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With FDA Clearance of NephroCheck, Astute Secures Access to $30M from CRG


NEW YORK (GenomeWeb) – With the recent clearance by the US Food and Drug Administration of its NephroCheck test for acute kidney injury, Astute Medical has achieved a milestone under the terms of its loan agreement with CRG which releases from CRG up to $30 million to support commercialization of the test.

An additional $10 million will become available to Astute upon achievement of certain revenue milestones, the companies noted.

CRG is a healthcare investment firm with $1.5 billion in assets that partners with commercial-stage healthcare companies to provide them financing, primarily through structured debt and senior secured loans.

"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, said in a statement. “We are excited about the commercial opportunity for NephroCheck, which represents a vast improvement to the current standard for risk assessment of AKI."

The test measures the presence of two proteins – insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2) – in urine, allowing clinicians to assess in about 20 minutes the risk of a patient developing AKI in the next 12 hours.

According to numbers from Astute, of the more than 5 million critically ill patients accepted into US hospital intensive care units each year, roughly half will develop AKI. The condition is associated with significantly increased hospital stays and readmission rates as well as increased costs and worse patient outcomes.