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RenalGuard Solutions

RenalGuard Solutions

Milford, United States· Est.
cardiorenalsystems.com
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Private Company

Total funding raised: $28M

Overview

RenalGuard Solutions has developed RenalPro, an automated fluid management system designed to prevent Acute Kidney Injury (AKI). The technology, which has received FDA Breakthrough Device designation, demonstrated a 52% reduction in AKI following cardiac surgery in a randomized controlled trial. The company is positioned to address a major hospital-acquired harm, with CMS set to mandate AKI reporting starting in 2025, creating a significant market driver for preventative solutions.

CardiovascularNephrology

Technology Platform

RenalPro/RenalGuard automated fluid management system. A closed-loop device that monitors real-time urine output and administers replacement IV fluids in precise, 1ml increments to maintain balanced forced diuresis and prevent Acute Kidney Injury.

Funding History

3
Total raised:$28M
Debt$5M
Series B$15M
Series A$8M

Opportunities

The 2025 CMS mandate requiring hospitals to report AKI as a 'Hospital Harm' creates a powerful regulatory and economic driver for adoption of preventative technologies.
The high incidence of AKI in cardiac surgery (~30%), contrast procedures, and ICUs (>50%) represents a large and underserved patient population across multiple clinical settings.

Risk Factors

Commercial success depends on overcoming hospital procurement hurdles and demonstrating cost-effectiveness beyond clinical efficacy.
Securing favorable and specific reimbursement codes from Medicare and private payers is critical.
Broader real-world evidence is needed to confirm trial results across diverse clinical environments.

Competitive Landscape

Competes against guideline-based manual fluid management protocols (e.g., KDIGO bundle), which are standard of care but suffer from poor compliance and limited efficacy. Potential competition from other automated fluid management systems or pharmacologic agents, but RenalPro's specific indication for AKI prevention and Breakthrough Device status provide differentiation.

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