
Imaging technologies developer Lumicell has announced the US commercial availability and first commercial use of the LumiSystem device.
LumiSystem is a fluorescence-guided imaging technology designed for real-time detection of residual breast cancer during lumpectomy.
It combines two US Food and Drug Administration (FDA)-approved products, LUMISIGHT and the Lumicell Direct Visualization System (DVS). Both products secured FDA approval in April last year.
LUMISIGHT (pegulicianine) is an optical imaging agent that highlights cancerous tissues.
Lumicell DVS, on the other hand, is a fluorescence imaging device that offers real-time fluorescence guidance during lumpectomy surgery for scanning the breast cavity.
LumiSystem provides real-time cancer detection inside the breast during surgery.
Unlike other systems that analyse tissue after removal, LumiSystem helps surgeons spot and remove suspicious tissue on the spot. This leads to more complete resections and reduces the need for follow-up procedures.
Lumicell CEO Howard Hechler said: “Today, with LumiSystem’s commercial launch, we empower surgeons with a groundbreaking tool that detects cancer where and when it matters most, inside the breast cavity and in real-time.
“This launch reflects Lumicell’s unwavering commitment to enhancing surgical outcomes for patients.”
According to Lumicell, LumiSystem improved surgical outcomes in 10% of patients in the INSITE pivotal trial, with an 84% diagnostic accuracy rate.
It provides a more thorough approach to breast-conserving surgery, improving patient care by detecting cancerous tissue that might be missed by surgeons and pathologists.
Stanford University School of Medicine surgery professor and breast surgical oncologist Irene Wapnir said: “We breast surgeons know all too well the limitations of lumpectomy and the difficult conversations we have with patients about the possibility of a second surgery due to positive margins.
“Stanford is excited to adopt LumiSystem because, with its real-time fluorescence guidance, we are now able to detect and remove more cancerous tissue during surgery while still sparing as much healthy breast tissue as possible.”
LUMISIGHT is also being explored for further development in various solid tumour indications.
In September 2024, Lumicell received a Phase I Small Business Innovation Research (SBIR) contract from the National Cancer Institute (NCI) to develop a flexible endoscopic platform.
The platform will detect precancerous and early-stage oesophageal adenocarcinoma (EAC) during standard clinical endoscopy.