UroMems has reached one other checkpoint in bringing the primary automated synthetic urinary sphincter to market after the corporate introduced its scientific feasibility examine met major and secondary endpoints.
The feasibility examine (NCT05547672) enrolled six male sufferers with urinary continence who didn’t reply to different types of therapy. UroMems acknowledged that the cohort handled with its UroActive system met the six-month major endpoints, which included the speed of explants and revisions and the speed of system activation successes.
The outcomes from the potential, multicentre scientific examine will assist the design and planning of an upcoming pivotal trial in Europe and the US.
France-headquartered UroMems mentioned that the six sufferers’ implants, which have been in use for greater than seven months, have been working as anticipated and constructive comply with ups reported through profitable secondary end result measures.
UroMem is carving out a brand new therapy method for individuals dwelling with stress urinary incontinence with the UroActive system. In line with the corporate, it’s the first good automated system that treats the situation characterised by the leakage of urine when the bladder is below excessive intra-abdominal strain comparable to whereas coughing, sneezing, or exercising.
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Stress urinary incontinence, which impacts round 40 million People and is extra frequent in girls, is presently handled with surgical procedure or with Eli Lily’s antidepressant Cymbalta (duloxetine).
UroMem’s UroActive system makes use of the corporate’s MyoElectroMechanical System which is positioned across the urethral duct and routinely modifications the sphincter opening by strain changes based mostly on the affected person’s exercise. This has the benefit of not inserting sustained strain on the tissue when the affected person is at relaxation.
In April 2023, the US Meals and Drug Administration (FDA) granted UroActive with Safer Applied sciences Programme designation to hurry up the system’s path to market.
UroMems chief medical officer and co-founder Pierre Mozer mentioned: “The outcomes of this examine will enable us to organize our pivotal examine which will likely be a significant step within the improvement of UroActive.”
In November 2023, Aviation Medical released positive data on its non-invasive bladder-control system for the therapy of urinary urgency and urge urinary incontinence brought on by overactive bladder syndrome.
The pharma business can be becoming a member of the medtech world in concentrating on new therapy choices for sufferers with stress urinary incontinence. In November 2023, Switzerland-based Versameb obtained approval from the FDA to begin a Phase I clinical trial with the corporate’s mRNA remedy in girls with the situation.