Vensica Medical Receives FDA IND Clearance to Initiate Phase 2 Study of ViXe, Its Needle-Free Xeomin ® Delivery System for Overactive Bladder
28.4.2026 15:42:00 EEST | Business Wire | Press release
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).
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260414145279/en/
Avner Geva, Cofounder, CEO (left), and Avi Eftel, Cofounder, CTO (right)
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].
View source version on businesswire.com: https://www.businesswire.com/news/home/20260414145279/en/
Contacts
Media Contact:
Noa Raish
Noa@vensica.com
P:347-477-3362
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
www.businesswire.com
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
BTG Pactual Timberland Investment Group Raises US$1.24 Billion for Largest Reforestation Fund to Date[1]28.4.2026 18:00:00 EEST | Press release
BTG Pactual Timberland Investment Group (BTG Pactual TIG), one of the world’s largest timberland managers, today announced the close of fundraising for its Latin American Reforestation Strategy, reaching US$1.24 billion in commitments. This represents the largest reforestation fund closed to date,1 providing a model for large-scale reforestation and restoration that seeks to deliver durable climate impact, tangible benefits for rural communities, biodiversity outcomes, and sustainable commercial production. Global environmental organization Conservation International serves as Impact Adviser to the strategy, providing input and advice to help strengthen environmental, climate, and social outcomes related to the strategy’s conservation and restoration activities. Together, BTG Pactual TIG and Conservation International are advancing an approach that aims to conserve, restore, and reforest approximately 660,000 acres of degraded landscapes in Latin America. The approach blends commercial
Qatar Implements Relief Measures to Support Business Community28.4.2026 17:56:00 EEST | Press release
Qatar has activated a comprehensive package of support measures designed to maintain market stability and reinforce investor confidence amid evolving regional conditions. These measures, delivered through the nation’s foreign direct investment ecosystem, provide immediate financial, regulatory and operational relief to Qatar’s international business community. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428904909/en/ Infographic highlights key relief measures implemented in Qatar to support the business community (Infographic: AETOSWire) H.E. Sheikh Faisal bin Thani Al Thani, Minister of Commerce and Industry and Chairman of Invest Qatar, stated: “Qatar’s commitment to its business community is unwavering. As regional conditions continue to evolve, we remain fully focused on acting decisively to support companies operating in our market, safeguard business continuity and reinforce confidence. Our approach is grounded i
Dubai’s Medcare Hospital Becomes the World’s First to Treat an Adult Spinal Muscular Atrophy (SMA) Patient Outside the US28.4.2026 16:57:00 EEST | Press release
Medcare Royal Speciality Hospital (MRSH) in Dubai has become the world’s first hospital outside the USA, to offer a newly licensed intrathecal gene therapy - Itvisma, to adult patients with Spinal Muscular Atrophy (SMA). This one-time treatment was recently administered to a 22-year-old Egyptian patient, who was diagnosed at 18 months and confined to a wheelchair for most of his life. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428038416/en/ Dr. Vivek Mundada with Medcare multidisciplinary medical team (Photo: AETOSWire) Last year, Medcare also became the first healthcare provider globally to administer the newly licensed Itvisma to a four-year-old international SMA patient. SMA is a rare neuromuscular disease that leads to progressive muscle weakness and loss of mobility, impacting movement, breathing, and swallowing. Until now, advancements in gene therapy for SMA were primarily restricted to children under the age o
Perpetual Atomics and QSA Global Fuel the World’s First Americium-Powered Radioisotope Heater Unit Core28.4.2026 16:48:00 EEST | Press release
In a landmark achievement for international space exploration, Perpetual Atomics, QSA Global, Inc. and the University of Leicester have completed the first historical production of an Americium-fuelled Radioisotope Heater Unit (RHU) full scale core containing ceramic form americium-241 pellets in a metal containment structure. This breakthrough builds on the successful americium pelleting work in late 2025 and on two decades of experience in leading the development of americium space nuclear power systems by the Leicester team. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428027123/en/ QSA Global and Perpetual Atomics Team Born out of ENDURE, a European Space Agency (ESA) project, and part of a transatlantic collaboration, this achievement provides the steppingstones for an industrial pathway to deliver radioisotope power systems for spacecraft enabling these to survive and thrive in the most extreme environments in the
Alipay Launches AI Payment Processing Product to Help Businesses and OPCs Thrive in the Agentic Economy28.4.2026 16:47:00 EEST | Press release
Alipay today launched a new AI payment processing product that enables businesses, large and small, including One Person Companies (OPCs) in the Chinese mainland, to receive payments seamlessly when autonomous AI agents, including OpenClaw-type agents, purchase their services. This new product is being launched as AI agents are increasingly executing tasks on behalf of users, from booking travel and comparing prices, to allocating computing power and buying tokens. The product is available on Alipay’s website (https://aipay.alipay.com/). With Alipay’s AI payment processing product, small and medium-sized businesses do not need to build complex payment or settlement systems. By simply onboarding their monetizable services, businesses can reach more customers and receive payment each time an AI agent purchases their service. Bocha, an AI-powered search tool offering web search support for AI applications including DeepSeek, has already adopted Alipay’s AI payment processing product, tran
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom