REVOLUTIONARY ELECTROMAGNETIC ENDOSCOPY ACCESSORY TO AUTOMATIZE POLYP DETECTION

Project Information

MiWEndo

Grant agreement ID: 960251

DOI

10.3030/960251

Project closed

EC signature date 21 September 2020

Start date 1 October 2020

End date 31 December 2023

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 2 077 043,75

EU contribution

€ 1 453 930,63

Coordinated by

MIWENDO SOLUTIONS SL
Spain

Periodic Reporting for period 2 - MiWEndo (REVOLUTIONARY ELECTROMAGNETIC ENDOSCOPY ACCESSORY TO AUTOMATIZE POLYP DETECTION)

Reporting period: 2021-10-01 to 2023-12-31

Summary of the context and overall objectives of the project

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. Our strategic objectives focused on achieving TRL7 readiness for market deployment, elevated to TRL8 after safety and performance validation. Pursuing regulatory approval and Class IIa classification, alongside effective project management and communication, formed a clear roadmap.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In recent months, significant strides have been made in the project. The MiWEndo accessory prototype was designed, manufactured, and verified. A clinical trial assessed its effectiveness in detecting colorectal polyps. Regulatory milestones were achieved, including ISO 13485 implementation, CE mark progress, Phase I trial completion, and FDA DeNovo pathway approval. Plans are underway for device introduction in 2024. Additionally, a communication plan has been developed for wider dissemination of project outcomes. This progress reflects a dedicated effort to advance colorectal health technology.
The clinical trials have shown that microwave-based colonoscopy is safe and effective, achieving 100% cecal intubation and successful polyp identification. No adverse events occurred, and patient discomfort was minimal. While technical challenges were noted, the method holds promise for polyp detection. Further algorithm optimization with clinical data is advised.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

In essence, our solution introduces a novel microwave-based contrast mechanism in endoscopy. MiWEndo offers faster and more accurate diagnoses, benefiting an aging population facing increasing colorectal cancer rates. It levels detection rates among endoscopists, regardless of expertise, reducing uncertainty in medical decisions. Additionally, its adoption aligns with trends, providing visibility and prestige. The device also provides cost-effective, permanent treatment options, cutting both direct and indirect costs. By addressing current protocol inefficiencies, it streamlines treatments and offers reimbursement options, making it a significant advancement in colorectal care.
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.

MiWEndo's Team