REVOLUTIONARY ELECTROMAGNETIC ENDOSCOPY ACCESSORY TO AUTOMATIZE POLYP DETECTION

Projektinformationen

MiWEndo

ID Finanzhilfevereinbarung: 960251

DOI

10.3030/960251

Projekt abgeschlossen

EK-Unterschriftsdatum 21 September 2020

Startdatum 1 Oktober 2020

Enddatum 31 Dezember 2023

Finanziert unter

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Gesamtkosten

€ 2 077 043,75

EU-Beitrag

€ 1 453 930,63

Koordiniert durch

MIWENDO SOLUTIONS SL
Spain

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

Berichtszeitraum: 2021-10-01 bis 2023-12-31

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

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.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

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.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

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