Astute Medical Highlights Clinical Presentations And Activities At Kidney Week 2017

SAN DIEGO, Oct. 31, 2017 /PRNewswire/ -- 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 today through Nov. 5 in New Orleans. The Company highlighted research focusing on the biomarkers TIMP-2 and IGFBP7, which were identified¹ and validated² in clinical studies for their utility in assessing the risk of acute kidney injury (AKI), leading to the commercialization of Astute Medical's NephroCheck Test.

Recent studies have shown that the use of the NephroCheck Test in conjunction with guided therapy based upon Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guidelines improved patient outcomes,³ shortened hospital stays and reduced per patient costs.⁴

Clinicians have found the use of the test for early identification of patients whose kidneys are stressed allows treatment to be tailored to mitigate risk.^5,6

The two biomarkers are involved in G1 cell-cycle arrest, a protective mechanism that prevents stressed cells from dividing in case of DNA damage.⁷ This allows the biomarkers to function as an early alarm of kidney cell stress before major damage and progression to AKI.⁸

Hospitals are using the NephroCheck Test as a risk assessment tool and developing patient management strategies based on their protocols to address the danger that AKI poses to susceptible patients, including those suffering from serious injury, systemic illness, or who have recently undergone surgery.⁹ AKI is known to strike in up to 50 percent of critically ill patients,¹⁰ heightening risk of mortality, lengthening intensive care stays and driving health care costs higher.¹¹

Kidney Week attendees can learn more about the NephroCheck Test at Astute Medical's exhibition booth #501.

"Presentations at Kidney Week include a new multicenter analysis of the NephroCheck Test in patients presenting to the emergency department with sepsis," said Astute Chief Scientific Officer Paul McPherson, Ph.D. "This study provides additional insight for how physicians may use the test to improve assessment of these difficult to manage patients, leading to better care."

Presentations include:

Biomarkers of AKI

• Pre-conference session Critical Care Nephrology
• Tuesday, Oct. 31, Ballroom C, 1:00 to 1:30 p.m.  

Cell-Cycle Arrest Biomarkers TIMP2*IGFBP7 Predict Worse Outcomes in Septic Patients Without Clinical Evidence of AKI

• Poster identifier: PO302
• Acute Kidney Injury, oral abstract presentation, Thursday, Nov. 2, Room 282, 5:42 to 5:54 p.m. 

On Wednesday, Nov. 1, the Cardio Renal Society of America (CRSA) will host a dinner symposium at the Audubon Zoo in New Orleans, during which physicians will discuss their experience using the NephroCheck Test. The event is supported by an unrestricted educational grant from Astute Medical.

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.

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.

The NephroCheckTest Intended Use (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 on the NephroCheck Test visit NephroCheck.com.

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. PN0652 Rev A 2017/10/29

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 Meersch M, Schmidt C, Hoffmeier A, et al. Prevention of cardiac surgery-associated AKI by implementing the KDIGO guidelines in high risk patients identified by biomarkers: The PrevAKI randomized control trial. Intensive Care Med. (2017) Jan. 21.
⁴ Göcze I, Jauch D, Götz M, et al. Biomarker-guided intervention to prevent acute kidney injury after major surgery: the prospective randomized BiK Study. Ann Surg. Published online August 2017.
⁵ Laviano B, DiGiorgi P, Buss R, Comas G, Hummel B. Utility of Urinary [TIMP-2] *[IGFBP7] as a Predictor of Acute Kidney Injury in Cardiac Surgery Patients. Abstract presented at the 14^th Annual Multidiscipline Cardiovascular and Thoracic Critical Care Conference from the Society of Thoracic Surgeons; October 5, 2017; Washington, D.C.
⁶ Schanz M, Shi J, Wasser C, Alscher MD and Kimmel M. Urinary [TIMP-2] x [IGFBP7] for risk prediction of acute kidney injury in decompensated heart failure. Clin Cardiol. 2017. https://doi.org/10.1002/clc.22683.
⁷ Kellum JA, Chawla LS. Cell-cycle arrest and acute kidney injury: the light and dark sides. Nephrol Dial Transplant (2015) 0:1-7 doi: 10.1093/ndt/gfv130.
⁸ Kellum JA, Chawla LS. Cell-cycle arrest and acute kidney injury: the light and dark sides. Nephrol Dial Transplant (2015) 0:1-7 doi: 10.1093/ndt/gfv130.
⁹ 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.
¹⁰ 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.
¹¹ Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2014;00:1-8.

SOURCE Astute Medical, Inc.

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