Location: Newton, MA
Press Release, Regulatory May 22, 2023 Lumicell Comment: 1

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™ Direct Visualization System (DVS). The Lumicell DVS is an investigational system designed for...
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Clinical Studies, Press Release April 27, 2023 Lumicell Comments: 4

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 results highlight the safety and effectiveness findings of the company’s...
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Press Release, Regulatory April 18, 2023 Lumicell Comments: 2

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)....
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Press Release, Regulatory March 21, 2023 Lumicell Comments: 0

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)....
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Company News, Press Release June 22, 2022 Lumicell Comments: 0

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....
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Clinical Studies, Press Release March 9, 2022 Lumicell Comments: 0

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)....
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Clinical Studies, Press Release September 30, 2021 Lumicell Comments: 0

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)....
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Press Release, Regulatory November 17, 2020 Lumicell Comments: 0

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....
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Clinical Studies, Press Release September 29, 2020 Lumicell Comments: 0

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, randomized clinical study utilizing the LUM Imaging System to obtain additional safety and efficacy data in brea...
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Company News, Press Release September 16, 2020 Lumicell Comments: 0

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 operational experience across a range of life sciences technologies to optimize and execute Lumicell’s c...
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