Advanced Surgical Pathology Device

摘要 诊断疾病在很大程度上依赖于对患者的组织样本进行病理分析。仅就癌症而言， 在美国，每年有超过3000万人接受组织活检。虽然手术目前代表着最好的 治愈浸润性癌症的标准护理治疗，其成功与否取决于肿瘤能否及时切除 它可以传播。对于皮肤癌的切除尤其如此，皮肤癌在人群中比其他所有癌症都更常见 恶性肿瘤合并，莫氏手术被认为是治疗高度皮肤癌的最佳选择 费率。然而，该程序需要对患者组织样本进行反复的组织病理学评估，以 癌组织或非癌组织的确认。这一耗时的步骤需要冻结、切片和 保存显微镜载玻片之间的组织以获取图像，使手术时间增加2-3个小时。它 增加手术时间和术后并发症的风险，包括皮肤感染、出血或 血肿、伤口裂开(新近修复的伤口破裂)、组织坏死和疼痛。这个过程 也很昂贵，需要大约7万美元的设备来安装，以及昂贵的试剂和训练有素的工作人员来维护。 市场上对高性价比的数字病理解决方案的需求尚未得到满足，以快速生产高质量的 图像。SurgiVance正在开发一种基于共焦的外科病理系统(SPS)，以无创和 以高分辨率快速成像完整的标本。SPS系统使用了一种新颖的、获得专利的行扫描， 台式扫描共聚焦显微镜。美国国立卫生研究院第一阶段资助的原型成功地拍摄了标准尺寸的图像 在1.2微米的横向分辨率和8.6微米的光学切片厚度下，仅需17秒即可获得样品(5 Mm X 10 Mm)。 在此第二阶段项目中，SurgiVance有3个具体目标：1)在合作伙伴中重新创建SPS设备原型 设施，将执行设计和工程工作，以使设备微型化，降低其复杂性，以及 提高其市场使用的耐用性；2)开发基于人工智能的软件，快速扫描和绘制生鲜表面 直接从患者身上切除样本，以及3)临床验证3D创建的SPS的卓越性能 中国MoHs患者新鲜组织标本的数字图像与标准护理组织病理学的比较 由SurgiVance FDA Q-Sub Class II，510(K)路径建立的基准以满足滩头市场 需要。这项第二阶段的研究将使SurgiVance能够将范式转向即时、数字的3D病理学， 当与SurgiVance的基于AI的诊断集成时，可以实现健壮、可重复性和快速 自动诊断。

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.