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Lumicell Awarded Direct Phase II Small Business Innovation Research (SBIR) Grant from the National Cancer Institute to Conduct Multi-Center Pivotal Study

Funding will Support Trial of the Lumicell Margin Assessment System (MAS) in Breast Cancer Surgery

Wellesley, Mass., August 9, 2016 – Lumicell, a leader in the field of image-guided surgery, today announced that the National Cancer Institute (NCI) has awarded the Company a Phase II Small Business Innovation Research (SBIR) grant to fund a prospective multi-center pivotal study of the Lumicell Margin Assessment System (MAS) in breast cancer surgery. The company aims to demonstrate that the investigational optical agent and handheld illumination device empowers surgeons to increase complete resection rates and decrease re-excisions in breast cancer surgery. The second part of a two-stage feasibility study is currently being conducted with Massachusetts General Hospital Cancer Center as part of an ongoing collaboration. Additional collaborators for the pivotal study include: Duke University Medical Center, The University of Texas MD Anderson Cancer Center, Stanford Cancer Institute, and Yale Cancer Center/Smilow Cancer Hospital at Yale New Haven.

“We are very pleased to receive this SBIR grant from NCI,” said W. David Lee, CEO of Lumicell. “This SBIR grant will allow us, in collaboration with several top cancer institutions, to generate the data required to submit our marketing application to the FDA. We believe that Lumicell’s Margin Assessment System will help to improve care for breast cancer patients while potentially lowering overall healthcare costs once it is made available for broader use.”

Every year more than 60,000 women undergoing lumpectomy must endure re-excision due to positive margins discovered on final histopathology examination. Second surgeries increase discomfort, add emotional and cosmetic expenses to the patient, and may cost the healthcare system close to $1B annually.

To address this unmet need, Lumicell has developed the Lumicell MAS which consists of a protease-activated fluorescent optical contrast agent (LUM015) and handheld illumination system with integrated software for exquisite single-cell detection (LUM 2.6 Device). LUM015 uniquely targets the physiology of the tumor margin (tumor cells and host response) which does not rely on binding events to specific cellular markers, and the illumination system captures the fluorescence emission of the agent in real time to guide the surgeon. Initial studies in breast cancer have demonstrated safety, with zero adverse events, and complete detection of residual cancer in humans with minimal impact to surgical workflow.

About Lumicell, Inc.

Lumicell illuminates cancer and other diseased tissues at the molecular level, enabling physicians to take action in real time during surgeries to improve patient outcomes. The company’s lead product, the Lumicell Margin Assessment System (MAS), is in late-stage development for breast cancer surgery. It features an investigational optical agent and a handheld device that enable cancer surgeons to see and remove cancer cells in real time during operations. The Lumicell MAS was designed and developed by MIT engineers in partnership with leading breast cancer surgeons to fit seamlessly within the existing surgical workflow. The Lumicell MAS is also under investigation for colorectal cancer, Barrett’s esophagus and brain metastases.