Tissue Oxygen Monitoring in Peripheral Vascular Disease

 描述（由申请人提供）：本快速通道SBIR的目的是证明PROFUSA新型可注射组织氧监测仪在外周动脉疾病（PAD）患者中的功能，并确定其检测关键血管再狭窄的能力。 肢体缺血（CLI）。PAD是系统性动脉粥样硬化的一种表现，在美国影响1000万至1200万人，患病率随着年龄的增长而增加。PAD的范围从轻度（伴有间歇性跛行或运动疼痛）到重度（伴有CLI和坏疽），并且与截肢率、死亡率和生活质量差相关。 通过适当的监测和治疗，疾病进展可以停止甚至逆转，但易于使用，准确的监测产品指示何时需要改变治疗并不存在。PROFUSA的氧传感技术可以通过提供一种方法来测量治疗前、治疗中和治疗后缺血肢体的实时组织氧水平，从而在晚期症状出现之前及时给予适当的治疗，从而帮助挽救截肢肢体。在本快速通道SBIR中，我们建议1）根据ISO 10993标准确认生物相容性，2）通过最小化传感器尺寸来增强商业化的用户体验，3）临床验证PROFUSA组织氧传感器检测PAD/CLI患者再狭窄的能力。除了强大的科学和临床前团队外，医学，临床，法规和业务人员将成为该项目的组成部分，为成功的产品开发提供早期策略。这些数据对于推动PROFUSA走向商业化和监管批准至关重要。

 DESCRIPTION (provided by applicant): The goal of this Fast Track SBIR is to demonstrate the functionality of PROFUSA's novel injectable tissue oxygen monitors in patients with peripheral arterial disease (PAD) and to determine the its ability to detect restenosis in critical limb ischemia (CLI). PAD is a manifestation of systemic atherosclerosis that affects 10-12 million people in the U.S., with prevalence increasing with age. PAD ranges from mild (accompanied by intermittent claudication or pain with exercise) to severe (accompanied by CLI and gangrene), and is associated with high rates of amputation, mortality and poor quality of life. With the appropriate monitoring and treatment, disease progression can be halted and even reversed, but easy-to-use, accurate monitoring products to indicate when a change in therapy is needed do not exist. PROFUSA's oxygen sensing technology can help salvage limbs from amputation by providing a way to measure real-time tissue oxygen levels in the ischemic limb before, during, and after treatment, thus enabling appropriate therapy to be administered in a timely fashion before advanced symptoms appear. In this Fast Track SBIR, we propose 1) to confirm biocompatibility according to ISO 10993 standards, 2) to enhance user experience for commercialization by minimizing sensor size and 3) to clinically verify the ability of PROFUSA's tissue oxygen sensors to detect restenosis in PAD/CLI patients. In addition to the strong scientific and pre-clinical teams, medical, clinical, regulatory and business personnel will be an integral part of this project to provide early strategy for successful product development. These data will be crucial in advancing PROFUSA towards commercialization and regulatory approvals.