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
NEWTON, Massachusetts – 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 […]
Lumicell Announces Initial Data Demonstrating LUMISIGHT™’s Ability to Detect Tumors Metastasized to Multiple Organs in the Peritoneum
Promising feasibility study results for imaging technology that identified malignant peritoneal tumor metastasis during surgery NEWTON, Mass.–(BUSINESS WIRE)–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. The […]
Lumicell Co-Founder Moungi Bawendi Awarded Nobel Prize in Chemistry
Bawendi’s expertise in optics, fluorescent molecules and tissue imaging were instrumental in development of Lumicell Direct Visualization System, which is currently under FDA review NEWTON, Mass., October 5, 2023—Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced company co-founder Moungi G. Bawendi, PhD, is one of three […]
Lumicell Announces FDA Acceptance and Priority Review of New Drug Application for LUMISIGHT™ Optical Imaging Agent for Breast Cancer
NEWTON, Mass., May 22, 2023—Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, 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™ 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
NEWTON, Mass., April 27, 2023—Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, 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. The […]
Lumicell Direct Visualization System Premarket Approval Application Submitted to U.S. FDA for Intraoperative Breast Cancer Detection and Removal
Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, 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).
Lumicell Submits New Drug Application for LUMISIGHT™ Optical Imaging Agent to U.S. FDA for Intraoperative Breast Cancer Detection and Removal
Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, 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).
Lumicell Appoints Brent Palmisano Chief Commercial Officer, Builds Commercial Team
Lumicell, Inc. today announced it is building a commercial team to prepare for market launch of the Lumicell Direct Visualization System (DVS) which includes its novel optical imaging agent LUMISIGHT, upon FDA approval.
Clinical Data on Lumicell’s Direct Visualization System to Be Presented at International Conference on Surgical Cancer Care
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).
Lumicell Completes Enrollment in the INSITE Pivotal Trial for Intraoperative Breast Cancer Detection & Removal
In a significant milestone for breast cancer patients and advancement toward submission of its Lumicell Imaging System for regulatory approval, Lumicell has completed enrollment in their Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal clinical trial (NCT03686215).
