Roivios Unveils Promising New Clinical Data on the JuxtaFlow® Renal Assist Device (RAD) at the Society of Thoracic Surgeons (STS) Perioperative Care Meeting in Philadelphia

NASSAU, Bahamas, Oct. 28, 2024 /PRNewswire/ -- Roivios, a pioneering clinical-stage medical device company dedicated to revolutionizing kidney health, is proud to announce new clinical data from the BIPASS-AKI Feasibility Study of the JuxtaFlow® Renal Assist Device (RAD). Presented at the STS Perioperative Care meeting in Philadelphia, this study successfully met its objectives, revealing its potential to enhance renal function post-cardiac surgery with cardiopulmonary bypass, a critical advancement for patients with existing renal impairment.

Cardiac surgeries involving cardiopulmonary bypass often increase postoperative complications, including elevated morbidity and mortality, and extended hospitalizations. Patients with chronic kidney disease (CKD) face a particularly high risk of acute kidney injury (AKI), with incidence rates up to 50% or more, largely influenced by the length of time a patient is on cardiopulmonary bypass.

The study aimed to evaluate the safety and feasibility of the JuxtaFlow RAD, a novel device designed to sustain or enhance renal function immediately following such surgeries. Dr. Evelio Rodriguez, chief of cardiothoracic surgery at Nashville's St Thomas Hospital, presented the study's compelling findings at a conference poster session, emphasizing the following key outcomes: 

Feasibility:

• The average device placement time was 35 +/- 15 minutes post-surgery,
• Catheters were successfully placed in 100% of subjects under fluoroscopic guidance and 83% without fluoroscopy.
• Treatment initiation occurred 104 +/- 30 minutes after surgery completion.

Safety:

• No cases of gross hematuria were observed.
  No adverse events were linked to the device's active energy.

Efficacy:

• Only 2 of the 10 patients treated with the RAD experienced a postoperative AKI, with one of these cases resulting from a protocol deviation.

The study marks the first use of the JuxtaFlow RAD in a surgical setting. John Erbey, CEO of Roivios, stated, "This study tested the initiation of the JuxtaFlow RAD nearly two hours after patients were weaned from cardiopulmonary bypass, likely after the insult to their kidneys already occurred. The results highlight the potential of JuxtaFlow RAD in enhancing postoperative recovery."

For more information about Roivios and the BIPASS Study, please visit Roivios.com.

About JuxtaFlow RAD
The JuxtaFlow RAD is a pioneering investigational device to transform kidney support therapy. Acknowledging the harmful effects of fluid accumulation and pressure on the kidneys, Roivios has advanced beyond traditional blood filtration methods that can further stress the kidneys. By applying mild, controlled negative pressure within the kidney's collecting system, the device has the potential to maintain and improve filtration and support recovery. This novel approach holds promise for a compelling value proposition by preserving kidney function and expediting patient recovery, ultimately reducing hospital stays and associated costs. Equipped with a proprietary specialized catheters and pump, the device optimizes kidney function during critical recovery periods, such as post-surgery. Currently, the JuxtaFlow RAD is under investigation and is not available for sale in any geography.

About Roivios
Roivios is a clinical-stage medical device company committed to pioneering solutions for kidney health. Our lead product, the JuxtaFlow Renal Assist Device (RAD), is designed to preserve kidney function and offer a proactive approach to managing kidney disease. We aim to demonstrate improved 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, [email protected]

SOURCE Roivios, ltd

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