Lumicell Submits New Drug Application for LUMISIGHT™ Optical Imaging...

Your unfiltered news center. ®

The world you see depends upon the news you get. ®

HOME

ARTS

RSS

Today's Date: June 4, 2023

Cupshe Celebrates 8th Birthday with Exclusive Collection in Collaboration with Chanel Iman, Heather Rae El Moussa, and Brittany • TAGRISSO® achieved unprecedented survival in early-stage EGFR-mutated lung cancer, with 88% of patients alive at five years • Bijou Ikli named new CEO by Florida Assisted Living Association • Tips for a smooth transition to senior living from the San Luis Obispo assisted living professionals • Statement by the Prime Minister to mark four years since the publication of the final report of the National Inquiry into Missin • New PATHFINDER Study Analysis Demonstrates Efficient Diagnostic Resolution Following Multi-Cancer Early Detection Testing • Dorsett Wanchai Marks World Environment Day 2023 with Bold Paperless and Plastic-Free Sustainability Initiatives • Reigniting the Cancer Moonshot: Massive Bio Joins CancerX as Founding Member to Accelerate Innovation and AI Implementation in C • Government of Canada releases summary of actions taken to address the safety and wellbeing of Indigenous women, girls and 2SLGBT • Air Canada's Inaugural Amsterdam-Montreal Route Takes Off; Uplifts Sustainable Aviation Fuel in Amsterdam • Nucleai and Mayo Clinic BioPharma Diagnostics Announce Strategic Collaboration to Transform Digital Pathology for Drug Developme • Four-Year Outcomes from Phase 3 CheckMate -9LA Trial Show Durable, Long-Term Survival with Opdivo (nivolumab) Plus Yervoy (ipili • Promoting Diversity and Equity in Cancer Research, Women Leaders in Oncology® and Vaniam Group Announce Recipients of 2023 Y • GRAIL Presents Real-World Experience With The Galleri® Multi-Cancer Early Detection Test At 2023 ASCO Annual Meeting • ELAHERE® Demonstrates 35% Reduction in the Risk of Disease Progression or Death Versus Chemotherapy in FRα-Positive Pl • High Schooler empowers Youth with Nonprofit "Unlimited Potential", raises $100,000 for Sports Medicine Research and Advocacy • Research Results from Ontada HOPE Studies Presented at ASCO 2023 Illuminate How Social Determinants of Health Impact Different P • Puma Biotechnology Announces Presentation of Biomarker Findings from a Phase II Study of Alisertib with Paclitaxel versus Paclit • Statement by the Prime Minister on Canadian Armed Forces Day • Promising Data for Investigational Innovative Bispecific Ivonescimab Featured at ASCO 2023

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

NEWTON, Mass. , March 21 /Businesswire/ - 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).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230303005315/en/

The investigational Lumicell™ Direct Visualization System (DVS) is intended for use with the LUMISIGHT Optical Imaging Agent and features a hand-held imaging probe that is designed to go inside the breast cavity and a patient-calibrated cancer detection software to assist in the detection of residual cancer, thereby enabling a more complete resection. To learn more about detecting residual cancer in real time, please visit www.illuminatecancerrealtime.com. The Lumicell DVS and LUMISIGHT are limited by Federal (or United States) law to investigational use only. The Lumicell DVS is not commercially available. (Photo: Business Wire)

LUMISIGHT is intended for use with the Lumicell™ Direct Visualization System (DVS), an investigational system designed to assist in the detection of residual cancerous tissue within the lumpectomy cavity following removal of the primary specimen during breast conserving surgery.

“Lumicell is committed to revolutionizing the way breast cancer surgery is performed and bringing the benefits of the Lumicell Direct Visualization System to breast cancer patients,” said Kevin Hershberger, president and chief executive officer of Lumicell. “Submission of the LUMISIGHT NDA is a significant step toward achieving this goal. We look forward to working with the FDA on acceptance of our LUMISIGHT application for review and submitting the PMA for the Lumicell DVS in the second quarter.”

The LUMISIGHT NDA submission is supported by data from more than 700 breast cancer patients across five clinical studies at top academic and regional community cancer centers. Results from the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial (NCT03686215) of 406 patients at 14 sites will be presented at the upcoming American Society of Breast Surgeons (ASBrS) annual meeting. The FDA granted LUMISIGHT Fast Track designation and the Lumicell DVS Breakthrough Device designation in recognition of its potential benefit of identifying residual cancer after the initial lumpectomy.

“Data has shown that the risk of local recurrence is directly related to incomplete tumor removal. Currently, at least 20% of women having breast conserving surgery require a second surgery because of positive margins and 6-10% of women with breast cancer experience a local recurrence,” said Barbara Smith, MD, PhD, director of the Breast Program at Massachusetts General Hospital, professor of surgery at Harvard Medical School and lead investigator of the INSITE clinical trial. “As surgeons, technology that helps ensure we are doing everything in our power to remove cancer during the initial lumpectomy gives us and patients greater piece of mind and has the potential to support improved outcomes.”

About the Lumicell Direct Visualization System

The investigational Lumicell Direct Visualization System (DVS) is intended for use with the LUMISIGHT Optical Imaging Agent and features a hand-held imaging probe that is designed to go inside the breast cavity and a patient-calibrated cancer detection software to assist in the detection of residual cancer, thereby enabling a more complete resection. The safety and efficacy of the Lumicell DVS in detecting residual cancer left behind by standard of care surgical procedures has been evaluated in two studies: INSITE and a feasibility study of 234 patients at 16 sites, results of which were published in JAMA Surgery.

The Lumicell DVS and LUMISIGHT are limited by Federal (or United States) law to investigational use only. The Lumicell DVS is not commercially available.

About Lumicell, Inc.

Lumicell is a privately held company focused on improving surgical outcomes and reducing healthcare costs by utilizing its innovative fluorescence-guided surgical technologies to enable a more complete resection of cancer that may have otherwise been left behind. The company’s first product in development is the Lumicell Direct Visualization System, designed to illuminate cancerous tissue within the breast cavity during the initial lumpectomy procedure. Lumicell’s proprietary, pan-oncologic optical imaging agent LUMISIGHT is also being explored across a wide variety of solid tumor indications. For more information, please visit www.lumicell.com and follow the company on Facebook, Twitter and LinkedIn.