Daily News: October 13, 2014

Astute Medical, CRG Announce Term Loan Agreement Milestone

Astute Medical and CRG announced that Astute recently achieved a milestone under the terms of its existing term loan agreement with CRG. Under the term loan agreement, CRG will provide up to $30 million to support the commercialization of the NephroCheck Test System. An additional $10 million will become available to Astute upon the achievement of certain revenue milestones.

Last month, Astute announced receipt of 510(k) clearance for the NephroCheck Test System from the United States Food and Drug Administration. The NephroCheck Test System is the first test for risk assessment of acute kidney injury (AKI) to receive FDA clearance.

In certain hospitalized patients, AKI can take a serious health situation and make it significantly worse, which is why there is such a need for the NephroCheck® Test System, said Chris Hibberd, Astute Medical’s chief executive officer. CRG has a deep understanding of our industry and developed a structure to help us grow our business.

Astute Medical received 510(k) clearance through the FDA’s de novo classification process, clearing the path to commence sales in the coming weeks with its strategic partner Ortho-Clinical Diagnostics, Inc., whom Astute has designated as the exclusive sales agent for Astute’s NephroCheck® Test System. This test is the only biomarker test available to assess risk of AKI.

The investment in Astute Medical represents our continued commitment to providing minimally dilutive financing alternatives to growing companies with novel products, said Charles Tate, chairman of CRG. We are excited about the commercial opportunity for NephroCheck, which represents a vast improvement to the current standard for risk assessment of AKI.

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 patients, as an aid in the risk assessment for moderate or severe AKI within 12 hours of patient assessment.