Today's Date: March 28, 2024
Gale Primary Sources Release Four New Archives Devoted to Contributions from Underrecognized Communities   •   Scotiabank ranks on The Globe and Mail's annual Women Lead Here benchmark of executive gender diversity for the fourth consecuti   •   University of Phoenix Receives Arizona Veteran Supportive Campus Recertification   •   Key Piece of “Titanic” Movie Memorabilia Purchased By Titanic Museum Attraction   •   80 M/other Artists Converge for MICAfest 2024 in Northampton, MA this May   •   New Report Shows Massachusetts Customers Could Have Saved Hundreds of Millions in 2024 Through Competitive Energy Supply   •   Consolidated Credit Launches Free Webinar Series to Empower Individuals During Challenging Economic Climate   •   Dawson-Forté Cashmere Shareholders Sell Majority Equity Stake to Tempus Partners   •   Pushing Policy: Women Uniting for Legislative Change; Four Trailblazing women at the forefront of the Quad Caucus   •   Bill Introduced in Minnesota Would Increase Access To Genetic Testing   •   Taro Pharmaceuticals U.S.A., Inc. Expands OTC Portfolio for Children with the Introduction of bébé Bottoms™   •   Impact Communications Signs Best-Selling Book Author and Financial Advisor Coach Derrick Kinney   •   Argonne-Supported Critical Materials Assessment Tags Potential Supply Chain Bottlenecks   •   UC Berkeley FHL Vive Center Teams Up with BeamNG   •   More $10-a-day child care spaces   •   Impacts of Extreme Weather on Interior Design Examined in New Research   •   Chevron Announces Opening of Fab Labs at HBCUs   •   JAMS Diversity Fellowship Accepting Applications   •   Paralyzed Veterans of America to honor former Senator Elizabeth Dole with 2024 Gordon H. Mansfield Congressional Leadership Awar   •   PMI Foods Gives Easter Donation of 15,000 Pounds of Prime Rib to New Life Church in Arkansas
Bookmark and Share

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)

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.


STORY TAGS: Photo/Multimedia, United States, North America, Biotechnology, FDA, Medical Devices, Health, Oncology, Massachusetts, Product/Service,

Video

White House Live Stream
LIVE VIDEO EVERY SATURDAY
alsharpton Rev. Al Sharpton
9 to 11 am EST
jjackson Rev. Jesse Jackson
10 to noon CST


Video

LIVE BROADCASTS
Sounds Make the News ®
WAOK-Urban
Atlanta - WAOK-Urban
KPFA-Progressive
Berkley / San Francisco - KPFA-Progressive
WVON-Urban
Chicago - WVON-Urban
KJLH - Urban
Los Angeles - KJLH - Urban
WKDM-Mandarin Chinese
New York - WKDM-Mandarin Chinese
WADO-Spanish
New York - WADO-Spanish
WBAI - Progressive
New York - WBAI - Progressive
WOL-Urban
Washington - WOL-Urban

Listen to United Natiosns News