Astute Medical Receives FDA Clearance For NephroCheck® Test Improvements Extending Shelf Life

SAN DIEGO, June 9, 2016 /PRNewswire/ -- Astute Medical, Inc., developer of biomarkers for better healthcare, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for improvements to the NephroCheck^® Test Kit U.S that will extend the shelf life for the test to 12 months when refrigerated.

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 acute kidney injury (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.

"Improved shelf life enables hospital labs to better optimize their inventory and ordering process providing multiple advantages for customers," said Ryan Roberts, Astute chief commercial officer. "Labs will be able to maintain larger inventories to support test demand from critical care units and also place larger orders, which may help them qualify for our volume purchasing agreements."

Astute expects to make the product with extended shelf life available to customers later this year. The contents and formulations of the test kit have not changed.

Hospital-acquired AKI has been shown to strike in up to 18 percent of hospital patients¹ and up to 50 percent of intensive care unit patients.² It often arises as a complication of common events, including infection, surgery or trauma,³ and requires timely intervention in order to prevent irreversible kidney damage.¹ By one estimate, the healthcare cost burden for AKI is as high as $10 billion in the United States alone,⁴ driven by cost of care, longer hospital stays⁵ and readmissions.⁶ AKI has also been linked to exponential increases in hospital mortality rates⁷ and premature death.⁸

For more information on the NephroCheck^® Test visit NephroCheck.com. Hospitals interested in purchasing can call 855-317-2788.

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 acute kidney injury (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 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 process in September 2014. The test was CE-marked in 2012 and is available in Europe.

For additional information, please visit AstuteMedical.com.

Astute Medical^®, the AM logo, Astute140^®, NephroCheck^® and the NephroCheck^® logo are registered trademarks of Astute Medical, Inc. in the United States. AKIRisk^™ is a trademark of Astute Medical, Inc. For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see AstuteMedical.com/us/about/intellectualproperty. PN0581 Rev A 2016/06/08

¹ 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.
² Mandelbaum 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.
³ 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.
⁴ Chertow GM et al. Acute kidney injury, mortality, length of stay, and costs in hospitalized patients. J Am Soc Nephrol. 2005;16:3365-3370.
⁵ 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.
⁶ 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.
⁷ Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2014;00:1-8.
⁸ Mehta 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. Lancet. 2015.

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SOURCE Astute Medical, Inc.

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