Versameb AG Announces FDA Clearance of IND Application for VMB-100 in the Treatment of Stress Urinary Incontinence

Versameb AG (“Versameb”), a pre-clinical stage company focused on transforming RNA therapeutics to treat unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application of VMB-100, a potency enhanced messenger ribonucleic acid (mRNA) encoding human insulin-like growth factor-1 (IGF-1), for the treatment of stress urinary incontinence (SUI). Following this clearance, Versameb plans to launch a Phase 2a open label, first-in-human dose ascending study in the first half of 2024. The study will evaluate the safety, tolerability, and efficacy of VMB-100 in female subjects with stress urinary incontinence, a highly common condition resulting in involuntary leakage of urine due to a weakened urinary sphincter muscle. Read more.

Source: Pharmaweb.com, November 17, 2023

Multi-center Study Published in Urology Confirms Efficacy and Safety of Avation Medical’s Noninvasive Vivally® System for OAB

Avation Medical, Inc., an innovative neuromodulation and digital health company with a mission to make wearable peripheral neuromodulation accessible to patients across a variety of clinical conditions, today announced the publication of safety and efficacy results from a multi-center study, “FREEOAB”, for its novel Vivally System in Urology, a leading, peer–reviewed journal for urologists. “The Vivally System represents a significant advancement in bladder control therapy as a non-invasive, patient-centered therapy providing patients with effective treatment, performed in the home, without the need for surgery or drugs,” said Dr. Colin Goudelocke, Principal Investigator for the FREEOAB Study. “In our study, significant reductions in symptom burden were observed at 12 weeks which, notably, persisted out to 12 months, even with a reduction in frequency of therapy sessions.” Read more.

Source: PRNewswire, November 15, 2023

UroMems Announces Results of First Patient in Smart Implant Study to Treat Stress Urinary Incontinence

UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully met the primary endpoints for the initial male patient in its SOPHIA study. SOPHIA is the first-in-man study of the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI. The results of this clinical study will support design and implementation of UroMems’ pivotal clinical trial in Europe and the U.S. Read more

Source: PRNewswire, June 6, 2023

Clinical Study Results of the BlueWind System for Patients with Overactive Bladder Featured at the 2023 AUA Annual Meeting

BlueWind Medical, Ltd., the developer of a transformative implantable tibial neuromodulation therapy for Overactive Bladder (OAB), today announced results from the OASIS pivotal trial evaluating the safety and efficacy of the BlueWind System in the treatment of OAB. The results were featured in the late-breaking session (LBA01-05) at the American Urological Association (AUA) 2023 Annual Meeting in Chicago on Sunday, April 30^th. Read more.

Source: PRNewswire, May 1, 2023

Digital Therapeutic Device for Urinary Incontinence

The prescription leva Pelvic Health System (Renovia) is the first device to offer a digital therapeutic therapy for pelvic floor muscle training to improve symptoms of urinary incontinence and fecal incontinence. In study findings published in Obstetrics & Gynecology, leva achieved significantly greater urinary incontinence symptom improvement than a standard home pelvic floor muscle training program at 6 and 12 months. Read more.

Source: Contemporary OB/GYN.net, March 8, 2023

Amber Therapeutics Announces Successful First-in-human Implants of Amber-UI: An Intelligent, Closed-loop Bioelectrical Therapy for Urge and Mixed Urinary Incontinence

Amber Therapeutics (‘Amber’ or the ‘Company’), a University of Oxford spinout developing next-generation, intelligent bioelectrical therapies to transform clinical outcomes in patients with functional disorders of the peripheral nervous system, announces that the first participants have been implanted with Amber-UI, the Company’s proprietary therapy for urge and mixed urinary incontinence (UI). Amber-UI is the first fully implantable closed-loop bioelectrical therapy in clinical development for UI, which is made possible by being able to access and target the pudendal nerve – the nerve that directly controls continence – through a novel, minimally invasive surgical procedure. Read more.

Source: PRNewswire, January 24, 2023

UroMems Initiates First-in-Human Study of Its Smart Implant to Treat Stress Urinary Incontinence

UroMems, a global company developing breakthrough, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-in-human implant of the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) investigational device to treat SUI. This initial clinical study is a key milestone in the development of UroActive. Read more.

Source: PRNewswire, November 29, 2022

Urinary Incontinence May Increase Risk for Depressive Symptoms Among Adults

Risk for symptoms of depression may be associated with urinary incontinence (UI) which was mediated by functional impairment among middle-aged and older adults. These findings, from a cross-sectional study, were published in the Journal of Affective Disorders. Read more.

Source: Psychiatry Advisor, July 27, 2022

Prasterone Shows Promise In Reducing Severity of Urinary Urge Incontinence

Because of a decrease in estrogen, menopause is often accompanied by multiple vaginal and urinary issues. To date, most treatment options focus on vulvar and vaginal atrophy, with fewer options available to treat urinary incontinence. A new study, however, suggests prasterone is effective in improving the severity of urinary urge incontinence. Study results are published online today in Menopause, the journal of The North American Menopause Society (NAMS). Read more.

Source: Newswise, July 27, 2022

Urovant Sciences Announces Positive Topline Results of Phase 2a Trial of its Potential Novel Gene Therapy, URO-902

Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced positive topline results from its Phase 2a, double-blind, placebo-controlled exploratory study of URO-902, an investigational, novel, locally injected gene therapy product (plasmid human cDNA encoding maxi-K channel), in patients with overactive bladder (OAB), who were not well managed by oral therapies. Read more.

Source: Pharmiweb.com, March 7, 2022