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ASTUTE MEDICAL HIGHLIGHTS CLINICAL PRESENTATIONS AND ACTIVITIES AT KIDNEY WEEK 2016

SAN DIEGO – November 10, 2016 – Astute Medical, Inc., developer of biomarkers for better healthcare, today previewed several presentations taking place in conjunction with the annual American Society of Nephrology Kidney Week meeting, which will be held November 15 through November 20 in Chicago. The Company highlighted research exploring TIMP-2 and IGFBP7, which were identified1 and validated2 as biomarkers of acute kidney injury (AKI) risk in clinical studies leading to the commercialization of the Astute Medical’s NephroCheck® Test.

Hospitals are implementing risk assessment utilizing the NephroCheck® Test and developing potential intervention strategies based on their own AKI protocols to address the danger that AKI poses to susceptible patients, including those suffering from systemic illness or injury, or who have recently undergone surgery. AKI is known to strike in up to 50 percent of critically ill patients,3 heightening risk of mortality, lengthening intensive care stays and driving healthcare costs higher.4

Kidney Week attendees can learn more about the NephroCheck® Test at Astute Medical’s exhibition booth #1523.

“Physicians tell us that the NephroCheck® Test is the first significant innovation in decades to gauge the risk of kidney injury before damage occurs,” said Paul McPherson, Astute Medical chief scientific officer. “Now that the test is available, more and more hospitals are incorporating it into their kidney care protocols. The research presented at meetings such as Kidney Week is important to advancing AKI risk assessment, understanding the threat it poses to patients and improving the possibility of earlier intervention to preserve kidney health.”

Abstracts to be presented in clinical poster sessions include:

Urinary [TIMP-2]·[IGFBP7] in Platin-induced Renal Injury
  • Poster Identifier: TH-PO636
  • AKI Biomarker Poster Session: Thursday, November 17 at 10 a.m. in Exhibit Hall F2 in the McCormick Place Convention Center.
Urinary [TIMP-2]·[IGFBP7] for Risk Prediction of Acute Kidney Injury in Decompensated Heart Failure.
  • Poster Identifier: TH-PO635
  • AKI Biomarker Poster Session: Thursday, November 17 at 10 a.m. in Exhibit Hall F2 in the McCormick Place Convention Center.
Localization of Kidney Injury Markers TIMP-2 and IGFBP7 in Human Kidney Biopsies
  • Poster Identifier: FR-PO667
  • Diagnostic Pathology-I Session: Friday, November 18 at 10 a.m. in Exhibit Hall F2 in the McCormick Place Convention Center.

In addition, the Cardio Renal Society of America (CRSA) will host “Guiding AKI Prevention Using Next-gen Biomarkers: Real World Experiences from Modern Practices” on November 18. Dr. Peter McCullough, CRSA Chairman, will lead a panel of expert intensivists and nephrologists including: Dr. John Kellum (University of Pittsburgh), Dr. Claudio Ronco (Institute IRRIV San Bartolo Hospital), Dr. Ravi Mehta (University of California, San Diego), Dr. James Tumlin (University of Tennessee) and Dr. Harold Szerlip (Baylor University).

Using a patient case-based format, the group will discuss their new protocols for risk assessment, prevention, diagnosis and treatment of AKI directed at improving patient outcomes. Kidney Week attendees seeking more information can contact the CRSA at (855) 712-5084 or click here. Astute Medical has provided an educational grant to the CRSA.

Attended by more than 13,000 kidney professionals, Kidney Week promotes the opportunity to discuss the latest scientifically advanced medicine and technology, the chance to exchange knowledge and listen to discussions from the top specialists in the field.

The NephroCheck® Test helps clinicians 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.

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 FDA’s de novo classification pathway. 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. PN0604 Rev A 2016/11/01

References

1 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.

2 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.

3 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.

4 Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2014;00:1-8.

 

©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