"Despite best efforts, achieving microscopically-clear surgical margins in the operating room has been a persistent challenge," said Dune Medical CEO, Bill Densel. "We are extremely pleased with the positive outcome of the study. These results confirm that our breakthrough technology can benefit patients by providing physicians with the ability to detect cancerous tissues during procedures and immediately react."

Pivotal Study Details

664 women aged 18 years and older, histologically diagnosed with carcinoma of the breast, with non-palpable malignant lesions requiring image guided localization, and undergoing lumpectomy surgery at one of 21 sites in the U.S. and Israel, were enrolled in the study.  Of these women, 596 were randomized in the operating room to one of two evenly distributed groups, either device or control.  In the device group, the MarginProbe System was used in addition to standard of care methods to measure each margin of the excised lumpectomy specimen. If the device registered a positive reading, additional tissue was immediately resected from the breast cavity corresponding to the positive margin. All tissue, in both groups, underwent intraoperative specimen imaging before being sent to routine pathology per standard of care.

A primary endpoint of the study was Complete Surgical Resection (CSR), the rate of patients with one or more positive margins (< 1mm) on the lumpectomy specimen, as determined by histology, in whom all positive margins were identified and immediately resected. In the device arm, the rate of CSR was 72 percent>

No safety concerns were noted in the study.  Events were similar across both study groups.

SOURCE Dune Medical Devices, Inc.