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.

Data readout expected by the end of 2021 for the Lumicell Imaging System for intraoperative detection and removal of residual cancer in breast-conserving surgery. 

Newton, Mass., September 30  –Lumicell, Inc – In a significant milestone for breast cancer patients and advancement toward submission of its Lumicell Imaging System for regulatory approval, Lumicell has completed enrollment in their Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal clinical trial (NCT03686215). This trial was designed to further assess the safety and effectiveness of the Lumicell Imaging System for the detection and removal of residual cancer during the initial breast-conserving surgery.

More than 280,000 women are diagnosed with invasive breast cancer or ductal carcinoma in situ (DCIS) each year in the US, leading to approximately 43,000 deaths annually1,2. The majority of patients receive breast-conserving surgery as a critical first treatment step, with the goal of removing all cancer cells and leaving behind only healthy tissue. However, surgeons do not currently have the necessary tools to determine if all cancer has been removed during the initial surgery. Patients typically wait several days after surgery to learn if all cancer has been resected. Unfortunately, in as many as 20-40% of cases, cancer cells are found at the margins of the removed tissue, suggesting that residual cancer cells may remain and requiring patients to undergo a second invasive surgery to remove the remaining cancer.

Lumicell has developed a novel investigational imaging system consisting of a proprietary drug, a hand-held imaging device, and patient calibrated tumor detection software that work in combination to illuminate the cancer cells in real time and enable surgeons to see and remove residual cancer during the initial surgery. The ultimate goals are to reduce the risk of second surgeries, reduce the potential for local cancer recurrence, and minimize healthy tissue removal while maintaining efficiency in the operating room.

“This is an important potential breakthrough for breast cancer patients and their physicians. It has been gratifying to participate in clinical research designed to meet a longstanding clinical need of eliminating cancer left behind during the initial surgical procedure,” said Dr. Barbara Smith, MD, PhD, Director of the Breast Program at Massachusetts General Hospital, Professor of Surgery at Harvard Medical School, and the lead investigator of the Lumicell breast cancer trials. “Completion of this large study brings us closer to finalizing a submission to FDA for marketing approval and the potential opportunity to improve patient care. I am looking forward to seeing the final results of this trial.”

The INSITE pivotal trial was a multi-center, two-arm randomized, blinded prospective clinical study of 406 adult patients across 14 sites, comprised of both academic medical centers and community hospitals across the US. The study was designed to evaluate the ability to detect and guide removal of cancerous tissue that was missed by the current standard of care lumpectomy surgery and to accomplish this during the initial procedure. Other trial endpoints include reduction in rates of positive margins and re-excisions, as well as assessing the incremental volume of tissue removed.

“With patients now fully enrolled in the INSITE trial, we are quickly moving forward and analyzing the data with the goal of data readout later this year to support our PMA and NDA submissions to FDA in early 2022,” said Jorge Ferrer, PhD, SVP, Clinical Research and Strategy at Lumicell. “We eagerly await the INSITE trial results with the goal of demonstrating the clinical value of the Lumicell Imaging System in the treatment of breast cancer, underscoring our commitment to delivering meaningful innovation to the surgeon community and improving patient outcomes.”

Currently, the Lumicell Imaging System is an investigational combination product and is not commercially available.

About Lumicell, Inc.

Lumicell is a technology leader in the field of image-guided cancer surgery focused on innovative technologies with the potential to improve patient outcomes. The company has developed a novel system designed for real-time detection and removal of tumor tissue in patients during the initial surgery. The Lumicell Imaging System is designed with an unprecedented ability to identify cancer cells remaining in the surgical cavity for removal – 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 Imaging System in patients undergoing surgery for breast cancer, peritoneal metastases from colon and ovarian cancer, prostate cancer, brain cancer, colorectal, esophageal, pancreatic, and gastric 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