SamanTree Medical, a leader in oncologic surgical imaging innovation, announced promising results from the SHIELD study, to be presented at the 2024 San Antonio Breast Cancer Symposium (SABCS) on Dec. 12. The findings reveal that the Histolog® Scanner, a confocal laser microscope, reduced reoperation rates for breast-conserving surgery (BCS) by 67%, from 30% to 10%. Additionally, the device demonstrated high accuracy in detecting positive margins, with impressive sensitivity and specificity.
SamanTree Medical, a leader in oncologic surgical imaging innovation, announced groundbreaking results from the SHIELD study, presented at the 2024 San Antonio Breast Cancer Symposium (SABCS). The study highlights the effectiveness of the Histolog® Scanner, a confocal laser microscope, in reducing reoperation rates during breast-conserving surgery (BCS). The findings demonstrated a 67% reduction in reoperation rates, from 30% in a historical study (POLARHIS) to just 10% with the Histolog Scanner. Additionally, the device showed remarkable accuracy in detecting positive margins with a sensitivity of 80.9% and specificity of 99.5%, significantly outperforming standard techniques.
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, emphasized the significance of these results. “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,” he said. “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 SHIELD study, a prospective trial conducted at St. Vincenz Hospital, enrolled 50 patients with invasive breast cancer and/or ductal carcinoma in situ (DCIS). The objective was to assess how the Histolog Scanner impacted reoperation rates during BCS. The reoperation rates observed in this study were compared to the POLARHIS study, a retrospective observational study performed at the same institution using standard intraoperative margin assessment techniques. The results were striking: with the Histolog Scanner, reoperation rates were reduced to 10%, a 67% improvement compared to the 30% reoperation rate in the POLARHIS study.
The Histolog Scanner also outperformed standard margin detection methods in terms of sensitivity and specificity. The device achieved a sensitivity of 80.9% and a specificity of 99.5% for detecting positive margins, while standard techniques showed a combined sensitivity of just 17.4% and specificity of 97.3%. These findings further underline the Histolog Scanner’s ability to significantly improve the precision and outcomes of breast-conserving surgery.
Olivier Delporte, CEO of SamanTree Medical, highlighted the potential impact of these results on oncologic surgical outcomes. “These outstanding results underscore the potential of the Histolog Scanner to enhance oncologic surgical outcomes significantly,” Delporte said. “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 recent FDA clearance, SamanTree Medical is now able to offer the Histolog Scanner to surgeons across the U.S. The approval marks a key milestone in the company’s mission to improve surgical precision and patient care globally. “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,” Delporte added.
About SamanTree Medical
Headquartered in Liège, Belgium, with U.S. regional headquarters in Boston, SamanTree Medical is committed to enhancing oncologic surgery with innovative imaging solutions. Its flagship product, the Histolog Scanner, uses cutting-edge massive parallel confocal microscopy technology, offering real-time, high-resolution imaging of fresh tissue samples during surgery. This advanced device allows surgeons to visualize large tissue areas with exceptional clarity and precision, providing valuable information for intraoperative decision-making. Founded in 2010, SamanTree Medical continues to advance surgical outcomes through innovative imaging technology based on research from the École Polytechnique Fédérale de Lausanne (EPFL) in Switzerland.
