Research Background

Liver transplantation remains the sole therapeutic option for patients with end‑stage liver disease. However, organ injury can occur in donors after brain death (DBD) and donors after circulatory death (DCD), potentially reducing transplant success rates. Normothermic machine perfusion (NMP) extends preservation time and enables real‑time assessment of organ condition. This study explores the use of perfusate and bile samples collected during NMP to objectively measure tissue viability.

Biomarker FMN Overview

Flavin mononucleotide (FMN) is released from mitochondria upon injury and serves as an early signal of tissue damage. Rising FMN concentrations are associated with impaired cellular respiration, indicating ongoing organ injury. Consequently, FMN measurement is gaining attention as a potential real‑time biomarker for organ status during NMP.

Study Design and Current Status

The study is actively recruiting and commenced on 13 March 2026. It is coordinated by the Cleveland Clinic, with multiple participating centers following standardized sample collection and transport procedures. Collected perfusate and bile samples are preserved and shipped in accordance with IATA guidelines and are disposed of after analysis. This workflow runs in parallel with standard NMP protocols and does not add additional burden to patients.

Expected Impact and Clinical Significance

Clarifying the relationship between FMN levels and transplant outcomes would enable more accurate prediction of organ quality, reduce unnecessary organ discard, and increase the number of suitable grafts available to patients on waiting lists. It would also create new market opportunities for NMP device manufacturers and diagnostic‑kit developers.

Industry and Investment Implications

If the results are favorable, biotech companies offering NMP platforms and FMN assay kits are likely to expand their product portfolios. The current market for NMP equipment is limited, and biomarker‑based diagnostic solutions are still in early stages. Companies that invest early or pursue strategic partnerships in these technologies could secure a competitive advantage. Should regulatory agencies tighten organ‑quality assessment criteria, early‑mover firms may capture market leadership.