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FDA

Lumicell’s Cutting-Edge Imaging Platform Receives Historic FDA Approval to Illuminate Residual Breast Cancer

Lumicell, Inc. today announced the U.S. Food & Drug Administration (FDA) approved the company’s New Drug Application (NDA) for its LUMISIGHT™ (pegulicianine) optical imaging agent and its Premarket Approval (PMA) application for Lumicell™ Direct Visualization System (DVS), together referred to as LumiSystem™.

April 18, 2024

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7 min read

Genetown

Lumicell Introduces Further Research and Insights in Fluorescence-Guided Surgery at the Society of Surgical Oncology (SSO) Annual Meeting

Lumicell Inc highlights presentations from clinical studies examining the use of investigational LUMISIGHT™ (pegulicianine) in combination with Lumicell™ Direct Visualization System (DVS) at the Society of Surgical Oncology Annual Meeting in Atlanta, Georgia, March 20-23, 2024.

March 25, 2024

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4 min read

Press Releases

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

September 30, 2024

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6 min read

Genetown

Lumicell Announces Initial Data Demonstrating LUMISIGHT™’s Ability to Detect Tumors Metastasized to Multiple Organs in the Peritoneum

Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced promising initial data from its ongoing feasibility study for lead candidate LUMISIGHT™ to detect peritoneal malignancies during surgical debulking.

February 20, 2024

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4 min read

Genetown

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

Lumicell, Inc 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.

March 6, 2024

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3 min read

Genetown

Lumicell Co-Founder Moungi Bawendi Awarded Nobel Prize in Chemistry

Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, announced company co-founder Moungi G. Bawendi, PhD, is one of three recipients of the Nobel Prize in Chemistry 2023 for the discovery and synthesis of quantum dots.

October 5, 2023

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3 min read

Genetown

Lumicell Announces FDA Acceptance and Priority Review of New Drug Application for LUMISIGHT™ Optical Imaging Agent for Breast Cancer

Lumicell, Inc today announced the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for the LUMISIGHT™ Optical Imaging Agent and accepted the Premarket Approval (PMA) application for the Lumicell™ Direct Visualization System (DVS).

May 22, 2023

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5 min read

Genetown

Lumicell™ Direct Visualization System Premarket Approval Application Submitted to U.S. FDA for Intraoperative Breast Cancer Detection and Removal

Lumicell, Inc today announced a Premarket Approval (PMA) application for its Lumicell™ Direct Visualization System (DVS) has been submitted to the U.S. Food and Drug Administration (FDA).

April 18, 2023

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4 min read

Genetown

Lumicell Submits New Drug Application for LUMISIGHT™ Optical Imaging Agent to U.S. FDA for Intraoperative Breast Cancer Detection and Removal

Lumicell, Inc. today announced a New Drug Application (NDA) for its LUMISIGHT™ Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA).

March 21, 2023

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5 min read

Genetown

Lumicell™ DVS Pivotal Trial Results Published in NEJM Evidence and to Be Presented at ASBrS Assess Safety and Effectiveness of System for Identifying Residual Breast Cancer During Lumpectomy

Lumicell, Inc. today announced that results of the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial have been published online in NEJM Evidence and will be presented at the American Society of Breast Surgeons (ASBrS) annual meeting.

April 27, 2023

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7 min read