SamanTree Medical, a leader in oncologic surgical imaging innovation, today announced promising results from the SHIELD study, which will be presented by researchers on Dec. 12 at the 2024 San Antonio Breast Cancer Symposium (SABCS). The findings show that the Histolog® Scanner, a confocal laser microscope, reduced reoperation rates during breast-conserving surgery (BCS) from 30% to 10%, representing a 67% reduction. The innovative imaging device also demonstrated significant accuracy in detecting positive margins with high sensitivity and specificity.
“The results of the SHIELD study impressively demonstrate a proof-of-concept of the Histolog Scanner in patients with breast cancer and also confirm the non-interventional POLARHIS study,” said Professor Michael Patrick Lux, M.D., principal investigator of the SHIELD study and Head of the Department of Gynecology and Obstetrics at St. Vincenz Hospital, Paderborn, Germany. “The data are absolutely relevant for clinical care, as the system can reduce the re-section rate in a clinically relevant and significant way, thus optimizing oncological safety, cosmetics, and the economic aspects of care.”
The prospective study, conducted at St. Vincenz Hospital, evaluated the impact of the Histolog Scanner on reducing reoperation rates during BCS. Fifty patients with invasive breast cancer and/or ductal carcinoma in situ (DCIS) were enrolled, and reoperation rates were compared to historical data from the POLARHIS study, a retrospective observational study performed at the same breast center by the same surgical team using standard intraoperative margin assessment techniques.
The results showed a dramatic reduction in reoperation rates from 30% in the POLARHIS study to 10% in the SHIELD study, representing a 67% improvement when the Histolog Scanner was used. Moreover, the Histolog Scanner outperformed standard techniques by achieving a sensitivity of 80.9% and a specificity of 99.5% for positive margin detection, compared to the combined sensitivity of 17.4% and specificity of 97.3% achieved with standard methods, as seen in the SHIELD study.
“These outstanding results underscore the potential of the Histolog Scanner to enhance oncologic surgical outcomes significantly,” said Olivier Delporte, CEO of SamanTree Medical. “By enabling real-time, high-resolution tissue microstructure assessments during BCS, our technology addresses a critical unmet need, reducing reoperation rates and improving patient outcomes.
“With the recent FDA clearance, we are pleased to make this groundbreaking technology available to surgeons throughout the U.S. The Histolog Scanner sets a new standard for precision and care in oncologic surgery, marking a significant milestone in our mission to transform oncologic surgery and improve patient care globally,” continued Delporte.
