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ASTUTE MEDICAL SAYS METHODIST DALLAS MEDICAL CENTER FIRST IN TEXAS TO START BIOMARKER-BASED AKI RISK ASSESSMENT USING THE NEPHROCHECK® TEST

New Approach Aimed At Getting a Jump On Dangerous Hospital Complication

SAN DIEGO – January 4, 2017 – Astute Medical, Inc., developer of biomarkers for better healthcare, today announced that Methodist Dallas Medical Center, one of North Texas’ leading providers of quality, compassionate and integrated healthcare, is the first in the state to begin biomarker-based testing of patients at risk for acute kidney injury (AKI). AKI is a stealthy, unpredictable and dangerous complication known to strike up to half of the 5.7 million people admitted to intensive care units in the United States each year.1

Clinicians at Methodist Dallas are using Astute Medical’s NephroCheck® Test to quickly identify patients at risk of developing moderate to severe AKI so that intervention can occur early enough to reduce the threat of irreparable kidney damage. If left undetected, AKI can quickly lead to permanent kidney damage that can result in long-term complications and death.2

“Many of our cases involve patients susceptible to AKI, which is common, prevalent, expensive and deadly,” said Roberto Collazo-Maldonado, M.D., F.A.C.P, program director, nephrology fellowship program at Methodist Dallas. “For us, AKI risk assessment is a game-changer. Having a biomarker test allows us to identify high-risk early in the process and come up with a strategic plan to help prevent AKI.”

The first-of-its-kind test quantitatively measures two urinary biomarkers – tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP-7), which are associated with kidney stress.3 In high-risk hospital patients, elevated levels of the biomarkers can signal that patients are at risk of developing moderate to severe AKI in the 12 hours following test administration.

Earlier detection of AKI risk will allow nephrologists at Methodist Dallas to get involved with patient care sooner rather than later. “Current methods are slow and rely on tests that only inform us that damage is already underway. Consequently, we are often not called in until AKI has caused severe damage,” said Dr. Collazo. “At that late point, the decision is about whether or not to start dialysis. Now we will be able to discuss preventative changes, such as avoiding drugs that are toxic to the kidney.”

“We are delighted that Methodist Dallas Medical Center has implemented our technology with the aim of achieving earlier identification of patients at risk for AKI” said Paul McPherson, Astute Medical’s chief scientific officer. “Earlier identification enables the physician to take steps that can prevent potentially deadly or debilitating AKI complications.”

About AKI

AKI is as common and life-threatening as a heart attack. But unlike a heart attack, it lacks symptoms that guide risk assessment and can progress silently for hours to days, sometimes causing irreversible damage before it is detected.4 Patients recovering from major surgery or being treated for infection, trauma, and systemic illness are among the most vulnerable to the condition.5 Each year, AKI claims approximately 2 million lives worldwide.6

The financial burdens of AKI are also significant. If a patient develops the complication, the length of stay in the ICU,7 hospital costs7 and 30-day readmissions8 have been shown to double or triple. It has been estimated that annual healthcare expenditures attributed to hospital- acquired AKI could exceed $10 billion.9

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.

About Astute Medical, Inc.

Astute Medical is devoted to improving patient healthcare outcomes through the identification and validation of novel biomarkers.

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 has developed the NephroCheck® Test for use in determining whether a hospitalized patient is 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.

The company 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, 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 www.astutemedical.com/US/About/IntellectualProperty. PN0614 Rev B 2017/01/03


Contact:

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

References

1 Critical Care Statistics. Society of Critical Care Medicine [accessed January 25, 2016]. Available at www.sccm.org.

2 Lewington AJ, Cerdá J, Mehta RL. Raising awareness of acute kidney injury: a global perspective of a silent killer. Kidney Int. 2013;84(3):457-467.

3 Kellum JA, Chawla LS. Cell-cycle arrest and acute kidney injury: the light and dark sides. Nephrol Dial Transplant (2015) 0: 1–7doi: 10.1093/ndt/gfv130.

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

5 Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney inter., Suppl. 2013; 3:1-150.

6 Chawla L, Kimmel P. Acute kidney injury and chronic kidney disease. Kidney Int. 2012;82(5):516-524.

7 Dasta 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.

8 Brown JR, Parikh CR, Ross CS, et al. Impact of Perioperative Acute Kidney Injury as a Severity Index for Thirty-Day Readmission After Cardiac Surgery. Ann Thorac Surg. 2014;97(1):111-117.

9 Chertow GM et al. Acute kidney injury, mortality, length of stay, and costs in hospitalized patients. J Am Soc Nephrol. 2005;16:3365-3370.

©2018 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/us/about/intellectualproperty. PN 0276 Rev A 2014/06/17