Roswell, Georgia – 9 October, 2023 – Roivios Ltd., a medical device company pioneering a revolutionary treatment to reduce poor surgical outcomes associated with Acute Kidney Injury (AKI), today announces the first patient has been enrolled in the BIPASS-AKI early feasibility study for the JuxtaFlow Renal Assist Device (RAD). Insertion of the proprietary JuxtaFlow catheters was overseen by principal investigators Prof. Slobodan Micovic and Dr. Dragana Kosevic from the Institute for Cardiovascular Diseases Dedinje in Belgrade, Serbia.
“This is an exciting moment for patients with renal insufficiency who undergo cardiac surgery,” said Prof. Micovic “These individuals frequently develop post-surgical complications and become some of our most challenging and complex patients, so I am proud to be the first to offer this novel therapy in the study.” Cardiac surgery-associated AKI (CSA-AKI) occurs in up to 73% of patients who have preexisting renal insufficiency documented as part of their standard pre-surgical workup.
This type of AKI then impacts a patient’s ability to recover from surgery, leading to a longer and morecostly hospital stay, a higher risk of morbidity and mortality, and a more frequent need for chronic dialysis treatment. The JuxtaFlow RAD is used in the hospital setting where itenables the kidneys to function optimally and thereby improve overall patient outcomes.
“Patients who develop AKI after cardiac surgery have few options. This unmet clinical need has driven the team at Roivios to design an innovative solution that enhances the kidneys’ own natural ability to function without altering the patient’s hemodynamic status in any way.”, said John Erbey, PhD, Chief Executive Officer of Roivios. “We are incredibly excited about the opportunity to apply this novel therapy to at-risk patients and serve as the bridge to their successful recovery. We look forward to partnering 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 feasibility trial is being conducted pursuant to Medicines and Medical Devices Agency of Serbia (aka ALIMS) regulations. Ten patients will be enrolled across two hospitals in Serbia, one located in the capital of Belgrade and the other in the city of Sremska Kamenica. Regulatory submissions and comprehensive study operations oversight will be provided by SCIRENT Clinical Research & Science, a specialty cardiovascular CRO with offices in Belgrade and Berlin.
“We are very excited to lead the study operations for this groundbreaking JuxtaFlow® Renal Assist Device for Roivios, Ltd..” said Prof. Hans-Dirk Duengen, Chief Executive Officer of SCIRENT. As a contract research organization, SCIRENT specializes in cardiovascular trials, with a specific focus on medical device trials.
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
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.
About SCIRENT
SCIRENT was founded in 2012 with the vision to help clients develop innovative therapies and medical devices for patients with cardiovascular diseases. At SCIRENT, we are dedicated to advancing knowledge in cardiovascular medicine and supporting the development of groundbreaking therapies. As a contract research organization, we specialize in cardiovascular trials, with a specific focus on medical device trials for heart failure and structural heart disease, accounting for 70% of our trial portfolio.
Photo by JAFAR AHMED on Unsplash
