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.

Pivotal trial expected to begin by end of 2019 for the Lumicell Imaging System for intraoperative detection and removal of residual cancer in breast-conserving surgery.

Newton, Mass., August 19, 2019 — Lumicell, Inc. an innovation leader in image guided cancer surgery, today announced that it has completed enrollment in its Phase C feasibility clinical trial of the Lumicell Imaging System for breast cancer. With results from the Phase C feasibility trial expected in late 2019, Lumicell expects to begin the pivotal trial by the end of 2019 before applying for FDA approval.

Breast-conserving surgery is a critical first step of treatment for many women with breast cancer. The goal is to remove all the cancer cells, leaving behind only healthy tissue. However, today, surgeons do not have adequate tools to determine if all cancer has been removed during the initial surgery; instead, patients must wait until days after surgery to find out if all the cancer has been removed. Unfortunately, in as many as 20-40% of cases, cancer cells are found at the margins of the removed tissue, typically requiring patients to undergo a second surgery to remove the remaining cancer.

Lumicell has developed a novel system intended to enable surgeons to see and remove residual cancer cells in real-time during the initial surgery, with the ultimate goal of reducing the risk of second surgeries and cancer recurrence, while also minimizing healthy tissue removal and improving efficiency in the operating room.

“My goal is to provide the best outcomes for patients under our care at Novant Health. One of the most important ways we do that is through innovative technology. The Lumicell System gives me increased confidence during my lumpectomy procedures; for numerous patients enrolled in the Phase C trial, my team was able to avoid a second surgery by identifying and removing tissue highlighted by the Lumicell System. I’m encouraged by our experiences with the system thus far, and I’m eager to have this as an option available for all of our breast cancer patients,” said Dr. David Carr, MD, General Surgeon at Novant Health Salem Surgical Associates and principal investigator for the Lumicell breast cancer trial at Novant Health.

The Lumicell Phase C trial is a multi-center, prospective clinical study of 234 patients across 16 sites, comprised of both academic medical centers and community hospitals. 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 Lumicell breast cancer trials. Findings from this trial — the third feasibility study of the Lumicell System for Breast Cancer — will be published at the end of 2019. Lumicell is also expecting to initiate the pivotal trial stage later this year to support an FDA submission for approval of the Lumicell System for the treatment of breast cancer.

“With the Lumicell Phase C trial now fully enrolled, we are quickly moving forward with the data review, and finalizing the design and plans for the pivotal study to begin later this year,” said Andrey Zarur, PhD, Executive Chairman at Lumicell. “We’re confident that we have developed a pivotal trial design that is compelling to patients and surgeons. And we’re optimistic that the pivotal trial will deliver results clearly demonstrating the clinical value of the Lumicell System in the treatment of breast cancer and benefits to the patients.”

The Lumicell System is also in early 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 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

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