PathoS’ ClearView

Patients undergoing Breast Conserving Surgery (BCS) have a one in five chance of requiring a reoperation because surgeons cannot determine if the entire tumor has been removed. Surgeons rely on pathologists to assess margins through histological evaluation. Due to the inherent mechanical properties of breast tissue, this cannot be done before the surgery ends. ClearView allows pathologists to produce high-quality histology slides within minutes, enabling intra-operative assessment of tumor margins. This could prevent up to 66,000 unnecessary BCS procedures in the U.S. annually.

Using ClearView, a typical surgery will require $120 of disposables, covered by insurance companies under existing reimbursement codes. According to FDA regulations, ClearView is a Class I device, the lowest-risk device category. This affords a quick time to market, with minimal testing and regulatory requirements. Our team is collaborating closely with leading clinicians from the Johns Hopkins Breast Center, who are excited about our initial results.