Roivios, a clinical-stage medical device company, and Caresyntax, a global leader in real-world evidence (RWE) and surgical intelligence, have joined forces to revolutionize renal care. This partnership aims to accelerate the integration of clinical and economic insights during product launch, driving the development of innovative medical technologies to improve patient outcomes and reduce healthcare costs.
Advancing Innovation in Kidney Health
Central to this collaboration is the pivotal trial of Roivios’ JuxtaFlow Renal Assist Device (RAD), an investigational technology specifically engineered to sustain or enhance kidney function for patients with renal impairment undergoing an on-pump cardiac surgery. This first-of-its-kind device has the potential to transform kidney care for high-risk patients.
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Caresyntax’s clinical data as a service (CDaaS) platform will capture RWE to complement the pivotal trial and help Roivios measure and optimize the value of the JuxtaFlow RAD. The partnership will establish a new model in renal disease management—one that prioritizes actionable clinical insights and financial efficacy to deliver superior patient care.
“We’re thrilled to partner with Caresyntax, a recognized leader in surgical intelligence and RWE,” said John Erbey, CEO of Roivios. “The future of medical device innovation depends on robust, real-time evidence. Together, we’re addressing unmet needs and equipping physicians with dynamic insights that enable informed, patient-centered decision-making.”
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Caresyntax will guide the implementation of real-time data collection in dynamic surgical environments. Their clinical quality improvement methodology utilizes advanced systems science and user-friendly dashboards to measure and understand clinical and financial outcomes.
Tangible Benefits for Hospitals and Clinicians
For Hospitals
The collaboration seeks to reduce the financial burden associated with prolonged ICU stays caused by complex kidney disease (CKD). CKD is responsible for over 14 million hospital admissions annually in the U.S., with associated inpatient costs exceeding $250 billion. JuxtaFlow RAD aims to reduce ICU stays and lower inpatient costs, alleviating strain on hospital resources.
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For Clinicians
Combining RWE data with trial outcomes, a package which Caresyntax offers as an “IDE Wrapper”, can enable value-based analysis and provide clinicians with access to tailored, evidence-based tools designed to improve decision-making at the point of care. This enables healthcare providers to deliver personalized interventions that align with their patients’ unique needs.
“This initiative not only lays the groundwork for JuxtaFlow’s launch but also builds a robust body of clinical and financial evidence to support more informed decision-making,” added Erbey.
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Strategic Areas of Collaboration
This partnership is underpinned by three key areas that will drive its innovation and success:
Real-World Evidence Integration
- Incorporating RWE alongside the clinical trial of JuxtaFlow RAD allows the development of evidence-based clinical and operational strategies. This methodology guides future applications, helping providers make informed decisions about care pathways.
Value-Based Insights
- By linking clinical outcomes with economic metrics, the partnership offers hospitals and policymakers a comprehensive value-based perspective on the financial and medical value of the JuxtaFlow RAD.
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Rapid data via Connected Operating Room Technology
- With Caresyntax’s suite of advanced OR-integration technololgies, the collaboration will capture novel and unparalleled data and insights, optimizing surgical outcomes and patient care.
“Our platform gives partners like Roivios the ability to integrate RWE earlier in their product development cycle, which is a gamechanger for device innovation,” said Dr. Bruce Ramshaw, Chief Medical Informatics Officer of Caresyntax. “Rather than waiting for post-market data, Roivios will be able to validate JuxtaFlow RAD’s value in real-time, significantly accelerating its path to market and, more importantly, to patient impact. JuxtaFlow has the potential to transform kidney care and cardiac surgery, and we’re honored to contribute to this meaningful mission.”
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Building a Vision for the Future of Healthcare
Roivios and Caresyntax share a forward-thinking vision that targets the unmet needs of vulnerable populations, while championing evidence-based solutions for chronic diseases like CKD. By seamlessly linking clinical and economic data, this partnership represents a new direction for healthcare innovation, one that aligns state-of-the-art technologies with practical and measurable outcomes.
“As we prepare for the future launch of JuxtaFlow, this data-driven approach will not only ensure a successful rollout, but will also establish JuxtaFlow as a crucial tool for reshaping kidney healthcare,” said Erbey. “Together with Caresyntax, we’re reimagining what patient care can look like—systematic, informed, and impact-driven.”
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Source – prnewswire
