The FDA has accepted the Premarket Approval application for Lumicell™ Direct Visualization System, allowing for a revolutionary imaging technique that provides clear visualization of cells deep within the body! This cutting-edge technology has the potential to revolutionize medical diagnosis and treatments, providing faster, more accurate results and revolutionizing our understanding of the body.
If approved, Lumisight and the Lumicell DVS will become revolutionary agents and devices that allow clinicians to perform a real-time assessment of the lumpectomy cavity – a groundbreaking innovation in the field of optical imaging.
The revolutionary system uses cutting edge technology to visually detect cancer cells that may be missed by standard of care. This groundbreaking system is designed to further enhance early-stage detection, ensuring those affected get the care they need at the earliest opportunity.
The U.S. Food and Drug Administration (FDA) has granted Lumicell, Inc. a priority review for their fluorescence-guided imaging technologies for cancer surgery. This includes their LUMISIGHT™ Optical Imaging Agent, and their Lumicell™ Direct Visualization System (DVS). Lumicell is excited to have their breakthrough technology bringing hope to those battling cancer as they work towards potential FDA approval.
The Lumicell DVS offers an innovative solution to assist in the detection of residual cancerous tissue in the lumpectomy cavity post-surgery. By combining the advanced imaging techonology with the investigational optical agent LUMISIGHT, this system can help to ensure that no trace of cancerous cells is left behind and improve outcomes for patients undergoing breast conserving surgery.
We are thrilled to announce that the FDA have accepted both the NDA and PMA submissions for our Lumisight Optical Imaging Agent and Lumicell Direct Visualization System, bringing us closer to revolutionizing the treatment of breast cancer.
The Priority Review designation further highlights the immense potential of our system in creating an ever more effective approach to breast cancer care. We look forward to the FDA’s review and the possibility of offering surgeons a first-of-its-kind visualization system to enable more complete removal of cancerous tumors during lumpectomies.
The FDA has given LUMISIGHT Fast Track and Lumicell DVS Breakthrough Device designations to investigate the potential important benefits of pinpointing residual cancer during lumpectomies. Five clinical studies at top academic and regional community cancer centers have provided valuable data from over 700 breast cancer patients.
Results of the INSITE study were published in NEJM Evidence and the Phase C study in JAMA Surgery, confirming the efficacy of this novel surgical imaging technology. With its success in finding and removing residual cancer, Lumisight could have a tremendous impact on breast cancer treatment outcomes.
Currently, a large percentage of lumpectomies have positive margins, and more disturbingly, roughly 14% of cases initially determined to have negative margins still have residual cancer left behind.
Our system, if approved, has the potential to revolutionize lumpectomy surgery by allowing breast surgeons to look inside the lumpectomy cavity during the initial procedure and identify, and remove, any residual cancer more reliably. With this potentially life-saving technology, lumpectomy surgery can move from the current standard of care to a more comprehensive and effective cancer resection.
About the Lumicell Direct Visualization System and LUMISIGHT Optical Imaging Agent
The Lumicell™ DVS is an exciting new system under investigation to aid in the detection of residual malignant tissue in patients with breast cancer who have undergone a lumpectomy. The device, intended to be used with the proprietary Lumisight Optical Imaging Agent, harnesses a hand-held imaging probe that takes a visual tour of the breast cavity along with patient-specific software to assist in the efficient removal of any remaining cancer. This revolutionary and versatile system is being actively explored for a variety of solid tumor indications.
The Lumicell DVS and LUMISIGHT technology, while promising in the realm of medical imaging, are unfortunately restricted to only investigational use in the United States. Unfortunately, this means they are not currently available for commercial use. Nevertheless, advancements are being made as this revolutionary technology holds great potential for improving disease diagnosis and treatment in the medical field.