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November 25, 2015 7:59 AM ET


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





Key Executives for Astute Medical, Inc.

Co-Founder, Chief Executive Officer and Director
Age: 49
Co-Founder, Chief Scientific Officer and Director
Age: 56
Chief Financial Officer
Age: 47
Vice President of Clinical, Quality and Regulatory Strategy
Compensation as of Fiscal Year 2015.

Astute Medical, Inc. Key Developments

Astute Medical, Inc. Highlights Study of NephroCheck Test Biomarkers in Patients with Sepsis

Astute Medical, Inc. highlighted an oral presentation to be delivered at the CHEST Annual Meeting in Montreal on October 28, 2015 at 2:45 p.m. Eastern. The presentation describes a study of two urinary cell cycle arrest biomarkers, TIMP-2 and IGFBP-7, that were used to assess patients with sepsis for risk of moderate to severe acute kidney injury (AKI), a precursor to kidney failure. Astute's test was used in the study. Sepsis is the most common condition associated with acute kidney failure in the intensive care unit and the combination is deadly. AKI has been shown to nearly double the mortality rate in sepsis cases. The abstract "Urinary Tissue Inhibitor of Metalloproteinase-2 and Insulin-like Growth Factor-Binding Protein 7 ([TIMP-2]x[IGFBP7]) Accurately Risk Stratify Acute Kidney Injury in Patients with Sepsis" will be presented by Dr. H. Bryant Nguyen, M.D., M.S., vice-chair for research, Department of Medicine, Loma Linda University School of Medicine. The NephroCheck® Test is designed to detect the two urinary biomarkers featured in the presentation, TIMP-2 and IGFBP-7. Both biomarkers are involved in a wide array of responses to tissue insult (inflammation, oxidative stress, ultra-violet radiation, drugs and toxins) and are thought to be involved in G1 cell-cycle arrest during the earliest phases of injury to the kidney. With results in just 20 minutes, the NephroCheck® Test helps healthcare professionals evaluate intensive care patients' risk of moderate to severe acute kidney injury in the next 12 hours. The test was created for use alongside clinical evaluation of intensive care patients over 21 who have or have had acute cardiovascular and/or respiratory compromise in the past 24 hours. Once at-risk patients have been identified and their risk stratified, healthcare professionals can implement kidney-sparing strategies to potentially temper the severe consequences associated with AKI.

Astute Medical, Inc. Announces Signing of Distribution Agreement with Shanghai Fosun Pharmaceutical (Group) Co. Ltd. for NephroCheck Test in China

Astute Medical, Inc. announced the signing of an agreement with Shanghai Fosun Long March Medicine Science Co. Ltd. for distribution of Astute's NephroCheck Test on the Astute140 Meter in China. In addition to its planned launch of the NephroCheck Test in China, FOSUNPHARMA invested $20 million in Astute. The agreement with Fosun Long-March will expand the global presence of the NephroCheck Test, the only test that has received U.S. regulatory clearance as an aid in the assessment of risk for acute kidney injury, a dangerous complication that afflicts up to 50% of intensive care unit patients in the United States and is recognized as a health threat worldwide. A recent study states that AKI is both common in hospitalized adults in China, and associated with significantly higher in-hospital mortality and resource utilization. Under the terms of the multi-year agreement, Fosun Long-March will be the distributor of the NephroCheck Test on the Astute140 Meter in China. Further financial details of the transaction were not disclosed.

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.

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