InfanDx focuses on developing and commercializing novel diagnostic solutions for acute and critical care conditions in newborns, with its lead product the HypoxE® Test for HIE. The HypoxE® Test is designed to reliably identify HIE within the first hours after birth to enable timely neuroprotective hypothermia treatment. The company is advancing the product through two prospective longitudinal cohort studies (AAMBI completed; BANON to be completed by end of Q1‑2022) to validate biomarkers and diagnostic tests. R&D activities are reported to be on track, and the company is developing prototype tests for laboratory and point‑of‑care settings plus a cloud‑based interpretation software for clinical decision support. InfanDx has headquarters in Cologne, Germany, a branch office in Berlin, and a wholly owned subsidiary in Boston, MA, USA. Recent financing activity has provided additional runway to reach key milestones and support planned US clinical development. InfanDx AG is a privately held neonatal diagnostics company focused on developing and commercializing rapid tests for acute and critical care conditions in newborns. Its lead product, the HypoxE® test, is designed to identify hypoxic‑ischemic encephalopathy (HIE) within the first hours after birth to support timely neuroprotective hypothermia treatment. The HypoxE® program is in advanced clinical development and leverages two prospective longitudinal cohorts—AAMBI (completed) and BANON (nearing completion)—to validate biomarkers and the diagnostic algorithm. Proceeds from the recent Series A will fund final design and validation of the biomarker panel and interpretative algorithm, development of prototype tests for laboratory and point‑of‑care settings, and a cloud‑based interpretation software for clinical decision support. The company closed a first Series A totaling EUR 4 million to reach key value‑creating milestones over the next 12–18 months and is targeting a Series B in the second half of 2022 to support European launches and potential U.S. FDA approval. InfanDx was incorporated in 2010, incubated at the Life Science Incubator in Bonn, and in 2018 relocated to BioCampus Cologne.

Total raised

$7M

Funding rounds

2

Latest round

Series A

Latest activity

Mar 2022