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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Success with In Vivo Examination of Cancerous Tissue via the Lumicell Imaging System During the Pivotal Trial will Propel the Technology Toward FDA Submission

Newton, Mass., November 5, 2019 – Lumicell, Inc., an innovation leader in image guided cancer surgery, today announced it has begun its pivotal trial of the Lumicell Imaging System for breast cancer — a major milestone on its path toward FDA submission for approval. The two-arm, randomized pivotal study follows completion of our feasibility clinical study of 234 patients at 16 sites. In the pivotal study, the technology will be used on 170 patients at up to 20 large academic centers and community breast cancer centers for intraoperative detection and removal of residual cancer in breast conserving surgery.

“This is an exciting moment for breast cancer patients and their physicians. Since the very beginning, I’ve been encouraged by the results generated using the Lumicell System,” said Barbara Smith, MD, PhD, lead investigator of the Lumicell breast cancer trials. Dr. Smith, Director of the Breast Program at Massachusetts General Hospital and Professor of Surgery at Harvard Medical School, also shared, “with this pivotal trial, the system gets an important step closer to FDA approval, but more importantly, patients and physicians are one step closer to having an innovative technology available for care.”

Breast-conserving surgery is a critical first step in the treatment for many women with breast cancer with the goal of removing all cancer cells while minimizing the removal of healthy tissue. However, today, surgeons do not have adequate tools to determine in real-time if all the cancer has been removed during the initial surgery; instead, patients must wait multiple days after surgery to find out if all the cancer has been completely removed. Unfortunately, for 1 in 4 breast cancer patients, cancer cells are found at the margins of the removed tissue, suggesting cancer cells may remain in the cavity, typically requiring patients to undergo a second surgery to remove the remaining cancer.

The Lumicell System was developed to enable surgeons to see and remove residual cancer in real-time, in vivo, during the initial surgery — with the goal of reducing the risk of second surgeries and cancer recurrence. The system is designed to minimize healthy tissue removal while integrating easily into the surgical workflow.

“We are very excited to move into the pivotal trial stage for the Lumicell System,” said Andrey Zarur, PhD, Executive Chairman at Lumicell. “We believe we have developed a trial design which will be compelling to patients and surgeons, demonstrate the clinical benefit of using the system in the treatment of breast cancer and generate data to submit for FDA approval.”

The Lumicell System is potentially useful for surgical guidance in the removal of numerous other cancer types, and it is currently being tested in feasibility trials for treatment of prostate, brain, colorectal, esophageal and pancreatic cancers, as well as peritoneal metastases from primary ovarian and colon cancers.

For more information about Lumicell’s clinical trials, visit

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 guide removal of 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

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