Lumicell Announces U.S. Launch and First Commercial Use of LumiSystem™, Pioneering Real-Time Detection of Residual Breast Cancer During Lumpectomy

LumiSystem is the first and only fluorescence-guided imaging technology for breast cancer detection, enabling a more complete resection

NEWTON, Mass., Jan. 27, 2025 /PRNewswire/ -- Lumicell, Inc., a leader in developing innovative fluorescence-guided imaging technologies for cancer detection, today announced the U.S. commercial availability and first commercial use of LumiSystem™. This groundbreaking system combines two recently FDA-approved products: LUMISIGHT™, an optical imaging agent that fluoresces at sites of suspected cancerous tissue, and Lumicell™ Direct Visualization System (DVS), an imaging device that provides real-time fluorescence guidance for scanning the breast cavity during lumpectomy surgery.

Unlike other detection systems that only evaluate tissue after it has been surgically removed, LumiSystem™ allows for real-time visualization of cancer inside the breast.  This enables surgeons to identify and immediately resect any suspicious tissue during the surgery, improving the likelihood of achieving a more complete resection and reducing the need for follow-up procedures. 

"We breast surgeons know all too well the limitations of lumpectomy and the difficult conversations we have with patients about the possibility of a second surgery due to positive margins," said Irene Wapnir, MD, Professor of Surgery at Stanford University School of Medicine and Director of Breast Cancer Surgical Clinical Research at the Stanford Cancer Institute. "Stanford is excited to adopt LumiSystem because, with its real-time fluorescence guidance, we are now able to detect and remove more cancerous tissue during surgery while still sparing as much healthy breast tissue as possible."

With 84% diagnostic accuracy, LumiSystem improved surgical outcomes in 10% of patients treated in the INSITE pivotal trial.^1-2 By identifying cancerous tissue completely missed by surgeons and pathologists, LumiSystem offers a more comprehensive approach to breast-conserving surgery and ultimately enhances patient care.

"Today, with LumiSystem's commercial launch, we empower surgeons with a groundbreaking tool that detects cancer where and when it matters most, inside the breast cavity and in real-time," said Howard Hechler, CEO of Lumicell. "This launch reflects Lumicell's unwavering commitment to enhancing surgical outcomes for patients."

For more information about LumiSystem™ and its capabilities, visit www.LumiSystem.com.

About Lumicell Inc.

Lumicell is a privately held company focused on developing innovative fluorescence-guided imaging technologies for the detection of cancerous tissue during surgery. The company's lead products are LUMISIGHT (pegulicianine) and Lumicell DVS which are approved for use in combination to illuminate cancerous tissue within the breast cavity during the initial lumpectomy procedure, as an adjunct to the standard of care. Lumicell's proprietary, pan-oncologic optical imaging agent, LUMISIGHT, is also being explored for further development across a wide variety of solid tumor indications. For more information, please visit www.Lumicell.com and follow the company on Facebook, X, and LinkedIn.

Media Contact: [email protected] 

Indications for Use

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

What is LUMISIGHT (pegulicianine) and Lumicell DVS?

• LUMISIGHT (pegulicianine) is an optical imaging agent and Lumicell DVS is a fluorescence imaging device. LUMISIGHT and Lumicell DVS, in combination, are 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.

What is the most important information to know about LUMISIGHT?

• Hypersensitivity Reactions: 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 the 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.
• The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine.

What additional important information should I know about LUMISIGHT and Lumicell DVS?

• Adjunctive Use: Lumicell DVS is for use as part of the lumpectomy procedure and is not a replacement for the standard of care lumpectomy procedure and pathology.
• Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in noncancerous tissue.
• Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid use of dyes before imaging the lumpectomy cavity in patients who have received LUMISIGHT.
• Other Risks: Using the Lumicell DVS handheld probe may cause tissue damage or infection.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use. For complete product information http://www.lumisystem.com/.

Rx only

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1. Diagnostic accuracy is based on true positive and true negative images detected in the LumiSystem pivotal trial
2. Smith, et al., NEJM Evidence 2023; 2(7)

SOURCE Lumicell, Inc.