Funding of approximately $400,000 will support development of novel endoscopic imaging platform combining far-red fluorescence and reflected light imaging to detect esophageal cancer

Lumicell Awarded Phase I NIH SBIR Contract to Develop Novel Flexible Endoscope for Fluorescence Imaging of LUMISIGHT™ to Detect Early Esophageal Lesions in Patients with Barrett’s Esophagus

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Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, today announced Lumicell was awarded a Phase I Small Business Innovation Research (SBIR) contract from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to develop a novel flexible endoscopic platform that combines far-red fluorescence and reflected light imaging to detect precancerous and early-stage esophageal adenocarcinoma (EAC) under standard clinical endoscopy.

Collaborating with Lumicell on the project are Dr. Andrew T. Chan, MD, MPH, Vice-chair of Research in the Division of Gastroenterology at MGH and Dr. David A. Drew, Assistant Professor in the MGH Clinical and Translational Epidemiology Unit. “This award enables the team to expand upon Lumicell’s groundbreaking breast cancer research into additional oncological surgical applications,” said Dr. Chan. “We are looking forward to collaborating with Lumicell to transform the early detection of esophageal cancer.”

EAC is one of the more common gastrointestinal cancers and is potentially curable; however, it is typically detected in advanced stages with a five-year survival rate less than 15%¹. The current approach to early detection is through endoscopy and random biopsy in patients with precancerous lesions (Barrett’s esophagus). This approach has poor sensitivity, is resource-intensive, and does not permit real-time identification of lesions for immediate treatment.

Lumicell will use the NIH awarded funds to develop a novel flexible endoscopic imaging platform, leveraging the company’s proprietary fluorescence imaging technology to detect, in real-time and in situ, potentially cancerous lesions in patients with Barrett’s esophagus. This novel approach has the potential to improve early detection of commonly missed esophageal lesions.

“Lumicell’s novel fluorescence technology could be a game-changer in the early detection of dysplasia that may otherwise not be detectable within a background of Barrett’s esophagus,” said Brian Schlossberg, Ph.D., Vice President, New Business Strategy and Innovation, Lumicell. “This grant is a very exciting opportunity to further develop our platform technology in a new indication that may alter the extent of esophageal resections and cancer-related morbidity.”

The award period for the contract begins September of 2024 with a funding period of one year.

Currently, LUMISIGHT™ (pegulicianine) is approved for use in combination with Lumicell™ DVS to detect cancerous tissue within the breast cavity as an adjunct during the lumpectomy procedure. Lumicell is investigating a novel flexible endoscope for use with LUMISIGHT to detect early esophageal lesions.

About Lumicell Inc.

Lumicell is a privately held company focused on enabling a more complete resection of cancer by advancing the development and commercialization of its innovative fluorescence guided surgery technology. 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.

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 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.

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.

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. 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 in patients who have received LUMISIGHT.
• Tissue Perforation or Damage: During the procedure, your healthcare provider should avoid excessive pressure or torque with the Lumicell DVS handheld probe while inside the cavity as it can cause tissue perforation or damage.
• Infection Risk: To avoid infection risk, the reusable Lumicell DVS 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 Lumicell DVS sterile, single-use probe cover.
• Eye Discomfort: Your healthcare provider should avoid direct eye exposure to the Lumicell DVS 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.

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1. M. A. Eloubeidi, A. C. Mason, R. A. Desmond, and H. B. El-Serag, “Temporal trends (1973-1997) in survival of patients with esophageal adenocarcinoma in the United States: a glimmer of hope?,” Am. J. Gastroenterol., vol. 98, no. 7, pp. 1627–1633, Jul. 2003, doi: 10.1111/j.1572-0241.2003.07454.x.

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