Needle-Free Bladder Treatment Enters Key Trial, Offering Hope for Millions

NEW YORK, NY – April 28, 2026 – For the estimated 33 million American adults living with the disruptive symptoms of overactive bladder (OAB), a promising new era of treatment may be on the horizon. Vensica Medical, a clinical-stage company, announced today it has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial for its novel ViXe system. The clearance marks a pivotal moment for a technology that aims to deliver a proven therapy without the use of needles, potentially transforming the treatment landscape for a condition that significantly impacts quality of life.

The upcoming study will evaluate ViXe, which combines the company's proprietary Vibe® ultrasound delivery system with Xeomin® (incobotulinumtoxinA), a well-established botulinum toxin. This milestone not only validates Vensica’s innovative approach but also triggers a contractual development payment from strategic partners, providing further financial support for the crucial next phase of research.

The Challenge of Current OAB Therapies

Overactive bladder is characterized by a sudden, compelling urge to urinate that is difficult to control, often accompanied by frequent urination and incontinence. The condition can lead to social isolation, anxiety, and a significant reduction in daily activities. While first-line treatments involve behavioral therapies and oral medications, many patients do not find adequate relief or cannot tolerate the side effects, which include dry mouth and constipation.

For these individuals, intravesical (in-bladder) injections of botulinum toxin have become an effective second-line therapy. The toxin works by relaxing the bladder muscle, increasing its storage capacity and reducing episodes of urgency and incontinence. However, the procedure itself presents a major barrier for many patients.

Currently, the therapy requires a cystoscopy, where a physician inserts a scope into the bladder and uses a long, thin needle to perform multiple injections directly into the bladder wall. The procedure can be uncomfortable, painful, and carries risks of urinary tract infections (UTIs) and, most notably, urinary retention. A significant percentage of patients who undergo the procedure may temporarily—or in some cases, permanently—be unable to empty their bladder completely and require the use of a catheter.

This invasive nature and the potential for complications deter many from pursuing an otherwise effective treatment. The unmet need is clear: a method that can deliver the proven benefits of botulinum toxin without the pain, fear, and risks associated with needle-based injections.

Ultrasound Unleashed: A New Delivery Paradigm

Vensica Medical aims to solve this problem with its Vibe® platform. Instead of needles, the system uses focused ultrasound to create a temporary, localized effect on the bladder wall. This process, known as cavitation, generates microscopic bubbles that gently and precisely enable the medication—in this case, Xeomin®—to penetrate the bladder's natural barrier and reach the underlying muscle.

The technology is designed to provide a uniform and controlled delivery of the drug across the target area, a feat that can be challenging with multiple discrete needle injections. This needle-free approach could dramatically improve the patient experience, making the treatment more accessible and palatable to a much broader population of OAB sufferers.

“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, in a statement. “We look forward to executing this study and generating data to further demonstrate the clinical value of our approach.”

The potential extends beyond just patient comfort. By simplifying the delivery method, the ViXe system could potentially shift the procedure from a more specialized surgical setting to a standard urology office, increasing efficiency and access.

Strategic Backing and the Path Forward

The FDA’s clearance is more than a scientific achievement; it is a powerful validation of Vensica's strategy and technology, underscored by the confidence of major industry players. Vensica is supported by strategic partners including Merz Pharma, the manufacturer of Xeomin®; Laborie, a global leader in urologic diagnostic and therapeutic devices; and the Israel Biotech Fund.

This robust backing provides not only capital but also deep domain expertise. The partnership with Merz gives Vensica access to a leading neurotoxin, while Laborie's involvement signals a clear path to market within the urology community should the technology prove successful. The IND clearance itself triggers a milestone payment, further strengthening the company's financial position as it embarks on the costly and complex Phase 2 trial.

“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.”

Ken Berlin, Executive Chairman of the Board, echoed this sentiment, highlighting the broader implications. “A needle-free approach to botulinum toxin delivery could meaningfully expand patient access and create significant value for patients, partners, and investors,” he stated.

The upcoming Phase 2 study is designed to provide the rigorous data needed to confirm these beliefs. The trial is expected to enroll approximately 210 patients across clinical sites in the United States and Europe, with patient enrollment slated to begin in the third quarter of 2026. Its primary goals will be to assess the safety of the Vibe-enabled delivery and to measure its efficacy in reducing the symptoms of overactive bladder. Success in this trial would represent a critical step toward bringing this transformative, needle-free therapy to the millions who stand to benefit.