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NEPHROCHECK® TEST PREDICTS ACUTE KIDNEY INJURY RISK IN SEPSIS PATIENTS INCLUDING THOSE WITH OTHER ORGAN FAILURES

Rapid Identification of Septic Patients at High Risk for Developing AKI Could Substantially Improve the Therapeutic Approach

SAN DIEGO – July 8, 2016 – Astute Medical, Inc., developer of biomarkers for better healthcare, today said that a new ancillary analysis of two multicenter studies utilizing the Company’s NephroCheck® Test demonstrates that TIMP-2 and IGFBP-7, the biomarkers detected and measured by the test, accurately predict acute kidney injury (AKI) in septic patients with or without other organ failures. The results were published online last week in the journal Critical Care Medicine.1

Results from the analysis showed significantly higher urine biomarker levels in patients with AKI than without AKI (p < 0.001). The presence of (nonrenal) organ failures that commonly occur in septic patients did not affect the overall TIMP-2*IGFBP-7 value. The overall AUC for predicting AKI in this cohort was 0.84.

Authors said that rapid identification of septic patients at high risk for developing AKI could extend the therapeutic window for renal protection, while describing the TIMP-2 and IGFBP-7 combination as “a notable advance in comparison with other biomarkers that are available around the world.”

Kidney function is a crucial factor in the fate of a patient infected with sepsis. The occurrence of AKI in hospitalized septic patients has been shown to double mortality.2 In the United States, sepsis is believed to be a contributing factor in up to 50 percent of all hospital deaths.3

“Early awareness of kidney failure in a septic patient could change a number of clinical decisions that impact outcomes,” said Dr. Donald Chalfin, Astute vice president of medical affairs. “Such decisions might relate to consultations with a nephrologist, choice and prescribing of drugs, use of contrast agents that could be toxic to the kidney, optimization of fluids and other strategies that could help avoid the preventable complications of AKI.”

The analysis examined 232 hospitalized patients with sepsis enrolled in either of two previously reported studies, SAPPHIRE4 and TOPAZ,5 which were conducted in the United States and Europe. Clinicians used the NephroCheck® Test to obtain an AKIRisk Score indicating which patients were at risk for developing moderate to severe AKI. The primary endpoint was moderate to severe AKI (equivalent to Kidney Disease Improving Global Outcome stage 2-3) within 12 hours of enrollment.

The NephroCheck® Test is a first-of-a-kind laboratory test to help determine if certain hospitalized patients are at risk of developing moderate to severe AKI in the 12 hours following test administration. Early knowledge that a patient is likely to develop AKI may prompt closer patient surveillance and help prevent permanent kidney damage or death.

Important Information About The NephroCheck® Test
The NephroCheck® Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are intensive care unit (ICU) patients as an aid in the risk assessment for moderate or severe AKI within 12 hours of patient assessment. The NephroCheck® Test System is intended to be used in patients 21 years of age or older.

For more information on the NephroCheck® Test visit NephroCheck.com.

About Astute Medical, Inc.
Astute Medical is dedicated to improving the diagnosis 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-acquired acute conditions that require rapid diagnosis and risk assessment. Astute Medical’s current areas of interest include abdominal pain, acute coronary syndromes, cerebrovascular injury, kidney injury and sepsis.

Astute Medical is a founding corporate partner of 0by25, a human rights initiative aimed at eliminating preventable and treatable deaths from AKI worldwide by 2025.

Astute Medical’s NephroCheck® Test received 510(k)-clearance through the FDA’s de novo classification. The test is CE-marked and available in Europe.

For additional information, please visit AstuteMedical.com.

For information regarding trademarks and other intellectual property applicable to this product, please see astutemedical.com/us/about/intellectualproperty. PN0582 Rev A 2016/07/07

References
1 Honore PM, Nguyen HB, Gong M et al. Urinary Tissue Inhibitor of Metalloproteinase-2 and Insulin-Like Growth Factor-Binding Protein 7 for Risk Stratification of Acute Kidney Injury in Patients With Sepsis. Critical Care Medicine. Published Online June 28, 2016. doi: 10.1097/CCM.0000000000001827.

2 Hoste EAJ et al. Acute Renal Failure in Patients with Sepsis in a Surgical ICU: Predictive Factors, Incidence, Comorbidity, and Outcome. J Am Soc Nephrol. 2003;14:1022-1030.

3 Liu V, Escobar GJ, Greene JD et al. Hospital Deaths in Patients With Sepsis From Two Independent Cohorts. JAMA, July 2, 2014 Volume 312, Number 1.

4 Kashani K, Al-Khafaji A, Ardiles T, et al. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013;17:R25.

5 Bihorac A, Chawla LS, Shaw AD et al. Validation of cell-cycle arrest biomarkers for acute kidney injury using clinical adjudication. Am J Respir Crit Care Med 2014; 189: 932–939.

 

©2017 Astute Medical, Inc. Astute Medical®, the AM logo, Astute140®NephroCheck®, the NephroCheck® logo, and AKIRisk® are registered trademarks of Astute Medical, Inc. in the United States. For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see AstuteMedical.com/about/intellectualproperty.