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ASTUTE MEDICAL, INC. PREVIEWS SCIENTIFIC PRESENTATIONS AT UPCOMING INTERNATIONAL INTENSIVE CARE AND EMERGENCY MEDICINE CONFERENCE

Sessions Highlight Risk Assessment Capabilities of NephroCheck® Test Biomarkers

SAN DIEGO – March 16, 2017 – Astute Medical, Inc., developer of biomarkers for better health care, today previewed presentations highlighting advances in the area of acute kidney injury (AKI) risk assessment to be presented at the 37th International Symposium on Intensive Care and Emergency Medicine (ISICEM) in Brussels March 21 through March 24. The presentations relate to study of the biomarkers TIMP-2 and IGFBP-7, which were identified1 and validated2 as biomarkers of AKI risk in clinical studies leading to the commercialization of Astute Medical’s NephroCheck Test.

Details of the presentations follow:

Session: Assessing Renal Function
Title: Should We Use Renal Biomarkers in Clinical Practice
Speaker: Alex Zarbock, M.D.
Date: Tuesday, March 21
Time: 11:45-noon

Session: Preventing Renal Failure
Title: After Major Surgery
Speaker: Alex Zarbock, M.D.
Date: Wednesday, March 22
Time: 3:35-3:50 p.m.

Session: Preventing Renal Failure
Title: Do We Need Biomarkers
Speaker: Ivan Göcze, M.D.
Date: Wednesday, March 22
Time: 4:05-4:20 p.m.

Session: When to Start Renal Replacement Therapy
Title: The Role of Biomarkers
Speaker: Ivan Göcze, M.D.
Date: Wednesday, March 22
Time: 5:30-5:45 p.m.

Session: Acute Renal Failure
Title: Biomarkers
Speaker: Ivan Göcze, M.D.
Date: Thursday, March 23
Time: 2:40-2:55 p.m.

“We are pleased to see yet another major conference where respected thought leaders from around the world will be presenting the results of their investigations highlighting the practical clinical utility of the NephroCheck Test to gauge the risk of acute kidney injury before damage occurs,” said Paul McPherson, Astute Medical chief scientific officer. “This rapidly growing body of evidence, including peer-reviewed outcomes studies, illustrates the increasing acceptance that AKI is not an inevitable complication for critically ill patients, and fuels the paradigm shift from diagnosis to prevention.”

It is estimated that up to 50 percent of patients in the ICU will develop AKI,3 a condition associated with a tenfold increase in hospital mortality rates,4 exponential increases in cost of care4 and a higher rate of chronic kidney disease.5

Unlike other potentially catastrophic events, such as myocardial infarction, AKI often has no signs or symptoms,6 hindering assessment. Studies suggest that traditional methods of assessing kidney function using serum creatinine could lead to late diagnosis of AKI.7

Important Information About The NephroCheck® Test
In the United States, 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 visit NephroCheck.com.

In the EU (European Union), the NephroCheck® Test result is intended to be used in conjunction with clinical evaluation as an aid in the risk assessment of acute kidney injury in the critically ill. The NephroCheck® Test is indicated for prescription use only.

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.

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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 www.astutemedical.com/about/intellectualproperty. PN0632 Rev A 2017/03/14

Contact:

Nadine Padilla
LawPadilla Communications
+1 (619) 507-9306
nadine@lawpadilla.com

References

1Kashani 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.

2Bihorac A, Chawla L, Shaw A, et al. Validation of Cell-Cycle Arrest Biomarkers for Acute Kidney Injury Using Clinical Adjudication. Am J Respir Crit Care Med. Vol 189, Iss 8, pp 932– 939, Apr 15, 2014.

3Mandelbaum T, Scott DJ, Lee J, et al. Outcome of critically ill patients with acute kidney injury using the AKIN criteria. Crit Care Med. 2011;39(12):2659-2664.

4Dasta JF, Kane-Fill SL, Durtschi, AJ, Pathak DS, Kellum JA. Costs and outcomes of acute kidney injury (AKI) following cardiac surgery. Nephrol Dial Transplant. 2008;23:1970-1974.

5Mehta RL, Cerda J, Burdmann EA, et al. International Society of Nephrology’s 0by25 initiative for acute kidney injury (zero preventable deaths by 2025):a human rights case for nephrology. The Lancet. Volume 385, No. 9987, p2616–2643, 27 June 2015.

6Ronco C, Ricci Z. The concept of risk and the value of novel markers of acute kidney injury. Crit Care. 2013;17:117-118.

7McCullough PA et al. Diagnosis of acute kidney injury using functional and injury biomarkers: workgroup statements from the tenth Acute Dialysis Quality Initiative Consensus Conference. Contrib Nephrol. 2013;182:13-29.

 

©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.