REVOLUTIONARY ELECTROMAGNETIC ENDOSCOPY ACCESSORY TO AUTOMATIZE POLYP DETECTION

Informazioni relative al progetto

MiWEndo

ID dell’accordo di sovvenzione: 960251

DOI

10.3030/960251

Progetto chiuso

Data della firma CE 21 Settembre 2020

Data di avvio 1 Ottobre 2020

Data di completamento 31 Dicembre 2023

Finanziato da

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Costo totale

€ 2 077 043,75

Contributo UE

€ 1 453 930,63

Coordinato da

MIWENDO SOLUTIONS SL
Spain

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

Periodo di rendicontazione: 2021-10-01 al 2023-12-31

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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