Lumicell’s LumiSystem™ Featured on Viewpoint with Dennis Quaid for New Episode on Fluorescence-Imaging Guidance During Lumpectomy Surgery

Media inquiries – media@lumicell.com

Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, is thrilled to announce its upcoming collaboration for an episode of “Viewpoint,” the acclaimed educational program hosted by Dennis Quaid.

The segment exploring advancements in fluorescence-imaging technology in surgery for breast cancer will delve into imaging innovation that improves surgical outcomes and highlight LumiSystem.¹ It will feature key Lumicell team members, a surgical oncologist, and a patient who has received this treatment during the INSITE clinical trial. LumiSystem, which combines an optical imaging agent called LUMISIGHT™ (pegulicianine) and an imaging device known as Lumicell™ Direct Visualization System (DVS), enables surgeons to scan inside the breast following a lumpectomy to check for residual cancer that might have been missed. If any suspicious tissue is detected, the surgeon can remove it immediately to potentially improve surgical outcomes.

“A lot of people know the statistics around breast cancer, but it’s actually staggering when you think about it. One in eight women in the US will have breast cancer and lumpectomy surgery remains the mainstay of treatment for most patients,”² said Dr. Shelley Hwang, Leader of the Breast Oncology Program at Duke University and investigator in clinical study. “An important challenge of surgery is that cancer cells look very similar to normal cells in the operating room, so we need technology that allows us to differentiate cancer cells from the normal cells during surgery. New imaging advancements that allow us to see the cancer during surgery are incredibly exciting and have the potential to help patients avoid second surgeries.”

“We are excited to partner with Viewpoint, a program known for its educational excellence and engaging storytelling,” said Howard Hechler, President and Chief Operating Officer of Lumicell. “We are proud to share Lumicell’s story and showcase the first and only imaging combination product approved for detecting cancerous tissue where and when it matters most, inside the breast cavity during surgery.”

About Viewpoint

About Viewpoint with Dennis Quaid:

Viewpoint is an award-winning educational series that highlights innovations and important issues impacting today's world. Hosted by veteran actor Dennis Quaid, the show works with industry leaders and experts to provide insights and educate viewers on trends shaping various sectors.

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-imaging technology. The company’s lead products are LUMISIGHT™ and Lumicell™ DVS which are designed 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.

IMPORTANT SAFETY INFORMATION

What is LumiSystem™?

• LumiSystem is the combination of the following FDA approved products: LUMISIGHT™, an optical imaging agent, and Lumicell™ Direct Visualization System (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.

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.

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 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.

Rx only

1. Smith BL, Hunt KK, Carr D, et al. Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery. NEJM Evid. 2023;2(7). doi:10.1056/EVIDoa2200333
2. Key Statistics for Breast Cancer. Accessed September 18, 2024. https://www.cancer.org/cancer/types/breastcancer/about/how-common-is-breast-cancer.html

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"We are proud to share Lumicell’s story and showcase the first and only imaging combination product approved for detecting cancerous tissue where and when it matters most, inside the breast cavity during surgery,” said Howard Hechler, President, Lumicell.