Roivios® announces final patient enrollment in feasibility trial for JuxtaFlow® Renal Assist Device (RAD)
04 Dec 2023
AHAClinical Study
ROSWELL, Ga., Dec. 4, 2023 /PRNewswire/ -- Roivios Ltd., a medical device company pioneering a revolutionary treatment to reduce poor surgical outcomes associated with Acute Kidney Injury (AKI), today announces that the final patient has been enrolled in the BIPASS-AKI study for the JuxtaFlow Renal Assist Device (RAD). The Institute of Cardiovascular Diseases, Sremska Kamenica in Serbia was the highest enrolling site, led by principal investigator Prof Dr Milovan Petrovic, cardiac surgeon Prof Dr Lazar Velicki and urologist Dr Dimitrije Jeremic. Additional study sites include The American Heart Hospital in Bielsko Biala, Poland and The Institute for Cardiovascular DiseasesCardiovascular Diseases Dedinje, Serbia.
"When we began this feasibility trial, we anticipated the use of the JuxtaFlow RAD to be an exciting moment," said Prof. Petrovic. "We frequently perform cardiac surgery on patients with renal impairment and they are among our most complicated cases, so we are proud to have enrolled several patients into this study to contribute insights into this novel therapy in advance of its pivotal trial."
Cardiac surgery-associated AKI (CSA-AKI) occurs in up to 73% of patients who have pre-existing renal insufficiency documented as part of their standard pre-surgical workup1. This type of AKI then impacts a patient's ability to recover from surgery, leading to a longer and more costly hospital stay, a higher risk of morbidity and mortality, and a more frequent need for chronic dialysis treatment2-5. The JuxtaFlow RAD is used in the hospital setting and is designed to enable the kidneys to function optimally and thereby improve overall patient outcomes.
"The mission of Roivios is to give clinicians the tools to protect, preserve and improve kidney function. Cardiac surgery is a major stress on the kidneys, and today these patients have few options. Our team is inspired to design a system that would assist critical renal function during times of acute stress, employing an innovative solution that enhances the kidneys' own natural function to support recovery.", said John Erbey, PhD, Chief Executive Officer of Roivios. "We are incredibly excited to have completed the first step in providing this novel therapy for at-risk patients and serve as the bridge to their successful recovery. We look forward to sharing this BIPASS-AKI data shortly and then continuing to partner with hospitals, surgeons, and critical care teams around the world who share our vision for reducing this all-too-frequent adverse event of surgery."
The BIPASS-AKI feasibility trial was being conducted pursuant to the regulations of both ALIMS in Serbia and URPL in Poland. Ten patients were enrolled between September and December.
The JuxtaFlow RAD is not commercially available in any geography. The system is limited by United States law to Investigational Use Only and is not available for sale in the United States.
For more information about the JuxtaFlow RAD system, please visit www.roivios.com
For more information about BIPASS-AKI, see https://clinicaltrials.gov/study/NCT05990660
Contact
John Erbey, PhD, Chief Executive Officer
[email protected]
Shen W, Aguilar R, Montero AR, et al. Acute Kidney Injury and In-Hospital Mortality after Coronary Artery Bypass Graft versus Percutaneous Coronary Intervention: A Nationwide Study. Am J Nephrol. 2017;45(3):217-225.
Bowdish ME, D'Agostino RS, Thourani VH, et al. STS Adult Cardiac Surgery Database: 2021 Update on Outcomes, Quality, and Research. Ann Thorac Surg. 2021;111(6):1770-1780.
Robert AM, Kramer RS, Dacey LJ, et al. Cardiac surgery-associated acute kidney injury: a comparison of two consensus criteria. Ann Thorac Surg. 2010;90(6):1939-1943.
Palomba H, de Castro I, Neto AL, Lage S, Yu L. Acute kidney injury prediction following elective cardiac surgery: AKICS Score. Kidney Int. 2007;72(5):624-631.
Brown JR, Kramer RS, Coca SG, Parikh CR. Duration of acute kidney injury impacts long-term survival after cardiac surgery. Ann Thorac Surg. 2010;90(4):1142-1148.
About Roivios
Roivios® is a medical device company pioneering a novel renal assist device designed to reduce or eliminate acute kidney injury (AKI) in patients who are at elevated risk.
Initially focused on meeting an unmet need of cardiac surgery associated-acute kidney injury (CSA-AKI) in the coronary artery bypass and surgical valve population, our pioneering renal assist device has the potential to address a range of poor outcomes.
Our first product, the JuxtaFlow Renal Assist Device, is the world's first negative pressure renal assist device, featuring a patented catheter and unique energy delivery system.
SOURCE Roivios, ltd
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