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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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.

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