Lumeda DigiLum™ is a complete photodynamic therapy (PDT) solution for treating Non-Small Cell Lung Cancer (NSCLC) and pleural disease. Our plan is to market DigiLum as a cross-labeled photosensitizer agent and light activation system. The photosensitizer and disposable light delivery device will be ordered as a single-use, co-packaged item for activation using the DigiLum™ light source instrumentation module in the operating room.
The photosensitizer agent used with DigiLum produces a cytotoxic reactive oxygen species upon visible light illumination that promotes cell death. The agent is administered by intravenous infusion prior to treatment and selectively accumulates in cancer cells. Minor precautions such as avoiding direct sunlight are taken after administration and continue following light activation for several days.
Conformal Light Applicator (CLA)
The core technology behind Lumeda DigiLum™ is a novel optical surface applicator device demonstrated by Roswell Park Comprehensive Cancer Center, a global center of excellence in translational photodynamic therapy research. This revolutionary device incorporates multiple light delivery and monitoring fiber optics in a flexible mesh that enables PDT light administration directly in contact with target tissue. This design and method of light-tissue interaction is unique in its ability to quickly administer light precisely to prescribed light dosimetry parameters. The DigiLum™ kit will include the photosensitizer agent and the disposable light applicator that will come in sterilized packaging and be equipped with a keyed connector to easily and securely attach to the light source instrument in the surgical setting.
DigiLum™ Instrumentation Module
The DigiLum™ light source instrumentation module has a touch-screen interface and is a portable unit on a wheeled cart designed for ease of use in the operating room environment. The instrument chassis houses the light source, electronics processor, and optical detection and routing circuit. The instrument output is an optical umbilical cable supported by an articulating arm that connects to the light applicator. The self-contained unit includes all power, communications, and data collection and storage components and interfaces.
The DigiLum™ instrument comes pre-loaded with Lumeda Odyssey™ operating software that controls the system. Prior to surgery, the operator inputs target light delivery intensity profile and dosimetry parameters. Once the applicator is connected, the DigiLum™ system is touchscreen-activated which initiates a systems self-diagnostic check that confirms all components are properly connected, operational, and the system ready for PDT light delivery. The operator then activates PDT light delivery in which the system runs a sequence that automatically delivers light to the OSA to programmed parameters, while monitoring and recording the light delivery parameters in real time. Once complete, the system confirms PDT light delivery and notifies the operator that treatment has been completed and it is safe to remove the device from the patient. The system is capable of light delivery to a broad range of intensity profiles and dosimetry parameters based on CT images to define tumor size, shape and anatomical structure. Lumeda DigiLum™ software calculates the instrument light delivery routine based on an Artificial Intelligence machine-learning algorithm (Patent Pending) to accurately reproduce the input profile and dosimetry settings.