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).
Lumicell Granted Fast Track Designation Approval by the FDA for Breast Cancer Treatment
Lumicell, Inc., an innovation leader in image guided cancer surgery, today announced it has received Fast Track designation with rolling review from the FDA Center for Drug Evaluation and Research (CDER) to expedite the development and review of the LUM Imaging System in the treatment of Breast Cancer.
Lumicell Announces Initiation of NIH/NCI Academic-Industry Study of its LUM Imaging System
R01 Award to fund multi-phase randomized study to expand clinical safety and efficacy data of the system in the detection of residual tumor in breast cancer patients receiving neoadjuvant therapies Newton, Mass., Sept. 29, 2020 – Lumicell, Inc. today announced that Dr. Barbara Smith, Director of the Breast Program at Massachusetts General Hospital, has begun a multi-phase, […]
Howard Hechler Joins Lumicell as Senior Vice President of Strategy & Business Development
Hechler brings more than 15 years of focused life-sciences experience in M&A, strategy, andoperations Newton, Mass., Sept. 16, 2020 – Lumicell, Inc., a leader in image-guided cancer surgery, today announced the addition of Howard Hechler as Senior Vice President of Strategy & Business Development. In this new role, Mr. Hechler will leverage his depth of transactional and […]
Lumicell Initiates Pivotal Trial for Breast Cancer Surgical Guidance Solution
Success with In Vivo Examination of Cancerous Tissue via the Lumicell Imaging System During the Pivotal Trial will Propel the Technology Toward FDA Submission Newton, Mass., November 5, 2019 – Lumicell, Inc., an innovation leader in image guided cancer surgery, today announced it has begun its pivotal trial of the Lumicell Imaging System for breast cancer — a major […]
Lumicell Completes Enrollment of Phase C Feasibility Trial for Breast Cancer Surgical Guidance Solution
Pivotal trial expected to begin by end of 2019 for the Lumicell Imaging System for intraoperative detection and removal of residual cancer in breast-conserving surgery. Newton, Mass., August 19, 2019 — Lumicell, Inc. an innovation leader in image guided cancer surgery, today announced that it has completed enrollment in its Phase C feasibility clinical trial […]
