Press communication
Lund, Sweden, April 18, 2024
This is a translation of the Swedish press release published 2024-04-18
Neola Medical AB (publ) has completed the Human Factors Validation Study with Neola®, the company’s medical device for continuous lung monitoring of preterm born infants, in March 2024. The study was conducted in Boston, USA, to validate the usability of the medical device Neola®, and the successful results of the study will be included in Neola Medical’s application to the FDA for market approval ahead of the market launch in the USA.
Evaluation of usability is a regulatory requirement from the FDA, and the goal of the study is 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 collected results have been evaluated after the completion of the study in March 2024, and the report clearly indicates a usable and safe design. The report will be part of the forthcoming FDA application for market approval of Neola® in the USA.
The study was led by Custom Medical, global experts in usability studies, and conducted at a study center in Boston during March 2024. The study’s design has been aligned during a pre-submission meeting with the FDA, and the study has been executed entirely according to plan. The participants in the study consisted of 15 neonatal nurses, with varying levels of experience in the field, from several neonatal intensive care units in the USA. Neola Medical’s staff were present in Boston to train the study participants in the use of Neola®.
“We are very pleased with the results, and it has been valuable to be on-site and observe the execution of the Human Factors Validation Study at the study center in Boston. We have had the opportunity to meet and train the participating neonatal nurses and have received their positive response regarding the potential of Neola®. They found Neola® easy to use and immediately understood its clinical value, which provides favourable conditions for Neola® to be integrated effortlessly into neonatal intensive care.”, says Magnus Johnsson, Director of Quality Assurance and Regulatory Affairs at Neola Medical.
“It is gratifying that the final results of the Human Factors Validation Study with Neola® in Boston, USA, confirm that our medical device is safe for its intended use by healthcare professionals. We have achieved an important milestone in line with the company’s strategy and continue to reach our goals and milestones as planned. Successful results from the study are of great significance as we will use them as part of our forthcoming FDA application for market approval in the USA, which is an important step towards the market launch of Neola®.”, says CEO Hanna Sjöström.
For further information, contact:
Hanna Sjöström, CEO Neola Medical, phone: +46 (0)760-10 71 16, e-mail: hanna.sjostrom@neolamedical.com
Neola Medical AB (publ) develops medical technology device for continuous monitoring of preterm born infants’ lungs. Immediate detection of complications provides the possibility of early treatment and improved health care. The patented technology is based on a spectroscopic method developed at Lund University in Sweden. The company was founded in 2016 and is listed on NASDAQ First North Growth Market (ticker: NEOLA). Read more at www.neolamedical.com. The company’s Certified Adviser is FNCA Sweden AB.