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.

R01 Award to fund multi-phase randomized study to expand clinical safety and efficacy data of the system in the detection of residual tumor in breast cancer patients receiving neoadjuvant therapies

Newton, Mass., Sept. 29, 2020 – Lumicell, Inc. today announced that Dr. Barbara Smith, Director of the Breast Program at Massachusetts General Hospital, has begun a multi-phase, randomized clinical study utilizing the LUM Imaging System to obtain additional safety and efficacy data in breast cancer supported by an R01 award from the National Cancer Institute. The study follows compelling results from a multi-center Feasibility Phase C trial and runs concurrently with Lumicell’s pivotal trial. The study, led by Barbara Smith, is a collaboration with investigators Dr. Shelley Hwang at Duke, Dr. Irene Wapnir at Stanford, Dr. Anees Chagpar at Yale, and Dr. Kelly Hunt at MD Anderson and with Lumicell.

“This new NCI academic-industry clinical study will enroll approximately 400 patients, including an arm consisting of patients receiving neoadjuvant therapy. The study also focuses on collecting data as the first step to investigate the potential long-term impact of the LUM Imaging System in breast cancer treatment.

“Over the last decade, neoadjuvant therapies have become more prevalent as a standard treatment for breast-conserving surgeries. While there have been studies on the effectiveness of neoadjuvant therapies alone, we’re eager to study long-term outcomes of patients who also have the benefit of using in-vivo imaging to find residual cancer,” said Dr. Smith. “We’re encouraged by the data shown in the Phase C trial – and this next study supplements the ongoing pivotal study as an important piece in improving patient care and furthering innovations in breast cancer treatment.”

The LUM Imaging System was developed to enable surgeons to see and remove residual cancer in real time during the initial surgery. It is designed to reduce the risk of second surgeries and cancer recurrence while minimizing healthy tissue removal. This new study follows compelling clinical results from Lumicell’s 234-patient, 16-site Feasibility Phase C study that demonstrated the detection and removal of residual cancer, for both invasive cancers and ductal carcinoma in situ (DCIS), in 11% of patients after standard of care lumpectomy. Data from the Phase C study and the ongoing pivotal study will be used to support an application to the FDA for market approval for the LUM Imaging System.

“We are very excited to collaborate with Dr. Smith and this prestigious group of investigators on this important trial and look forward to evaluating the potential for improved treatment in breast cancer care by using the LUM Imaging System,” said Kevin Hershberger, CEO of Lumicell. “Our focus in developing the Lumicell System has been to improve patient outcomes by guiding the removal of residual cancer during initial surgeries and we are thrilled to extend this to patients receiving neoadjuvant therapies.”

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