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TRIAL RESULTS SHOW ASTUTE MEDICAL’S NEPHROCHECK TEST WITH GUIDED INTERVENTION PREVENTS ACUTE KIDNEY INJURY, SHORTENS HOSPITAL STAYS AND REDUCES COSTS

RANDOMIZED CONTROL TRIAL REPORTS 66 PERCENT REDUCTION IN
MODERATE TO SEVERE AKI; $2,000 PER PATIENT SAVINGS

SAN DIEGO – September 5, 2017 – Astute Medical, Inc., developer of biomarkers for better healthcare, said a newly published trial showing improved patient outcomes, shorter hospital stays, and cost savings associated with a 66 percent reduction in moderate and severe acute kidney injury (AKI) following noncardiac surgery further validates the case for early AKI risk assessment in combination with guided therapy. The randomized trial, published online in Annals of Surgery,1 utilized Astute’s NephroCheck Test to identify patients at high risk of developing AKI, triggering the implementation of preventative intervention. Patients in the intervention group spent fewer days in the intensive care unit (ICU) (approximately one day) and hospital (approximately five days) yielding net savings of more than $2,000 per patient.

“Interestingly, it appears the prediction of imminent AKI at the very early stage, followed by optimal fluid resuscitation with less positive fluid balance and kidney protection, led to the improved outcomes, meaning the reduced incidence and severity of AKI, as well as a decrease in postoperative creatinine levels and length of hospital stay,” said Ivan Göcze, M.D., the trial’s lead author. “In fact, these benefits were present soon after intervention,” Göcze said.

The findings add to the evidence gathered in a trial published earlier this year in the journal Intensive Care Medicine,2 in which the NephroCheck Test was used to evaluate patients after cardiac surgery, resulting in a 33.9 percent reduction in moderate to severe AKI.

“Again, we are seeing that a biomarker-guided protocol can reduce AKI, providing medical and economic benefit,” said John Kellum, M.D., a critical care physician and past president of the Acute Dialysis Quality Initiative (ADQI). “The cell-cycle arrest biomarkers are ushering in a new era in which AKI can be reduced by identifying patients destined to develop it. More protocols are needed especially for the most vulnerable patients,” Kellum said.

AKI is a frequent complication in patients undergoing major surgery, and is known to increase morbidity, mortality risk and costs.3 A recent estimate of AKI-associated increases in U.S. hospitalization costs ranged from $5.4 billion to $24.0 billion.4 Although the complication can be managed, today’s standard indicators of AKI, such as elevated levels of serum creatinine, may not be present until kidney damage has already occurred.5 Recent studies have called for the pursuit of innovative strategies to combat this major public health concern.4,6

“Today’s health care environment not only emphasizes outcomes, but also value and cost,” said Paul McPherson, Ph.D., Astute’s co-founder and chief scientific officer. “We believe the $2,000 per-patient savings from shorter hospital stays demonstrated in this trial could represent as much as a 10-to-1 return on investment in the NephroCheck Test system.”

The NephroCheck® Test detects two biomarkers, urinary tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP7), that increase in a patient’s urine in response to the earliest kidney cell stress which, if left unmitigated, can lead to AKI. The two markers, usually elevated before serum creatinine, are involved in G1 cell-cycle arrest, a protective mechanism that prevents stressed cells from dividing in case of DNA damage. This allows the biomarkers to function as an early alarm of kidney cell stress before major damage and progression to AKI.7

In the prospective randomized control trial at University Hospital in Regensburg, Germany, patients who had undergone major noncardiac surgery were screened with the NephroCheck Test immediately after admission to the ICU. Patients found to be NephroCheck Test positive (AKIRisk Score > 0.3) for the risk of AKI were then randomized to standard care (61 patients) or intervention (60 patients). The intervention group received treatment with a kidney-sparing care bundle based on Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guidelines, which can be provided in any ICU.

The study’s primary endpoint was the incidence of AKI during the first seven days after surgery. In the intervention group, 19 patients (31.7 percent) developed some level of AKI, while 29 patients (47.5 percent) in the control group developed some level of AKI.

Biomarker-guided therapy significantly reduced the incidence of moderate and severe AKI in the intervention group to 6.7 percent compared to 19.7 percent in the standard care group, a 66 percent reduction.

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 NephroCheck Test 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.

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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/about/intellectualproperty. PN0650 Rev B 2017/09/4

Contact:

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

References

1Göcze I, Jauch D, Götz M, et al. Biomarker-guided intervention to prevent acute kidney injury after major surgery: the prospective randomized BigpAK Study. Ann Surg. Published online August 2017.

2Meersch 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 controlled trial. Intensive Care Med. 2017 Jan 21.

3Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2014;00:1-8.

4Silver SA, Chertow GM. The Economic consequences of AKI. Nephron. https://doi.org/10.1159/000475607. Published online June 9, 2017.

5McCullough PA, Shaw AD, Haase M, et al. Diagnosis of acute kidney injury using functional and injury biomarkers: workgroup statements from the tenth Acute Dialysis Quality Initiative Consensus Conference. Contrib Nephrol. 2013;182:13-29.

6Thakar CV. Acute Kidney Injury: A Paradigm In Quality and Patient Safety. Adv Chronic Kid Dis. 2017;24(4):192-193.

7Kellum 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.

©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.