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Mar17Astute Medical, Inc. Lauds Launch of Global Initiative to End Acute Kidney Injury


-- Company Joins in Call to Eliminate Preventable Deaths by 2025--

 

SAN DIEGO – March 17, 2015 

 

Astute Medical, Inc. today hailed the launch of a collaborative global initiative calling for the elimination of preventable deaths from acute kidney injury (AKI) by 2025. The Company cited the publication of a new Commission1 from The Lancet and the International Society of Nephrology (ISN), along with the release of results from the 0by25 AKI “Global Snapshot” study, as key steps forward in the effort to reduce the global burden of AKI.

 

The AKI “Global Snapshot” is the first in a series of landmark projects to be released by ISN under the 0by25 initiative, a human rights initiative aimed at eliminating preventable and treatable deaths from AKI worldwide by 2025. Astute Medical, developer of the NephroCheck® Test, is a founding partner of 0by25.

 

“We share the consensus that no one should be dying of preventable AKI by 2025, and that a comprehensive approach is needed to mitigate AKI-related mortality, as well as complications that can result in a poor quality of life,” said Chris Hibberd, Astute Medical chief executive officer. “As a developer of a test aimed at providing better risk assessment of AKI, we are proud to collaborate in this effort.”

 

Astute Medical’s NephroCheck® Test is a biomarker-based immunoassay that detects the presence of two biomarkers to aid in risk assessment for moderate to severe AKI. The Commission authors stated that AKI is believed to occur in 13.3 million people per year with 1.7 million deaths.1

Results of the AKI “Global Snapshot,” presented at the ISN Congress in Cape Town, South Africa on Saturday morning, found that one-third of the AKI cases reported in the study occurred in hospitalized patients, with the remainder being community-acquired cases. The study, which was weighted toward developing countries, also revealed that an average of one-fourth of the AKI patients seen by the participating centers required dialysis, but did not receive treatment, largely due to the late presentation and disease severity of patients.

 

In the Commission, authors recommended a 5-pronged approach including: risk assessment, recognition, response, renal support and rehabilitation. In regards to risk, they cited the identification of high-risk patients as particularly relevant in the hospital setting, as it would allow physicians to intervene in order to potentially prevent kidney injury.

 

“While the AKI problem is particularly severe in developing countries, it also impacts U.S. communities  -- with many U.S. hospitals grappling to control the costs and human consequences of AKI,” said Paul McPherson, Astute Medical chief scientific officer. “We too believe that risk assessment can play an important role in the identification and management of patients at risk for developing AKI.”

 

About Astute Medical, Inc.

Selected to the 2014 Fierce 15 by Fierce Medical Devices, 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 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’sde novo classification process in September of 2014. The test was CE-marked in 2012 and is available in Europe.

 

For additional information, please visit AstuteMedical.com.

 

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For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see astutemedical.com/about/intellectual-property. PN0450 Rev A 2015/03/14

 

1 Mehta RL, et al. International Society of Nephrology’s 0by25 initiative for acute kidney injury (zero preventable deaths by 2025): a human rights case for nephrology. The Lancet. Published online March 13, 2015 http://dx.doi.org/10.1016/S0140-6736(15)60126-X 1.