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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Lumicell Announces Initial Data Demonstrating LUMISIGHT™’s Ability to Detect Tumors Metastasized to Multiple Organs in the Peritoneum

Promising feasibility study results for imaging technology that identified malignant peritoneal tumor metastasis during surgery

NEWTON, Mass.–(BUSINESS WIRE)–Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced promising initial data from its ongoing feasibility study for lead candidate LUMISIGHT™ to detect peritoneal malignancies during surgical debulking. The ongoing study is utilizing the investigational LUMISIGHT optical imaging drug and accompanying imaging device to distinguish tumor metastases to organs within the peritoneum. The initial results from adult patients were shared in a podium presentation by James C. Cusack, Jr. MD, Associate Professor of Surgery at Massachusetts General Hospital, at the Advanced Cancer Therapies meeting organized by the Society of Surgical Oncology.

“This data advances the potential for image-guided surgery to detect small tumors and metastases to organs in the peritoneal cavity which could provide better outcomes for our patients,” said Dr. Cusack. “Further innovation is desperately needed to improve the benefits of cytoreductive surgery for this invasive and elusive cancer. We look forward to continuing the clinical development program with Lumicell and advancing patient care.”

The presence of peritoneal metastases has a significant negative impact on survival for patients. One of the most important determinants of treatment success and long-term overall survival is the ability to achieve removal of all visible cancer during initial surgery prior to the heated chemotherapy for a complete cytoreduction.2-5

“We are highly encouraged by this initial data in a promising new indication, as we continue to expand the development of LUMISIGHT across the spectrum of solid tumors. Everything we do at Lumicell is focused on improving surgical outcomes for patients,” said Howard Hechler, President of Lumicell.

About Peritoneal Surface Malignancies and Metastasis

Peritoneal surface malignancies include primary peritoneal malignant mesothelioma and tumors that have spread from different organs, referred to as peritoneal metastases. These metastases can originate from organs such as appendiceal, colorectal, gastric, pancreatic, and ovarian cancers, and affect more than 75,000 patients each year in the United States.1

The presence of disease and the extent of disease are often difficult to be fully evaluated by conventional non-invasive imaging techniques such as CT scan, PET scan, or MRI. Small peritoneal surface nodules are often detected at the time of surgical exploration by the surgeon’s eyes versus conventional imaging techniques.

One of the most important determinants of treatment success and overall survival is the ability to achieve complete cytoreduction (CCR).2-5 While patients with no residual disease (CCR0) or minimal residual peritoneal surface tumor nodules less than 2.5 mm in maximum diameter (CCR1) have significantly better survival than those with residual nodules more than 2.5 mm in maximum diameter (CCR2), patients with CCR0 have experienced the best clinical outcomes.2,3,5

About Lumicell, Inc.

Lumicell is a privately held company focused on the development and commercialization of innovative fluorescence-guided technologies for cancer surgery with the potential to improve patient outcomes and reduce healthcare costs. The company’s first products pending approval are LUMISIGHT™ and the Lumicell™ Direct Visualization System which, in combination, are designed to illuminate cancerous tissue during initial surgery potentially reducing the frequency of repeat surgeries. LUMISIGHT and the Lumicell Direct Visualization System are investigational products, both limited by federal law to investigational use only and are not commercially available. These products are currently under FDA review for their first indication in breast conserving surgery; and are also being explored across a wide variety of solid tumor indications to enhance the standard of care treatment by guiding the resection of additional cancer that may have otherwise been left behind. For more information, please visit www.lumicell.com or follow us at LinkedIn and X.

  1. Foster, J.M., Zhang, C., Rehman, S., Sharma, P. and Alexander, H.R. (2023), The contemporary management of peritoneal metastasis: A journey from the cold past of treatment futility to a warm present and a bright future. CA A Cancer J Clin, 73: 49-71. https://doi.org/10.3322/caac.21749
  2. Elias, D., F. Quenet, and D. Goere, Current status and future directions in the treatment of peritoneal dissemination from colorectal carcinoma. Surg Oncol Clin N Am, 2012. 21(4): p. 611-23.
  3. Glockzin, G. and P. Piso, Current status and future directions in gastric cancer with peritoneal dissemination. Surg Oncol Clin N Am, 2012. 21(4): p. 625-33.
  4. Helm, C.W., Current status and future directions of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in the treatment of ovarian cancer. Surg Oncol Clin N Am, 2012. 21(4): p. 645-63.
  5. Votanopoulos, K.I., et al., Current status and future directions in appendiceal cancer with peritoneal dissemination. Surg Oncol Clin N Am, 2012. 21(4): p. 599-609.
  6. Chan, C.H., et al., Preclinical Evaluation of Cathepsin-Based Fluorescent Imaging System for Cytoreductive Surgery. Ann Surg Oncol, 2017. 24(4): p. 931-938.

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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.

IMPORTANT SAFETY INFORMATION FOR LUMICELL™ DVS and LUMISIGHT™

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 www.LumiSystem.com.