ClearCut Medical's ClearCoast™ Breakthrough in Breast Cancer Surgery Improvements
ClearCut Medical's Innovations in Breast Cancer Surgery
ClearCut Medical, a pioneering company in the medical field, has unveiled significant findings from a recent study on their innovative portable MRI system, ClearCoast™, at the San Antonio Breast Cancer Symposium. This groundbreaking device is the first of its kind to offer real-time, objective assessments of tumor margins during breast-conserving surgery (BCS), aiming to enhance surgical outcomes and minimize the need for further procedures.
The Importance of Clear Margins
Achieving clear margins is crucial in breast cancer surgeries. It is essential for reducing the chances of cancer recurrence and limiting the extent of rework necessary post-surgery. ClearCoast™ addresses this by enabling immediate insights into the malignancy status of removed breast tissue during operations.
Study Overview
The study primarily focused on comparing reoperation rates between different patient cohorts according to the SSO-ASTRO guidelines. Secondary evaluations compared the diagnostic capabilities of ClearCoast™ against standard care practices in detecting positive margins intraoperatively and assessed the total volume of breast tissue removed during surgeries.
Marc Thill, head of the gynecology and gynecological oncology department at Agaplesion Markus Hospital in Frankfurt, Germany, and the lead researcher, remarked, "ClearCoast™ is the most promising technique available for intraoperative margin assessment in both in situ and invasive breast cancer surgeries. Based on previous trials and our current post-marketing intervention study, I firmly believe this technology is ready for clinical implementation."
Results of the Study
The clinical evaluation demonstrated an impressive sensitivity of 81% and a specificity rate of 70%. ClearCoast™ successfully identified 92% of Ductal Carcinoma In Situ (DCIS) cases compared to just 18% in the control group. Moreover, patients undergoing surgery with ClearCoast™ had less tissue excised (69.9 cm³ versus 153.2 cm³) without extending surgery duration. Most notably, the use of ClearCoast™ suggested a remarkable potential to decrease re-excision rates by up to 80%.
Hezi Himelfarb, CEO of ClearCut Medical, stated, "These results showcase ClearCut Medical's potential to alleviate the burden of re-excision for patients and the associated healthcare costs, all without compromising precision or surgical time. The intuitive display of the system allows surgeons to instantly interpret images without needing additional specialist input."
Technological Advancements
ClearCoast™ utilizes proprietary MRI technology designed for real-time assessment of tissue margins. With its innovative approach, the system provides quantitative data presented in a topographically intuitive manner, facilitating the surgical decision-making process. It allows surgeons to quickly identify areas of concern and excise additional tissue before sending samples to pathology, thereby significantly improving patient outcomes.
Future Outlook
Having received CE marking approval, ClearCoast™ is now available for sale across Europe through pfm medical gmbh. ClearCut Medical remains committed to enhancing cancer patient care through advanced imaging solutions, with ClearCoast™ standing as a testament to their innovative spirit in revolutionizing breast cancer surgery. Overall, the introduction of this system could lead to significant advancements in surgical practices, supporting healthcare professionals in their mission to provide the best possible care for their patients.
For inquiries, please contact Hezi Himelfarb at [email protected]