LUMICELL, INC.


Associated tags: Lung, Brain, Prostate cancer, Patient, Breast cancer, Health, FDA, Oncology, Medical Devices, Surgery, Medical imaging, Lumicel Animation Studios, DVS, Pharmaceutical industry, Surgeon, Federal, Optical flow, Biotechnology, New Drug Application, PMA, Society, Clinical Trials, NDA

Locations: MASSACHUSETTS, UNITED STATES, NORTH AMERICA

Lumicell’s Cutting-Edge Imaging Platform Receives Historic FDA Approval to Illuminate Residual Breast Cancer

Retrieved on: 
Thursday, April 18, 2024
Medical Devices, Surgery, FDA, Clinical Trials, Health Technology, Other Health, Biotechnology, Pharmaceutical, Health, Oncology, Urine, Society, Cancer, Hospital, Safety, Woman, NDA, New Drug Application, Surgeon, Breast, MD, Doctor of Philosophy, Patient, DVS, Anaphylaxis, Hypersensitivity, NEJM, Harvard Medical School, Multimedia, MD Anderson Cancer Center, Surgical oncology, Neoplasm, Massachusetts General Hospital, PMA, Breast cancer, Medical imaging

The most common side effects with LUMISIGHT are hypersensitivity and an abnormal color in urine.

Key Points: 
  • The most common side effects with LUMISIGHT are hypersensitivity and an abnormal color in urine.
  • Results of the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial, used to support the efficacy of the system, were published in NEJM Evidence .
  • “We want to thank our clinical investigators and the hundreds of women who participated in our breast program for LUMISIGHT and Lumicell DVS,” said Jorge Ferrer, Chief Scientific Officer, Lumicell.
  • “Due to your important contributions, LUMISIGHT and Lumicell DVS are now approved and will be available in the United States shortly.”
    Please visit www.LumiSystem.com to learn more about LUMISIGHT and Lumicell DVS.

Lumicell Announces Initial Data Demonstrating LUMISIGHT™’s Ability to Detect Tumors Metastasized to Multiple Organs in the Peritoneum

Retrieved on: 
Tuesday, February 20, 2024
Research, Medical Devices, Surgery, Clinical Trials, Health Technology, Biotechnology, Radiology, Health, Science, Oncology, Society, Survival, Massachusetts General Hospital, Peritoneum, Hospital, Optical flow, Peritoneal cavity, Surgical oncology, Associate, Patient, Dentistry

The ongoing study is utilizing the investigational LUMISIGHT optical imaging drug and accompanying imaging device to distinguish tumor metastases to organs within the peritoneum.

Key Points: 
  • The ongoing study is utilizing the investigational LUMISIGHT optical imaging drug and accompanying imaging device to distinguish tumor metastases to organs within the peritoneum.
  • “This data advances the potential for image-guided surgery to detect small tumors and metastases to organs in the peritoneal cavity which could provide better outcomes for our patients,” said Dr. Cusack.
  • “Further innovation is desperately needed to improve the benefits of cytoreductive surgery for this invasive and elusive cancer.
  • Everything we do at Lumicell is focused on improving surgical outcomes for patients,” said Howard Hechler, President of Lumicell.

Lumicell Co-Founder Moungi Bawendi Awarded Nobel Prize in Chemistry

Retrieved on: 
Thursday, October 5, 2023
Surgery, Medical Devices, FDA, Health Technology, Biotechnology, Other Health, Health, General Health, Oncology, Quantum, Massachusetts Institute of Technology School of Science, Doctor of Philosophy, Breast cancer, Nobel Prize, DVS, Patient, NDA, MIT, New Drug Application, PMA, Research, Medical imaging, Pharmaceutical industry, Chemistry, Lumicel Animation Studios

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 recipients of the Nobel Prize in Chemistry 2023 for the discovery and synthesis of quantum dots.

Key Points: 
  • 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 recipients of the Nobel Prize in Chemistry 2023 for the discovery and synthesis of quantum dots.
  • The investigational Lumicell Direct Visualization System (DVS), which is designed to assist in the detection of residual cancerous tissue during lumpectomy using fluorescence imaging, was developed in Bawendi’s lab at the Massachusetts Institute of Technology (MIT).
  • The New Drug Application (NDA) for the LUMISIGHT™ Optical Imaging Agent and Premarket Approval (PMA) application for the Lumicell™ Direct Visualization System (DVS) are currently under review by the U.S. Food & Drug Administration.
  • Images are available for download from the Massachusetts Institute of Technology.

Lumicell Announces FDA Acceptance and Priority Review of New Drug Application for LUMISIGHT™ Optical Imaging Agent for Breast Cancer

Retrieved on: 
Monday, May 22, 2023
Biotechnology, Pharmaceutical, Surgery, Oncology, Health, FDA, Medical Devices, Clinical Trials, Surgeon, American Society of Breast Surgeons, Food, Marie Cassidy, JAMA Surgery, New Drug Application, The New England Journal of Medicine, Pathology, NDA, Woman, Optical flow, Multimedia, Federal, Lumpectomy, NEJM, PMA, Patient, DVS, Phase, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Breast cancer, Pharmaceutical industry, Medical imaging, Lumicel Animation Studios

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).

Key Points: 
  • 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 and LUMISIGHT are limited by Federal (or United States) law to investigational use only.
  • The Lumicell DVS is intended for use with the investigational optical imaging agent LUMISIGHT (pegulicianine) for fluorescence imaging of the lumpectomy cavity.
  • “Priority Review designation is further recognition of the potential of our system to significantly improve the effectiveness of breast cancer treatment.

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

Retrieved on: 
Thursday, April 27, 2023
Biotechnology, Health, Women, Oncology, Men, Health Technology, Medical Devices, Hospitals, Surgery, Consumer, Clinical Trials, Surgeon, The New England Journal of Medicine, Marie Cassidy, New Drug Application, NDA, Cancer, Operation Time, Optical flow, Multimedia, Federal, Research, Doctor of Philosophy, Lumpectomy, NEJM, Harvard Medical School, PMA, MD, Patient, Neoplasm, Hospital, DVS, FDA, Massachusetts General Hospital, Breast cancer, Society, Safety, Medical imaging, Lumicel Animation Studios

The results highlight the safety and effectiveness findings of the company’s pivotal trial of its investigational Lumicell™ Direct Visualization System (DVS) to identify residual breast cancer following removal of the primary specimen during initial lumpectomy.

Key Points: 
  • The results highlight the safety and effectiveness findings of the company’s pivotal trial of its investigational Lumicell™ Direct Visualization System (DVS) to identify residual breast cancer following removal of the primary specimen during initial lumpectomy.
  • The Lumicell DVS and LUMISIGHT are limited by Federal (or United States) law to investigational use only.
  • (Photo: Business Wire)
    In the INSITE trial, the Lumicell DVS identified cancer remaining after the standard of care lumpectomy procedure in approximately 8% of patients.
  • The additional residual cancer identified by the Lumicell DVS measured 1-13 mm and included areas of low- and high-grade tumor in patients across all tumor types.

Lumicell™ Direct Visualization System Premarket Approval Application Submitted to U.S. FDA for Intraoperative Breast Cancer Detection and Removal

Retrieved on: 
Tuesday, April 18, 2023
Oncology, Health, FDA, Medical Devices, Surgery, Clinical Trials, Pharmaceutical, Surgeon, Food, New Drug Application, NDA, Optical flow, Multimedia, Federal, Stanford University School of Medicine, PMA, MD, Patient, DVS, Breast cancer, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Pharmaceutical industry, Medical imaging, Lumicel Animation Studios

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).

Key Points: 
  • 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).
  • To learn more about detecting residual cancer in real time, please visit www.illuminatecancerrealtime.com.
  • The New Drug Application (NDA) for LUMISIGHT was submitted to the FDA in March 2023.
  • “A device like the Lumicell DVS which can look inside the breast cavity for residual cancer could be a crucial tool to help improve patient outcomes.”

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

Retrieved on: 
Tuesday, March 21, 2023
Biotechnology, FDA, Medical Devices, Health, Oncology, Surgeon, Food, New Drug Application, NDA, Cancer, Woman, Optical flow, Multimedia, Federal, Doctor of Philosophy, Harvard Medical School, PMA, MD, Patient, Risk, Hospital, DVS, Massachusetts General Hospital, Recurrence, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Breast cancer, Pharmaceutical industry, Medical imaging, Lumicel Animation Studios

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).

Key Points: 
  • 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).
  • 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.
  • “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.

Lumicell Appoints Brent Palmisano Chief Commercial Officer, Builds Commercial Team

Retrieved on: 
Monday, June 13, 2022
Pharmaceutical, Surgery, Oncology, Health, FDA, Medical Devices, Hospitals, Clinical Trials, Endius, Marketing, LinkedIn, Software, Breast cancer, Lumicel Animation Studios, Organization, Cervical cancer, FDA, DVS, Patient, Technology, Health, Twitter, JAMA Surgery, Federal, Surgeon, Cancer, Safety, Boston Scientific, Television, Pharmaceutical industry, Medical imaging, Facebook, Palmisano

The company appointed industry veterans Brent Palmisano as chief commercial officer and Lauren Cohen as vice president of marketing and communications.

Key Points: 
  • The company appointed industry veterans Brent Palmisano as chief commercial officer and Lauren Cohen as vice president of marketing and communications.
  • Brent and Laurens experience in launching womens health and medical device technologies will be instrumental as we focus on bringing our innovative Lumicell DVS to market, said Kevin Hershberger, president and chief executive officer of Lumicell.
  • Palmisano brings more than 20 years of experience to Lumicell and has a demonstrated track record in building and leading medical device commercial organizations.
  • Most recently he served as senior vice president of global commercial operations for Dysis Medical, a company focused on the cervical cancer market.

Clinical Data on Lumicell’s Direct Visualization System to Be Presented at International Conference on Surgical Cancer Care

Retrieved on: 
Wednesday, March 9, 2022
Oncology, Medical Devices, Health, Hospitals, Surgery, Radiology, Safety, Duke University Health System, University, Patient, DVS, FDA, Ductal carcinoma, Cancer, Conference, NCI, Woman, MD Anderson Cancer Center, Death, Society, Neoadjuvant therapy, Duke Cancer Institute, Breast cancer, DCIS, Technology, Software, Surgeon, Method, BCS, Surgery, Federal, Adult, Pharmaceutical industry, Medical imaging, Lumicel Animation Studios, Lumicell DVS Clinical Studies, Breast Cancer Surgery, Lumicell, Inc., LUMICELL DVS CLINICAL STUDIES, BREAST CANCER SURGERY, LUMICELL, INC.

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 Oncologys International Conference on Surgical Cancer Care (SSO2022).

Key Points: 
  • 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 Oncologys International Conference on Surgical Cancer Care (SSO2022).
  • The system will also be featured in an industry-sponsored symposium at the conference, which is taking place March 9-12 in Dallas.
  • The Lumicell DVS features the proprietary LUMISIGHT optical imaging agent, hand-held imaging probe and patient calibrated software.
  • The company aims to enhance the standard of care treatment by guiding the resection of additional cancer that may have otherwise been left behind.

Lumicell Announces Initiation of NIH/NCI Academic-Industry Study of its LUM Imaging System

Retrieved on: 
Tuesday, September 29, 2020
RTT, Health, Clinical medicine, Prostate cancer, Cancer, Breast cancer, Ovarian cancer, Treatment of cancer, Brain metastasis, NeuVax

The study also focuses on collecting data as the first step to investigate the potential long-term impact of the LUM Imaging System in breast cancer treatment.

Key Points: 
  • The study also focuses on collecting data as the first step to investigate the potential long-term impact of the LUM Imaging System in breast cancer treatment.
  • The LUM Imaging System was developed to enable surgeons to see and remove residual cancer in real time during the initial surgery.
  • Data from the Phase C study and the ongoing pivotal study will be used to support an application to the FDA for market approval for the LUM Imaging System.
  • Lumicell is investigating the LUM Imaging System in patients undergoing surgery for breast cancer, prostate cancer, colorectal, esophageal, ovarian, peritoneal and brain cancers.