Strataca Systems, Ltd., a clinical stage company developing medical devices designed to improve kidney function in patients with congestion and fluid overload, today announces new animal data presented during Kidney Week which has been posted on the conference website. The study features the company’s JuxtaFlow® renal negative pressure treatment (rNPT) device demonstrating improved kidney function, including increased urine output, sodium excr
FLORIANA, Malta, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Strataca Systems, Ltd., a clinical stage company developing medical devices designed to improve kidney function in patients with congestion and fluid overload, today announces new animal data presented during Kidney Week which has been posted on the conference website. The study features the company’s JuxtaFlow® renal negative pressure treatment (rNPT) device demonstrating improved kidney function, including increased urine output, sodium excretion, and glomerular filtration rate (GFR, a measure of kidney function) without compromising renal plasma flow (RPF, a measure of kidney perfusion) in porcine model of fluid overload and heart failure.
According to Poster #P01499, ten pigs weighing approximately 80 kgs. (~176lbs.), who were fluid overloaded and given a high dose of diuretics, underwent placement of the JuxtaFlow catheter in one kidney, while the second kidney served as a control. Results showed that the kidney receiving rNPT with the JuxtaFlow system had markedly increased urine output, sodium excretion and GFR compared to the control kidney (p<0.001), while preserving RPF. These metrics are critical to removing the fluid overload and are therefore critical to the clinical management of renal dysfunction.
This study further supports the hypothesis that rising venous pressures via a heart failure model directly impair renal function, as measured by decreases in urine output, sodium excretion, GFR and RPF. Treatment with rNPT from JuxtaFlow significantly increased urine output, sodium excretion and GFR, without impairing RPF. These data also support the hypothesis that rNPT using the JuxtaFlow System can directly impact the impaired renal function that may be caused or worsened by increased venous pressures and fluid overload.
“The data offer an intriguing approach to improving kidney function in patients who remain persistently fluid overloaded despite iv diuretics. Renal negative pressure treatment may be an important adjunct to current medical therapy and warrants further investigation in human trials,” said Jeffrey Testani, M.D., lead investigator and director of heart failure research, cardiovascular medicine at Yale School of Medicine, New Haven, Conn. “Additionally, these data reinforce that elevated venous pressure, such as during decompensated heart failure, directly impair renal function.”
“The opportunity to present these findings at Kidney Week allows us to continue to interact with the important stakeholders who are struggling to manage a very sick patient population to address the challenge of fluid overload and its impact on kidney function. The introduction of our JuxtaFlow system suggests a new paradigm in thinking about how to better optimize outcomes for these patients,” commented John Erbey, Ph.D., founder of Strataca Systems, Ltd. “We look forward to further discussing the clinical potential of JuxtaFlow and to its continued development.”
The vast majority of acute heart failure patients come to the hospital because of shortness of breath. The primary clinical goal of hospital admission is to achieve clinical decongestion and restore normal breathing. However, even among the best medical centers in the US, nearly half of these patients never achieve clinical decongestion prior to being released1.
A study of 105,388 heart failure patients in the Acute Decompensated Heart Failure National Registry (ADHERE) reported 91% had abnormal renal function, including over 60% having moderate to severe kidney disease.2 This connection reveals the interdependence between the two organs, marked by the heart’s reliance on the kidney’s regulation of salt and water content of the body while the kidneys depend upon the blood flow and pressure generated by the heart. Increased congestion and extracellular water content -- such as in heart failure – indicate that the kidneys are not able to appropriately regulate the body’s internal environment. This condition is commonly referred to as the cardiorenal syndrome.
About Cardiorenal Syndrome
Cardiorenal syndrome is a condition where an abrupt decline in heart function causes a decline in renal function. The kidneys are complex organs responsible for at least five critical functions; (1) eliminate waste and excess fluid, (2) help regulate blood pressure, (3) stimulate red blood cell production, (4) keep bones healthy, and (5) regulate pH levels. Fluid overload, and the resulting venous congestion are an early indicator of declining renal function, for which the underlying causes may include prediabetes, diabetes, chronic kidney disease or heart disease. Since the kidneys are encapsulated, they are unable to expand to accommodate the excess volume associated with rising venous pressures. Therefore, increasing venous pressure decreases filtration and further impairs all of the other renal functions. Dialysis is the treatment of last resort. By filtering the blood, dialysis can reduce waste and excess fluid. However, it does not replace the other vital kidney functions.
About JuxtaFlow®
Strataca Systems’ lead investigational product, JuxtaFlow, is an endoscopically delivered, memory polymer catheter designed to allow rNPT without obstruction by adjoining tissue placed in the renal pelvis, to deliver a mild controlled negative pressure (suction) through a specially designed vacuum pump. Because each nephron is an unobstructed fluid column, negative pressure will transmit through to the Bowman’s space, which will reestablish the filtration gradient lost due to venous congestion and increase the production of filtrate. In preclinical studies, JuxtaFlow has demonstrated improvements in creatinine clearance, sodium excretion, and urine output; all key indicators of improvement and preservation of renal function.
The JuxtaFlow system is the first treatment to simultaneously improve renal function and decrease venous congestion, the “holy grail” for fluid overloaded patients. This combination not only relieves pressure from the kidneys but also the heart, lungs and other organs. These benefits should translate to meaningful and objective endpoints, to include reduced hospitalization, need for dialysis and overall improved survival. Primary market research confirms that the value proposition is compelling to physicians. More importantly, the approach is well suited for a wide range of other acute congestion syndromes; including pre-renal acute kidney injury, hemodilutional anemia during bypass, and sepsis. The company initiated its human feasibility study, VOID-HF in the second quarter of 2020.
About Strataca Systems
Strataca Systems, Ltd., is a clinical stage medical device company that develops solutions for the improvement of renal function. Strataca Systems is developing the JuxtaFlow system as a De Novo, Class II device in the United States and has a second device in development to slow the progression of chronic kidney disease.
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1 http://circheartfailure.ahajournals.org/content/8/4/741
2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2900793/#:~:text=A%20study%20of%20105%2C388%20heart,disease%20%5B5%2C%206%5D.