BREAKING NEWS: We are pleased to announce FDA approval of LUMISIGHT™ (pegulicianine) and Lumicell™ DVS. To the hundreds of women and dedicated investigators who participated in this important clinical work that brought us to where we are today, THANK YOU! We wouldn’t be here without your support. 

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See what matters most. Illuminate breast cancer in real-time.

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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

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:

  • Identifying residual cancer, undetected by the current standard of care
  • Potentially avoiding the need for a second surgery
  • Integrating seamlessly into the surgical workflow, with on average less than 10 minutes of time added to the procedure

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.

Click to expand graphic.

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

Phase C multi-center feasibility study in breast cancer

October 2017

Single-site feasibility study

Massachusetts General Hospital

Single-site feasibility study

Massachusetts General Hospital

Breast Cancer Research and Treatment 

Annals of Surgical Oncology 

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.

Lumicell featured in key peer-reviewed publications

*CAUTION: LUMISIGHT and Lumicell Direct Visualization System (DVS) are investigational products that are limited by Federal (or United States) law to investigational use. LUMISIGHT and Lumicell DVS are not authorized for marketing for any indication in any jurisdiction.

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The Lumicell DVS In Action
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What is LumiSystem™?

LumiSystem is the combination of the following FDA approved products – LUMISIGHT™, an optical imaging agent, and Lumicell™ DVS, a fluorescence imaging device. These products are used as an adjunct by surgeons to intraoperatively detect residual breast cancer, in real-time, during lumpectomy surgery.

Indications for Use (Test)

LUMISIGHT, an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.

IMPORTANT SAFETY INFORMATION FOR LUMICELL™ DVS and LUMISIGHT™

LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Tell your doctor if you have any history of hypersensitivity reactions to pegulicianine or to contrast media or products containing polyethylene glycol (PEG).

Your healthcare provider should have emergency resuscitation drugs, equipment, and trained personnel available during use of LUMISIGHT. Healthcare providers should monitor all patients for hypersensitivity reactions and if one is suspected, immediately discontinue the injection and initiate appropriate therapy.

LUMISIGHT™ (pegulicianine) Important Safety Information

What is LUMISIGHT (pegulicianine)?

LUMISIGHT (pegulicianine) is an optical fluorescence imaging agent used in adults with breast cancer to help detect any remaining cancerous tissue at the surgical site following removal of the primary specimen during a lumpectomy procedure.

Important Safety Information

  • Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue.
  • Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid using dyes before imaging with LUMISIGHT.

What are the most common side effects of LUMISIGHT?

The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning.

Lumicell™ Direct Visualization System (DVS) Important Safety Information

What is the Lumicell™ DVS?

The Lumicell™ Direct Visualization System (DVS) is for use in patients with breast cancer to help detect cancerous tissue within the lumpectomy cavity after the removal of the primary specimen during surgery. The Lumicell DVS is used with LUMISIGHT™ (pegulicianine), an imaging agent to visualize the lumpectomy cavity.

Important Safety Information

  • Adjunctive use: Lumicell DVS is for use as part of the lumpectomy procedure and is not a replacement for the standard of care procedures and pathology. Your healthcare provider must be trained on proper use of the Lumicell DVS, and breast conserving surgery prior to performing any procedures.
  • Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue.
  • Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid use of dyes before imaging the lumpectomy cavity who have received LUMISIGHT.
  • Tissue perforation or damage: During the procedure, your healthcare provider should avoid excessive pressure or torque with the handheld probe while inside the cavity as it can cause tissue perforation or damage.
  • Infection risk: To avoid infection risk, the reusable handheld probe and cables should be properly and completely disinfected and reprocessed after each use by your healthcare provider. Your healthcare provider should also ensure proper use of the sterile, single-use probe cover.
  • Eye discomfort: Your healthcare provider should avoid direct eye exposure to handheld light probe as it may cause pain.

Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use.  For complete product information visit www.LumiSystem.com.