Location: Newton, MA

The Science Propelling Lumicell

Discover a Brand-New Vision in Real-Time Excision

What if you had the power to see invasive breast cancer and ductal carcinoma in situ (DCIS) during surgery and remove it in real time? The Lumicell Direct Visualization System (DVS) is the first and only solution designed for use in patients with breast cancer to assist surgeons in the detection of cancerous tissue within the lumpectomy cavity following removal of the primary specimen during lumpectomy surgery.

Find

LUMISIGHT*, an investigational proprietary onco-fluorescent agent, is administered pre-operatively (same day) to highlight cancer cells.

Detect

The hand-held imaging probe enables the surgeon to scan, inside the breast cavity, to illuminate and find activated LUMISIGHT in residual cancer.

Guide

Real-time images from the cavity based on a patient-calibrated cancer detection software, guides the surgeon in removal of residual cancerous tissue.

Originally designed by engineers and scientists from MIT in partnership with leading breast cancer surgeons, and then further developed at Lumicell, the Lumicell DVS aims to seamlessly integrate into the existing surgical workflow, using a handheld probe that is placed inside the breast cavity.

The Lumicell DVS in Action

Lumi Stills03

Despite the emergence of new surgical approaches, there remains a significant unmet need for surgeons and patients of real-time detection of residual cancer.

Lumicell DVS is designed to provide significant value to the healthcare system in the form of:

asian senior cancer patient during chemo therapy feel happy with smiling face and confident have hugging with doctor

Clinical Trials in Multiple Solid Tumor Indications

The investigational optical imaging agent, LUMISIGHT, contains a fluorescent dye that is optically inactive when injected into the patient. It is designed to be activated by enzymatic activity in and around the tumor. LUMISIGHT leverages the body’s host immune response common to all solid tumors, rather than targeting specific receptors of a particular type of cancer. 

The Lumicell DVS has potential utility for development in multiple solid tumor indications.

Over 800 patients have been clinically evaluated in 7 different cancer types across 18 leading medical centers in the United States.

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Exploratory
Feasibility
Pivotal
FDA Approval
Breast
Peritoneal Metastases
GI Cancers
Sarcoma
Brain
Prostate
Awarded FDA Breakthrough Designation for the investigational Lumicell Direct Visualization System (DVS) in breast, GI and all solid tumors. Awarded Fast Track Designation for the investigational LUMISIGHT Optical Imaging Agent for breast cancer.

Completed Clinical Trials

Breast Cancer

May 2022

Lumicell’s pivotal INSITE (Investigation of Novel Surgical Imaging for Tumor Excision) Breast Cancer clinical trial (NCT03686215). Results of the INSITE trial are published in NEJM Evidence and have been included in Lumicell’s Premarket Approval and New Drug Application submissions to the U.S. Food & Drug Administration

April 2020

October 2017

Single-site feasibility study

Massachusetts General Hospital

Single-site feasibility study

Massachusetts General Hospital

Breast Cancer Research and Treatment 

January 2016

Phase 1 safety study in breast cancer and sarcoma

Duke University Medical Center

Science Translational Medicine 

Prostate Cancer (ex vivo)

February 2021

Feasibility study to detect prostate cancer in resected tissue; next steps include an in vivo study (NCT03441464)

Ongoing Clinical Trials

Breast Cancer

Initiated September 2020

Feasibility study (NCT04440982), to evaluate for the first-time use of the Lumicell DVS in breast cancer patients undergoing neoadjuvant therapy

Gastrointestinal Cancer (ex vivo)

Initiated August 2016

Feasibility study of the Lumicell DVS to detect GI cancers including gastric, colorectal, pancreatic, and esophageal cancers (NCT03834272)

Peritoneal Metastases (in vivo)

Initiated March 2019

Feasibility study of the Lumicell DVS to detect peritoneal surface malignancies, including peritoneal metastases from primary ovarian and colon cancer, as well as mesothelioma (NCT03834272)

Brain Cancer (in vivo)

Initiated May 2019

Feasibility study of the Lumicell DVS to detect brain cancers that include glioblastomas, low-grade gliomas and metastases to the brain (NCT03717142)

For detailed information on Lumicell’s clinical trials, visit ClinicalTrials.gov.

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