enroll 130 patients in the study.