VERIFY CLEAR MARGINS
- LS BioPath has developed and clinically tested three generations of the ClearEdge imaging device. The 3rd generation product is CE Mark certified and ready for sales in Europe. The sterilization process of ClearEdge head and drape has been established and its validation and verification has been completed.LS BioPath successfully demonstrated ClearEdge’s proof-of-concept and feasibility on freshly excised breast tissue from more than 180 patients. These IRB approved clinical studies were conducted in a pathology lab setting in 3 hospitals in the US. The device is found to be safe and efficacious, demonstrating a high potential to reduce the re-operation rate. The clinical efficacy of the ClearEdge imaging device has been also tested by surgeons during surgery and was shown to successfully compared to permanent section pathology results with margins up to 2 mm deep.
ClearEdge imaging device is currently used by surgeons under clinical studies that use the device in the operating room during surgery. To date, ClearEdge’s clinical study results suggest that it will outperform other predicate imaging devices based on X-ray and/or Ultrasound with an intended use to determine sufficiency of excision.