CALIBRATION AND PRE-CLINICAL TRIALS OF AN OPTICAL DEVICE

医疗光学成像公司的战略目标是制造和销售一种光学乳房摄影设备。该设备将同时用于筛查和诊断目的。该设备包含两个关键组件：硬件和软件。这些组件将相互配合工作。最先进的硬件单元使用近红外光测量从300 kHz到1 GHz范围内的许多调制频率的频域输出漫反射光，以及3个或更多波长的输出漫反射光。该软件将使用这些数据作为输入，重建乳腺组织中异常的图像，并提供诊断。该软件将基于一种全新的图像重建数学算法，即所谓的椭圆系统方法(ESM)。通过这一应用，该公司请求部分支持这两个组件在模体介质上的测试和校准，以及最重要的是在数十名乳房志愿者身上进行的临床前试验。其余的支持将来自该公司筹集的私人资本。北卡罗来纳大学夏洛特分校将是这笔STTR赠款的分包商，以部分支持椭圆系统方法的共同发明人、该公司的主要股东迈克尔·V·克利巴诺夫和托马斯·R·卢卡斯教授的努力。拟议的商业应用：该项目的最终目标是制造和销售一种可用作癌症筛查或诊断工具的光学乳房X光照相设备。

The strategic goal of Medical Optical Imaging, Inc. is to build and market an Optical Mammography device. The device will serve both screening and diagnostic purposes. The device incorporates two key components as integral parts: hardware and software. These components will work in conjunction with each other. The state-of-the-art hardware unit measures output diffuse light in the frequency domain for many modulated frequencies in the range from 300kHz to 1 GHz for 3 or more wavelengths using near infrared light. The software will use this data as input to reconstruct images of abnormalities in the breast tissues and to provide diagnosis. The software will be based on a fundamentally new mathematical algorithm for image reconstruction, the so called Elliptic System Method (ESM). Through this application the company requests partial support for the test and calibration of these two components on phantom media and, most important pre-clinical trials on several tens of breast volunteers. The remainder of the support will come from private capital raised by the company.The University of North Carolina at Charlotte will be a sub- contractor for this STTR grant to partially support the efforts of professors Michael V. Klibanov and Thomas R. Lucas, who are co-inventors of the Elliptic Systems Method and major stockholders of the company. PROPOSED COMMERCIAL APPLICATIONS: The ultimate aim of this project is to build and market an optical mammography device that could be used as a screening or diagnostic tool for cancer.