ASTUTE MEDICAL AND CRG ANNOUNCE FDA MILESTONE UNDER TERM LOAN AGREEMENT
SAN DIEGO – October 9, 2014 – Astute Medical, Inc. and CRG today 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 (FDA). 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.
About Astute Medical, Inc.
Named by the Wall Street Journal as one of the Top 10 Healthcare Start-Ups of 2012, 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. For additional information, please visit AstuteMedical.com.
Founded in 2003, CRG (previously known as Capital Royalty L.P) is a healthcare-focused investment firm with $1.5 billion of assets under management that provides capital to healthcare companies primarily through structured debt and senior secured loans. CRG works across the spectrum of life science products and technologies and targets investment sizes ranging between $20 million and $200 million. The firm partners with commercial-stage healthcare companies to provide flexible financing solutions so they can achieve their growth objectives. CRG is headquartered in Houston, Texas with offices in Boulder, Colorado and New York City. For additional information, please visit www.crglp.com.
Astute Medical®, the AM logo, ASTUTE140®, NEPHROCHECK® and the NEPHROCHECK® logo are registered trademarks of Astute Medical, Inc. in the United States. AKIRISK™ is a trademark of Astute Medical, Inc. For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see AstuteMedical.com/US/about/intellectual-property. PN 0382 Rev A 2014/09/16