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UroMems declares positive results for stress urinary incontinence implant

Stress urinary incontinence, marked by urine leakage during activities like exercise or sneezing, is the focus of UroMems' latest trial evaluating its UroActive device.

The company, headquartered in France, disclosed positive outcomes from its female first-in-human feasibility trial (NCT05828979). The initial patient treated with UroActive met the six-month primary endpoint. UroMems is conducting parallel trials for men and women with stress urinary incontinence, unresponsive to current treatments like surgery or Eli Lily's antidepressant Cymbalta (duloxetine).

Primary endpoints in these trials include explant and revision rates six months post-device activation. These findings will guide the design of upcoming pivotal trials in Europe and the US, although specifics weren't disclosed by UroMems.

UroMems' UroActive system uses MyoElectroMechanical technology to adjust sphincter opening based on patient activity, offering relief without sustained tissue pressure during rest. The FDA granted UroActive Safer Technologies Programme designation in April 2023, expediting its market entry.

Meanwhile, Aviation Medical reported positive data on its non-invasive bladder-control device for urinary incontinence. Additionally, Versameb, a Swiss pharma company, received FDA approval to commence a Phase I clinical trial for mRNA therapy targeting stress urinary incontinence in women, signalling collaboration between pharma and MedTech in addressing this condition.