Tissue Oxygen Monitoring in Peripheral Vascular Disease

 描述(申请人提供)：此快速跟踪SBIR的目标是证明PROFUSA的新型可注射组织氧监测仪在周围动脉疾病(PAD)患者中的功能，并确定其检测危重患者再狭窄的能力 肢体缺血(CLI)。PAD是系统性动脉粥样硬化的一种表现，在美国有1000-1200万人受到影响，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)，并与高截肢率、死亡率和较低的生活质量有关。 有了适当的监测和治疗，疾病的发展可以停止，甚至逆转，但简单易用、准确的监测产品并不存在，以指示何时需要改变治疗。PROFUSA的氧气传感技术可以提供一种方法，在治疗前、治疗中和治疗后实时测量缺血肢体的组织氧水平，从而帮助挽救截肢，从而使适当的治疗能够在高级症状出现之前及时实施。在这项快速跟踪SBIR中，我们建议1)根据ISO 10993标准确认生物兼容性，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的组织氧传感器检测PAD/CLI患者再狭窄的能力。除了强大的科研和临床前团队外，医疗、临床、监管和商业人员将是该项目不可或缺的一部分，为成功的产品开发提供早期战略。这些数据将是推动PROFUSA走向商业化和监管批准的关键。

 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.