Revolutionary Advances in Breast Cancer Surgery with ClearCoast™

Transforming Breast Cancer Surgery with ClearCoast™

ClearCoast™ stands out as a pioneering Portable MRI system, delivering real-time, objective, and quantitative data crucial for assessing margin malignancy during Breast Conserving Surgery.

Overview of ClearCoast™

ClearCut Medical has developed ClearCoast™, a revolutionary portable MRI system that allows for immediate intraoperative margin assessment of excised breast tumors during Breast Conserving Surgery (BCS). Clear margins are vital for minimizing the risk of recurrence and reducing the necessity for further treatment.

Study Highlights and Results

The recent study primarily aimed to analyze retreatment proportions within and across various study groups, aligning with the SSO-ASTRO guideline. The secondary goal assessed the diagnostic capabilities of ClearCoast™ compared to the Standard of Care (SoC) in detecting positive margins intraoperatively, alongside evaluating the total excised breast tissue volume.

Prof. Dr. Marc Thill, director of Gynecology at the Agaplesion Markus Hospital, noted, "ClearCoast™ represents the most promising technique for intraoperative margin assessment in breast conserving surgery involving both in situ and invasive breast cancer." He expressed confidence in the technique's readiness for routine clinical use.

ClearCoast™ showcased a sensitivity of 81% and specificity of 70%, detecting 92% of DCIS cases compared to only 18% in the control group. Additionally, surgeons reported removing less breast tissue (69.9 cm³ versus 153.2 cm³) without extending the surgical duration. Remarkably, ClearCoast™ hinted at an 80% reduction in re-excision rates.

Implications for Patients and Healthcare Costs

Hezi Himelfarb, CEO of ClearCut Medical, emphasized the system's potential to alleviate the burden of re-excision for patients, while also lowering healthcare costs—all without compromising precision for time. The intuitive display allows surgeons to interpret images immediately, eliminating reliance on additional specialist input.

CE Mark Approval and Distribution

ClearCoast™ has received CE Mark approval and is currently marketed in Europe by pfm medical gmbh, underscoring its global reach and recognition in the medical community.

About ClearCut Medical

ClearCut Medical is committed to advancing cancer care through innovative MRI technology, regarded as the gold standard in cancer diagnostics. The ClearCoast™ system incorporates a powerful 1.2T MRI to assess lumpectomy specimen margins encased in a specialized disposable chamber. Completely shielded, it operates without specialized facility requirements or interference with other operating room instruments, providing real-time quantitative insights displayed in an intuitive topographic format.

Surgeons can swiftly pinpoint questionable margins and remove additional tissue before sending specimens to pathology, significantly curbing re-excision rates. The incorporation of state-of-the-art proprietary MRI technology allows for precise real-time tissue margin assessment, with clinical trials revealing high sensitivity and specificity alongside potential re-excision reductions of up to 80%.

Contact:
Hezi Himelfarb
For inquiries, please reach out via email.

Frequently Asked Questions

What is ClearCoast™?

ClearCoast™ is a portable MRI system that provides real-time information for assessing margins during Breast Conserving Surgery.

What are the benefits of using ClearCoast™?

This system aids in achieving clear margins, potentially reducing re-excision rates and improving patient outcomes in breast cancer surgery.

How does ClearCoast™ compare to traditional methods?

ClearCoast™ has shown higher sensitivity and specificity in detecting positive margins compared to standard diagnostic methods.

Who developed ClearCoast™?

ClearCut Medical, a company specializing in cancer care technologies, developed the ClearCoast™ system.

Where is ClearCoast™ available?

ClearCoast™ has received CE Mark approval and is currently sold in Europe through pfm medical gmbh.

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