Advanced Surgical Pathology Device

Each year, millions of Americans are diagnosed with skin cancer. The treatment with the highest cure rate and best functional and cosmetic outcomes is Mohs Surgery. Mohs depends on standard histopathology, which is slow, tedious and costly and is a 2-dimensional diagnosis, which may miss 3Dimensional information. This process is usually analog, with humans evaluating the processed tissue to determine the diagnosis. There is a need for an alternative that is faster and digital so that advanced analytics can improve diagnosis. Such a product could tighten our diagnostic targeting of cancer and improve patient experience. Our product is an advanced surgical pathology device and method to bring rapid diagnosis to the point of care. In our product, an innovative optical imaging device is combined with innovative healthcare software that integrates into the healthcare workflow with minimal re-structuring and minimal re-training of staff. Our long-term goal is to replace standard histopathology with our device, that we believe will protect public health by increasing the efficacy of surgical intervention against cancer. In the USA, there are 1,500 specialty Mohs surgeons, 20,000 general dermatologists and 1,000,000 total doctors of medicine who need highly accurate and easily accessible pathology services. Our project investigates the potential of our device to improve patient satisfaction and reduce morbidity and mortality by serving as a preferable alternative to standard frozen histopathology in Mohs Surgery. Our Phase I specific aims are to show equivalent optical imaging performance (quantified by the resolution, contrast and signal-to-noise ratio) of our product compared to standard pathologic imaging and also show the potential for high throughput imaging and image processing, which will suggest superiority over standard pathologic imaging. Our Phase II Aim will be to generate a deployment prototype capable of supporting a multi-center clinical trial that will enable us to achieve FDA approval as a primary diagnostic. Overall, biopsy processing is a multi-billion dollar market with several potential revenue streams including disposable tissue compression chambers for tissue sample analysis, cryogenic storage, trade secret staining solution that optimizes diagnostic image contrast, and remote or automated pathologic assessment of specimens using generated digital images.The process of cancer diagnosis is slow, tedious and costly. Standard histopathology, the rate-limiting step, is the processing a biopsy specimen to produce a microscope slide for observation through a standard light microscope by a pathologist who makes a diagnosis based on the visual image. As an alternative, this project develops a novel confocal microscope to accomplish this task rapidly, digitally and with the potential for advanced analysis not possible with standard histopathology while maintaining resemblance to the appearance of standard histopathology so as to be easily adoptable in the healthcare workflow without the need for major retraining of personnel.