Deal Expands Global Access to First-Of-Its-Kind FDA-Cleared Test for Acute Kidney Injury Risk
SAN DIEGO – October 12, 2015 -- Astute Medical, Inc., today announced the signing of an agreement with Shanghai Fosun Long March Medicine Science Co. Ltd. (Fosun Long-March), a wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co. Ltd. (FOSUNPHARMA), 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 (AKI), a dangerous complication that afflicts up to 50 percent of intensive care unit (ICU) patients in the United States1 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.2
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.
"Astute's product helps us with early detection of AKI, which is still an unmet market in China. It enables a great improvement in the treatment and prognosis of the disease and reduces the incidence of serious consequences that may arise. The test provides a great help to individual patients and the medical system as a whole," said Dr. Joel Zhang, chief executive officer of Fosun Long-March.
“Our strategy is to deliver the benefits of the NephroCheck® Test to hospitals around the globe, and we are delighted to have Fosun Long-March as a partner,” said Chris Hibberd, Astute chief executive officer. “Worldwide, hospital physicians attempting to manage AKI are plagued by delayed detection, uncertainty and a lack of diagnostic tools that are useful in preliminary or early stages. The NephroCheck® Test addresses this gap by aiding in risk assessment, which could help prevent irreversible damage.”
The NephroCheck® Test is an innovation in AKI risk assessment that is designed to help ICU physicians proactively identify and stratify patients at risk of developing AKI, in the hopes of avoiding severe consequences. The NephroCheck® Test is designed to detect the presence of two key biomarkers, TIMP-2 and IGFBP-7, which have been rigorously validated as predictors of moderate to severe AKI.3,4
About Astute Medical, Inc.
Selected to the 2014 Fierce 15 by Fierce Medical Devices, 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.
Astute Medical’s NephroCheck® Test is currently available in the United States and Europe. The test received 510(k)-clearance through the FDA’s de novo classification process in September 2014. The test was CE-marked in 2012.
Astute Medical is a founding partner of 0by25, an initiative aimed at eliminating preventable and treatable deaths from AKI worldwide by 2025.
For additional information, please visit AstuteMedical.com.
About Shanghai Fosun Long March Medicine Science Co., Ltd.
Fosun Long-March is a wholly-owned subsidiary of FOSUNPHARMA. FOSUNPHARMA is a leading China based healthcare company. Its business covers a wide range of sectors of the healthcare industry, including pharmaceutical manufacturing, distribution and healthcare services etc. In 1998, FOSUNPHARMA listed on the Shanghai Stock Exchange, followed by a listing on the Hong Kong Stock Exchange in 2012. Fosun Long-March is a high tech in-vitro diagnostics enterprise that is active in manufacturing, marketing and research and development of diagnostic and laboratory instruments and reagents.
With products ranging from Clinical Chemistry kits, ELISA kits, Immunoturbidimetric kits, blood gas to electrolyte analyzer kits, Fosun Long-March is one of the most influential brands in in- vitro diagnostics. Our nation-wide sales network provides our customers reputable products. Our quick and efficient after-sales service network meets the demand of our customers throughout the country. Our products are manufactured under GMP and ISO13485 certification.
For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see astutemedical.com/about/intellectual-property. PN0502 Rev B 2015/10/08
1 Mandelbaum T, Scott DJ, Lee J, et al. Outcome of critically ill patients with acute kidney injury using the AKIN criteria. Crit Care Med. 2011;39(12):2659-2664.
2 Xu X, Nie S, Liu Z, et al. Clin J Am Soc Nephrol 10: 1510–1518, 2015. doi: 10.2215/CJN.02140215.
3 Kashani K, Al-Khafaji A, Ardiles T, et al. Discovery and validation of cell cycle arrest biomarkers in human acutekidney injury. Crit Care. 2013;17:R25.
4 Bihorac A, Chawla L, Shaw A, et al. Validation of Cell-Cycle Arrest Biomarkers for Acute Kidney Injury Using Clinical Adjudication. Am J Respir Crit Care Med. Vol 189, Iss 8, pp 932–939, Apr 15, 2014.