NIH-funded research Sbir 2 grant

Low‑volume kidney support for newborns and young children

Official title: Kidney Support in Pediatric Patients using an Ultrafiltration Device

Funded at Koronis Biomedical Technologies Corporat · NIH-11256219 · Data updated 2026-11-12

This project is bringing a new low‑blood‑volume dialysis device to help newborns and small children with sudden kidney failure or dangerous fluid overload.

Quick facts

Grant typeSbir 2 grant
Study typeNIH-funded research
Funding institutionKoronis Biomedical Technologies Corporat
NIH-funded
Lab location1 site (Minneapolis, UNITED STATES)
Project startMay 18, 2021
Project endJuly 31, 2028
Funding year2025
Award (this year)$1,100,003
NIH project number2R44DK127631-04
Project IDNIH-11256219 on NIH RePORTER

Who could benefit from this research

Could help

Newborns, premature infants, and young children with acute kidney injury or severe fluid overload who need continuous renal replacement therapy are the ideal candidates.

Less likely to help

Patients who do not require CRRT, older children or adults who are too large for a pediatric device, or those with conditions better treated by other kidney therapies may not benefit from this pediatric‑focused device.

What this research studies

This effort aims to deliver a pediatric Continuous Renal Replacement Therapy machine called Vivian that uses ultrafiltration and a much smaller extracorporeal blood volume than current systems. Because babies and neonates have very small total blood volume, the smaller circuit is meant to reduce the risk of complications during dialysis. The company and its manufacturing partner will complete device development, perform safety and performance testing, and prepare for clinical use and regulatory approval. If successful, hospitals could start using the device in neonatal and pediatric intensive care units.

Why it matters

Potential benefit: Could make dialysis safer and more feasible for newborns and very small children by lowering the amount of blood outside the body and reducing complications.

How similar studies have gone: Adult CRRT machines are well established, but commercial devices specifically designed with extra‑low extracorporeal blood volume for neonates are limited, so this represents a relatively novel pediatric device development.

Where this research is happening

  • Koronis Biomedical Technologies Corporat
    Minneapolis, United States
    Active

Researchers

  • Principal investigator: Knuesel, Robert J — Koronis Biomedical Technologies Corporat
  • Study coordinator: Knuesel, Robert J

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About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.