# CardioRenal Systems, Inc.

> CardioRenal Systems is a Milford, Massachusetts medical device company developing RenalPro (marketed as RenalGuard outside the US), an automated fluid-management system that prevents acute kidney injury in high-risk hospital settings. By monitoring urine output in real time and matching IV hydration in milliliter increments, the system keeps patients balanced during cardiac surgery, catheter procedures, and ICU care. RenalPro holds FDA Breakthrough Device Designation and a CE Mark, and in a 220-patient randomized UK trial cut AKI by 52% versus standard care.

- **Headquarters:** Milford, Massachusetts, United States
- **Founders:** Ilya Budik (CEO)
- **Team size:** 36
- **Products:** RenalPro System, RenalGuard Therapy, RenalGuard Single Use Set
- **Notable:** FDA Breakthrough Device Designation for prevention of Cardiac Surgery-Associated AKI (announced late 2022)., CE Mark for RenalGuard Therapy in Europe., 52% reduction in AKI versus standard of care in the 220-patient randomized controlled KIDNEY study, with no reported adverse events.

## Products & services

- **RenalPro System** — FDA-designated Breakthrough Device that autonomously bundles fluid management and therapeutic systems, monitoring urine output in real time and adjusting IV fluid administration in milliliter increments to keep patients hemodynamically stable and prevent acute kidney injury.
- **RenalGuard Therapy** — The CE-marked version of RenalPro marketed outside the US for fluid balance management and AKI prevention in cardiac surgery, interventional cardiology, and ICU settings.
- **RenalGuard Single Use Set** — Disposable fluid-management set used with the console to deliver balanced forced diuresis and matched hydration.

## Achievements

- FDA Breakthrough Device Designation for prevention of Cardiac Surgery-Associated AKI (announced late 2022).
- CE Mark for RenalGuard Therapy in Europe.
- 52% reduction in AKI versus standard of care in the 220-patient randomized controlled KIDNEY study, with no reported adverse events.
- FDA IDE approval (July 7, 2026) authorizing enrollment in the US pivotal trial.
- Strategic investment from a top-decile US cardiac surgery hospital, St. Elizabeth Healthcare.
- Portfolio of 20 patents and pending applications.

## Latest updates

- **2026-07** — Secured FDA IDE approval to begin enrollment in the US pivotal trial of RenalPro for prevention of Cardiac Surgery-Associated AKI, alongside a strategic investment from St. Elizabeth Healthcare and Angel Physicians Fund.
- **2022-12** — RenalGuard Therapy received FDA Breakthrough Device Designation for prevention of Cardiac Surgery-Associated AKI.

## Links

- Website: https://cardiorenalsystems.com
- LinkedIn: https://www.linkedin.com/company/cardiorenalsystems

---

Profile page: https://yespress.io/cardiorenal-systems-inc
Published by YesPress — https://yespress.io
Last updated: 2026-07-22