SAN DIEGO – March 13, 2017 – Astute Medical, Inc. (“Company”), developer of biomarkers for better healthcare, today announced two agreements aimed at expanding global access to the NephroCheck Test, a biomarker-based risk assessment tool that is changing the way hospital physicians approach acute kidney injury (AKI), a common and dangerous complication. Astute Medical has expanded its agreement with Ortho Clinical Diagnostics (“Ortho”), adding more countries under a new European distribution deal. The Company has also entered into a distribution agreement with bioMérieux in the United States. As a result, both companies will promote Astute Medical’s NephroCheck® Test on the Astute140 Meter in the United States.
The new agreements build upon Astute Medical’s licensing and collaboration agreements with each company. In 2015, Astute Medical granted bioMérieux a license to develop and market the NephroCheck® Test for the VIDAS® immunoassay system. In 2014, Astute Medical granted Ortho a license to develop and market the NephroCheck® Test for Ortho’s VITROS® line of automated, high-volume testing platforms.
“Enhancing customers’ ability to provide the NephroCheck® Test to their physicians is important for Astute, and for healthcare,” said Ryan Roberts, Astute Medical chief commercial officer. “Acute kidney injury is a $10 billion drain on the U.S. healthcare system,1 and recent peer-reviewed publications involving physicians’ use of the NephroCheck® Test to gauge the risk of injury before kidney damage occurs have shattered the myth that AKI is an inevitable consequence of ICU care for millions of patients.2 Enabling customers to acquire the test from their trusted diagnostics partners, on simple-to-deploy and cost-effective platforms, is paramount.”
Today, up to 50 percent of severely ill patients develop AKI,3 which can result in prolonged hospital stays,4 chronic kidney disease,5 a greater risk of mortality,4 and higher cost of care.4 An outcomes study2 published recently by the journal Intensive Care Medicine reported a 33.9 percent reduction in the occurrence of moderate to severe AKI following cardiac surgery when clinicians used the NephroCheck® Test to identify patients with moderate to severe risk for AKI and then implemented a bundle of care recommended by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines.
Important Information About The NephroCheck® Test In the 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 visit NephroCheck.com.
In the EU (European Union), the NephroCheck® Test result is intended to be used in conjunction with clinical evaluation as an aid in the risk assessment of acute kidney injury in the critically ill. The NephroCheck® Test is indicated for prescription use only.
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.
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.
For additional information, please visit AstuteMedical.com.
A world leader in the field of in vitro diagnostics for 50 years, bioMérieux is present in more than 150 countries through 42 subsidiaries and a large network of distributors.
bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products. bioMérieux is listed on the NYSE Euronext Paris market (Symbol: BIM - ISIN: FR0010096479). Corporate website: www.biomerieux.com. Investor website: www.biomerieux-finance.com.
About Ortho Clinical Diagnostics
Ortho Clinical Diagnostics is a global leader of in vitro diagnostics serving the clinical laboratory and immunohematology communities. Across hospitals, hospital networks, blood banks and labs in more than 120 countries, Ortho’s high-quality products and services enable health care professionals to make better-informed treatment decisions. For the immunohematology community, Ortho’s blood typing products help ensure every patient receives blood that is safe, the right type and the right unit. Ortho brings sophisticated testing technologies, automation, information management and interpretation tools to clinical laboratories around the world to help them run more efficiently and effectively and improve patient care. Ortho’s purpose is to improve and save lives with diagnostics, and it does that by reimagining what’s possible. This is what has defined Ortho for more than 75 years, and it’s what drives Ortho forward. For more information, visit www.orthoclinicaldiagnostics.com.
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. PN0634 Rev B 2017/03/10
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1Chertow GM et al. Acute kidney injury, mortality, length of stay, and costs in hospitalized patients. J Am Soc Nephrol. 2005;16:3365-3370.
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). doi:10.1007/s00134-016-4670-3.
3Mandelbaum 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.
4Dasta 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.
5Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2014;00:1-8.