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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Clinical Data on Lumicell’s Direct Visualization System to Be Presented at International Conference on Surgical Cancer Care

Newton, Mass., March 9, 2022  —Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced that clinical data from a 234-patient, multi-center feasibility study of the Lumicell Direct Visualization System (DVS) will be presented at the Society of Surgical Oncology’s International Conference on Surgical Cancer Care (SSO2022). The system will also be featured in an industry-sponsored symposium at the conference, which is taking place March 9-12 in Dallas.

The investigational Lumicell DVS is a novel solution designed to enable real-time assessment of the breast cavity, illuminating cancerous tissue that may have otherwise been left behind during the initial lumpectomy. The Lumicell DVS features the proprietary LUMISIGHT optical imaging agent, hand-held imaging probe and patient calibrated software.

“The Lumicell DVS is the first technology to image inside the breast surgical cavity vs. the removed tissue, and we are excited that the data being presented at this meeting will highlight the meaningful benefits it can offer surgeons and their patients,” said Kevin Hershberger, president and chief executive officer of Lumicell. “We look forward to completing the FDA filing for approval later this year, as well as sharing data from our pivotal INSITE Breast Cancer Trial in a peer-reviewed forum.”

Podium Presentation

Dr. Eun-Sil Shelley Hwang of Duke Cancer Institute and Duke University Health System will present results of the feasibility study evaluating the safety and initial efficacy of the investigational Lumicell DVS in identifying residual cancer in the tumor bed of patients undergoing breast conserving surgery (BCS) on Friday, March 11 at 10 a.m. CT. Abstract #20.

Industry Sponsored Symposium

Dr. Kelly Hunt of the University of Texas MD Anderson Cancer Center will discuss methods for intraoperative detection of positive margins in breast conserving surgery in a company-sponsored symposium on Friday, March 11 at 2 p.m. CT.

Live demonstrations of the system will be available at the Lumicell booth in the Breast Cancer Hub.

For more information, visit the Lumicell SSO2022 website.

About Lumicell DVS Clinical Studies

The prospective single arm feasibility study completed enrollment in late 2019 and included 234 patients newly diagnosed with invasive or intraductal cancer undergoing BCS at 16 U.S. sites; the results will be submitted for publication to a peer-review journal. This study preceded the company’s pivotal INSITE (Investigation of Novel Surgical Imaging for Tumor Excision) Breast Cancer Trial (NCT03686215) that completed enrollment in late 2021 with 406 adult patients across 14 sites, and the NCI-funded feasibility study (NCT04440982) that was initiated in fall 2020 to evaluate for the first time use of the Lumicell System in patients undergoing neoadjuvant therapy. Results of the INSITE Trial will be submitted for presentation and publication, as well as included in the company’s Premarket Approval and New Drug Application submissions to the U.S. Food & Drug Administration later this year.
The Lumicell DVS is a new combination product, and its components, including the new drug LUMISIGHT, are limited by Federal (or United States) law to investigational use only. The Lumicell DVS is not commercially available.

About Breast Cancer Surgery

More than 280,000 women are diagnosed with invasive breast cancer or ductal carcinoma in situ (DCIS) each year in the U.S., leading to approximately 43,000 deaths annually. , The majority of patients receive breast-conserving surgery as a critical first treatment step, with the goal of removing all cancer cells and leaving behind only healthy tissue. However, surgeons do not currently have the necessary tools to determine if all cancer has been removed during the initial surgery. Patients typically wait several days after surgery to learn if all cancer has been resected. Unfortunately, in as many as 20-40% of cases, cancer cells are found at the margins of the removed tissue, suggesting that residual cancer cells may remain and requiring patients to undergo a second invasive surgery to remove it.

About Lumicell, Inc.

Lumicell is a privately held company focused on innovative fluorescence-guided technologies for cancer surgery with the potential to improve patient outcomes and reduce healthcare costs. The company’s first product is the Lumicell Direct Visualization System, designed to illuminate cancerous tissue within the breast cavity during the initial lumpectomy, potentially reducing repeat surgeries. Lumicell’s proprietary, pan-oncologic optical imaging agent is also being explored across a wide variety of solid tumor indications. The company aims 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

1www.cancer.org/cancer/breast-cancer/
2seer.cancer.gov/statfacts/html/breast.html

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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.