What RenalGuard Solutions does

RenalGuard Solutions, operating as CardioRenal Systems, Inc., is a private, pre-commercial medical device company headquartered at 459 Fortune Boulevard, Milford, Massachusetts (founded 2013, 11–50 employees). It develops the RenalPro system — branded RenalGuard outside the United States — an FDA-designated Breakthrough Device that autonomously bundles fluid management and therapeutic delivery to prevent Acute Kidney Injury (AKI). The platform responds in real time to minute fluctuations in patient urine output and adjusts IV fluid administration in one-milliliter increments to maintain hemodynamic stability, with clinical evidence anchored by a 220-patient UK randomized controlled trial (Heyman Luckraz et al., European Journal of Cardio-Thoracic Surgery, March 2021) demonstrating a 52% reduction in AKI versus standard care and zero reported adverse events. The intended clinical settings are cardiac surgery programs (primary), cardiac catheterization labs (Contrast-Associated AKI), and intensive care units, addressing a US burden of approximately 3.1 million AKI cases and 285,000 deaths annually.

The company is pre-revenue in the United States, where the system is available only for investigational use under applicable regulatory guidelines, and is CE-marked for Fluid Balance Management outside the US. The anticipated revenue model post-clearance is hardware-led: capital equipment placement to hospitals paired with single-use disposables and service contracts, sold through a direct enterprise field-sales motion that engages hospital value analysis committees, cardiac surgeons, and nephrologists. Marketing is clinical-evidence-led, leveraging peer-reviewed publications and medical conferences rather than conventional sales motions, and the company holds EN ISO 13485:2016 certification (expiring July 31, 2027) covering design, development, and distribution.

RenalGuard has raised $21.5M across two disclosed Series 2 rounds (March 2017: $14.5M; September 2018: $7M led by Abiomed). Leadership disclosed includes Andrew Halpert as Chief Technology Officer and Greg Mann as Managing Director and Chief Financial Officer; no further management team detail is publicly available.

Name

RenalGuard Solutions

Legal name

CardioRenal Systems, Inc.

Website

https://renalguard.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

11–50 employees

Short description

RenalGuard Solutions (CardioRenal Systems) is a pre-commercial medical device company developing the RenalPro/RenalGuard system, an FDA Breakthrough Device that autonomously manages IV fluids in real time to prevent Acute Kidney Injury in cardiac surgery, cath lab, and ICU settings.

Ownership category

akta.pro rank

Product category

Acute Kidney Injury Prevention Medical Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Renal Diagnostics & Monitoring (eGFR/Creatinine POC, Urine Analyzers, BP/Fluid Status) (HLAHAKAJ)

Keywords

• Acute kidney injury prevention
• Fluid management systems
• Cardiac surgery devices
• Contrast-induced nephropathy
• Medical device therapy

Headquarters

HQ city

Milford

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Medical Device Sales (Post-Regulatory Clearance): Once FDA clearance is obtained, RenalGuard/CardiRenal Systems is expected to generate revenue through the sale or lease of RenalPro systems to hospitals, along with associated consumables and support services. The company currently operates in an investigational use phase, with the device available only through clinical studies and research settings under applicable regulatory guidelines. Revenue streams will likely include capital equipment placement, single-use disposables, and potential service/maintenance contracts.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

RenalGuard Solutions develops and sells the RenalPro/RenalGuard System, a proprietary medical device that autonomously bundles fluid management and therapeutic delivery to prevent acute kidney injury (AKI) in patients undergoing cardiac surgery, cardiac catheterization, and ICU care. The system uses a urine output-responsive mechanism that balances IV fluid administration in real time, and is sold internationally under the RenalGuard brand with CE Mark while remaining investigational in the U.S.

Product overview

RenalGuard Solutions (CardioRenal Systems) offers a single unified medical device system branded as RenalPro in the US and RenalGuard internationally. The core RenalPro/RenalGuard System provides FDA-designated breakthrough technology for acute kidney injury (AKI) prevention, combining fluid management with therapeutic delivery capabilities. RenalPro Therapy is the treatment protocol delivered by this system. The system is designed for multiple clinical settings including cardiac surgery (CSA-AKI), contrast procedures (CA-AKI), and ICU environments.

Differentiator

Problem solved

Functional benefit

Brands

• RenalPro: FDA designated breakthrough device technology for preventing Acute Kidney Injury (AKI). Autonomously bundles fluid management and therapeutic systems. Available inside the US market.
• RenalGuard

Products and services

• RenalPro/RenalGuard System & Therapy

Quantifiable outcome

• 52% reduction in AKI incidence vs standard care in 220-patient randomized controlled trial (UK study, Heyman Luckraz et al., European Journal of Cardio-Thoracic Surgery, March 2021)
• +2 more outcomes

Segments3 records

Ideal customer profiles3 records

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators4 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Outset Medical: Outset Medical (NASDAQ: OM) commercializes the Tablo Hemodialysis System, a direct peer in compact, easy-to-deploy renal care devices. Both companies target decentralized/point-of-care renal treatment and share similar hospital procurement and value analysis committee pathways.

Broad incumbents

• Fresenius Medical Care: Fresenius Medical Care is the global leader in dialysis products and services, including renal therapies and NxStage home hemodialysis. As a broad incumbent in renal care, it competes for hospital fluid management and renal therapy budgets and represents the dominant incumbent RenalGuard would compete against or partner with for distribution.
• Baxter International: Baxter is a major medical device and pharmaceutical company with deep presence in renal therapies (peritoneal dialysis, hemodialysis) and IV infusion/ fluid management. Baxter overlaps with RenalPro's fluid delivery and renal care end markets, and its scale represents both competitive and partnership implications.
• B. Braun Medical: B. Braun is a global medical device and pharmaceutical company with significant IV infusion therapy, fluid management, and renal care offerings. Its infusion pump portfolio overlaps with the IV fluid administration component of RenalPro's value proposition in hospital settings.
• ICU Medical: ICU Medical is a specialist in IV infusion pumps, IV consumables, and critical care medical devices. It competes in the same hospital infusion therapy and fluid management procurement category as RenalPro and represents a plausible incumbent or acquisition target for RenalGuard.
• Terumo Medical: Terumo manufactures medical devices including infusion systems, blood management, and cardiovascular products. Its hospital infusion portfolio overlaps with RenalPro's IV fluid administration mechanism, particularly in cardiac surgery and critical care settings.

Others

• Edwards Lifesciences: Edwards Lifesciences is a leader in cardiac surgery and critical care monitoring, including hemodynamic monitoring technologies used in cardiac surgery and ICU. While not a fluid management peer, Edwards sells into the same cardiac surgery and ICU customer base and represents both a potential partner and an adjacent strategic acquirer.
• Medtronic: Medtronic is the largest medical device company globally, with strong positions in cardiac surgery, perfusion, and patient monitoring. While not a fluid management peer, Medtronic's relationships with cardiac surgeons and perfusionists create a strategic adjacency and potential acquisition angle for RenalGuard.

Emerging players

• Spectral Medical: Spectral Medical is developing PMX (polymyxin B hemoperfusion) for endotoxemia and septic AKI in the ICU. As an emerging player in AKI prevention/treatment in critical care, Spectral targets an overlapping patient population (ICU AKI) using a different therapeutic modality, making it a relevant emerging peer.

Regional players

• Chiesi Group: Chiesi Group is a multinational pharmaceutical company headquartered in Italy with historical involvement in the RenalGuard franchise in Europe. As a potential or prior licensee/distributor of the RenalGuard system in select international markets, Chiesi represents a relevant regional/commercial peer rather than a device competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/renalguard

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds2 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about RenalGuard Solutions