The Healthcare Stage I Episode 5 I ClearCut’s novel device for margin assessment of tissue excised during lumpectomy

This episode is dedicated to ClearCut medical, a commercial-stage medical device company based in Israel. The company developed the @ClearCoast™ system, a novel portable @MRI scanner for real-time intra-operative margin assessment of excised tissue during Breast Conserving Surgery (BCS), also known as lumpectomy.

With the ClearCoast™ @MRI system the surgeon can instantly identify, while at the operating room, marginal areas suspected to be malignant without special training for interpretation. As a result, there is no need to wait for pathologist assessment, and the surgeon can immediately proceed to remove the remaining malignant tissue at the margins without waiting days for a pathology report. Traditionally, the process to identify cancerous cells near the margins of a removed breast tumor involves waiting for a pathological examination, which can take several days to weeks after the surgery. Following pathological assessment, a second surgery is recommended in about 25% of cases when malignant cells are found at the margins, leading to significant costs, inefficiencies in the healthcare system, and most importantly, added emotional distress for patients.

The company launched the ClearCoast™ system in Europe in 2022 and started sales in 2023. They are currently working towards an FDA approval. Up until now ClearCut raised $23M and is now planning to raise $15M. The proceeds will be used for supporting sales in Europe, attaining FDA approval and exploring the system in additional indications.

 

This episode is available at The Healthcare Stage YouTube channel,  Spotify and Apple podcast.