Wide-Field Quantitative Fluorescence Imaging System

项目总结 在此Fast Track(第一阶段+第二阶段)SBIR应用中，我们将评估(在第一阶段)准确、 快速低成本绝对浓度广域成像仪器(QF-ImageTM)的设计 PpIX荧光团(CPPIX)在外科领域用于指导脑肿瘤切除，并证明 设计符合临床验收所需的最终用户数量规格。在第二阶段，我们将最终确定 在设计控制的全面质量管理体系(QMS)下，第一阶段确定的QF-ImageTM设计 并符合行业规定，生产最多5个全功能QF-ImageTM单元，验证最终 设计通过临床可用性和调查数据，并向FDA申请510k监管许可。QF- ImageTM概念作为NIH-Funding(R01NS052274-10；PI：Roberts)的一部分出现在荧光引导手术中 达特茅斯和多伦多的生物医学工程/光学和神经外科研究团队。洞察力 外科技术(IST)是最近由该合作的高级成员创建的，他们带来了 丰富的领域专业知识。商业化特别及时：(I)ALA-PPIX荧光引导 手术已被FDA批准用于高级别胶质瘤，(Ii)公司在 荧光引导手术预示着巨大的全球市场(例如，Stryker收购NOVADAC 2017年约7亿美元，并由手术机器人市场领先者纳入荧光检测，直觉 外科)，(Iii)其他医疗技术公司(例如美敦力、蔡司)的兴趣很高，(Iv)广泛的临床 结果表明，与定性和主观视觉相比，定量CPPIX具有显著优势 荧光成像，以及(V)IST是追求定量广域商业化的唯一企业 CPpIX图像(该技术受9项已发布/正在申请的专利保护)。事实上，我们的研究级 该仪器已在150名脑肿瘤患者中部署：结果表明，PpIX水平 商用系统(例如蔡司蓝400)不可见的荧光可以用更大的 白光切除后检测残留病的敏感性和特异性，使 完全切除肿瘤，包括低级别和高级别癌症。此外，QF-ImageTM可以 被修改以检测(I)其他荧光团，(Ii)位于切除床以下的深部肿瘤，以及(Iii)多个 在相同的情况下，荧光团-将在未来的产品中实施的能力。洞察力的商业计划 将QF-ImageTM定位为市场上第一款CPpIX广场成像产品-绝对 脑肿瘤组织中PPIX的浓度。

PROJECT SUMMARY In this Fast Track (Phase I + Phase II) SBIR application, we will evaluate feasibility (in Phase I) of an accurate, fast and low-cost instrument (qF-ImageTM) design for accurate wide-field imaging of the absolute concentration of the fluorophore PpIX (CPpIX) in the surgical field for guiding brain tumor resection, and demonstrate that design meets quantitative end-user specifications required for clinical acceptance. In Phase II, we will finalize the qF-ImageTM design identified in Phase I under a full quality management system (QMS) for design-control and in compliance with industry regulations, produce up to 5 fully functional qF-ImageTM units, validate the final design through clinical usability and survey data, and apply to FDA for 510k regulatory clearance. The qF- ImageTM concept arose as part of NIH-funding (R01NS052274-10; PI: Roberts) in fluorescence-guided surgery involving biomedical engineering/optics and neurosurgical research teams at Dartmouth and Toronto. InSight Surgical Technologies (IST) was founded recently by the senior members of this collaboration who bring substantial domain expertise. Commercialization is particularly timely: (i) ALA-PpIX fluorescence-guided surgery has been FDA-approved for high-grade glioma, (ii) substantial corporate moves have occurred in fluorescence-guided surgery indicating a significant global market (e.g., Stryker purchase of NOVADAC for ~$700M in 2017, and incorporation of fluorescence detection by a market leader in surgical robotics, Intuitive Surgical.), (iii) interest from other MedTech companies (e.g., Medtronic, Zeiss) is high, (iv) extensive clinical results demonstrate compelling advantages of quantitative CPpIX over qualitative and subjective visual fluorescence imaging, and (v) IST is the only venture pursuing commercialization of quantitative wide-field CPpIX images (the technology is protected by 9 issued/pending patents). Indeed, our research-grade instrument has been deployed in >150 brain tumor patients: results demonstrate that levels of PpIX fluorescence not visible with commercial systems (e.g., Zeiss Blue 400) can be quantified with greater sensitivity and specificity for detection of residual disease at end of white-light resection, enabling more complete tumor removal, including in low-grade as well as high-grade cancers. Additionally, qF-ImageTM can be modified to detect (i) other fluorophores, (ii) tumor at depth below the resection bed, and (iii) multiple fluorophores in the same case – capabilities to be implemented in future products. InSight’s business plan positions qF-ImageTM as the first product on the market for wide-field imaging of CPpIX – the absolute concentration of PpIX in brain tumor.