SAN DIEGO, July 26, 2016 /PRNewswire/ -- Astute Medical, Inc., developer of novel biomarkers for better healthcare, today announced the launch of the AIM™ (Astute Implementation Methodology) Program, a suite of tools to help new NephroCheck® Test users achieve rapid, successful and measurable test deployment aimed at improving care for patients susceptible to acute kidney injury (AKI).
Through the AIM™ Program, Astute Medical will partner with adopting institutions to deploy a simple project management toolset that includes: multi-disciplined clinical education (laboratory, nursing and physician); a financial modeling calculator to assess the impact of AKI in the institution and the opportunity for improvement; a project management calendar to coordinate Company and hospital resources; and training addressing effective test use and documentation of the test experience through case studies. Astute Medical has launched a team of dedicated clinical specialists to support training.
"To achieve our goal of making risk assessment for moderate to severe AKI a reality in every hospital, we must strive to see that every NephroCheck® Test implementation leads to the desired outcome," said Ryan Roberts, Astute Medical chief commercial officer. "The AIM™ Program draws upon established best practices for successful implementation of new technology and clinical process improvement in hospitals. Our investment in AIM™ reflects our commitment to helping our healthcare partners realize the financial and clinical advantages of better risk assessment."
The NephroCheck® Test measures TIMP-2 and IGFBP-7, two biomarkers believed to be related to early kidney stress. In high-risk hospital patients, this early stress can signal the threat of moderate to severe AKI.1 Advance determination of impending AKI may prompt closer patient surveillance and help prevent permanent kidney damage or death.
"With higher patient mortality, morbidity2 and increased hospital costs,3 the consequences of AKI are severe," said Paul McPherson, Astute Medical chief scientific officer. "For this reason, there is a greater interest in identifying risk of moderate to severe AKI, so that kidney-sparing patient management strategies can be utilized. We believe the NephroCheck® Test, which predicts patient risk of AKI before traditional signs emerge, will have a high value among clinicians seeking better ways to manage high-risk patients."
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.
For more information on the NephroCheck® Test visit NephroCheck.com.
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.
Astute Medical, Inc. 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 www.AstuteMedical.com/US/About/IntellectualProperty. PN0585 Rev A 2016/07/25
1 Kellum 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.
2McCullough PA 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.
3 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.