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NEPHROCHECK® BIOMARKERS TIMP-2 AND IGFBP7 INCLUDED IN ACUTE DIALYSIS QUALITY INITIATIVE RECOMMENDATIONS

Marcy l’Étoile (France) and San Diego (California) – June 12, 2018 – The biomarkers in the NEPHROCHECK® test, an FDA-cleared and CE-marked urine test that indicates kidney stress in advance of acute kidney injury (AKI), have been included in a second set of consensus recommendations, the Acute Dialysis Quality Initiative (ADQI). This follows the inclusion of this assay in the guidelines issued recently by ERAS® Cardiac Surgery.

ADQI is an international, interdisciplinary organization with over 150 members from leading universities around the world. Founded in 2000, the non-profit, member run organization’s mission is to provide an objective, dispassionate distillation of the literature and description of the current state of practice of diagnosis and management of acute kidney injury as well as other conditions in which dialysis and related therapies are applied to acutely ill patients.

The ADQI recommendation follows the recent publication of two randomized controlled trials1,2 that demonstrated significant improvement in patient outcomes, length of stay, and decreased costs due to AKI following cardiac and non-cardiac surgery by using NEPHROCHECK® to guide the use of kidney-protecting interventions.

“Since its founding in 2000, ADQI has been advancing the international standard of care for acute kidney health,” said Pr. Claudio Ronco, MD, current President of ADQI. John Kellum, MD, MCCM, past President of ADQI, added: “As research and literature has advanced and market access has occurred, biomarkers have shown that they can play an important role in improving patient care and outcomes as they have become more routinely used in practice. As such they are now included in the consensus recommendations. In the future they are likely to change the way we define acute kidney injury.”

“We are thrilled that the two biomarkers in the NEPHROCHECK® test are included once more in consensus guidelines,” said Mark Miller, Executive Vice President and Chief Medical Officer for bioMérieux. “The increasing recognition of the NEPHROCHECK® test in evidence based patient care recommendations will help standardize the medical approach to prevent AKI and improve patient outcomes. This test brings high medical value information to clinicians in order to help them make actionable decisions which are crucial to protect patients’ kidneys from both acute and long term damage.”

The guidelines “Cardiac and Vascular Surgery-Associated Acute Kidney Injury: The 20th International Consensus Conference of the ADQI (Acute Disease Quality Initiative) Group”, or ADQI 20 for short, were published June 1, 2018 in the Journal of the American Heart Association (JAHA).

ABOUT AKI

AKI is a frequent complication in patients undergoing major surgery, and is known to increase morbidity, mortality and costs3. Additional AKI-associated expenses during U.S. hospitalizations have been reported at $38,000 per patient4, resulting in U.S. healthcare expenditures between $5 to $24 billion annually5. Currently available indicators of AKI, such as elevated blood levels of creatinine, may not be present until kidney damage has already occurred6. Recent studies have called for the pursuit of innovative strategies to combat this major public health concern 7,8.

ABOUT THE NEPHROCHECK® TEST

The NEPHROCHECK® test detects two biomarkers, urinary tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP7), that increase in a patient’s urine in response to early kidney cell stress which can lead to AKI. This allows the biomarkers to function as an early alarm of kidney stress before progression to AKI so that maneuvers to protect the kidneys can be undertaken9.

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 (ICU) patients as an aid in the risk assessment for moderate or severe AKI within 12 hours of patient assessment. The NEPHROCHECK® Test System is intended to be used in patients 21 years of age or older. For more information on the NEPHROCHECK® Test visit www.nephrocheck.com.

Astute Medical®, the AM logo, ASTUTE140®, NephroCheck®, the NephroCheck® logo, and AKIRisk® are registered trademarks of Astute Medical, Inc. in the United States. For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see www.astutemedical.com/about/intellectualproperty.

ABOUT BIOMÉRIEUX

Pioneering Diagnostics

A world leader in the field of in vitro diagnostics for more than 50 years, bioMérieux is present in more than 150 countries through 43 subsidiaries and a large network of distributors. In 2017, revenues reached €2,288 million, with over 90% of international sales.

bioMérieux provides diagnostic solutions (systems, reagents, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.

bioMérieux is listed on the Euronext Paris stock market
Symbol: BIM – ISIN Code: FR0013280286
Reuters: BIOX.PA/Bloomberg: BIM.FP

Corporate website: www.biomerieux.com.

Contacts

Media Relations
bioMérieux
Aurore Sergeant
Tel.: + 33 4 78 87 20 53
media@biomerieux.com
bioMérieux Inc.
Tim Baker
Tel.: + 1 216-407-5354
timothy.baker@biomerieux.com
Image Sept
Laurence Heilbronn
Tel.: + 33 1 53 70 74 64
lheilbronn@image7.fr

 References

1 Göcze I, Jauch D, Götz M, et al. Biomarker-guided intervention to prevent acute kidney injury after major surgery: the prospective randomized BigpAK Study. Ann Surg. Published online August 2017.

2 Meersch M, Schmidt C, Hoffmeier A, et al. Prevention of cardiac surgery-associated AKI by implementing the KDIGO guidelines in high risk patients identified by biomarkers: the PrevAKI randomized controlled trial. Intensive Care Med. 2017 Jan 21.

3 Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2014;00:1-8.

4 Alshaikh H, Katz N, Gani F, et al. Financial Impact of Acute Kidney Injury After Cardiac Operations in the United States. Ann Thorac Surg. 2018 Feb;105(2):469-475.

5 Silver SA, Chertow GM. The Economic consequences of AKI. Nephron. 2017;137:297-301.

6 McCullough PA, Shaw AD, Haase M, et al. Diagnosis of acute kidney injury using functional and injury biomarkers: workgroup statements from the tenth Acute Dialysis Quality Initiative Consensus Conference. Contrib Nephrol. 2013;182:13-29.

7 Thakar CV. Acute Kidney Injury: A Paradigm In Quality and Patient Safety. Adv Chronic Kid Dis. 2017;24(4):192-193.

8 Silver SA, Chertow GM. The Economic consequences of AKI. Nephron. https://doi.org/10.1159/000475607. Published online June 9, 2017.

9 Kellum JA, Chawla LS. Cell-cycle arrest and acute kidney injury: the light and dark sides. Nephrol Dial Transplant. (2015) 0: 1–7doi: 10.1093/ndt/gfv130.

NEPHROCHECK BIOMARKERS TIMP-2 AND IGFBP7 INCLUDED IN GROUNDBREAKING CONSENSUS STATEMENT OF BEST PRACTICES TO ENHANCE RECOVERY AFTER HEART SURGERY

Marcy l’Étoile (France) and San Diego (California) – May 2nd, 2018 – The biomarkers in the NEPHROCHECK test, an FDA-cleared and CE-marked urine test that indicates kidney stress in advance of acute kidney injury (AKI), have been included in consensus guidelines from ERAS® Cardiac Surgery, a non-profit, multi-professional and multi- disciplinary medical society whose mission is to optimize perioperative care of cardiac surgical patients through collaborative discovery, analysis, expert consensus, and dissemination of best practices that will improve both short- and long-term outcomes and decrease complications and readmissions.

This follows the recent publication of two randomized controlled trials1,2 that demonstrated significant improvement in patient outcomes, length of stay, and decreased costs due to AKI following cardiac and non-cardiac surgery by using NEPHROCHECK to initiate kidney-protecting interventions.

The new guidelines were presented as part of evidenced-based expert consensus statements at the American Association for Thoracic Surgery (AATS) meeting on April 28th, 2018. These were developed in a formal process over 15 months to provide cardiac surgery programs best practices to enhance recovery after surgery. It is anticipated that the final work product will be submitted for peer review publication, facilitating its dissemination to surgeons and heart programs around the world.

“We hope that these recommendations will encourage cardiac surgical programs around the world to join us to standardize best practice,” said ERAS® Cardiac Surgery President Daniel T. Engelman, M.D.. “Since our inaugural meeting a year ago, we’ve solicited input, considered protocols, and assessed the class and strength of evidence for each that may help enhance recovery after heart surgery. This is the first time such a comprehensive evidence-based approach has been presented at a major cardiovascular surgery meeting.”

“Evidence-based patient care guidelines are crucial for standardizing medical care and enhancing patient outcomes,” said Mark Miller, Executive Vice President and Chief Medical Officer for bioMérieux. “NEPHROCHECK is a simple, urine-based test that provides vital information to healthcare providers so that they can act promptly to prevent harmful consequences for the patient’s kidneys. The evidence continues to grow that routine use of NEPHROCHECK will be an important tool for improving the management of adult cardiac surgery patients in order to protect their kidneys from both acute and long-term damage. Additional studies of NEPHROCHECK in other patient populations are also underway.”

AKI is a frequent complication in patients undergoing major surgery, and is known to increase morbidity, mortality and costs3. Additional AKI-associated expenses during U.S. hospitalizations have been reported at $38,000 per patient4, resulting in U.S. healthcare expenditures between $5.4 to $24 billion annually5. Currently available indicators of AKI, such as elevated blood levels of creatinine, may not be present until kidney damage has already occurred6. Recent studies have called for the pursuit of innovative strategies to combat this major public health concern7,8.

ABOUT NEPHROCHECK

The NEPHROCHECK test detects two biomarkers, urinary tissue inhibitor of metalloproteinases -2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP7), that increase in a patient’s urine in response to early kidney cell stress which can lead to AKI. This allows the biomarkers to function as an early alarm of kidney stress before progression to AKI so that maneuvers to
protect the kidneys can be undertaken9.

The NEPHROCHECK test 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 (ICU) patients as an aid in the risk asses sment for moderate or severe AKI within 12 hours of patient assessment. The NEPHROCHECK test is intended to be used in patients 21 years of age or older. For more information on the NEPHROCHECK test visit www.NephroCheck.com.

ABOUT ASTUTE MEDICAL

Astute Medical Inc., a company dedicated to improving the diagnosis of high -risk medical conditions and diseases through the identification and validation of protein biomarkers. In particular, Astute developed the NEPHROCHECK test, an FDA-cleared and CE marked test for the early risk assessment of acute kidney injuries (AKI) based on the level of two biomarkers, IGFBP-7 (Insulin-like Growth Factor-Binding Protein-7) and TIMP-2 (Tissue Inhibitor Metalloproteinases-2).
bioMérieux has announced the acquisition of Astute Medical Inc, on April 4 th, 2018.

Astute Medical®, the AM logo, ASTUTE140®, NephroCheck®, the NephroCheck® logo, and AKIRisk® are registered trademarks of Astute Medical, Inc. in the United States. For information regarding trademarks and other intellectual property applicable to this product, including inter national trademarks, please see: www.astutemedical.com/about/intellectualproperty.

ABOUT BIOMÉRIEUX

Pioneering Diagnostics

A world leader in the field of in vitro diagnostics for more than 50 years, bioMérieux is present in more than 150 countries through 43 subsidiaries and a large network of distributors. In 2017, revenues reached €2,288 million, with over 90% of international sales.

bioMérieux provides diagnostic solutions (systems, reagents, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.

bioMérieux is listed on the Euronext Paris stock market
Symbol: BIM – ISIN Code: FR0013280286
Reuters: BIOX.PA/Bloomberg: BIM.FP

Corporate website: www.biomerieux.com.  Investor website: www.biomerieux-finance.com.

More about ERAS: www.erassociety.org
More about ERAS® Cardiac Surgery: www.erascardiac.org

Contacts

Investor Relations
bioMérieux
Sylvain Morgeau
Tel.: + 33 4 78 87 22 37
investor.relations@biomerieux.com
Media Relations
bioMérieux
Aurore Sergeant
Tel.: + 33 4 78 87 20 53
media@biomerieux.com
bioMérieux Inc.
Tim Baker
Tel.: + 1 216-407-5354
timothy.baker@biomerieux.com
Image Sept
Laurence Heilbronn
Tel.: + 33 1 53 70 74 64
lheilbronn@image7.fr

 References

1 Göcze I, Jauch D, Götz M, et al. Biomarker-guided intervention to prevent acute kidney injury after major surgery: the prospective randomized BigpAK Study. Ann Surg. Published online August 2017.

2 Meersch M, Schmidt C, Hoffmeier A, et al. Prevention of cardiac surgery -associated AKI by implementing the KDIGO guidelines in high risk patients identified by biomarkers: the PrevAKI randomized controlled trial. Intensive Care Med. 2017 Jan 21.

3 Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2014;00:1-8.

4 Alshaikh H, Katz N, Gani F, et al. Financial Impact of Acute Kidney Injury After Cardiac Operations in the United States . Ann Thorac Surg. 2018 Feb;105(2):469-475.

5 Silver SA, Chertow GM. The Economic consequences of AKI. Nephron. 2017;137:297-301.

6 McCullough PA, Shaw AD, Haase M, et al. Diagnosis of acute kidney injury using functional and injury biomarkers: workgroup statements from the tenth Acute Dialysis Quality Initiative Consensus Conference. Contrib Nephrol. 2013;182:13-29.

7 Thakar CV. Acute Kidney Injury: A Paradigm In Quality and Patient Safety. Adv Chronic Kid Dis. 2017;24(4):192 -193.

8 Silver SA, Chertow GM. The Economic consequences of AKI. Nephron. https://doi.org/10.1159/000475607. Published online June 9, 2017.

9 Kellum JA, Chaw la LS. Cell-cycle arrest and acute kidney injury: the light and dark sides. Nephrol Dial Transplant. (2015) 0: 1–7doi: 10.1093/ndt/gf v130.

BIOMÉRIEUX REINFORCES ITS OFFERING OF HIGH MEDICAL VALUE IMMUNOASSAY BIOMARKERS WITH THE ACQUISITION OF ASTUTE MEDICAL

Marcy l’Étoile, France – April 4th, 2018 – bioMérieux, a world leader in the field of in vitro diagnostics, announces today the acquisition of Astute Medical Inc., a company dedicated to improving the diagnosis of high-risk medical conditions and diseases through the identification and validation of protein biomarkers. In particular, Astute developed the NEPHROCHECK® test, an FDA-cleared test for the early risk assessment of acute kidney injuries (AKI) based on the level of two biomarkers, IGFBP-7 (Insulin-like Growth Factor-Binding Protein-7) and TIMP-2 (Tissue Inhibitor Metalloproteinases-2).

This acquisition builds upon the fruitful partnership developed in 2015 between Astute Medical and bioMérieux when Astute granted bioMérieux a license to develop and market the NEPHROCHECK® test for the VIDAS® automated immunoassay system. Since 2017, bioMérieux has been a licensed distributor with Astute for the NEPHROCHECK® test on the Astute140 Meter in the US.

Astute Medical has developed a strong network of Key Opinion Leaders and demonstrated significant value for NEPHROCHECK® with peer-reviewed outcomes studies. bioMérieux intends to continue to invest in health economic and outcome studies for NEPHROCHECK®, explore the other promising biomarkers in the Astute pipeline as well as work with Astute’s current license
and distribution partners in order to make the NEPHROCHECK® test available to as many patients as possible worldwide.

AKI is a major public health threat that is common, costly and potentially fatal in hospitalized patients1. Today, up to 50 percent of severely ill patients develop AKI2 which can result in prolonged hospital stays3, chronic kidney disease4, a greater risk of mortality3, and higher cost of care3. An outcomes study published recently by the journal Intensive Care Medicine5 reported a 33.9 percent reduction in the occurrence of moderate to severe AKI following cardiac surgery when clinicians used the NEPHROCHECK® test to identify patients with moderate to severe risk for AKI and then implemented a bundle of care recommended by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines.

For the critically ill patient, unique biomarker tests such as the VIDAS® BRAHMS PCT™ and the NEPHROCHECK® test are complementary: procalcitonin guidance shortens antibiotic exposure, which can be important in preserving kidney health, while the NEPHROCHECK® test determines AKI risk, which is key for antibiotic management and other medical interventions.

“We are very enthusiastic to welcome the Astute team as part of bioMérieux after 3 years of beneficial collaboration,” commented Alexandre Mérieux, Chairman and Chief Executive Officer. “Because of its relevance in many severe medical conditions, the NEPHROCHECK® test developed by Astute perfectly fits bioMérieux’s strategy to differentiate VIDAS® through proprietary markers and to provide our customers with innovative and high medical value diagnostic solutions for improved patient care.”

Chris Hibberd, Astute Medical Chief Executive Officer, added: “Astute’s innovative Acute Kidney Injuries products offer a unique opportunity to address an important area of critical care in the hospital. bioMérieux’s global footprint, critical care presence and dedication to areas of high medical need positions the Company well to advance and scale this opportunity with the Astute team and its partners. The Astute team has enjoyed a wonderful collaboration with bioMérieux and we look forward to building this together.”

bioMérieux has agreed to acquire all shares of Astute Medical Inc. for approximately $90 million in cash. Due to investments for commercialization, and further health economic and outcome research, the estimated operating expenses related to Astute for the remaining 9 months of the year could drive an impact of -60 bps on the 2018 contributive operating income of bioMérieux.

ABOUT NEPHROCHECK®

The NEPHROCHECK® test 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 (ICU) patients as an aid in the risk assessment for moderate or severe AKI within 12 hours of patient assessment.

The NEPHROCHECK® test System is intended to be used in patients 21 years of age or older. NEPHROCHECK® received 510(k)-clearance through the FDA’s de novo classification and is CE-marked and available in Europe.

For more information on the NEPHROCHECK® test visit www.nephrocheck.com

ABOUT BIOMÉRIEUX

Pioneering Diagnostics

A world leader in the field of in vitro diagnostics for more than 50 years, bioMérieux is present in more than 150 countries through 43 subsidiaries and a large network of distributors. In 2017, revenues reached €2,288 million, with over 90% of international sales.

bioMérieux provides diagnostic solutions (systems, reagents, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.

bioMérieux is listed on the Euronext Paris stock market
Symbol: BIM – ISIN Code: FR0013280286
Reuters: BIOX.PA/Bloomberg: BIM.FP

Corporate website: www.biomerieux.com. Investor website: www.biomerieux-finance.com.

Contacts

Investor Relations
bioMérieux
Sylvain Morgeau
Tel.: + 33 4 78 87 22 37
investor.relations@biomerieux.com
Media Relations
bioMérieux
Aurore Sergeant
Tel.: + 33 4 78 87 20 53
media@biomerieux.com
Image Sept
Laurence Heilbronn
Tel.: + 33 1 53 70 74 64
lheilbronn@image7.fr
Claire Doligez
Tel.: + 33 1 53 70 74 48
cdoligez@image7.fr

 References

1 Lewington AJP, Cerdá J, Mehta RL Raising Awareness of Acute Kidney Injury: A Global Perspective of a Silent Killer. Kidney Int. 2013;84(3):457-467

2 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

3 Dasta JF, Kane -Fill SL, Durtschi, AJ, Pathak DS, Kellum JA. Costs and outcomes of acute kidney injury (AKI) following cardiac surgery. Nephrol Dial Transplant . 2008;23:1970 -1974.

4 Hobson C, Ozrazgat -Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2014;00:1-8

5 Meersch M, Schmidt C, Hoffmeier A, et al. Prevention of cardiac surgery-associated AKI by implementing the KDIGO guidelines in high risk patients identified by biomarkers: the PrevAKI randomized controlled trial. Intensive Care Med. (2017). doi:10.1007/s00134-016-4670-3.

ASTUTE MEDICAL TO EXHIBIT AT SOCIETY OF THORACIC SURGEONS ANNUAL MEETING

 

SAN DIEGO – Astute Medical, Inc., developer of biomarkers for better healthcare, announced today that it will be exhibiting at the Society of Thoracic Surgeons (STS) 54th Annual Meeting at the Broward County Convention Center in Fort Lauderdale, Florida, from Saturday, Jan. 27, through Wednesday, Jan. 31.

“Astute is enthusiastic about its opportunity to participate in this gathering of cardiothoracic surgeons from all over the world, following a year in which many STS members and hospitals have adopted the NephroCheck Test as a new tool to gauge a patient’s risk for acute kidney injury (AKI) so that corrective measures can be taken before injury occurs,” said Ryan Roberts, Astute Medical’s chief commercial officer.

Florida Hospital Waterman in Central Florida, a member of the Adventist-Florida Hospital System, recently adopted use of the NephroCheck Test, joining the University of Florida Health in Northern Florida, Morton Plant Hospital in Clearwater, and other providers in the state that were early adopters.

“The potential utility of the NephroCheck Test for more personalized, multidisciplinary care is growing,” said Louis Guzzi, M.D., an intensivist at Florida Hospital Waterman. “The utility extends to many types of critically ill patients, including those who have major surgery, suspected sepsis, and cardiac or pulmonary issues that can create challenges in multiple organs including the kidneys. It is also useful in identifying renal stress that can be caused by drugs commonly used for critically ill patients, such as broad-spectrum antibiotics, ” Dr. Guzzi said.

Peer-reviewed publications continue to demonstrate the tremendous health and cost impacts of AKI. , , In a study of cardiac surgery patients, mortality was 500 percent higher among those who developed AKI during hospitalization.2 “Kidney failure is an important element of STS quality metrics, as well as CMS quality and payment incentives,” Roberts said.

Early identification of patients at risk of AKI can improve cardiac surgery patient outcomes and reduce costs. Results from a 13-month study at Lee Health’s Health Park Medical Center in Fort Meyers, Florida, presented at an STS meeting in October 2017, showed that use of the NephroCheck Test to determine AKI risk on 1,116 patients after open heart surgery reduced both the incidence of AKI and the delays in patient care that occur as a result of the complication.

“With this test, we now can identify stress on the kidneys and intervene earlier and more effectively,” said Paul DiGiorgi, M.D., an author of the study, which was the largest on cardiac surgery patients. “It is the intelligent application of the test results and care coordination that ultimately makes the difference in practice,” DiGiorgi said.

Significant improvements in outcomes were also reported in a study published in January 2017, in the journal Intensive Care Medicine, in which the NephroCheck Test was used to identify patients at high risk for AKI after open-heart surgery. At-risk patients were treated under KDIGO (Kidney Disease: Improving Global Outcomes) guidelines, resulting in a more than 33 percent reduction in the occurrence of moderate to severe AKI.

The NephroCheck Test quantitatively measures two urinary biomarkers, tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP-7), which have been related to early kidney stress, thus signaling elevated risk for imminent AKI. In high-risk hospital patients, this stress can signal the threat of moderate to severe AKI if left unmitigated.

Astute Medical can be found in booth #730 from Sunday, Jan. 28, to Tuesday, Jan. 30.

About Astute Medical, Inc.

Astute Medical is dedicated to improving outcomes for patients with 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 is a founding corporate partner of 0by25, a human rights initiative aimed at eliminating preventable and treatable deaths from AKI worldwide by 2025.

For additional information, please visit AstuteMedical.com.

The NephroCheck Test Intended Use (United States)

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 (ICU) patients as an aid in the risk assessment for moderate or severe AKI within 12 hours of patient assessment. The NephroCheck Test System is intended to be used in patients 21 years of age or older.
For more information on the NephroCheck Test visit NephroCheck.com.

###

Astute Medical®, the AM logo, ASTUTE140®, NephroCheck®, the NephroCheck® logo, and AKIRISK® are registered trademarks of Astute Medical, Inc. in the United States. For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see astutemedical.com/US/About/IntellectualProperty/. PN0658 2018/01/25

References

1 Silver SA, Chertow GM. The Economic consequences of AKI. Nephron. 2017;137:297-301.

2 Dasta JF, Kane-Fill SL, Durtschi, AJ, Pathak DS, Kellum JA. Costs and outcomes of acute kidney injury (AKI) following cardiac surgery. Nephrol Dial Transplant. 2008;23:1970-1974.

3 Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2014;00:1-8.

4 Lee Health Press Release. “Shipley Cardiothoracic Center Study Findings Featured At National Conference.” Published online October 12, 2017. http://www.leehealth.org/publicaffairs/press-releasesoct17/shipley-urine-test.htm

TEST FOR AKI RISK ASSESSMENT COULD LEAD TO SAFER ICU CARE

SAN DIEGO – December 27, 2017 – Hospital clinicians have long been frustrated by the prospect of intensive care unit (ICU) patients developing acute kidney injury (AKI), a stealthy and potentially deadly condition that can arise from renal insults stemming from treatments and care intended to help patients. The complication may be avoidable if clinicians can identify those at risk and apply countermeasures, but they lacked reliable tools to do so until the introduction of Astute Medical’s NephroCheck Test, which measures urinary biomarkers linked to AKI, said Daniel T. Engelman, M.D., associate professor of surgery at the University of Massachusetts-Baystate.

Patients in the ICU are frequently exposed to measures that could be potentially harmful to renal function, often simultaneously and/or in succession, including medications, transfusions and efforts to maintain hemodynamic stability, said Engelman. These renal insults can include broad-spectrum antibiotics used to fight infection in the ICU.

According to Astute Medical, a multicenter study recently published online in the journal Critical Care Medicine showed the NephroCheck Test detected sharp rises in levels of biomarkers indicative of AKI risk on the first day of exposure to broad-spectrum antibiotics vancomycin and piperacillin/tazobactam in patients who developed moderate-to-severe AKI within 48 hours. The study also showed distinct biomarker level increases indicating when major surgery and nonsteroidal anti-inflammatory drugs put patients at risk of AKI. The biomarkers did not elevate at any time following exposure to the same renal insults in patients who did not develop AKI within 48 hours of exposure.

“Early use of the biomarkers could potentially help clinicians to identify patients with renal stress who may benefit from early intervention to prevent progression of kidney injury,” wrote the study authors.

This hypothesis may be borne out as more clinicians put the test into practical use. “The biomarkers provide an early-warning for AKI by telling us when the kidneys are stressed by any of these insults and not yet injured,” Engelman said. “It’s like decades ago when we figured out that cardiac enzymes can show when someone is in the early stages of having a heart attack. It directly impacts the quality of patient care and safety because it gives clinicians more information to determine how to direct our attention and resources properly,” he said.

Identification of patients at risk of AKI can help advance quality of care by improving AKI outcomes, shortening hospital stays, including time in the ICU, and reducing costs, as shown by randomized controlled trials. A recent estimate of AKI-associated increases in U.S. hospitalization costs ranged from $5.4 billion to $24.0 billion, while a study published last month in the Clinical Journal of the American Society of Nephrology reported that the incremental cost of AKI in Canada was approximately CAN $200 million a year, with hospital stays for patients with Stage 2 and Stage 3 AKI averaging 14 days with an average cost of CAN $17,817.

Results from the study published in Critical Care Medicine suggest that testing to assess risk of AKI could also be useful in determining when to move patients from the ICU to a lower care unit, Engelman said. In the study,1 surgery patients’ biomarkers peaked at 24 hours. This correlates with how Engelman said the NephroCheck Test is used in a Springfield, Massachusetts hospital where he performs surgery. Routinely, on the day after surgery, clinicians there evaluate whether the patient is ready to leave the ICU, and its higher levels of monitoring and nursing care, for a step-down unit that allows the removal of many lines, catheters and monitors, he said.

“The biomarkers alert us that a patient might not be doing as well as we thought and may not be ready to make that move, but requires more attention to maintain their stability for a little longer,” he said. “And it allows us to move the other 80 percent of patients out of the ICU with no delay, injury or increased costs,” he said.

The study results also help clinicians understand how a patient’s exposure to a renal insult may relate to the timing and need for further testing, said John Kellum, M.D., a critical care physician, past president of the Acute Dialysis Quality Initiative (ADQI) and an author of the study.

“If I’m faced with a patient who’s had an exposure and I may want to do a urine or blood test, I need to understand how those tests relate to each other in specific ways, not just in ideal cases, and that’s what this study does,” Kellum said.

The negative predictive value of the test is another important finding, he said.

“Now we know that very few patients without an increase in the biomarkers will go on to develop AKI. If I gave a potentially nephrotoxic drug such as vancomycin to a patient and the test results are negative, I have confidence I’m not hurting the patient’s kidneys as a result of the drug. I might have to test again later, but it helps me with regard to determining the patient’s treatment,” he said.

AKI, which has no obvious symptoms, strikes up to half of critically ill patients and has been linked to longer hospital stays and a tenfold increase in mortality. Recent clinical articles have called for the pursuit of innovative strategies to combat AKI, calling it a major public health concern.3

The NephroCheck Test measures levels of the urinary biomarkers TIMP-2 and IGFBP7, which play a role in cell-cycle arrest, a protective mechanism that prevents stressed cells from dividing in case of DNA damage.

The current standard measurement for AKI is serum creatinine levels, which often do not increase for at least 24 hours, after kidney damage has already occurred. “In a nutshell, this has been the problem,” Engelman said.

About Astute Medical

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 is a founding corporate partner of 0by25, a human rights initiative aimed at eliminating preventable and treatable deaths from AKI worldwide by 2025.
Astute Medical’s NephroCheck Test received 510(k)-clearance through the FDA’s de novo classification. The test is CE-marked and available in Europe. For additional information, please visit AstuteMedical.com.

The NephroCheck Test Intended Use (United States)

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 (ICU) patients as an aid in the risk assessment for moderate or severe AKI within 12 hours of patient assessment. The NephroCheck Test System is intended to be used in patients 21 years of age or older.
For more information on the NephroCheck Test visit NephroCheck.com.

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Astute Medical®, the AM logo, ASTUTE140®, NephroCheck®, the NephroCheck® logo, and AKIRisk® are registered trademarks of Astute Medical, Inc. in the United States. For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see www.astutemedical.com/about/intellectualproperty. PN0654 2017/12/18

References

1 Ostermann M, McCullough PA, et al. Kinetics of Urinary Cell Cycle Arrest Markers for Acute Kidney Injury Following Exposure to Potential Renal Insults. Crit Care Med. Published online November 10, 2017.

2 Göcze I, Jauch D, Götz M, et al. Biomarker-guided intervention to prevent acute kidney injury after major surgery: the prospective randomized BigpAK Study. Ann Surg. Published online August 29, 2017.

3 Silver SA, Chertow GM. The Economic consequences of AKI. Nephron. 2017;137:297-301.

4 Collister D, Pannu N, et al. Healthcare Costs Associated With AKI. CJASN. November 07, 2017 vol. 12 no. 11 1733-1743.

5 Ronco C, Ricci Z. The concept of risk and the value of novel markers of acute kidney injury. Crit Care. 2013:17:117-118.

6 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.

7 Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2014;00:1-8.

8 Kellum JA, Chawla LS. Cell-cycle arrest and acute kidney injury: the light and dark sides. Nephrol Dial Transplant. (2015) 0: 1–7.

9 Martensson J et al. Novel Biomarkers of Acute Kidney Injury and Failure: Clinical Applicability. Brit J Anesth. 2012;109(6):843-50.

©2019 Astute Medical, Inc. Astute Medical®, the AM logo, Astute140®NephroCheck®, the NephroCheck® logo, and AKIRisk® are registered trademarks of Astute Medical, Inc. in the United States. For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see AstuteMedical.com/about/intellectualproperty.