Real-time DW-MRI system
for excised breast tissue
the Problem
Doctors do not know in real-time whether they excised the entire cancerous tissue (i.e. left cancer residuals).
The global average re-excision rate (after analysis of the margin by pathologists) is estimated to be around 25% in Breast-Conserving Surgery.
These situations often require additional surgery, thereby creating massive avoidable cost burdens and loss of efficiency for the healthcare system together with enormous emotional distress for the patients.
A breakthrough new form factor enabling the use of MRI, the most trusted soft tissue imaging modality, now in the operating room, in real time. Highly accurate imaging of tumor margins, without changing any surgeon technique, without adding time to the procedure, and intuitively simple interpretation without the support of pathology or radiology.
Photographic image of a freshly excised, inked tumor (left) and corresponding ClearCoast™ diffusion map (right). The color code represents the degree of diffusion restriction. The red arrow points to an area of highly restricted diffusion, possibly malignant tissue, on both images. Diffusion-weighted magnetic resonance imaging (dw-MRI)
The Solution
- ClearCoast™ is an innovative, portable, DW-MRI system (Diffusion-Weighted Magnetic Resonance Imaging) that performs real-time intraoperative margin assessment in excised breast tumors during Breast Conserving Surgery (BCS).
- The ClearCoast™ system is considered a near-patient In-Vitro Diagnostic (IVD) system that performs ex-vivo scans outside the patient’s body.
- The system provides breast cancer surgeons with the ability to examine and indicate the margin status of the excised breast tissue and perform additional corrections during the surgical procedure, to reduce the re-excision rate
- the ClearCoast™ is ISO Certified and CE-Marked.