PRIOR LAKE, Minn.--(BUSINESS WIRE)--ExoStat Medical (“ExoStat”), a privately-held medical device company, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its MicroTREND System. The MicroTREND was designed to directly detect and monitor tissue hypoperfusion at the microcirculatory hemodynamic level (oral mucosa) as it manifests into a dangerous medical emergency.

明尼苏达州普莱尔市——（商业新闻短讯）——私营医疗器械公司ExoStat Medical（“ExoStat”）今天宣布，已获得美国食品和药物管理局（FDA）510（k）的许可，可以销售其MicroTREND系统。MicroTREND旨在直接检测和监测微循环血流动力学水平（口腔粘膜）的组织灌注不足，因为它表现为危险的医疗紧急情况。

The MicroTREND incorporates an electro-conductance platform with a disposable sensor that is seated non-invasively in the oral mucosal tissue of a patient, a convenient and accessible site from which to measure pCO2 , a clinically proven marker for tissue hypoperfusion..

MicroTREND结合了一个带有一次性传感器的电导平台，该传感器非侵入性地位于患者的口腔粘膜组织中，这是一个方便且可接近的部位，可用于测量pCO2，pCO2是一种临床证明的组织灌注不足的标志物。。

ExoStat has been engaged in the research and development of the MicroTREND since 2008. The first clinical work began in the late 1990’s at the Weil Institute of Critical Care Medicine (WICCM) under the guidance of Dr. Max Harry Weil, now known as The Father of Critical Care Medicine. He and his team focused on the capture and measurement of microcirculatory perfusion data using oral tissue as an available and reliable site to measure gut perfusion.

自2008年以来，ExoStat一直从事微观趋势的研究和开发。第一项临床工作始于20世纪90年代末，在如今被称为重症监护医学之父的马克斯·哈里·威尔博士的指导下，在威尔重症监护医学研究所（WICCM）进行。他和他的团队专注于捕获和测量微循环灌注数据，使用口腔组织作为测量肠道灌注的可用且可靠的部位。

Dr. Weil authored many studies and papers on the importance of using oral tissue perfusion pCO2 data to identify early symptoms of microcirculatory hypoperfusion. The MicroTREND is the culmination of decades of research and development. It is the world’s first and only real-time, bedside, non-invasive disposable sensor system approved for identifying and monitoring microcirculatory tissue hypoperfusion resulting from low blood flow..

Weil博士撰写了许多关于使用口腔组织灌注pCO2数据来识别微循环灌注不足早期症状的重要性的研究和论文。微观趋势是数十年研究和开发的高潮。它是世界上第一个也是唯一一个被批准用于识别和监测低血流量导致的微循环组织灌注不足的实时、床边、非侵入性一次性传感器系统。。

“Many of today’s top professors, researchers, and clinicians received early training at WICCM under Dr. Weil,” stated Jim Hays, Chief Executive Officer of ExoStat. “As a result of their keen understanding of the need to know a patient’s microcirculatory status, several of them have advised and supported our efforts to create the MicroTREND.

ExoStat首席执行官吉姆·海斯（JimHays）表示：“许多当今顶尖的教授、研究人员和临床医生在威尔博士的带领下在WICCM接受了早期培训。“由于他们对了解患者微循环状态的必要性有着深刻的理解，其中一些人建议并支持我们创造微观趋势的努力。

These key opinion leaders will lead the early adoption efforts needed to make pCO2 monitoring a standard of care. The 510(k) clearance of the MicroTREND marks an important commercial milestone for ExoStat, and we look forward to working with key strategic partners to advance the next steps of the journey to improve patient care.”.

这些关键的意见领袖将领导早期采用工作，使pCO2监测成为护理标准。MicroTREND的510（k）许可标志着ExoStat的一个重要商业里程碑，我们期待着与关键战略合作伙伴合作，推进改善患者护理的下一步。”。

“One area of particular importance to care providers is septic shock,” said Wanchun Tang MD, MCCM, FAHA, FNAI, professor and long-time President at WICCM and Senior Medical and Technical Advisor at ExoStat Medical. “This voracious killer is very complex and difficult to diagnose solely with existing macrohemodynamic parameters.

“对护理人员来说，脓毒性休克是一个特别重要的领域，”Wanchun Tang医学博士，MCCM，FAHA，FNAI说，他是WICCM的教授和长期总裁，也是ExoStat Medical的高级医学和技术顾问。“这种贪婪的杀手非常复杂，仅凭现有的宏观血液动力学参数很难诊断。

Knowing microcirculatory tissue perfusion status early in septic shock’s predictable cascade will provide physicians with evidence-based data that could lead to better patient outcomes. Monitoring pCO2 data later in the resuscitative process will also aide the care providers in determining the most effective end-point of resuscitation which is also critical to better outcomes for gravely ill ICU patients.”.

在感染性休克的可预测级联早期了解微循环组织灌注状态将为医生提供循证数据，从而可能导致更好的患者预后。在复苏过程的后期监测pCO2数据也将有助于护理人员确定最有效的复苏终点，这对于重症ICU患者取得更好的预后也至关重要。”。

About ExoStat Medical

关于ExoStat Medical

ExoStat Medical Inc. is a privately-held medical device company located in Prior Lake, MN. The research and development quest to create the MicroTrend began in 2008 as a vision of Max Harry Weil, MD, who is often called “the father of critical care medicine”. The technology platform developed by ExoStat provides data to enable physicians to assess and to treat microcirculatory hypoperfusion, a life-threatening medical emergency.

ExoStat Medical Inc.是一家位于明尼苏达州普里奥湖（Prior Lake）的私营医疗器械公司。创建微趋势的研发探索始于2008年，是医学博士马克斯·哈里·威尔（Max Harry Weil）的愿景，他常被称为“重症医学之父”。ExoStat开发的技术平台提供数据，使医生能够评估和治疗微循环灌注不足，这是一种危及生命的医疗紧急情况。