Lumicell, Inc. today announced the publication of clinical data demonstrating rapid and direct identification of residual tumor in the lumpectomy cavities of breast cancer patients during surgery with the LUM System. These results, which were published by investigators at Massachusetts General Hospital in the July 2018 issue of Breast Cancer Research and Treatment further support Phases 2 data presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2017 showing complete and instantaneous detection of residual cancer in the tumor cavity and the ability to detect all breast cancer sub-types with the integrated LUM system. The LUM System integrates the immuno- and cancer-targeted optical agent LUM015, the Lumicell handheld imaging device and decision software to detect cancer cells in real-time during surgery.
“A cavity-based margin assessment that provides direct identification of residual tumor in the patient’s surgical cavity would overcome many of the limitations of current specimen-based approaches," said Barbara L. Smith, MD, PhD. Director of the Breast Program at Massachusetts General Hospital and Professor of Surgery at Harvard Medical School. “The LUM System was sensitive for distinguishing benign and malignant breast tissue in tumor specimens and most importantly, could identify islands of residual tumor against a background of normal tissue in lumpectomy cavity walls and tissue specimen, thereby avoiding the problem of correlating sites of tumor on an excised lumpectomy surface with the location of residual tumor in the cavity wall.”
In the paper titled ‘Real-time interoperative detection of residual breast cancer in lumpectomy cavity walls using a novel cathepsin-activated fluorescent imaging system’ Barbara Smith and colleagues from Massachusetts General Hospital demonstrate that the LUM System provided high sensitivity for tumor detection, rapid assessment of the entire lumpectomy cavity and precise identification of sites of tumor in the lumpectomy cavity wall with no adverse effects. In addition, no significant background autofluorescence was detected in benign human breast tissue supporting the use of a fluorescence-based strategy for lumpectomy margin assessment.
“With current histopathology-based margin assessment technology, 20-40% of breast cancer lumpectomy patients have positive surgical margins that require a second surgery to achieve clear margins,” said Kelly Londy, Chief Executive Officer of Lumicell. “In contrast, the LUM System can directly identifying sites of residual tumor for excision and can be used repeatedly during that first surgery until no residual tumor signal remains.”
“Our colleagues at Massachusetts General Hospital have demonstrated that the LUM Imaging System can quickly and directly identify sites of residual tumor for excision allowing complete imaging of an entire lumpectomy cavity in a minute or less as compared to other imaging devices in development which can only assess a fraction of an excised lumpectomy specimen surface or current histopathology assessment which takes several days,” said Felix Geissler MD, PhD, Chief Medical Officer of Lumicell.
About the LUM System
The LUM System was designed by leading engineers and scientists in partnership with surgeons from academic and medical centers as an integrated system with three unified components: drug, device and decision software to guide cancer surgeons in the detection and removal of cancer cells in real-time during surgery. The LUM System includes three integrated components: a fluorescent optical contrast agent that is cancer- and immuno-activated, a novel hand-held imaging device that instantly scans the cavity walls to view the fluorescent cells with single-cell detection, and proprietary decision software that displays the image instantly on a monitor to guide surgical removal of cancerous tissue.
About Lumicell, Inc.
Lumicell is a technology leader in the field of image-guided cancer surgery. The company is developing a novel system that enables real-time detection of tumor tissue in patients so that no cancer cells are left behind during surgery. The company’s LUM System has unprecedented ability to see and remove cancer cells remaining in the surgical cavity – beyond the margin of the specimen – and has the potential to significantly improve surgical outcomes and reduce healthcare costs by eliminating the need for repeat surgeries. Lumicell is investigating the LUM System in patients undergoing surgery for breast cancer, prostate cancer, colorectal, esophageal and pancreatic cancers. Additional future indications are planned to include surgeries for lung, ovarian, and brain cancers. For more information, please visit www.lumicell.com.
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