Advanced Surgical Pathology Device

Abstract Diagnosing diseases relies heavily on pathologically analyzing tissue samples from patients. For cancers alone, over 30 million people undergo tissue biopsies annually in the US. While surgery currently represents the best standard of care treatment to cure invasive cancers, its success depends on timely excision of the tumor before it can spread. This is especially true for the removal of skin cancers, more common in the populace than all other malignancies combined, with Mohs surgery deemed the best treatment of choice for its high skin cancer cure rates. However, this procedure requires the repeated histopathological evaluation of patient tissue samples to confirmation of cancerous or non-cancerous tissue. This time-consuming step requires freezing, slicing, and preserving the tissue between microscope slides to take an image, adding 2-3 hours to surgical times. It increases operative times and the risk of postoperative complications including skin infections, bleeding or hematoma, wound dehiscence (disruption of recently repaired wounds), tissue necrosis, and pain. The process is also expensive, requiring ~$70k of equipment to set up, and pricy reagents and highly trained staff to maintain. There is an unmet need in the market for a cost-effective digital pathology solution to rapidly produce high-quality images. SurgiVance is developing a confocal-based Surgical Pathology System (SPS) to non-invasively and rapidly image intact specimens with high resolution. The SPS system uses a novel, patented line-scanning, stage-scanning confocal microscope. The NIH Phase 1 funded prototype successfully images standard sized specimens (5 mm x 10 mm) in only 17 seconds, at 1.2 µm lateral resolution and 8.6 µm optical section thickness. In this Phase II project, SurgiVance has 3 specific aims: 1) Recreate the prototype SPS device in a partner facility, which will perform design and engineering work to miniaturize the device, reduce its complexity, and increase its durability for market use, 2) develop AI-based software to rapidly scan and map the surfaces of fresh samples resected directly from patients, and 3) clinically validate the superior performance of SPS created 3D digital images of fresh tissue samples in comparison to the standard-of-care histopathology in Mohs patients in benchmarks established by the SurgiVance FDA Q-Sub Class II, 510(k) pathway to meet beachhead market needs. This Phase II study will enable SurgiVance to shift the paradigm towards instant, digital 3D pathology, that when integrated with SurgiVance’s AI-based diagnostics, could enable robust, reproducible, and rapid automated diagnoses.