#USA #San Antonio #Breast Cancer #ClearCut Medical #ClearCoast MRI

ClearCut Medical Unveils ClearCoast™ at San Antonio Breast Cancer Symposium

ClearCut Medical, a privately held company focused on innovative medical technology, has made significant strides in breast cancer surgery with its groundbreaking ClearCoast™ system. This portable MRI technology is distinguished as the first of its kind, enabling real-time, intraoperative assessments during breast-conserving surgery (BCS), which are crucial for ensuring clear surgical margins.

The Significance of Clear Margins in Breast Cancer Surgery

In breast-conserving surgery, achieving clear margins—or ensuring that no cancerous tissue remains—plays a vital role in reducing the likelihood of recurrence and the need for additional treatments. Traditional margin assessment methods often result in the need for re-excisions, which can increase patient burden and healthcare costs. The introduction of ClearCoast™ promises to transform this landscape by providing surgeons with immediate, accurate feedback during procedures.

Study Details and Findings

The recent study presented at the San Antonio Breast Cancer Symposium primarily aimed to evaluate the rate of repeat surgeries among different study groups in compliance with the SSO-ASTRO guidelines. The secondary goals were to assess the diagnostic capabilities of the ClearCoast™ system compared to the standard of care in identifying positive margins and evaluating excised breast tissue volume.

Prof. Dr. Marc Thill, the study leader and director of the Gynecology and Gynecological Oncology Clinic at Agaplesion Markus Hospital in Frankfurt, remarked, “ClearCoast™ represents a significant advancement in intraoperative margin assessment for breast-conserving surgery for both in situ and invasive breast cancers. Based on prior studies and our extensive post-marketing investigation, I am confident that this technique is ready for routine clinical use.”

The study revealed that the ClearCoast™ system achieved an impressive sensitivity of 81% and specificity of 70%, detecting 92% of Ductal Carcinoma In Situ (DCIS) compared to just 18% in the control group. Moreover, surgeons utilizing ClearCoast™ were able to remove less breast tissue while maintaining effectiveness, showing volumes of 69.9 cm³ against 153.2 cm³ in the control group, without prolonging surgical duration.

Potential for Reducing Re-excision Rates

One of the standout aspects of ClearCoast™ is its potential to reduce re-excision rates by as much as 80%. Hezi Himelfarb, CEO of ClearCut Medical, emphasized the importance of these findings, stating, “These results clearly indicate the ability of our system to alleviate the burden of re-excisions on patients, as well as the substantial costs incurred by healthcare systems, all while ensuring precision during surgery.”

The intuitive display of the ClearCoast™ system provides surgeons with images that are readily interpretable, eliminating the need for further specialist consultations and allowing for immediate decision-making on tissue removal before sending samples for pathology.

CE Approval and Future Availability

After undergoing rigorous testing, ClearCoast™ has received CE approval and is set to be distributed by pfm medical gmbh in Europe. ClearCut Medical is dedicated to enhancing the quality of cancer care through MRI technology, which is already regarded as the gold standard in cancer diagnostics. Uniquely, the ClearCoast™ integrates advanced 1.2T MRI technology trapped inside a proprietary single-use chamber, thus ensuring it remains shielded, avoiding interference with surgical instruments and fulfilling operational needs seamlessly.

The introduction of ClearCoast™ could revolutionize breast cancer surgery by allowing surgeons to identify malignancies at the margins promptly and remove any suspicious tissue in a single surgical session—streamlining the operations and significantly improving patient outcomes. With the promising results from ongoing trials, the medical community eagerly anticipates the routine adoption of ClearCoast™ into clinical practice.

Conclusion

ClearCut Medical’s ClearCoast™ system marks a promising development in the realm of breast cancer surgery. With its ability to provide real-time assessments during procedures, it holds significant potential for improving surgical outcomes and reducing the necessity for follow-up surgeries. As the medical industry continues to evolve, innovations like ClearCoast™ are pivotal in enhancing patient care and operational efficiency in surgical settings.