Botulinum toxin type A(HSM)

NEW YORK--(BUSINESS WIRE)--Vensica Medical, 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 the Vibe® ultrasound-based, needle-free drug delivery system in combination with Xeomin® (incobotulinumtoxinA) for the treatment of overactive bladder (OAB). Overactive bladder affects an estimated 33 million adults in the United States and is characterized by urinary urgency, frequency, and incontinence. While intravesical botulinum toxin injection is an established second-line treatment, the invasive procedure limits patient access and acceptance. The ViXe program is designed to enable effective delivery of botulinum toxin into the bladder wall without the need for needles. 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]. “FDA clearance of this IND is an important milestone for Vensica and validates the clinical rationale behind the ViXe program,” said Avner Geva, Chief Executive Officer of Vensica Medical. “Botulinum toxin is a proven therapy for OAB, but needle-based delivery remains a barrier for many patients. We believe ViXe has the potential to expand access to a much broader population.” “The Vibe platform was specifically engineered to overcome biological barriers that have historically limited needle-free delivery of large-molecule drugs,” said Avi Eftel, Co-Founder and Chief Technology Officer of Vensica Medical. “We look forward to executing this study and generating data to further demonstrate the clinical value of our approach.” “This IND clearance represents a key milestone in Vensica’s development and highlights the potential of the ViXe program,” said Ken Berlin, Executive Chairman of the Board of Vensica Medical. “A needle-free approach to botulinum toxin delivery could meaningfully expand patient access and create significant value for patients, partners, and investors.” The IND clearance triggers a contractual development milestone payment from Vensica’s strategic partners, supporting execution of the Phase 2 trial. Vensica is supported by its investors and strategic partners, including Merz Pharma, Laborie, and Israel Biotech Fund. About Vensica Medical Vensica Medical is a clinical-stage company developing needle-free therapeutic delivery solutions for urologic diseases. The Company’s proprietary Vibe® platform uses focused ultrasound to enable localized delivery of biologic and small-molecule drugs into the bladder wall. Vensica’s lead program, ViXe, combines the Vibe system with Xeomin® (incobotulinumtoxinA) for the treatment of overactive bladder. For more information, please visit [www.vensica.com].