Technology Overview

About the Lumicell Margin Assessment System (MAS)

 

The Lumicell MAS was designed by leading engineers and scientists in partnership with leading breast cancer surgeons to fit seamlessly within the existing surgical workflow. The Lumicell MAS is in late-stage development for patients undergoing surgery for breast cancer and also under investigation for colorectal, esophageal cancers and brain metastases.

 

LUM015 is an optical contrast agent that targets the tumor microenvironment and is designed to fluoresce near cancer cells at the tumor margin when activated by proteases.

 

LUM 2.6 Imaging Device is a hand-held (15 cm x 3.1 cm), lightweight (500g) single-cell resolution imaging device, designed to fit into the lumpectomy cavity to scan for residual cancer at the margins. Proprietary decision software produces real-time images indicating location of residual cancer.

 

Clinical Studies

 

Lumicell has completed two clinical studies to date:

 

  • A Phase 1 safety study at Duke University Medical Center in the lead indication of breast cancer as well as sarcoma with no adverse events observed
  • The first part of a two stage feasibility study at Massachusetts General Hospital (MGH) demonstrating the first ever use of the Lumicell MAS for invivo imaging in breast conserving surgeries. The study results show that the LUM Imaging System differentiates between tumor and normal tissue in vivo and ex vivo with administration of LUM015 just a few hours before the surgery with no impact to pre-operative and surgical workflow. Most importantly, it displayed 100% detection of residual cancer. Based on these results, the feasibility study has been expanded into a larger cohort of breast cancer patients in which the Lumicell MAS will be used in vivo to guide the resection of tumor and evaluate the reduction in positive margins and re-excisions.

The company is starting Part B of a two stage feasibility study under an FDA-approved IDE in breast cancer at Massachusetts General Hospital (MGH). Clinical trial information can be found here https://clinicaltrials.gov/show/NCT02438358.