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TRIAL RESULTS SHOW ASTUTE MEDICAL’S NEPHROCHECK TEST WITH GUIDED INTERVENTION PREVENTS ACUTE KIDNEY INJURY, SHORTENS HOSPITAL STAYS AND REDUCES COSTS

RANDOMIZED CONTROL TRIAL REPORTS 66 PERCENT REDUCTION IN
MODERATE TO SEVERE AKI; $2,000 PER PATIENT SAVINGS

SAN DIEGO – September 5, 2017 – Astute Medical, Inc., developer of biomarkers for better healthcare, said a newly published trial showing improved patient outcomes, shorter hospital stays, and cost savings associated with a 66 percent reduction in moderate and severe acute kidney injury (AKI) following noncardiac surgery further validates the case for early AKI risk assessment in combination with guided therapy. The randomized trial, published online in Annals of Surgery,1 utilized Astute’s NephroCheck Test to identify patients at high risk of developing AKI, triggering the implementation of preventative intervention. Patients in the intervention group spent fewer days in the intensive care unit (ICU) (approximately one day) and hospital (approximately five days) yielding net savings of more than $2,000 per patient.

“Interestingly, it appears the prediction of imminent AKI at the very early stage, followed by optimal fluid resuscitation with less positive fluid balance and kidney protection, led to the improved outcomes, meaning the reduced incidence and severity of AKI, as well as a decrease in postoperative creatinine levels and length of hospital stay,” said Ivan Göcze, M.D., the trial’s lead author. “In fact, these benefits were present soon after intervention,” Göcze said.

The findings add to the evidence gathered in a trial published earlier this year in the journal Intensive Care Medicine,2 in which the NephroCheck Test was used to evaluate patients after cardiac surgery, resulting in a 33.9 percent reduction in moderate to severe AKI.

“Again, we are seeing that a biomarker-guided protocol can reduce AKI, providing medical and economic benefit,” said John Kellum, M.D., a critical care physician and past president of the Acute Dialysis Quality Initiative (ADQI). “The cell-cycle arrest biomarkers are ushering in a new era in which AKI can be reduced by identifying patients destined to develop it. More protocols are needed especially for the most vulnerable patients,” Kellum said.

AKI is a frequent complication in patients undergoing major surgery, and is known to increase morbidity, mortality risk and costs.3 A recent estimate of AKI-associated increases in U.S. hospitalization costs ranged from $5.4 billion to $24.0 billion.4 Although the complication can be managed, today’s standard indicators of AKI, such as elevated levels of serum creatinine, may not be present until kidney damage has already occurred.5 Recent studies have called for the pursuit of innovative strategies to combat this major public health concern.4,6

“Today’s health care environment not only emphasizes outcomes, but also value and cost,” said Paul McPherson, Ph.D., Astute’s co-founder and chief scientific officer. “We believe the $2,000 per-patient savings from shorter hospital stays demonstrated in this trial could represent as much as a 10-to-1 return on investment in the NephroCheck Test system.”

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 the earliest kidney cell stress which, if left unmitigated, can lead to AKI. The two markers, usually elevated before serum creatinine, are involved in G1 cell-cycle arrest, a protective mechanism that prevents stressed cells from dividing in case of DNA damage. This allows the biomarkers to function as an early alarm of kidney cell stress before major damage and progression to AKI.7

In the prospective randomized control trial at University Hospital in Regensburg, Germany, patients who had undergone major noncardiac surgery were screened with the NephroCheck Test immediately after admission to the ICU. Patients found to be NephroCheck Test positive (AKIRisk Score > 0.3) for the risk of AKI were then randomized to standard care (61 patients) or intervention (60 patients). The intervention group received treatment with a kidney-sparing care bundle based on Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guidelines, which can be provided in any ICU.

The study’s primary endpoint was the incidence of AKI during the first seven days after surgery. In the intervention group, 19 patients (31.7 percent) developed some level of AKI, while 29 patients (47.5 percent) in the control group developed some level of AKI.

Biomarker-guided therapy significantly reduced the incidence of moderate and severe AKI in the intervention group to 6.7 percent compared to 19.7 percent in the standard care group, a 66 percent reduction.

About Astute Medical, Inc. 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.

###

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. PN0650 Rev B 2017/09/4

Contact:

Nadine Padilla
LawPadilla Communications
+1 (619) 507-9306
nadine@lawpadilla.com

References

1Göcze 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.

2Meersch 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.

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

4Silver SA, Chertow GM. The Economic consequences of AKI. Nephron. https://doi.org/10.1159/000475607. Published online June 9, 2017.

5McCullough 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.

6Thakar CV. Acute Kidney Injury: A Paradigm In Quality and Patient Safety. Adv Chronic Kid Dis. 2017;24(4):192-193.

7Kellum 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.

PLAYING IT SAFE: In Quest to Improve Patient Outcomes Hospitals Use Biomarkers to Gauge Patient Risk for Acute Kidney Injury

SAN DIEGO – July 12, 2017 – For critically ill hospital patients, no matter what the primary health problem, one of the most serious and frequent complications clinicians worry about is acute kidney injury, which is damage to the kidneys that impairs their ability to clear toxins from the blood and produce urine.1 Acute kidney injury (AKI) can progress without symptoms for hours to days and makes everything at least twice as bad for the patient: increased length of hospital stay,2 increased risk of long-term complications3 and increased risk of death.2 AKI kills an estimated 2 million people worldwide annually, and that number continues to grow.4

AKI has frustrated physicians for years because until recently there’s been no reliable way to determine which critically ill patients were at risk or in the earliest stages of injury. As a result, “it just seemed an inevitable outcome that some patients were just going to get AKI,” said Adan Mora, M.D., F.C.C.P., an intensivist at Baylor University Medical Center in Dallas. “It’s a big deal for us in the ICU when the kidneys fail because of the high mortality associated with this,” Dr. Mora said.

AKI is a risk for many patients. “It’s definitely a bad actor for cardiac surgery,” said V. Seenu Reddy, M.D., a cardio thoracic surgeon at Centennial Medical Center in Nashville. “It’s a very serious complication and can affect the outcome of major cardiac surgical procedures,” Dr. Reddy said.

The challenge, historically, has been a lack of biomarkers, or symptoms within the body that indicate the kidneys are stressed and at risk of failure, Dr. Mora said. Obvious biomarkers or symptoms could alert physicians to impending danger and allow them to stay ahead of the problem. Such tests exist for heart attacks and other organ failures, however, the indicators clinicians rely upon for kidney trouble, urine output and serum creatinine, often aren’t present until kidney damage has already occurred, Dr. Reddy said. And if these indicators are present they aren’t always reliable because of variables, such as a patient’s muscle mass and fluid intake, as well as inconsistency in how these are measured, he said.

Mora and Reddy are among a group of doctors who are leading a change in medicine to focus on stress to the kidneys with the help of a new test that has been shown to improve patient outcomes.

The NephroCheck® Test measures two biomarkers that indicate kidney stress, TIMP-2 and IGFBP-7,5 enabling clinicians to proactively identify patients who are at risk for AKI.6 Studies have demonstrated the biomarkers’ effectiveness in multiple patient populations, including those with sepsis,7 pre-existing conditions8 and those who have undergone cardiac and other major surgery.9

Earlier this year German researchers reported in a published study that by using the NephroCheck® Test to identify high-risk patients and then implementing a bundle of care recommended by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines, they were able to reduce the occurrence of moderate to severe AKI by nearly 35 percent.9

Dr. Reddy said he began using the test after reading several studies about the biomarkers and realizing there was a new tool by which he could try to deliver better outcomes and better care for heart surgery patients.

“A heart surgery program is measured on the quality of outcomes, including the avoidance of renal failure, which is second only to stroke as a dangerous complication,” he said. “Many heart programs are adopting best practices, so to remain a top program in the country I feel that as new tools become available to provide better outcomes and avoid unnecessary complications, we should seek to evaluate them carefully to possibly include them in our care pathway.”

Reddy’s patients often have multiple risk factors in addition to their heart disease, such as high blood pressure, atherosclerosis and diabetes, which means the patient can be starting out with underlying medical conditions that make them more prone to kidney injury.

The doctor has used the NephroCheck® Test after surgery to quickly determine whether a patient’s kidneys were under significant stress. Knowing the kidneys are under stress may lead him to alter his normal postoperative treatment, which could include adjusting the amount of fluids given to the patient or the drugs used to support the patient’s blood pressure, which may positively impact the kidneys, he said.

Reddy said he has also used the test in elderly patients who undergo a procedure in which an aortic valve is replaced through a catheter (TAVR), which involves the administration of contrast agents during the procedure. The contrast agents can impact these often frail and “elderly” kidneys more so than those in younger patients. Having access to the biomarkers may serve as an early warning system.

Mora said he recently had a 50-year-old man admitted to the ICU with flu and pneumonia. The doctor considered giving the patient medication that would have increased his blood pressure, which could impact the kidneys. Additionally, the doctor needed to decide whether the patient needed fluids, which would impact the kidneys.

“With the traditional markers it looked as though the patient could tolerate those treatments, but when I conducted the test it said the patient was in the danger zone for AKI,” Mora said. “This caused me to change things I normally would have done to spare any additional insult to the kidney.”

He’s also used the test on patients he thought might already be experiencing kidney stress before proceeding with a treatment, such as forcing fluids or use of a diuretic, that could harm the kidneys.

“In one such case I found that a patient was not in stress and could handle the treatment plan well,” he said.

“These biomarkers, this test, challenge us to think about treatment in a different way. It will absolutely allow us to improve outcomes, reduce morbidity and mortality of patients in the ICU. I think it’s going to be a game-changer,” he said.

###

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. PN0644 Rev A 2017/07/7

Contact:

Nadine Padilla
LawPadilla Communications
+1 (619) 507-9306
nadine@lawpadilla.com

References

1National Kidney and Urologic Diseases Information Clearinghouse. The Kidneys and How They Work [accessed 2017 June 8]. Available at: http://kidney.niddk.nih.gov/kudiseases/pubs/yourkidneys/.

1Dasta JF, Kane Gill 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.

3Chawla LS, Eggers P, Star R. Acute Kidney Injury and Chronic Kidney Disease as Interconnected Syndromes. N Engl J Med. 2014;371:58-66.

4Murugan R, Kellum JA. Acute kidney injury: what’s the prognosis? Nat. Rev. Nephrol. 7, 209–217 (2011); published online 22 February 2011; doi:10.1038/nrneph.2011.13.

5Kellum 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.

6Bihorac 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.

7Honore PM, Nguyen HB, Gong M et al. Urinary Tissue Inhibitor of Metalloproteinase-2 and Insulin-Like Growth Factor-Binding Protein 7 for Risk Stratification of Acute Kidney Injury in Patients With Sepsis. Critical Care Medicine. Published Online June 28, 2016.

8Heung M, Ortega L, et al. Common chronic conditions do not affect performance of cell cycle arrest biomarkers for risk stratification of acute kidney injury.Nephrol Dial Transplant. (2016) 0: 1–8.

9Meersch 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 control trial. Intensive Care Med. (2017) Jan 21.

SWEDISH COVENANT HOSPITAL AMONG FIRST TO DEPLOY NOVEL TEST TO COMBAT ACUTE KIDNEY INJURY RISK

SAN DIEGO – June 26, 2017 – Astute Medical, Inc., developer of biomarkers for better healthcare, today announced that Swedish Covenant Hospital is one of a rapidly growing number of hospitals in the United States, and among the first in Chicago, to begin using a first-of-its-kind risk assessment test for acute kidney injury (AKI), a stealthy, time-sensitive and potentially deadly condition that is a common complication in critically ill patients.

“Astute Medical’s NephroCheck® Test will allow Swedish Covenant clinicians to more quickly identify patients at risk of developing AKI so they can intervene earlier and reduce the threat of irreparable kidney damage,” said Eric Gluck, M.D., a pulmonologist and critical care specialist at the hospital. “Currently, most hospitals rely on renal tests that detect changes in kidney function, however these changes may not be evident until injury to the kidney has already occurred.”

AKI is known to strike in up to half of critically ill patients1 and has been linked to a tenfold increase in mortality.2 Like a “silent” heart attack, the condition lacks obvious signs and symptoms.3 Delays in recognition can lead to chronic kidney disease,4 kidney disease requiring dialysis,4 heart disease4 or death.5 Early knowledge that a patient is likely to develop AKI may prompt closer patient surveillance and help prevent permanent kidney damage or death.6

“I’m excited that we can now proactively address AKI using these new biomarkers, which have been shown to be helpful in improving patient outcomes by identifying those at risk for the condition,” said Dr. Gluck. “Doctors have always accepted AKI as inevitable in some critically ill patients, and now that does not have to be the case.”

The 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.7 In high-risk hospital patients, this stress can signal a future threat of
moderate to severe AKI.

About Astute Medical, Inc. 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.

For additional information, please visit AstuteMedical.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. PN0647 Rev A 2017/06/16

Contact:

Nadine Padilla
LawPadilla Communications
+1 (619) 507-9306
nadine@lawpadilla.com

References

1Mandelbaum 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.

1Dasta 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.

3Ronco C, Ricci Z. The concept of risk and the value of novel markers of acute kidney injury. Crit Care. 2013;17:117-118.

4Chawla LS, Eggers PW, Star RA, Kimmel PL. Acute Kidney Injury and Chronic Kidney Disease as Interconnected Syndromes. N Engl J Med. 2014;371:58-66.

5Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg 2014;00:1-8.

6Lewington AJ, Cerdá J, Mehta RL. Raising awareness of acute kidney injury: a global perspective of a silent killer. Kidney Int. 2013;84(3):457-467.

7Kellum 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.

ASTUTE MEDICAL TO DEMONSTRATE AKI RISK ASSESSMENT CAPABILITIES OF NEPHROCHECK® TEST AT NATIONAL CRITICAL CARE NURSING CONFERENCE

Educational sessions at AACN NTI 2017 to highlight shift from AKI diagnosis to prevention

SAN DIEGO – May 18, 2017 – Astute Medical, Inc., developer of biomarkers for better healthcare, today announced it will conduct educational sessions highlighting advances in the area of acute kidney injury (AKI) risk assessment at the American Association of Critical Care Nurses NTI 2017 in Houston May 22-25. The presentations will highlight how biomarkers measured by Astute Medical’s NephroCheck® Test can be used for risk assessment of AKI, shattering the myth that AKI is an unavoidable condition for many critically ill patients.

About half of the more than 5 million people admitted to intensive care units (ICU) in U.S. hospitals each year develop AKI,1 a potentially deadly condition that can progress for hours to days without symptoms.2 Clinicians encounter many dilemmas as they seek to risk assess critically ill patients and determine optimal therapies.2 Chief among these is overcoming the current limitations of standard-of-care kidney tests, which elevate only after damage has occurred and are compromised diagnostically in many types of patients.3

The NephroCheck® Test measures TIMP-2 and IGFBP-7, two biomarkers that have been associated with kidney stress indicative of AKI risk.4 Critical care nurses, who provide round-theclock care to these patients, can play a key role in earlier identification of those at risk of developing moderate to severe AKI. With early knowledge of AKI risk, the patient’s treatment can be tailored to mitigate risk.

During the NTI sessions, Astute Medical faculty will review the pathophysiology, etiology and epidemiology of AKI, as well as current definitions and classifications of the condition. They will also discuss the importance of [TIMP-2]x[IGFBP-7] as a tool for risk-assessment of AKI, and the role these biomarkers can play in the effort to prevent or mitigate the effects of AKI.

“Critical care nurses can be the patient’s first line of defense against AKI, so it’s crucial that they learn about this new tool, and see for themselves how this test can help them work smarter and faster to improve patient care,” said Tara Sanders, MSN, MA, APRN, ACNP-BC, a nurse practitioner in Dallas. “Historically we’ve been reactive to AKI, but by utilizing the NephroCheck® Test the critical care team can become proactive instead. The NephroCheck® Test is a great example of the new technology and cutting-edge science that nurses seek to learn about at the NTI,” Sanders said.

The American Association of Critical Care Nurses NTI attendees can learn more about the NephroCheck® Test at Astute Medical’s exhibition booth #4716.

Details of Astute Medical’s presentations follow:

Title: Shattering the Myth that AKI is Unavoidable: Shifting the Paradigm from Diagnosis to Prevention
Speakers: Teddie Proctor, BSN, RN; Elisha Lowe, MBA, RN; and Toni Rodriguez, BSN, RN
Dates and Times: Tuesday May 23 – 11:30 a.m. and 1:45 p.m.
                              Wednesday May 24 –11:30 a.m. and 1:45 p.m.
                              Thursday May 25 – 10:15 a.m.
Preregistration is not required.

Important Information About The NephroCheck® Test
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.

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 visit NephroCheck.com

About Astute Medical, Inc. 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.

For additional information, please visit AstuteMedical.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. PN0646 Rev A 2017/05/12

Contact:

Nadine Padilla
LawPadilla Communications
+1 (619) 507-9306
nadine@lawpadilla.com

References

1Mandelbaum 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.

2Ronco C, Ricci Z. The concept of risk and the value of novel markers of acute kidney injury. Crit Care. 2013;17:117-118.

3McCullough PA 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.

4Kellum 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.

 

ASTUTE MEDICAL, INC. HIGHLIGHTS ATS 2017 ABSTRACTS STUDYING DETECTION OF ACUTE KIDNEY INJURY IN CRITICALLY ILL PATIENTS

Educational sessions at AACN NTI 2017 to highlight shift from AKI diagnosis to prevention

SAN DIEGO – May 18, 2017 – Astute Medical, Inc., developer of biomarkers for better healthcare, today announced it will conduct educational sessions highlighting advances in the area of acute kidney injury (AKI) risk assessment at the American Association of Critical Care Nurses NTI 2017 in Houston May 22-25. The presentations will highlight how biomarkers measured by Astute Medical’s NephroCheck® Test can be used for risk assessment of AKI, shattering the myth that AKI is an unavoidable condition for many critically ill patients.

About half of the more than 5 million people admitted to intensive care units (ICU) in U.S. hospitals each year develop AKI,1 a potentially deadly condition that can progress for hours to days without symptoms.2 Clinicians encounter many dilemmas as they seek to risk assess critically ill patients and determine optimal therapies.2 Chief among these is overcoming the current limitations of standard-of-care kidney tests, which elevate only after damage has occurred and are compromised diagnostically in many types of patients.3

The NephroCheck® Test measures TIMP-2 and IGFBP-7, two biomarkers that have been associated with kidney stress indicative of AKI risk.4 Critical care nurses, who provide round-theclock care to these patients, can play a key role in earlier identification of those at risk of developing moderate to severe AKI. With early knowledge of AKI risk, the patient’s treatment can be tailored to mitigate risk.

During the NTI sessions, Astute Medical faculty will review the pathophysiology, etiology and epidemiology of AKI, as well as current definitions and classifications of the condition. They will also discuss the importance of [TIMP-2]x[IGFBP-7] as a tool for risk-assessment of AKI, and the role these biomarkers can play in the effort to prevent or mitigate the effects of AKI.

“Critical care nurses can be the patient’s first line of defense against AKI, so it’s crucial that they learn about this new tool, and see for themselves how this test can help them work smarter and faster to improve patient care,” said Tara Sanders, MSN, MA, APRN, ACNP-BC, a nurse practitioner in Dallas. “Historically we’ve been reactive to AKI, but by utilizing the NephroCheck® Test the critical care team can become proactive instead. The NephroCheck® Test is a great example of the new technology and cutting-edge science that nurses seek to learn about at the NTI,” Sanders said.

The American Association of Critical Care Nurses NTI attendees can learn more about the NephroCheck® Test at Astute Medical’s exhibition booth #4716.

Details of Astute Medical’s presentations follow:

Title: Shattering the Myth that AKI is Unavoidable: Shifting the Paradigm from Diagnosis to Prevention
Speakers: Teddie Proctor, BSN, RN; Elisha Lowe, MBA, RN; and Toni Rodriguez, BSN, RN
Dates and Times: Tuesday May 23 – 11:30 a.m. and 1:45 p.m.
                              Wednesday May 24 –11:30 a.m. and 1:45 p.m.
                              Thursday May 25 – 10:15 a.m.
Preregistration is not required.

Important Information About The NephroCheck® Test
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.

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 visit NephroCheck.com

About Astute Medical, Inc. 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.

For additional information, please visit AstuteMedical.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. PN0646 Rev A 2017/05/12

Contact:

Nadine Padilla
LawPadilla Communications
+1 (619) 507-9306
nadine@lawpadilla.com

References

1Mandelbaum 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.

2Ronco C, Ricci Z. The concept of risk and the value of novel markers of acute kidney injury. Crit Care. 2013;17:117-118.

3McCullough PA 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.

4Kellum 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.

 

ASTUTE MEDICAL, INC. PREVIEWS SCIENTIFIC PRESENTATION AT UPCOMING NATIONAL KIDNEY FOUNDATION SPRING CLINICAL MEETING

Educational sessions at AACN NTI 2017 to highlight shift from AKI diagnosis to prevention

SAN DIEGO – May 18, 2017 – Astute Medical, Inc., developer of biomarkers for better healthcare, today announced it will conduct educational sessions highlighting advances in the area of acute kidney injury (AKI) risk assessment at the American Association of Critical Care Nurses NTI 2017 in Houston May 22-25. The presentations will highlight how biomarkers measured by Astute Medical’s NephroCheck® Test can be used for risk assessment of AKI, shattering the myth that AKI is an unavoidable condition for many critically ill patients.

About half of the more than 5 million people admitted to intensive care units (ICU) in U.S. hospitals each year develop AKI,1 a potentially deadly condition that can progress for hours to days without symptoms.2 Clinicians encounter many dilemmas as they seek to risk assess critically ill patients and determine optimal therapies.2 Chief among these is overcoming the current limitations of standard-of-care kidney tests, which elevate only after damage has occurred and are compromised diagnostically in many types of patients.3

The NephroCheck® Test measures TIMP-2 and IGFBP-7, two biomarkers that have been associated with kidney stress indicative of AKI risk.4 Critical care nurses, who provide round-theclock care to these patients, can play a key role in earlier identification of those at risk of developing moderate to severe AKI. With early knowledge of AKI risk, the patient’s treatment can be tailored to mitigate risk.

During the NTI sessions, Astute Medical faculty will review the pathophysiology, etiology and epidemiology of AKI, as well as current definitions and classifications of the condition. They will also discuss the importance of [TIMP-2]x[IGFBP-7] as a tool for risk-assessment of AKI, and the role these biomarkers can play in the effort to prevent or mitigate the effects of AKI.

“Critical care nurses can be the patient’s first line of defense against AKI, so it’s crucial that they learn about this new tool, and see for themselves how this test can help them work smarter and faster to improve patient care,” said Tara Sanders, MSN, MA, APRN, ACNP-BC, a nurse practitioner in Dallas. “Historically we’ve been reactive to AKI, but by utilizing the NephroCheck® Test the critical care team can become proactive instead. The NephroCheck® Test is a great example of the new technology and cutting-edge science that nurses seek to learn about at the NTI,” Sanders said.

The American Association of Critical Care Nurses NTI attendees can learn more about the NephroCheck® Test at Astute Medical’s exhibition booth #4716.

Details of Astute Medical’s presentations follow:

Title: Shattering the Myth that AKI is Unavoidable: Shifting the Paradigm from Diagnosis to Prevention
Speakers: Teddie Proctor, BSN, RN; Elisha Lowe, MBA, RN; and Toni Rodriguez, BSN, RN
Dates and Times: Tuesday May 23 – 11:30 a.m. and 1:45 p.m.
                              Wednesday May 24 –11:30 a.m. and 1:45 p.m.
                              Thursday May 25 – 10:15 a.m.
Preregistration is not required.

Important Information About The NephroCheck® Test
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.

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 visit NephroCheck.com

About Astute Medical, Inc. 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.

For additional information, please visit AstuteMedical.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. PN0646 Rev A 2017/05/12

Contact:

Nadine Padilla
LawPadilla Communications
+1 (619) 507-9306
nadine@lawpadilla.com

References

1Mandelbaum 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.

2Ronco C, Ricci Z. The concept of risk and the value of novel markers of acute kidney injury. Crit Care. 2013;17:117-118.

3McCullough PA 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.

4Kellum 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.

 

ASTUTE MEDICAL, INC. PREVIEWS SCIENTIFIC PRESENTATIONS AT UPCOMING INTERNATIONAL INTENSIVE CARE AND EMERGENCY MEDICINE CONFERENCE

Educational sessions at AACN NTI 2017 to highlight shift from AKI diagnosis to prevention

SAN DIEGO – May 18, 2017 – Astute Medical, Inc., developer of biomarkers for better healthcare, today announced it will conduct educational sessions highlighting advances in the area of acute kidney injury (AKI) risk assessment at the American Association of Critical Care Nurses NTI 2017 in Houston May 22-25. The presentations will highlight how biomarkers measured by Astute Medical’s NephroCheck® Test can be used for risk assessment of AKI, shattering the myth that AKI is an unavoidable condition for many critically ill patients.

About half of the more than 5 million people admitted to intensive care units (ICU) in U.S. hospitals each year develop AKI,1 a potentially deadly condition that can progress for hours to days without symptoms.2 Clinicians encounter many dilemmas as they seek to risk assess critically ill patients and determine optimal therapies.2 Chief among these is overcoming the current limitations of standard-of-care kidney tests, which elevate only after damage has occurred and are compromised diagnostically in many types of patients.3

The NephroCheck® Test measures TIMP-2 and IGFBP-7, two biomarkers that have been associated with kidney stress indicative of AKI risk.4 Critical care nurses, who provide round-theclock care to these patients, can play a key role in earlier identification of those at risk of developing moderate to severe AKI. With early knowledge of AKI risk, the patient’s treatment can be tailored to mitigate risk.

During the NTI sessions, Astute Medical faculty will review the pathophysiology, etiology and epidemiology of AKI, as well as current definitions and classifications of the condition. They will also discuss the importance of [TIMP-2]x[IGFBP-7] as a tool for risk-assessment of AKI, and the role these biomarkers can play in the effort to prevent or mitigate the effects of AKI.

“Critical care nurses can be the patient’s first line of defense against AKI, so it’s crucial that they learn about this new tool, and see for themselves how this test can help them work smarter and faster to improve patient care,” said Tara Sanders, MSN, MA, APRN, ACNP-BC, a nurse practitioner in Dallas. “Historically we’ve been reactive to AKI, but by utilizing the NephroCheck® Test the critical care team can become proactive instead. The NephroCheck® Test is a great example of the new technology and cutting-edge science that nurses seek to learn about at the NTI,” Sanders said.

The American Association of Critical Care Nurses NTI attendees can learn more about the NephroCheck® Test at Astute Medical’s exhibition booth #4716.

Details of Astute Medical’s presentations follow:

Title: Shattering the Myth that AKI is Unavoidable: Shifting the Paradigm from Diagnosis to Prevention
Speakers: Teddie Proctor, BSN, RN; Elisha Lowe, MBA, RN; and Toni Rodriguez, BSN, RN
Dates and Times: Tuesday May 23 – 11:30 a.m. and 1:45 p.m.
                              Wednesday May 24 –11:30 a.m. and 1:45 p.m.
                              Thursday May 25 – 10:15 a.m.
Preregistration is not required.

Important Information About The NephroCheck® Test
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.

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 visit NephroCheck.com

About Astute Medical, Inc. 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.

For additional information, please visit AstuteMedical.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. PN0646 Rev A 2017/05/12

Contact:

Nadine Padilla
LawPadilla Communications
+1 (619) 507-9306
nadine@lawpadilla.com

References

1Mandelbaum 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.

2Ronco C, Ricci Z. The concept of risk and the value of novel markers of acute kidney injury. Crit Care. 2013;17:117-118.

3McCullough PA 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.

4Kellum 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.

 

BIOMARKERS ACCURATELY PREDICT ACUTE KIDNEY INJURY RISK IN ACUTE DECOMPENSATED HEART FAILURE PATIENTS

Educational sessions at AACN NTI 2017 to highlight shift from AKI diagnosis to prevention

SAN DIEGO – May 18, 2017 – Astute Medical, Inc., developer of biomarkers for better healthcare, today announced it will conduct educational sessions highlighting advances in the area of acute kidney injury (AKI) risk assessment at the American Association of Critical Care Nurses NTI 2017 in Houston May 22-25. The presentations will highlight how biomarkers measured by Astute Medical’s NephroCheck® Test can be used for risk assessment of AKI, shattering the myth that AKI is an unavoidable condition for many critically ill patients.

About half of the more than 5 million people admitted to intensive care units (ICU) in U.S. hospitals each year develop AKI,1 a potentially deadly condition that can progress for hours to days without symptoms.2 Clinicians encounter many dilemmas as they seek to risk assess critically ill patients and determine optimal therapies.2 Chief among these is overcoming the current limitations of standard-of-care kidney tests, which elevate only after damage has occurred and are compromised diagnostically in many types of patients.3

The NephroCheck® Test measures TIMP-2 and IGFBP-7, two biomarkers that have been associated with kidney stress indicative of AKI risk.4 Critical care nurses, who provide round-theclock care to these patients, can play a key role in earlier identification of those at risk of developing moderate to severe AKI. With early knowledge of AKI risk, the patient’s treatment can be tailored to mitigate risk.

During the NTI sessions, Astute Medical faculty will review the pathophysiology, etiology and epidemiology of AKI, as well as current definitions and classifications of the condition. They will also discuss the importance of [TIMP-2]x[IGFBP-7] as a tool for risk-assessment of AKI, and the role these biomarkers can play in the effort to prevent or mitigate the effects of AKI.

“Critical care nurses can be the patient’s first line of defense against AKI, so it’s crucial that they learn about this new tool, and see for themselves how this test can help them work smarter and faster to improve patient care,” said Tara Sanders, MSN, MA, APRN, ACNP-BC, a nurse practitioner in Dallas. “Historically we’ve been reactive to AKI, but by utilizing the NephroCheck® Test the critical care team can become proactive instead. The NephroCheck® Test is a great example of the new technology and cutting-edge science that nurses seek to learn about at the NTI,” Sanders said.

The American Association of Critical Care Nurses NTI attendees can learn more about the NephroCheck® Test at Astute Medical’s exhibition booth #4716.

Details of Astute Medical’s presentations follow:

Title: Shattering the Myth that AKI is Unavoidable: Shifting the Paradigm from Diagnosis to Prevention
Speakers: Teddie Proctor, BSN, RN; Elisha Lowe, MBA, RN; and Toni Rodriguez, BSN, RN
Dates and Times: Tuesday May 23 – 11:30 a.m. and 1:45 p.m.
                              Wednesday May 24 –11:30 a.m. and 1:45 p.m.
                              Thursday May 25 – 10:15 a.m.
Preregistration is not required.

Important Information About The NephroCheck® Test
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.

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 visit NephroCheck.com

About Astute Medical, Inc. 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.

For additional information, please visit AstuteMedical.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. PN0646 Rev A 2017/05/12

Contact:

Nadine Padilla
LawPadilla Communications
+1 (619) 507-9306
nadine@lawpadilla.com

References

1Mandelbaum 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.

2Ronco C, Ricci Z. The concept of risk and the value of novel markers of acute kidney injury. Crit Care. 2013;17:117-118.

3McCullough PA 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.

4Kellum 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.

 

ASTUTE MEDICAL EXPANDS RELATIONSHIP WITH BIOMÉRIEUX, INC. AND ORTHO CLINICAL DIAGNOSTICS TO ENHANCE NEPHROCHECK TEST MARKET ACCESS

Educational sessions at AACN NTI 2017 to highlight shift from AKI diagnosis to prevention

SAN DIEGO – May 18, 2017 – Astute Medical, Inc., developer of biomarkers for better healthcare, today announced it will conduct educational sessions highlighting advances in the area of acute kidney injury (AKI) risk assessment at the American Association of Critical Care Nurses NTI 2017 in Houston May 22-25. The presentations will highlight how biomarkers measured by Astute Medical’s NephroCheck® Test can be used for risk assessment of AKI, shattering the myth that AKI is an unavoidable condition for many critically ill patients.

About half of the more than 5 million people admitted to intensive care units (ICU) in U.S. hospitals each year develop AKI,1 a potentially deadly condition that can progress for hours to days without symptoms.2 Clinicians encounter many dilemmas as they seek to risk assess critically ill patients and determine optimal therapies.2 Chief among these is overcoming the current limitations of standard-of-care kidney tests, which elevate only after damage has occurred and are compromised diagnostically in many types of patients.3

The NephroCheck® Test measures TIMP-2 and IGFBP-7, two biomarkers that have been associated with kidney stress indicative of AKI risk.4 Critical care nurses, who provide round-theclock care to these patients, can play a key role in earlier identification of those at risk of developing moderate to severe AKI. With early knowledge of AKI risk, the patient’s treatment can be tailored to mitigate risk.

During the NTI sessions, Astute Medical faculty will review the pathophysiology, etiology and epidemiology of AKI, as well as current definitions and classifications of the condition. They will also discuss the importance of [TIMP-2]x[IGFBP-7] as a tool for risk-assessment of AKI, and the role these biomarkers can play in the effort to prevent or mitigate the effects of AKI.

“Critical care nurses can be the patient’s first line of defense against AKI, so it’s crucial that they learn about this new tool, and see for themselves how this test can help them work smarter and faster to improve patient care,” said Tara Sanders, MSN, MA, APRN, ACNP-BC, a nurse practitioner in Dallas. “Historically we’ve been reactive to AKI, but by utilizing the NephroCheck® Test the critical care team can become proactive instead. The NephroCheck® Test is a great example of the new technology and cutting-edge science that nurses seek to learn about at the NTI,” Sanders said.

The American Association of Critical Care Nurses NTI attendees can learn more about the NephroCheck® Test at Astute Medical’s exhibition booth #4716.

Details of Astute Medical’s presentations follow:

Title: Shattering the Myth that AKI is Unavoidable: Shifting the Paradigm from Diagnosis to Prevention
Speakers: Teddie Proctor, BSN, RN; Elisha Lowe, MBA, RN; and Toni Rodriguez, BSN, RN
Dates and Times: Tuesday May 23 – 11:30 a.m. and 1:45 p.m.
                              Wednesday May 24 –11:30 a.m. and 1:45 p.m.
                              Thursday May 25 – 10:15 a.m.
Preregistration is not required.

Important Information About The NephroCheck® Test
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.

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 visit NephroCheck.com

About Astute Medical, Inc. 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.

For additional information, please visit AstuteMedical.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. PN0646 Rev A 2017/05/12

Contact:

Nadine Padilla
LawPadilla Communications
+1 (619) 507-9306
nadine@lawpadilla.com

References

1Mandelbaum 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.

2Ronco C, Ricci Z. The concept of risk and the value of novel markers of acute kidney injury. Crit Care. 2013;17:117-118.

3McCullough PA 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.

4Kellum 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.

 

ASTUTE MEDICAL, INC. PREVIEWS SCIENTIFIC PRESENTATIONS AT UPCOMING INTERNATIONAL NEPHROLOGY CONFERENCE

Educational sessions at AACN NTI 2017 to highlight shift from AKI diagnosis to prevention

SAN DIEGO – May 18, 2017 – Astute Medical, Inc., developer of biomarkers for better healthcare, today announced it will conduct educational sessions highlighting advances in the area of acute kidney injury (AKI) risk assessment at the American Association of Critical Care Nurses NTI 2017 in Houston May 22-25. The presentations will highlight how biomarkers measured by Astute Medical’s NephroCheck® Test can be used for risk assessment of AKI, shattering the myth that AKI is an unavoidable condition for many critically ill patients.

About half of the more than 5 million people admitted to intensive care units (ICU) in U.S. hospitals each year develop AKI,1 a potentially deadly condition that can progress for hours to days without symptoms.2 Clinicians encounter many dilemmas as they seek to risk assess critically ill patients and determine optimal therapies.2 Chief among these is overcoming the current limitations of standard-of-care kidney tests, which elevate only after damage has occurred and are compromised diagnostically in many types of patients.3

The NephroCheck® Test measures TIMP-2 and IGFBP-7, two biomarkers that have been associated with kidney stress indicative of AKI risk.4 Critical care nurses, who provide round-theclock care to these patients, can play a key role in earlier identification of those at risk of developing moderate to severe AKI. With early knowledge of AKI risk, the patient’s treatment can be tailored to mitigate risk.

During the NTI sessions, Astute Medical faculty will review the pathophysiology, etiology and epidemiology of AKI, as well as current definitions and classifications of the condition. They will also discuss the importance of [TIMP-2]x[IGFBP-7] as a tool for risk-assessment of AKI, and the role these biomarkers can play in the effort to prevent or mitigate the effects of AKI.

“Critical care nurses can be the patient’s first line of defense against AKI, so it’s crucial that they learn about this new tool, and see for themselves how this test can help them work smarter and faster to improve patient care,” said Tara Sanders, MSN, MA, APRN, ACNP-BC, a nurse practitioner in Dallas. “Historically we’ve been reactive to AKI, but by utilizing the NephroCheck® Test the critical care team can become proactive instead. The NephroCheck® Test is a great example of the new technology and cutting-edge science that nurses seek to learn about at the NTI,” Sanders said.

The American Association of Critical Care Nurses NTI attendees can learn more about the NephroCheck® Test at Astute Medical’s exhibition booth #4716.

Details of Astute Medical’s presentations follow:

Title: Shattering the Myth that AKI is Unavoidable: Shifting the Paradigm from Diagnosis to Prevention
Speakers: Teddie Proctor, BSN, RN; Elisha Lowe, MBA, RN; and Toni Rodriguez, BSN, RN
Dates and Times: Tuesday May 23 – 11:30 a.m. and 1:45 p.m.
                              Wednesday May 24 –11:30 a.m. and 1:45 p.m.
                              Thursday May 25 – 10:15 a.m.
Preregistration is not required.

Important Information About The NephroCheck® Test
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.

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 visit NephroCheck.com

About Astute Medical, Inc. 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.

For additional information, please visit AstuteMedical.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. PN0646 Rev A 2017/05/12

Contact:

Nadine Padilla
LawPadilla Communications
+1 (619) 507-9306
nadine@lawpadilla.com

References

1Mandelbaum 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.

2Ronco C, Ricci Z. The concept of risk and the value of novel markers of acute kidney injury. Crit Care. 2013;17:117-118.

3McCullough PA 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.

4Kellum 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.

 

©2017 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.