Periodic Reporting for period 1 - MiWEndo (REVOLUTIONARY ELECTROMAGNETIC ENDOSCOPY ACCESSORY TO AUTOMATIZE POLYP DETECTION)
Berichtszeitraum: 2020-10-01 bis 2021-09-30
Globally, 1.9 million new cases of colorectal cancer (CRC) are diagnosed annually, and the five-year survival rate is 64%. Colonoscopy is the gold standard for CRC detection, but it has several limitations. Consequently, we face the lack of an efficient, accurate and objective method to early diagnose CRC. To solve this problem, MiWEndo Solutions is developing MiWEndo, a medical accessory that complements colonoscopy with microwave imaging technology. The objective of this project is to clinically validate MiWEndo, perform the submission of the required documentation to obtain the CE Mark and FDA approval and begin its industrialization.
Significant progress has been achieved since the start of the project. We have defined the requirements for the industrialization of MiWEndo, we have optimized the detection algorithm according to the pre-clinical tests and we have designed and validated the manufacturing process for first series. The next step envisaged in the project plan is to clinically validate MiWEndo at the Hospital Clínic de Barcelona. To do so, the whole documentation concerning the clinical trials is being prepared in accordance with good clinical practices for medical devices. Moreover, we are also following all the regulatory procedures envisaged in the project plan with the final aim to obtain the CE Mark and FDA Approval. A management of all technical, quality, safety and ethical issues is being performed to ensure reaching the project key objectives. The progress of the project has been communicated through the company’s website and its blog. Regarding scientific dissemination, two scientific articles have been submitted for publication.
The expected results of the project are to clinically validate MiWEndo and perform the submission to obtain the CE Mark and FDA Approval for its commercialization. MiWEndo will democratize high-quality colonoscopies by automating polyp detection thanks to the emission of an alarm when a polyp is detected. MiWEndo will benefit patients, hospitals and healthcare professionals that will dispose of a tool that will improve their current protocols and patient outcomes, and lastly, the public health systems that will save money and time using MiWEndo. MiWEndo’s socio-economic impact quantified with SROI method is 9.8. Social value is nearly 10 times higher than the investment needed. Our main goal is to prevent the 8% of colorectal cancers are originated by poor diagnosis, saving 87,000 lives/year in Europe.