Lumicell Announces FDA Advisory Committee’s Positive Recommendation on the Benefit-Risk Profile of LUMISIGHT in the Detection of Cancerous Tissue During Breast Conserving Surgery

March 8, 2024 — Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer, today announced the Medical Imaging Drugs Advisory Committee (MIDAC) of the U.S Food and Drug Administration (FDA) voted in support of the benefit-risk profile of LUMISIGHT (pegulicianine) during the March 5, 2024 meeting.

The positive 16 to 2 vote (with 1 abstain vote) was based on the independent review of LUMISIGHT, an optical imaging agent used in combination with the Lumicell Direct Visualization System (DVS) for use in patients with breast cancer. This combination product is an intracavity, fluorescence-guided surgical imaging tool used to detect residual cancer in real-time during a lumpectomy surgery, also known as breast conserving surgery.

“The MIDAC’s discussion underscored the need for better tools to achieve a more complete cancer resection and improve surgical outcomes,” said Dr. Shelley Hwang, Leader of the Breast Oncology Program at Duke University. “The use of LUMISIGH and Lumicell™ DVS, in the pivotal trial, enabled real-time assessment of the breast cavity to remove residual cancer tissue that otherwise would have been missed, unlike any other surgical tool available on the market today.”

The MIDAC’s positive decision was based on the totality of evidence presented by Lumicell and the FDA including efficacy data in over 350 patients in the pivotal study and safety findings from more than 700 patients across six clinical studies. Results of the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial were published in NEJM Evidence.

“This MIDAC vote, supported by more than 10 years of clinical evidence, is an exciting further validation of our work,” said Jorge Ferrer, Chief Scientific Officer, Lumicell. “We appreciate the valuable insights shared by the FDA, patients and the advisory community about the need for surgical advances in breast conserving surgery, and we look forward to working with the FDA as it completes its review of LUMISIGHT’s New Drug Application (NDA) and Lumicell DVS’ Premarket Approval (PMA) application.”

MIDAC is responsible for providing independent advice that contributes to the quality of the FDA’s regulatory decision-making, lending credibility to the product review process.

The FDA is expected to make a decision on Lumicell’s NDA and PMA in the near future.

About Breast Cancer Lumpectomy

The standard of care for a lumpectomy involves breast surgeons and pathologists examining the margins of excised breast tissue post-surgery to infer whether any residual cancer remains behind in the breast cavity. As a result, 9 -36% of lumpectomies have positive margins only identified days after surgery, necessitating the patient to undergo a second surgery or reoperation to obtain clear margins or removal of all cancerous tissue.[i],[ii]. According to published literature, approximately 14% of patients determined by pathology to have negative margins, implying that no cancer remained inside the cavity, had residual cancer left behind, leading to worse outcomes.[i]

For more information: www.lumicell.com