Real-Time Oxygen Monitoring for Tissue Health: Peripheral Artery Disease Application

 描述（由申请人提供）：持续的生化监测有能力改变目前公认的护理标准，将重点从治疗疾病转移到维护健康。患者健康状况的时间点快照可能会错过关键的波动， 早期预警信号可能需要早期干预或改变疾病治疗和管理。PROFUSA的传感器平台有望通过向医生和患者提供实时数据来改变医疗保健，而无需血液样本，繁琐的设备或医生访问。该快速通道STTR的目标是应用PROFUSA的可注射微传感器监测外周动脉疾病（PAD）的组织健康。连续氧监测将有助于治疗和管理各种疾病，如哮喘、COPD、睡眠呼吸暂停、间隔综合征、移植手术和PAD。PAD是系统性动脉粥样硬化的表现，在美国影响800 - 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（伴有严重肢体缺血和坏疽），并与截肢率、死亡率和生活质量差相关。 通过适当的治疗和监测，可以阻止甚至逆转疾病进展。PROFUSA的长期组织监测仪可用于在PAD患者的日常活动中持续监测组织氧水平和温度，从而及时提供疾病状态变化（例如再狭窄）的指示。在最近完成的具有里程碑意义的研究中，PROFUSA的原型氧传感器在健康大鼠中运行13个月，在大型健康哺乳动物中运行3个月。在本快速通道STTR中，我们建议在PAD动物模型中证明传感器功能：第I阶段为大鼠，第II阶段为猪。将在PAD诱导之前、期间和之后监测动物健康和缺血腿部的组织氧变化，直至90天，这是与慢性伤口愈合、溶栓药物治疗优化和再狭窄监测相关的时间段，以避免再次介入和截肢。第二阶段还将涉及PROFUSA的定制光学读取器系统的小型化，以改善体内使用的形状因素。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。拟议的研究将提供有价值的数据，推动PROFUSA走向PAD监测的临床研究和重要的投资者资金，使商业化的广泛临床应用。

 DESCRIPTION (provided by applicant): Continuous biochemical monitoring has the power to change currently accepted standards of care, shifting the emphasis from treating illness to maintaining health. Point-in-time snapshots of a patient's health can miss critical fluctuations or early warning signs that might warrant early interventions or changes in disease treatment and management. PROFUSA's sensor platform has the promise to transform healthcare by providing real-time data to physicians and patients without requiring blood samples, cumbersome equipment, or doctor visits. The goal of this Fast Track STTR is to apply PROFUSA's injectable microsensors for monitoring tissue health in peripheral artery disease (PAD). Continuous oxygen monitoring will be useful in the treatment and management of a variety of diseases, such as asthma, COPD, sleep apnea, compartment syndrome, transplant surgery, and PAD. PAD is a manifestation of systemic atherosclerosis that affects 8-12 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 critical limb ischemia and gangrene), and is associated with high rates of amputation, mortality and poor quality of life. With the appropriate treatment and monitoring, disease progression can be halted and even reversed. PROFUSA's long-term tissue monitors can be used to continuously monitor tissue oxygen levels and temperature in PAD patients during their daily activities and thus provide timely indications of changes in disease state (e.g. restenosis). In recently completed landmark studies, PROFUSA's prototype oxygen sensors were shown to function 13 months in healthy rats and 3 months in large, healthy mammals. In this Fast Track STTR, we propose to demonstrate sensor functionality in PAD animal models: rats in Phase I and pigs in Phase II. Changes in tissue oxygen in the animals' healthy and ischemic legs will be monitored before, during, and after induction of PAD out to 90 days, a time period relevant to chronic wound healing, thrombolytic drug therapy optimization and monitoring for restenosis to avoid re-intervention and amputation. Phase II will also involve miniaturization of PROFUSA's custom optical reader system to improve the form factor for in vivo use. In addition to the strong scientific and pre-clinical team, medical, clinical, regulatory and business personnel will be an integral part of this project to provide early strategy for successful product development. The proposed studies will provide valuable data for advancing PROFUSA towards clinical studies of PAD monitoring and significant investor funding to enable commercialization for widespread clinical application.