Lumicell Highlights Growing Role of LumiSystem® as Commercial Expansion Accelerates, including Implementation at Nation's Leading Cancer Center

Clinical and real-world data underscore the importance of real-time intraoperative detection of residual cancer as breast cancer care continues to move toward more personalized, de-escalated treatment approaches.

WALTHAM, Mass., Sept. 15, 2026 /PRNewswire/ -- Lumicell, Inc., a leader in fluorescence-guided imaging technologies for cancer detection, today highlighted the growing clinical relevance of LumiSystem®, the company's real-time intraoperative imaging platform for breast-conserving surgery, as Lumicell continues its commercial expansion in the U.S. breast lumpectomy market – including implementation at the nation's leading cancer center. This momentum underscores Lumicell's 2026 objectives of scaling LumiSystem in the breast lumpectomy market, driving revenue growth, and increasing access to as many patients as possible.

Modern breast cancer care is increasingly moving toward more personalized, de-escalated treatment approaches. As adjuvant therapy is de-escalated, a complete resection at the first operation becomes especially important. Finding residual cancer intraoperatively can support personalization decisions and instill surgical confidence.

Unlike specimen-based approaches that evaluate tissue after it has been removed, LumiSystem is designed to interrogate the lumpectomy cavity in situ and show where suspected residual disease remains in the cavity so it can be removed during the same operation. Real-world experience continues to support the clinical relevance of cavity-based imaging, including a recent study out of Stanford Health, titled Performance of Pegulicianine Fluorescence-Guided Evaluation of Lumpectomy Cavities
Following Primary Tumor Excision, presented at the American Society of Breast Surgeons (ASBrS) Annual Meeting.

"Commercial expansion is about more than broader availability. It is about supporting surgeons with real-time information when it matters most, before the patient leaves the OR," said Marnie Curbow, Chief Commercial Officer. "As breast cancer treatment becomes more personalized, Lumicell is focused on helping advance breast-conserving surgery with technology designed to detect residual cancer within the lumpectomy cavity during the index procedure. We believe our continued expansion into leading cancer institutions helps accelerate awareness of innovative surgical technologies and expand patient access."

For more information about LumiSystem, visit www.LumiSystem.com.

About Lumicell

Lumicell is a privately held life sciences company revolutionizing the intraoperative detection of cancer with its real-time fluorescence imaging technology. Lumicell's proprietary technology is FDA-approved for use in the treatment of breast cancer and is also being explored for further development across a wide variety of solid tumor indications. For more information, please visit www.Lumicell.com and www.Lumisystem.com. 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), an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, 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 I should 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 procedures 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 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 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 visit www.LumiSystem.com.

Rx only

This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this press release reflect Lumicell's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions, and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, the regulatory process to approve pharmaceutical drugs or medical devices.

SOURCE Lumicell, Inc.