The device that taught the IV drip to think - reading urine output in real time and matching fluids by the milliliter to keep kidneys out of harm's way.
THE MACHINE: The RenalPro console tracks infusion, urine output and fluid balance to the milliliter. Marketed as RenalGuard outside the US, it is the company's answer to a quiet, common complication - acute kidney injury.
The kidney is a quiet organ. It does not page a surgeon or set off an alarm. So when a patient's kidneys begin to fail during or after a major procedure, the first sign often arrives a day later, in a lab result, after the damage is already done. Acute kidney injury - AKI - is one of the most common complications of cardiac surgery, contrast-based heart procedures, and intensive care, and it lengthens hospital stays, raises costs, and worsens outcomes.
CardioRenal Systems, a medical device company based in Milford, Massachusetts, built its business around a single idea: what if hydration during those high-risk moments could be automated and precise, rather than estimated by hand? Its answer is the RenalPro System, sold outside the United States as RenalGuard. The console continuously measures a patient's urine output and adjusts the intravenous fluids they receive in milliliter increments - roughly a fifth of a teaspoon at a time - keeping the patient hemodynamically stable and the kidneys protected against both over- and under-hydration.
The approach is called balanced forced diuresis. The engineering that makes it reliable is protected by a portfolio of 20 patents and pending applications. And the clinical case behind it is not theoretical: in a 220-patient randomized, controlled trial known as the KIDNEY study, RenalPro Therapy reduced AKI by 52% compared with standard care, with no reported adverse events.
Standard hydration protocols are set in advance and adjusted by hand. RenalPro closes the loop - measuring, deciding, and dosing in a continuous cycle throughout the procedure.
Sensors track urine output in real time, catching minute fluctuations.
The system calculates exactly how much fluid the patient needs, moment to moment.
IV fluids are administered automatically in milliliter increments.
The patient stays balanced and hemodynamically stable - kidneys shielded.
The KIDNEY study - a 220-patient randomized, controlled trial in the UK - compared RenalPro Therapy against standard of care. The relative rate of acute kidney injury is shown below (illustrative of the reported 52% reduction).
Source: KIDNEY study, 220-patient randomized controlled trial. No adverse events reported. Bars illustrate the relative reduction, not absolute incidence.
RenalPro is the US name; RenalGuard is its CE-marked European identity. Both target the procedures where kidneys are most at risk.
Cardiac Surgery-Associated AKI is the company's lead US indication and the focus of its pivotal trial. Roughly one in three cardiac surgery patients is at risk.
Contrast media used in heart catheterization can injure kidneys. RenalGuard has been studied to reduce contrast-induced nephropathy in at-risk patients.
Fluid balance is precarious for the sickest patients. The system's automated matching aims to keep ICU patients stable without manual guesswork.
Who buys it: Hospitals and health systems - cardiac surgery programs, cath labs, and ICUs. The business runs on a razor-and-blade model: a durable console paired with recurring single-use disposable sets. Commercial today in Europe under CE Mark; investigational in the US pending the pivotal trial.
IDE approval is a significant milestone for CardioRenal and for the many patients who undergo cardiac surgery each year and remain at serious risk of acute kidney injury.
— Ilya Budik, Chief Executive Officer
Plenty of hospital equipment monitors fluids or hemodynamics. RenalPro is positioned differently: it is a dedicated AKI-prevention device rather than a general-purpose monitor. The distinction matters. Monitors report; RenalPro acts, closing the loop between measurement and dosing without a clinician re-calculating at the bedside.
Its competitive alternative is largely the status quo - manual hydration protocols and standard of care. That is a meaningful thing to compete against, because it is free and familiar. The company's argument is that automation delivers precision the manual approach cannot, and the KIDNEY study is the evidence it points to.
FDA Breakthrough Device Designation. A CE Mark backed by European clinical evidence. And, as of July 2026, FDA IDE approval to begin the US pivotal trial. Add a strategic investment from a top-decile cardiac surgery hospital, and the validation comes from the customer as much as the regulator.
The company raised roughly $7M as part of $21.5M total to advance its fluid-management platform.
RenalGuard Therapy earned FDA Breakthrough status for preventing Cardiac Surgery-Associated AKI.
The device advanced under the RenalPro name for the US market, with RenalGuard remaining the CE-marked European brand.
CardioRenal secured IDE approval to begin its US pivotal trial, alongside strategic investment from St. Elizabeth Healthcare and the Angel Physicians Fund.
The 36-person team pairs operators with a deep roster of surgeons and regulatory veterans - the kind of paperwork-and-scalpel combination medtech actually needs.
Scientific advisors include nephrology and cardiothoracic-surgery KOLs from the University of Vermont, Baylor College of Medicine, Thomas Jefferson University Hospital, Baystate Medical Center, and St. Elizabeth Healthcare.