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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Complete and Immediate Detection of Residual Cancer in Tumor Cavity During Lumpectomy Surgery

Data Presented by Investigators from Massachusetts General Hospital’s Breast Program at 2017 San Antonio Breast Cancer Symposium Integrated LUM System Correctly Identified Residual Cancer Cells Across Breast Cancer Subtypes

Wellesley, Mass., Dec. 7, 2017— Lumicell, Inc. today announced the presentation of clinical data from its ongoing Phase 2 breast cancer trial with the LUM System, which integrates the immuno- and cancer-targeted optical agent LUM015, the Lumicell handheld imaging device and decision software to detect cancer cells in real-time during surgery.  The Phase 2 data demonstrated that the integrated LUM System provided complete and instantaneous detection of residual cancer in tumor cavity and the ability to detect all breast cancer sub-types including invasive ductal cancer (IDC), invasive lobular cancer (ILC) and ductal carcinoma in situ (DCIS) during lumpectomy surgery. In addition, the LUM System correctly identified residual cancer (positive margins) within the tumor cavity in all patients studied, as confirmed by standard histopathology.  The Phase 2 data were presented at the 2017 San Antonio Breast Cancer Symposium (SABCS) being held December 5-9, 2017 in San Antonio, Texas.

“Our goal with the LUM System, is to provide surgeons with immediate cancer cell detection, thereby reducing the need for second surgeries,” said Kelly Londy, Chief Executive Officer of Lumicell. “The data presented at San Antonio further supports our advancement into pivotal breast cancer studies and continued clinical expansion into other solid tumor cancers including prostate cancer, colorectal, esophageal and pancreatic cancers, among others.”

Currently, up to 40% of breast cancer lumpectomy patients have positive margins that require surgical re-excision,” said Barbara L. Smith, MD, PhD. Director of the Breast Program at Massachusetts General Hospital and Professor of Surgery at Harvard Medical School. “By providing instantaneous identification of residual tumor in the lumpectomy cavity, the LUM System has the potential to provide surgeons with enhanced information to improve care for their breast cancer patients.”

In a poster presentation titled, “Real-time, intraoperative detection of residual breast cancer in lumpectomy cavity margins using the LUM Imaging System: Results of a feasibility study,” Lumicell collaborators at Massachusetts General Hospital’s Breast Program presented data from a Phase 2 clinical study in which tumor cavity walls of patients (N= 45) undergoing breast cancer lumpectomy were assessed intraoperatively using the LUM System. LUM015, a cathepsin-activatable fluorescent agent, was administered intravenously approximately four hours prior to surgery. Areas of fluorescence generated at potential sites of residual tumor in lumpectomy cavities were evaluated with a sterile hand-held device, displayed on a monitor, excised and correlated with histopathology. The data showed:

“The LUM System continues to be well-tolerated during breast cancer surgeries, and importantly, all residual cancer cells in the tumor cavity were correctly identified,” said Felix Geissler MD, PhD, Chief Medical Officer of Lumicell. “Additional studies are underway to continue to validate and optimize the LUM System in this setting.”

About the LUM System

The LUM System was designed by leading engineers and scientists in partnership with surgeons from academic and medical centers as an integrated system with three unified components: drug, device and decision software to guide cancer surgeons in the detection and removal of cancer cells in real-time during surgery.  The LUM System includes three integrated components: a fluorescent optical contrast agent that is cancer- and immuno-activated, a novel hand-held imaging device that instantly scans the cavity walls to view the fluorescent cells with single-cell detection, and proprietary decision software that displays the image instantly on a monitor to guide surgical removal of cancerous tissue.

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 LUM 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 LUM System in patients undergoing surgery for breast cancer, prostate cancer, colorectal, esophageal and pancreatic cancers. Additional future indications are planned to include surgeries for lung, ovarian, and brain 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