MiWEndo Solutions Initiates Final Stage of Pivotal Trial for Microwave-Based Colonoscopy System

Company advances clinical validation of its add-on technology designed to support lesion detection through real-time microwave sensing and acoustic alerts during colonoscopy

Barcelona, Spain, June 24th MiWEndo Solutions today announced the initiation of the second and final stage of its pivotal clinical trial evaluating the company’s microwave-based colonoscopy system, a novel add-on technology designed to complement standard visual colonoscopy by providing real-time, non-visual information during the procedure.

The milestone represents a key step in MiWEndo’s regulatory and clinical validation strategy as the company works to bring a new sensing modality into endoscopy.

MiWEndo’s system combines a single-use accessory attached to the distal tip of a conventional colonoscope with an external processing unit positioned in the endoscopy rack. During the procedure, the accessory emits microwave signals toward the surrounding tissue and measures how those signals behave after interacting with it, including the reflected waves received by the system. These microwave responses are then analyzed in real time to identify signal patterns that may be associated with the presence of lesions.

When MiWEndo detects a signal pattern of interest, the system generates an acoustic alert, prompting the physician to reinspect the area using conventional endoscopic vision. The technology is designed to support, not replace, the physician’s clinical judgment by adding a complementary sensing layer beyond what can be seen on the endoscopy screen.

“Reaching the final stage of our pivotal trial is an important validation step for the company and for the broader vision behind our technology,” said Tomás Escuin, CEO of MiWEndo Solutions. “Our goal is to help endoscopy evolve from a purely visual procedure toward a more data-driven one, starting with better lesion detection and building toward future characterization capabilities.”

From a technical perspective, MiWEndo has been designed to introduce microwave sensing into colonoscopy without disrupting the standard procedure. The system is intended to work alongside existing colonoscopy infrastructure, preserving the physician’s optical view while adding real-time information based on the interaction between microwave signals and tissue.

“One of the most important engineering challenges has been to make a highly complex sensing technology feel simple in the hands of the clinical team,” said Marta Guardiola, CTO of MiWEndo Solutions. “MiWEndo emits microwave signals, captures their response after interacting with tissue, and transforms that information into a real-time alert that can be easily interpreted during the procedure. This final stage of the study is an opportunity to continue validating not only the performance of the technology, but also its integration into real colonoscopy workflow.”

The clinical need remains significant. Despite advances in endoscopic imaging and software-based detection tools, colorectal lesions can still be missed during colonoscopy, particularly when they are flat, subtle, or located in areas that are difficult to assess visually. MiWEndo’s approach is based on the premise that new diagnostic information may be needed to complement what physicians can see.

“Colonoscopy is a powerful procedure, but it remains dependent on what can be visually identified during the examination,” said Gloria Fernández-Esparrach, Medical Director of MiWEndo Solutions. “Because the system can generate an acoustic alert before a lesion appears on the endoscopy screen, it has the potential not only to improve detection but also to reduce the cognitive burden of maintaining constant visual attention throughout the procedure. The generation of robust clinical evidence is essential to understand and demonstrate that value.”

MiWEndo has previously demonstrated safety and feasibility in early clinical work and continues to build scientific momentum through conference presentations and peer-reviewed publications. The company recently presented at Digestive Disease Week® 2026 and continues to expand the evidence base supporting its microwave-based approach.

Founded in Barcelona, MiWEndo is developing a platform technology with initial applications in colorectal endoscopy and future potential across broader gastrointestinal indications. The company’s differentiated approach is designed to combine clinical relevance, workflow compatibility and long-term scalability.