NASSAU,
Bahamas, April 26, 2024 /PRNewswire/ -- Roivios, a
pioneering clinical-stage medical device company dedicated to
transforming kidney health, is thrilled to announce it has been
awarded the prestigious Breakthrough Device Designation by the U.S.
Food and Drug Administration (FDA) for its cutting-edge JuxtaFlow®
Renal Assist Device (RAD). This landmark recognition, fueled by the
encouraging outcomes of the BIPASS-AKI feasibility study, coincides
with the unveiling of pioneering research at the Society of
Cardiovascular Anesthesiologists (SCA) Annual Meeting. It marks a
significant leap forward in safeguarding kidney function for
patients undergoing cardiac surgeries, addressing a key challenge
in cardiothoracic surgery and critical care.
The Breakthrough Device Designation emphasizes the JuxtaFlow®
RAD's potential to profoundly change the treatment paradigm for
patients facing kidney disease during cardiac surgery. The device
uses a unique, gentle negative pressure technique on the kidneys'
urine-collecting system to enhance function and shield against
hypoxia-induced damage under acute conditions.
Highlighting the device's transformative potential, Dr.
Mark Stafford-Smith, a leading
Professor of Cardiothoracic Anesthesiology at Duke University, stated, "It's become clear that
low oxygen levels in the kidneys during heart surgery are
increasingly recognized as a predictor of acute kidney injury (AKI)
and other complications after the operation. Despite numerous
attempts with medications to address this issue, we've seen limited
success. However, in our research where we replicated heart surgery
on pigs, the JuxtaFlow® RAD device reduced both the intensity and
duration of decreased kidney oxygen levels. This discovery opens up
exciting new avenues for research and strategies to safeguard the
kidneys in patients undergoing heart surgery."
John Erbey, CEO of Roivios,
reflected on the significance of this achievement saying, "Securing
the Breakthrough Device Designation marks a crucial milestone for
Roivios and underscores our dedication to advancing kidney health
innovation. We eagerly anticipate sharing the BIPASS-AKI
clinical data soon. We are proud to lead with innovative
solutions like the JuxtaFlow® RAD, which not only supports our
unique approach but also our commitment to improving outcomes
across a wide spectrum of conditions."
At the SCA Annual Meeting, Roivios will showcase the compelling
preclinical data showcasing the impact of the JuxtaFlow® RAD on
mitigating the harmful effects of cardiopulmonary bypass on the
kidneys. This breakthrough is poised to reduce ICU stays, minimize
the need for emergency dialysis, and generate substantial savings
for healthcare providers.
With the anticipated U.S. launch of the JuxtaFlow® RAD in late
2025, Roivios is set to expand the device's application beyond
cardiac thoracic surgery, aiming to revolutionize kidney health
management throughout the intensive care unit.
For more information about Roivios and the JuxtaFlow® Renal
Assist Device, please visit Roivios.com.
About Roivios
Roivios is a clinical-stage medical
device company committed to pioneering solutions for kidney health.
Our leading product, the JuxtaFlow® Renal Assist Device (RAD), is
designed to preserve kidney function and offer a preemptive
approach to managing kidney disease, demonstrating effectiveness in
improving renal outcomes, potentially reducing the need for
dialysis, and lowering healthcare costs. Holding proprietary
patents in key kidney technologies, we aim to revolutionize kidney
disease management. With plans to extend its application beyond
kidney disease to various medical settings, Roivios is preparing
for a transformative U.S. launch in 2025, aiming to redefine kidney
disease management and improve patient quality of life. Discover
more at roivios.com.
This release contains forward-looking statements subject to
risks and uncertainties. Actual results may differ
significantly.
Media Contact: Kelly
Krueger, Krueger PR, kelly@kruegerpr.com
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