February 01, 2015 6:40 PM ET

Biotechnology

Company Overview of Astute Medical, Inc.

Company Overview

Astute Medical, Inc. engages in the identification and validation of protein biomarkers that serve as the basis for in vitro diagnostic tests. It focuses on community and hospital acquired acute conditions that require diagnosis and risk assessment. The company offers its solutions to improve the diagnosis of high-risk medical conditions and diseases. Its areas of interest include abdominal pain, acute coronary syndromes, cerebrovascular injury, congestive heart failure, acute kidney injury, and sepsis. Astute Medical, Inc. has a strategic collaboration with Ortho-Clinical Diagnostics. The company was founded in 2007 and is based in San Diego, California.

3550 General Atomics Court

MS 02/641

San Diego, CA 92121-1194

United States

Founded in 2007

Phone:

858-792-3544

Fax:

858-882-0449

Key Executives for Astute Medical, Inc.

Co-Founder
Age: 48
Co-Founder
Age: 55
Chief Financial Officer
Age: 46
Vice President of Clinical
Compensation as of Fiscal Year 2014.

Astute Medical, Inc. Key Developments

bioMerieux and Astute Medical, Inc. Signs Agreement to Develop Test for Assessment of AKI

bioMerieux and Astute Medical, Inc. have signed a global, semi-exclusive agreement to develop a test for the early risk assessment of acute kidney injury, or AKI. This innovative test, known as the NephroCheck Test, detects the presence of two biomarkers: TIMP-2 (Tissue Inhibitor Metalloproteinases-2) and IGFBP-7 (Insulin-like Growth Factor-Binding Protein-7). Through this worldwide agreement, Astute Medical grants bioMerieux a license to develop, produce and market the NephroCheck Test for use on its immunoassay system range VIDAS, miniVIDAS and VIDAS 3. Deployment of the NephroCheck Test for the VIDAS platform will benefit from the VIDAS installed base of about 29,000 systems and from complementary large product offering dedicated to diagnosis of severe bacterial infections, in particular with VIDAS B.R.A.H.M.S. PCT. With this new assay, bioMerieux will reinforce its leading position in the risk assessment and diagnosis of patients in an emergency situation, including those with sepsis and high risk of severe medical complications. To validate TIMP-2 and IGFBP-7 as biomarkers for AKI risk assessment, Astute analyzed the biomarkers in two rigorous company-sponsored, multicenter, observational clinical studies. In these studies, the NephroCheck Test identified the majority of patients manifesting moderate or severe AKI within 12 hours of assessment.

bioMérieux and Astute Medical, Inc. Signs Global Agreement to Develop and Market Nephrocheck Test for Vidas

bioMérieux and Astute Medical, Inc. announced that they have signed a global, semi-exclusive agreement regarding the development of a test for the early risk assessment of acute kidney injury (AKI). This innovative test, known as the NephroCheck Test, detects the presence of two biomarkers: TIMP-2 (Tissue Inhibitor Metalloproteinases-2) and IGFBP-7 (Insulin-like Growth Factor-Binding Protein-7). AKI is a major public health threat that is common, costly and potentially fatal in hospitalized patients. Through this worldwide agreement, Astute Medical grants bioMérieux a license to develop, produce and market the NephroCheck Test for use on its immunoassay system range VIDAS, miniVIDAS and VIDAS. Up to 50% of severely ill patients develop AKI, which can result in prolonged stays at hospital, especially in intensive care units, thus leading to higher cost of care. The guidelines published by the foundation "Kidney Disease Improving Global Outcomes (KDIGO)" recommend that patients be assessed for risk of AKI to protect their kidney function. Current methods for risk assessment are insufficient, thereby placing substantial numbers of patients at serious risk of complications and death.

Astute Medical, Inc. Receives FDA Clearance in United States for Risk Assessment of Acute Kidney Injury

Astute Medical, Inc. announced that it has received 510(k) clearance through the Food and Drug Administration's (FDA's) de novo classification process for its first biomarker-based immunoassay known as the NephroCheck(R) Test System, clearing the path to commence sales in the coming weeks with its strategic partner Ortho-Clinical Diagnostics, Inc., whom Astute Medical has designated as the exclusive sales agent for Astute's NephroCheck(R) Test, which is the only biomarker test available to assess risk of AKI. While most are largely unaware of AKI, in hospitalized patients the condition has been shown to have worse outcomes than heart attack. The condition often occurs in the sickest patients, particularly those with sepsis or who have undergone major surgery, including cardiovascular surgery. The NephroCheck(R) Test System will introduce new information into the patient assessment process helping physicians establish which patients are at risk for moderate to severe AKI. Currently, in the United States, no other in vitro diagnostic device is available for the same intended use as the NephroCheck(R) Test System. The NephroCheck(R) Test System detects the presence of insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2) in the urine, which are associated with acute kidney injury. Within 20 minutes, the test provides a score based on the amount of the proteins present that correlates to the patient's risk of developing AKI within 12 hours of the test being performed. The biomarkers were discovered and validated through large multi-center clinical studies.

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