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

 描述(申请人提供)：持续的生化监测有能力改变目前被接受的护理标准，将重点从治疗疾病转移到维持健康。患者健康的时间点快照可能会遗漏关键波动或 可能需要及早干预或改变疾病治疗和管理的早期预警迹象。PROFUSA的传感器平台承诺通过向医生和患者提供实时数据来改变医疗保健，而不需要血液样本、繁琐的设备或看医生。这项Fast Track STTR的目标是应用PROFUSA的可注射微传感器来监测外周动脉疾病(PAD)的组织健康。持续的氧气监测将有助于各种疾病的治疗和管理，如哮喘、COPD、睡眠呼吸暂停、间隔室综合征、移植手术和PAD。PAD是系统性动脉粥样硬化的一种表现，在美国影响着800万至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)到严重(伴有严重的肢体缺血和坏疽)，并与高截肢率、死亡率和较低的生活质量有关。 有了适当的治疗和监测，疾病的发展可以停止，甚至逆转。PROFUSA的长期组织监测器可用于在PAD患者的日常活动中持续监测组织氧水平和温度，从而提供疾病状态变化(如再狭窄)的及时指示。在最近完成的里程碑式的研究中，PROFUSA的原型氧传感器被证明在健康的大鼠身上工作了13个月，在大型、健康的哺乳动物身上工作了3个月。在这篇Fast Track STTR中，我们建议在PAD动物模型中展示传感器功能：第一阶段的大鼠和第二阶段的猪。在PAD Out诱导到90天之前、期间和之后，将监测动物健康和缺血腿部组织氧的变化，这段时间与慢性伤口愈合、溶栓药物治疗优化和监测再狭窄相关，以避免再次干预和截肢。第二阶段还将涉及PROFUSA定制光学阅读器系统的微型化，以改善供活体使用的外形因素。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。建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，并提供大量投资者资金，使其能够商业化，用于广泛的临床应用。

 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.