Clinical trials of UroActive System receive support from Series C Financing

UroMems has raised $47 million in Series C financing to aid large-scale US and European clinical trials of the UroActive System, a smart automated artificial urinary sphincter for patients with stress urinary incontinence (SUI), the company announced in a news release.¹

The device was granted Safer Technologies Program (STeP) Designation from the FDA in 2023.

This achievement marks the largest funding series for the company to date.

“We are thrilled to lead this record round for UroMems,” Jérôme Feraud, Head of Health Division at Crédit Mutuel Innovation, which led the financing round, said in the news release.¹ “Based on very positive data and feedback from patients and physicians in the pilot clinical trials, we strongly believe that the UroActive smart implant has the potential to become the standard of care as the next-generation SUI treatment.”

The UroActive System is the first smart active implant to treat SUI. The device is powered by a MyoElectoMechanical System (MEMS) and is controlled based on a patient’s activity, without the need for manual adjustments. The technology is placed around the urethra in men and around the bladder neck in women.

The device was granted Safer Technologies Program (STeP) Designation from the FDA in 2023,² which is intended to allow more timely access to new products that have the potential to be safer than currently approved options, while maintaining the FDA’s standards for safety and effectiveness.

The UroActive System is currently under investigation in 2 first-in-human clinical trials in male and female patients with SUI. Data from the first-in-man study recently reported positive results regarding the study’s 6-month end point, and the first-in-female trial shared encouraging results from the first patient enrolled in the study. In both studies, all patients have had their implants for over 1 year, with no need for revisions or explants to date.

Data from the first-in-man SOPHIA trial (NCT05547672) were recently shared at the 2024 American Urological Association Annual Meeting in San Antonio, Texas.³ Overall, the study met its 2 primary end points of successful device activation and the rate of explants or revisions at the 6-month time point.

According to the researchers, the devices were successfully implanted and activated in all 6 patients enrolled in the study, and there was no explants or revision required. There was 1 severe adverse event reported, consisting of a hematoma after surgery with slow urinary stream, which was self-resolved. Control unit data at 3 months’ post-activation showed an average of 8 micturition per day (IQR= 3) and that patients experienced an average of 7 hours per day (IQR = 40 minutes) with low pressure.

A 50% or higher reduction in 24-hour pad weight test was experienced by all patients, with a median reduction of 84% (IQR = 8%). The median Qmax was 34 ml/s (IQR = 10).

Data from the first-in-female trial (NCT05828979) of the UroActive System reported results from the first patient enrolled in the trial in February 2024.⁴

Overall, the patient met the study’s 6-month primary end points of successful device activation and the rate of explants and revisions at 6 months. In addition to remaining revision-free, the patient has also experienced restored social continence. Secondary measures, including leak rate values, also showed a trend toward positive outcomes.

Both studies are sponsored by UroMems, the developer of the UroActive System. The device does not currently have FDA approval or CE Marking.

References

1. UroMems raises record $47 million (€44 Million) in Series C Financing to fund pivotal clinical trials of the UroActive System, the first smart automated implant to treat stress urinary incontinence. News release. UroMems. Published online and accessed June 25, 2024. https://www.uromems.com/en/press/article/15/uromems-raises-record-47-million-44-million-in-series-c-financing-to-fund-pivotal-clinical-trials-of-the-uroactive-system-the-first-smart-automated-implant-to-treat-stress-urinary-incontinence

2. UroMems granted Safer Technologies Program Designation from FDA for smart implant to treat stress urinary incontinence. News release. UroMems. April 20, 2023. Accessed June 25, 2024. https://www.prnewswire.com/news-releases/uromems-granted-safer-technologies-program-designation-from-fda-for-smart-implant-to-treat-stress-urinary-incontinence-301803090.html

3. Beaugerie A, Perrouin-Verbe M-A, Denormandie A, et al. The new artificial urinary sphincter UroActive: Results of the first in man study at 3 months post-activation (SOPHIA study). Presented at: 2024 American Urological Association Annual Meeting. May 2-6, San Antonio, Texas.

4. UroMems announces results of first-ever smart artificial urinary sphincter implant in female patient to treat stress urinary incontinence. News release. UroMems. February 14, 2024. Accessed June 25, 2024. https://www.prnewswire.com/news-releases/uromems-announces-results-of-first-ever-smart-artificial-urinary-sphincter-implant-in-female-patient-to-treat-stress-urinary-incontinence-302061348.html