Congrats to the Lumicell team on their FDA approval! This marks a significant moment in the company's history and a major milestone in our mission to revolutionize the paradigm of cancer surgery. Breast cancer ranks as the second leading cause of death among women, with a 1 in 8 risk of diagnosis. Up to 40% of patients experience cancer recurrence due to residual cancer cells. Powered by a Nobel Prize winning team and technology, Lumicell is on the mission to dramatically change the face of surgical oncology so that outcomes during cancer surgery are dramatically improved. Lumicell previously received FDA Fast Track and Breakthrough Device designations for its innovative technology. With the FDA’s historic approval, LumiSystem is now the first and only imaging combination product capable of detecting cancer where it matters most, inside the breast cavity. With 84% diagnostic accuracy, LumiSystem enables surgeons to scan the breast cavity post-lumpectomy, in real-time, to detect and resect residual cancer that may have otherwise been missed. Surgeons can use Lumicell's imaging platform to detect and remove cancer, cell by cell. #HealthcareInnovation #FDAapproval #CancerSurgery
BREAKING NEWS: LUMISIGHT™ and Lumicell™ DVS are FDA-approved, and together are referred to as LumiSystem™. With 84% diagnostic accuracy, LumiSystem enables surgeons to scan the breast cavity post-lumpectomy, in real-time, to detect and resect residual cancer that may have otherwise been missed, potentially sparing some patients from second surgeries. 1-2 The most common side effects with LUMISIGHT are hypersensitivity and an abnormal color in urine. LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Read our release here: https://bit.ly/4cXkvqR Please see the LUMISIGHT Prescribing Information (https://bit.ly/440dAZK), including Boxed Warning, and Lumicell DVS Instructions for Use (https://bit.ly/3Q78nK9). For complete product information, visit www.LumiSystem.com. 1. Diagnostic accuracy is based on true positive and true negative images detected in the LumiSystem pivotal trial 2. Smith, et al., NEJM Evidence 2023; 2(7) #FDA-Approved #LUMISIGHT, #LumicellDVS, #LumiSystem, #Lumicell