ghp June 2015
ghp June 2015 | 35 About Astute Medical, Inc. Selected to the 2014 Fierce 15 by Fierce Medical Devic- es, Astute Medical is dedicated to improving the diagno- sis of high-risk medical conditions and diseases through the identification and validation of protein biomarkers that can serve as the basis for novel diagnostic tests. The Company’s focus is community- and hospital-ac- quired acute conditions that require rapid diagnosis and risk assessment. Astute Medical’s current areas of inter- est include abdominal pain, acute coronary syndromes, cerebrovascular injury, kidney injury and sepsis. Astute Medical is a founding partner of 0by25, a hu- man rights initiative aimed at eliminating preventable and treatable deaths from AKI worldwide by 2025. Astute Medical’s NephroCheck® Test is currently available in the United States and Europe. The test received 510(k)-clearance through the FDA’s de novo classification process in September of 2014. In the United States the NephroCheck® Test is the only test that has received regulatory clearance as an aid in the assessment of risk for moderate or severe AKI. The test was CE-marked in 2012. For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see astutemedical.com/about/in- tellectual-property. PN0465 Rev A 2015/05/28
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