Bactericidal Intravascular Biosensor for Continuous Reading of Lactate in the ICU

 描述（申请人提供）：本产品将监测ICU中脓毒症、器官衰竭、创伤或急性炎症反应的重症患者以及心肺转流（CPB）手术后恢复的先天性心脏病（CHD）婴儿患者的静脉（IV）血乳酸水平（>7天）。当出现危险的乳酸盐增加率时，该设备将提醒ICU的医生或护士，允许早期干预以减少危及生命的并发症。我们的传感器具有我们专有的NO释放涂层，可防止感染、血栓形成和堵塞超过7天，否则会在几分钟内使IV传感器无法操作/不准确。1 -7该设备将能够区分CHD手术后发病率和死亡率高风险和低风险的婴儿，以防止接受CPB手术的婴儿猝死，11，12并显著降低高乳酸血症患者的住院死亡率。13 -15 Meyerhoff实验室已经研究各种NO释放技术>15年，迄今为止使用的化学物质具有显著的局限性，这阻碍了转化工作。我们最新的IP保护化合物的低成本和耐用性完全克服了先前的问题，并使这种IV血乳酸传感技术能够快速转化为临床实践。我们的目标市场是儿科介入心脏病学和ICU收治的高乳酸血症成人患者，这些患者患有败血症、器官衰竭、创伤或急性炎症反应综合征。到2018年，儿科介入心脏病市场估计为13.79亿美元，复合年增长率为9.0%，2 2014年血液和电解质检测市场为1.56 B美元，到2019年复合年增长率为3.5%，18.52亿美元，到2017年全球脓毒症治疗市场估计为7.4 B美元，复合年增长率为5.8。%.2，3

 DESCRIPTION (provided by applicant): Our product will monitor intravenous (IV) blood lactate levels (for >7 days) of critical ill patients with sepsis, organ failure, trauma, or acute inflammatory response in the ICU, and infant patients with congenital heart disease (CHD) recovering from cardiopulmonary bypass (CPB) surgery. This device will alert doctors or nurses at the ICU when dangerous lactate increase rates are present, allowing early intervention to reduce life-threatening complications. Our sensors possess our proprietary NO releasing coating that prevent infection, thrombosis, and blockages for >7days that would otherwise render IV sensors inoperable/ inaccurate within minutes.1-7 This device would enable discrimination between infants at high and low risk of morbidity and mortality after CHD surgery to prevent sudden infant death undergoing CPB surgery,11,12 and significantly reduce hospital mortality in patients with hyperlactatemia.13-15 The Meyerhoff lab has been working on various NO releasing technologies for >15 yrs, and the chemistries used to date have had significant limitations that have heretofore prevented translational efforts. The low cost and robustness of our newest IP-protected compounds have completely overcome prior issues and enabled rapid translation of this IV blood lactate sensing technology to clinical practice affordably. We are targeting the markets of pediatric interventional cardiology and adult patients with hyperlactatemia at ICU admission with sepsis, organ failure, trauma, or acute inflammatory response syndrome. The pediatric interventional cardiology market is estimated at $1,379 MM by 2018 with a CAGR of 9.0%,2 the blood and electrolyte testing market was $1.56 B in 2014 with a CAGR of 3.5% $1,852 MM by 2019, and the global sepsis therapeutics market is estimated to be $7.4 B by 2017 with a CAGR of 5.8. %.2,3