FluorLens - Loupe-Based Intraoperative Fluorescence Imaging Device for Tumor Resection скачать в хорошем качестве

FluorLens - Loupe-Based Intraoperative Fluorescence Imaging Device for Tumor Resection

Executive Summary - FluorLens The most common type of primary brain tumors are malignant gliomas (MGs) that account for an estimated 40% of all intracranial tumors (National Brain Tumor Society, 2016) and approximately 20,000 newly diagnosed brain tumors annually. There is compelling evidence that the extent of resection in MGs, including glioblastoma multiforme (GBM), correlates with survival. Consequently, a great deal of effort has been directed toward developing surgical techniques that allow more extensive resections with the goal of improving survival. Fluorescein, an FDA approved dye, has been extensively used to enhance the identification of MG margins for resection. Fluorescein-imaging-guided surgeries show significant improvements in gross-total-resection (GTR) rates over conventional surgeries. Based on contrast-enhanced MRI measurements, surgeries using fluorescein imaging achieve GTR rates of 75-100%, which are significantly higher than conventional surgeries.  At FluorLens, we are further developing a wearable fluorescence eye-loupe device that will overcome several major obstacles of current devices that include adjustable magnification necessary for neurosurgery, natural ocular view, tumor differentiation and specificity, as well as the length of observable time for long complex procedures. The FluroLens novel imaging device is a customized loupe-based device with visualization aid to direct visible light and fluorescent dye exciting light at the surgical site. This device is a low-cost, wearable, loupe-based fluorescence imaging technique to enable neurosurgeons to easily identify tumor margins during surgery.   The vast majority of medical device companies are considerably invested in cancer therapeutics and eager to launch innovative solutions for currently incurable diseases. The industry at large generates in excess of $50B USD to accelerate the development of medical devices in cancer research. This novel imaging device is the first wearable fluorescence eye-loupe for brain tumor imaging and has been tested in visualizing tissue for resection in a human patient. Based on this data, there are several avenues for product commercialization. FluorLens will seek funding from several sources including federal research grants, foundation grants such as the Bill & Melinda Gates Foundation, and venture capital investments, in partnership with several potential stakeholders. FluorLens has a diverse core team with scientific expertise, specific to neuroimaging and the medical device field, with experienced strategic operation leaders in clinical research and business development. We have also built a strong team of mentors and advisors to guide us in our endeavors. Our advisory board consists of four executives who have a wide range of capabilities. As a group, our board has over sixty years of biotech startup experience, has raised over $150M USD in capital, and possesses a strong understanding of regulatory, legal, and clinical trial processes. Collectively, we are passionate about bringing this solution to life and advancing novel neuroimaging techniques for tumor resection.