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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Positive Clinical Results in Breast Cancer Trial Shows Promise for Ovarian and Other Cancers

Newton, Mass., April 10, 2019 — Lumicell, Inc. today announced that a feasibility study is underway at Massachusetts General Hospital in Boston to determine the initial safety and efficacy of its Lumicell System for in vivo imaging of metastases to the peritoneum from primary ovarian cancer, appendiceal cancer, gastrointestinal cancer and mesothelioma.

The feasibility study is being conducted by Massachusetts General Hospital investigator Dr. James Cusack, MD. Dr. Cusack heads the Cusack Laboratory at Massachusetts General Hospital, which focuses on advancing cancer treatment resistance and the development of new targeted therapies to improve cancer patient survival. This application was developed in his laboratory and the promising results were published in 2017 in Annals of Surgical Oncology.1 He is the Director of the Peritoneal Surface Malignancy Program at the hospital as well as an Associate Professor of Surgery at Harvard Medical School. Dr. Cusack began using the Lumicell System for the study with the first patient’s surgical procedure on April 3, 2019.

“This feasibility study is a critical first step in determining if the Lumicell System will be effective in improving quality of life for people with peritoneal metastases and ovarian cancer,” said Dr. Cusack. “We will be evaluating the Lumicell System, by comparing the imaging results detected at the molecular level with the traditional microscopic evaluation, to improve surgical outcomes for patient with peritoneal surface malignancies.”

More than 225 participants have been treated with the Lumicell System in clinical trials. The majority of these participants are women undergoing lumpectomy for breast cancer. Dr. Barbara Smith, MD, PhD, Director of the Breast Program at Massachusetts General Hospital and Professor of Surgery at Harvard Medical School is the lead investigator of the breast cancer trials. Dr. Smith reported positive clinical results in 2018 using Lumicell technology during breast cancer surgery — demonstrating rapid and direct identification of residual tumor in lumpectomy cavities during breast cancer surgery.

“Our study found that the Lumicell Imaging System was effective for real time identification of residual cancer intraoperatively. This is an important advance as many breast cancer patients currently need second surgeries for positive margins,” said Dr. Smith. “We’re excited to determine whether this peritoneal feasibility study will bring the same advantages to treating patients with peritoneal metastases — with an ultimate goal to improve survival rates.”

Since 2008, Lumicell has been dedicated to developing technology to overcome limitations in detecting all cancer cells that are notoriously evasive and cannot be seen with the naked eye. The Lumicell System enables surgeons to visualize and distinguish cancer cells from healthy cells, so tumor cells aren’t left behind during the first surgery.

“We are very excited to have our solution support surgeons and patients in breast, ovarian/peritoneal and five other cancers in clinical trials at this time,” said Kelly Londy, Chief Executive Officer of Lumicell. “Because of this work, we’re one step closer to delivering on our promise: developing the technology that visualizes cancer cells in real-time during surgery and helps to improve and save lives. Our team is very hopeful that the outcome of the feasibility study will reveal the positive results that our industry, doctors, and patients are waiting for.”

For more information on Lumicell clinical trials, visit the Clinical Trials page of the Lumicell website.

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 Lumicell 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 Lumicell System in patients undergoing surgery for breast cancer, ovarian cancer, prostate cancer, brain cancer, colorectal, esophageal and pancreatic cancers. Additional future indications are planned to include perfusion, wound care and infection, and surgeries for lung, and liver cancers. For more information, please visit

1. Chan CHF, Liesenfeld LF, Ferreiro-Neira I, Cusack JC. Preclinical evaluation of cathepsin-based fluorescent imaging system for cytoreductive surgery. Ann Surg Onc, 2017 Apr 24(4):931-38

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.


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