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ASTUTE MEDICAL, INC. HIGHLIGHTS STUDY OF NEPHROCHECK® TEST BIOMARKERS IN PATIENTS WITH SEPSIS

SAN DIEGO – October 21, 2015 – Astute Medical, Inc., developer of the NephroCheck® Test, today highlighted an oral presentation to be delivered at the CHEST Annual Meeting in Montreal on October 28, 2015 at 2:45 p.m. Eastern. The presentation describes a study of two urinary cell cycle arrest biomarkers, TIMP-2 and IGFBP-7, that were used to assess patients with sepsis for risk of moderate to severe acute kidney injury (AKI), a precursor to kidney failure. Astute’s test was used in the study.

Sepsis is the most common condition associated with acute kidney failure in the intensive care unit1 and the combination is deadly. AKI has been shown to nearly double the mortality rate in sepsis cases.2

“The severe consequences of AKI in septic patients -- higher patient morbidity and mortality and increased hospital costs – have driven leading physicians to call for innovative strategies to improve the management of those patients to halt the devastating progression through AKI to kidney failure and death,” said Paul McPherson, Astute’s chief scientific officer. ”We believe the NephroCheck® Test For AKI risk assessment can aid in the management of septic patients, who are susceptible to moderate to severe AKI.”

The abstract “Urinary Tissue Inhibitor of Metalloproteinase-2 and Insulin-like Growth Factor- Binding Protein 7 ([TIMP-2]●[IGFBP7]) Accurately Risk Stratify Acute Kidney Injury in Patients with Sepsis” will be presented by Dr. H. Bryant Nguyen, M.D., M.S., vice-chair for research, Department of Medicine, Loma Linda University School of Medicine.

The NephroCheck® Test is designed to detect the two urinary biomarkers featured in the presentation, TIMP-2 and IGFBP-7. Both biomarkers are involved in a wide array of responses to tissue insult (inflammation, oxidative stress, ultra-violet radiation, drugs and toxins) and are thought to be involved in G1 cell-cycle arrest during the earliest phases of injury to the kidney.3,4

With results in just 20 minutes, the NephroCheck® Test helps healthcare professionals evaluate intensive care patients’ risk of moderate to severe acute kidney injury in the next 12 hours. The test was created for use alongside clinical evaluation of intensive care patients over 21 who have or have had acute cardiovascular and/or respiratory compromise in the past 24 hours.

Once at-risk patients have been identified and their risk stratified, healthcare professionals can implement kidney-sparing strategies to potentially temper the severe consequences associated with AKI.

About Astute Medical, Inc.
Selected to the 2014 Fierce 15 by Fierce Medical Devices, 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 globe to Europe.

For additional information, please visit NephroCheck.com or AstuteMedical.com.

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For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see astutemedical.com/about/intellectual-property. PN0501 Rev B 2015/10/16

References
1 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.

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 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.

4 Bihorac 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.

 

©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.