ClearCut Medical Announces Results of a Post Marketing ClearCoast™ Study Presented at the San Antonio Breast Cancer Symposium
ClearCoast™ is the only Portable MRI system that provides real time intraoperative objective, quantitative, and immediately actionable information on margin malignancy assessment during Breast Conserving Surgery
REHOVOT, Israel, Jan. 8, 2025 /PRNewswire/ -- ClearCut Medical, a commercial stage privately held company, developed the ClearCoast™, the first and only portable MRI system that performs real-time intraoperative margin assessment of excised breast tumors during Breast Conserving Surgery (BCS). Clear margins are critical in order to minimize the risk of recurrence and the need for retreatment.
The study aimed primarily to compare retreatment proportion within and between study groups with accordance to the SSO-ASTRO guideline. The secondary endpoint compared ClearCoast™ and the Standard of Care (SoC) diagnostic ability to detect positive margins intraoperatively, as well as the total excised breast tissue volume between study groups.
"ClearCoast™ is the most promising technique currently available for intraoperative margin assessment in breast conserving surgery of in situ and invasive breast cancer" said Prof. Dr. Marc Thill, director of the Department of Gynecology and Gynecological Oncology at the Agaplesion Markus Hospital in Frankfurt, Germany and PI of the study. "Following previous trials and after using the technique in our interventional post-marketing ClearCoast™ study, I am convinced that the technique is ready for clinical routine."
ClearCoast™ demonstrated a sensitivity of 81% and a specificity of 70%. It detected 92% of the DCIS compared to 18% in the control group. Moreover, the surgeon removed less breast tissue (69.9cm3 vs. 153.2 cm3) without increasing the duration of the procedure. Lastly, ClearCoast™ showed a potential for an 80% reduction in re-excisions.
"These results emphasize its potential in reducing the burden of re-excision for patients and the Healthcare costs without trading off time for precision", said Hezi Himelfarb, CEO of ClearCut Medical. "The intuitive display of the system produces images that can be immediately interpreted by the surgeon, without the need for other specialists."
The system received CE Mark approval and is being sold in Europe by pfm medical gmbh.
About Clear-Cut Medical
Clear-Cut Medical is dedicated to improve the quality of care for cancer patients using MRI, the trusted gold-standard imaging modality for cancer diagnostics.
The company developed the ClearCoast™, a powerful 1.2T MRI system used to assess the margin of the lumpectomy specimen that is encased in a proprietary disposable chamber inserted into the system. It is fully shielded with no special facility requirements or interference with other instruments in the OR, and provides real-time quantitative information in an intuitive topographic display that is interpreted by the surgeon with no need for additional experts.
The surgeon can instantly identify marginal areas suspected to be malignant and proceed to remove immediately additional tissue before sending the specimen to pathology and by this, reduce significantly the re-excision rate.
The system utilizes state-of-the-art proprietary MRI technology for real time tissue margin assessment. Clinical trial results in BCS have shown high sensitivity and specificity and a potential reduction in re-excision of up to 80%.
Contact:
Hezi Himelfarb
hezi@clrcut.com
Photo - https://mma.prnewswire.com/media/2589546/ClearCoast_MRI_System.jpg
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