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Home » FDA nod triggers $30m milestone for Astute Medical

FDA nod triggers $30m milestone for Astute Medical

October 10, 2014 By Alexander Soule

FDA nod triggers $30m milestone for Astute Medical

Astute Medical said it’s in line to receive up to $30 million under a standing loan agreement from funding partner CRG to commercialize its recently approved NephroCheck kidney-injury test, and could receive an additional $10 million if it hits certain revenue milestones.

Last month, San Diego-based Astute won 510(k) clearance for NephroCheck, which is used to test for acute kidney injury, or AKI, in patients who have recently suffered a serious cardiac or respiratory event. Astute said its the first biomarker test for AKI to be approved by the FDA.

NephroCheck will be marketed by Ortho-Clinical Diagnostics.

Astute’s last announced funding round was in 2012, when it raised $40.4 million in a Series C round led by Boston-based MPM Capital and the venture arms of Johnson & Johnson (NYSE:JNJ) and Kaiser Permanente.

The company indicated it plans to have representatives at the 2014 CVT Critical Care conference currently underway in Washington.

CRG has offices in New York City and Boulder, Colo.

Filed Under: Diagnostics, Funding Roundup, News Well, Regulatory/Compliance, Respiratory Tagged With: Astute Medical, CRG, Ortho-Clinical Diagnostics, Renal

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