Study: SamanTree Medical’s Scanner Reduces Reoperation Rates for Breast-Conserving Surgery

SamanTree Medical is sharing promising results from a study showing its Histolog Scanner reduced reoperation rates during breast-conserving surgery (BCS) by 67%. The a confocal laser microscope also accurately detected positive margins with high sensitivity and specificity.

“The results of the SHIELD study 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., study principal investigator and head of the Department of Gynecology and Obstetrics at St. Vincenz Hospital in Paderborn, Germany. “The data are 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 SHIELD 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 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 results underscore the potential of the Histolog Scanner to enhance oncologic surgical outcomes significantly,” SamanTree Medical CEO Olivier Delporte stated. “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 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.”

Headquartered in Liège, Belgium, with U.S. regional headquarters in Boston, SamanTree Medical SA is dedicated to improving oncologic surgery through innovative imaging solutions. Its flagship product, the Swiss-developed Histolog Scanner, features massive parallel confocal microscopy, a technology that expands the imaging field up to 40,000 times larger than standard confocal microscopy. The device enables surgeons and pathologists to visualize large, fresh tissue samples in real-time with exceptional resolution and accuracy, making it ideally suited for intraoperative environments in oncologic surgery. The company was founded in 2010 based on innovations from the École Polytechnique Fédérale de Lausanne (EPFL), a Swiss research institute renowned for engineering and technological advancements.