Revised Timeline Announced as Clinical Pilot Study Indicates Robust Safety and Need for Optimization of Neola®

The preliminary findings indicate variations in the data, providing valuable insight for further optimization of the medical device. As a consequence, Neola Medical will focus on optimizing the medical device before proceeding to the next clinical phase. This means that the pivotal clinical study in the U.S. will most likely not be initiated in 2026 as previously targeted. While findings are preliminary, the company will communicate any changes to the revised timeline once the clinical pilot study is completed, and final results are available.

Background
Neola Medical’s first clinical pilot study is being conducted at the neonatal intensive care unit at Södra Älvsborgs Sjukhus in Borås, Sweden. The study is designed to evaluate the safety and performance of Neola® in monitoring the lungs of preterm born babies. A total of 10 babies in neonatal intensive care with a gestational age from 28 weeks and a weight between 1000–3000 grams are included. Findings from this first clinical study on preterm born babies can contribute additional input to optimizing and refining Neola®, aiming to ensure it meets the specific needs of this vulnerable and unique patient group. The results will furthermore guide preparations for the pivotal U.S. clinical study that will be instrumental in supporting an FDA application for market authorization in the U.S.