REVOLUTIONARY ELECTROMAGNETIC ENDOSCOPY ACCESSORY TO AUTOMATIZE POLYP DETECTION

Informations projet

MiWEndo

N° de convention de subvention: 960251

DOI

10.3030/960251

Projet clôturé

Date de signature de la CE 21 Septembre 2020

Date de début 1 Octobre 2020

Date de fin 31 Decembre 2023

Financé au titre de

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coût total

€ 2 077 043,75

Contribution de l’UE

€ 1 453 930,63

Coordonné par

MIWENDO SOLUTIONS SL
Spain

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

Période du rapport: 2021-10-01 au 2023-12-31

Résumé du contexte et des objectifs généraux du projet

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.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

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.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

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