Vensica Medical Advances Needle-Free Bladder Therapy to Phase 2

• Strategic milestone validates clinical rationale for needle-free delivery and triggers milestone payment from strategic partners.
• ViXe aims to transform the standard of care for 33 million Americans living with overactive bladder through a non-invasive ultrasound-based solution.
• The Group holds approximately 9% in Vensica, founded by Avner Geva and incubated by Trendlines.

Vensica, a clinical-stage company developing needle-free therapeutic delivery solutions for urologic diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has cleared the Company’s Investigational New Drug (“IND”) application to initiate a Phase 2 clinical trial of ViXe. The study will evaluate Vensica’s Vibe® ultrasound-based, needle-free drug delivery system in combination with Xeomin® for the treatment of overactive bladder (“OAB”).

The Phase 2 study is expected to enroll approximately 210 patients across sites in the United States and Europe. This clinical milestone triggers a contractual development milestone payment from Vensica’s strategic partners. Vensica is supported by its investors and strategic partners, including Merz Pharma, Laborie, Israel Biotech Fund and Trendlines.

Overactive bladder affects an estimated 33 million adults in the United States.[1] While botulinum toxin injection is an established treatment, its invasive nature often limits patient acceptance. Vensica’s ViXe program is designed to deliver the therapy into the bladder wall without the use of needles, potentially expanding access to a much broader patient population.

The Phase 2 study is expected to enroll approximately 210 patients across sites in the United States and Europe and will evaluate the safety and efficacy of Vibe-enabled delivery of botulinum toxin type A. The Company anticipates initiating patient enrollment in Q3 2026.

[1] https://uuanj.com/men/overactive-bladder/