Advanced Surgical Pathology Device

每年，数百万美国人被诊断出患有皮肤癌。治愈率最高的治疗方法， 最好的功能和美容效果是莫氏手术。Mohs依赖于标准的组织病理学， 缓慢、乏味和昂贵，并且是二维诊断，其可能错过三维信息。这 该过程通常是模拟的，人类评估处理过的组织以确定诊断。有一个 需要一种更快的数字化替代方案，以便高级分析可以改善诊断。这样的 该产品可以加强我们对癌症的诊断靶向，改善患者体验。我们的产品是 先进的外科病理学设备和方法，将快速诊断带到护理点。在我们的产品中， 创新的光学成像设备与创新的医疗保健软件相结合， 卫生保健工作流程，对工作人员进行最少的重组和再培训。我们的长期目标是 用我们的设备取代标准的组织病理学，我们相信这将通过增加 手术干预对癌症的疗效。在美国，有1,500名专业的莫氏外科医生， 普通皮肤科医生和100万名医学医生，他们需要高度准确和轻松地 无障碍病理学服务。我们的项目调查了我们的设备改善患者的潜力， 通过作为标准冷冻食品的优选替代品， 莫氏手术中的组织病理学我们第一阶段的具体目标是显示等效的光学成像性能 （通过分辨率、对比度和信噪比进行量化），我们的产品与标准病理学 成像，也显示了高通量成像和图像处理的潜力，这将表明 优于标准病理成像。我们的第二阶段目标是生成一个部署原型 能够支持多中心临床试验，使我们能够获得FDA批准作为主要的 诊断总的来说，活检处理是一个数十亿美元的市场，有几个潜在的收入来源 包括用于组织样本分析的一次性组织压缩室、低温储存、商业机密 优化诊断图像对比度的染色溶液，以及远程或自动病理评估， 标本使用生成的数字图像。

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.