#United States #San Francisco #Roivios #Caresyntax #JuxtaFlow

A Transformative Partnership for Kidney Health

In a groundbreaking move, Roivios, a clinical-stage medical device firm, has forged a strategic alliance with Caresyntax, an esteemed leader in real-world evidence (RWE) and surgical intelligence. This collaboration, announced on January 9, 2025, aims to revolutionize renal care through the integration of clinical and economic insights, propelling the development of advanced medical technologies that promise to enhance patient outcomes and lower healthcare costs.

Driving Innovation in Kidney Healthcare

At the heart of this partnership is the pivotal trial for Roivios’ JuxtaFlow® Renal Assist Device (RAD). This investigational technology is purposefully designed to sustain or augment kidney function in patients experiencing renal impairment during on-pump cardiac surgeries. As the first device of its kind, the JuxtaFlow RAD is set to significantly transform kidney care for patients deemed high-risk.

Caresyntax's cutting-edge clinical data as a service (CDaaS) platform will play a crucial role in capturing real-world evidence. By complementing the essential trial of the JuxtaFlow RAD, this collaboration will empower Roivios to assess and refine the value of its innovative device. This partnership lays the groundwork for a new model of renal disease management, one that emphasizes actionable clinical insights and financial efficiency in delivering outstanding patient care.

A Vision for Healthcare Transformation

John Erbey, CEO of Roivios, expressed enthusiasm about the alliance, stating, "We are thrilled to partner with Caresyntax, a recognized leader in surgical intelligence and RWE. The future of medical device innovation is predicated on robust, real-time evidence. Together, we are addressing unmet needs while equipping physicians with dynamic insights that support informed, patient-centered decision-making."

Caresyntax will spearhead the implementation of real-time data collection in dynamic surgical settings. Their comprehensive clinical quality improvement methodology harnesses advanced systems science, coupled with user-friendly dashboards, to measure and analyze clinical and financial patient outcomes.

Benefits for Hospitals and Clinicians

For Hospitals

The collaboration targets the significant financial strain caused by prolonged ICU stays due to Chronic Kidney Disease (CKD). With over 14 million hospital admissions linked to CKD in the United States annually, and inpatient costs surpassing $250 billion, the JuxtaFlow RAD aspires to decrease ICU durations, thus alleviating pressure on hospital resources.

For Clinicians

By merging RWE data with trial outcomes, Caresyntax offers an innovative package termed the “IDE Wrapper.” This enables value-based analysis, granting clinicians access to tailored, evidence-based tools to enhance decision-making at the point of care. This bridges the gap between a patient's unique needs and interventions tailored to address them.

Strategic Enhancements

The partnership is structured around three strategic areas that drive its innovation and success:

Real-World Evidence Integration

By incorporating RWE alongside clinical trials for JuxtaFlow RAD, the collaboration facilitates the development of informed, evidence-based clinical and operational strategies that shape care pathways.

Value-Based Insights

Linking clinical outcomes to economic metrics presents a comprehensive view of the JuxtaFlow RAD's financial and medical value, benefitting hospitals and policymakers alike.

Rapid Data through Connected Operating Room Technology

Caresyntax's suite of advanced operating room integration technologies will yield novel data and insights, optimizing surgical outcomes further.

Dr. Bruce Ramshaw, Chief Medical Informatics Officer at Caresyntax, noted, "Our platform equips partners like Roivios to integrate RWE early in the product development cycle, marking a significant shift for device innovation. Real-time validation of JuxtaFlow RAD's value not only accelerates market entry but, importantly, enhances its impact on patient care."

Paving the Path for Future Innovations

Both Roivios and Caresyntax share an ambitious vision that seeks to address the unmet needs of vulnerable populations while endorsing evidence-based strategies for chronic conditions like CKD. This collaboration symbolizes a forward momentum in healthcare innovation, harmonizing cutting-edge technologies with practical, measurable outcomes.

According to Erbey, "As we gear up for JuxtaFlow’s launch, this data-driven approach not only ensures a successful rollout but positions JuxtaFlow as a vital tool in reshaping kidney healthcare. Together with Caresyntax, we are reimagining the future of patient care—systematic, informed, and impact-driven."

About Roivios

Roivios is a pioneering clinical-stage medical device company dedicated to advancing kidney health solutions. The JuxtaFlow Renal Assist Device (RAD) aims to sustain and enhance kidney function during critical recovery phases, such as post-cardiac surgery. With a commitment to innovative technology and reducing healthcare costs, Roivios aspires to redefine kidney disease management and enhance patients’ quality of life globally. Visit roivios.com for more information.

About Caresyntax

Caresyntax focuses on making surgeries smarter and safer, uniting AI-driven software, devices, and clinical services to enhance surgical outcomes. Their vendor-neutral, enterprise-grade surgical intelligence platform provides actionable insights aimed at improving patient results using AI to analyze extensive volumes of data in real time within and around the operating room. Learn more about their work at Caresyntax.com.