Technical performance and clinical acceptance

The first gas absorption measurement was performed on one full-term newborn baby at Lunds University Hospital.

Clinical research studies on a total of 32 healthy full-term newborns were conducted, and the results demonstrated the possibility of measuring gas in the lungs of full-term newborns.

An EU-funded project, including pre-clinical and clinical studies on healthy full-term newborns, laid the foundation for the company’s product, Neola®. An additional clinical study involving 12 full-term newborn babies was conducted in Lund. The study demonstrated clinical acceptance of the measurements and the design of the probes, which are attached to the baby’s chest, one of the most important perspectives to consider for this vulnerable patient group.

A pre-clinical study showed the technology’s ability to measure oxygen gas concentrations in the lungs, follow changes in lung volume and to detect respiratory complications.

Internal pre-clinical testing at Neola Medical.

During 2021 and 2022, a large investigator-initiated and independent clinical study (NIOMI) was conducted at the INFANT Centre at Cork University Hospital in Ireland. A total of 100 full-term newborns participated in the study, and the results demonstrated that the technology is safe and well tolerated for measuring the oxygen in the lungs. Oxygen detection in the lungs was successfully achieved in all participating babies. This study has further strengthened our confident in the performance of the measurements, the clinical acceptance and Neola®’s future role in neonatal intensive care. Learn more.

Internal pre-clinical performance studies at Neola Medical as part of the development process.

During 2024 Neola Medical successfully completed the Human Factors Validation Study with 15 neonatal nurser in Boston, USA. The study was conducted to validate the usability of the medical device Neola®, and the goal of the study was to assess how well participants interact with Neola® and demonstrate that it is safe for its intended use by healthcare professionals in neonatal intensive care units. The successful results of the study will be included in Neola Medical’s FDA submission for market authorization in the U.S. Learn more.

Neola® successfully passed the comprehensive and stringent testing against IEC 60601-1 and IEC 60601-1-2 standards. This resulted in the issuance of an IECEE CB Scheme certificate, by the accredited testing body FORCE Technology, which is recognized proof of the safety and essential performance of Neola®. As a result, Neola Medical is transitioning from the technical verification phase to the clinical phase, preparing for clinical studies. Learn more.

First clinical study on preterm born babies initiated in Sweden. The clinical pilot study is designed to evaluate the safety and performance of Neola® in monitoring the lungs of preterm born babies. 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. Learn more.