Neola Medical has developed a non-invasive technology that offers continuous monitoring of lung function in premature babies. Neola.The system uses probes placed on the skin, which is a welcome change from more invasive methods such as blood tests and X-rays.
The system also makes it possible to continuously monitor children's lung function, which in turn means that healthcare professionals can detect and treat complications much earlier than is possible with today's technology. The hope is that the system will become standard in neonatal care, thereby saving more lives.
Selected as an Impact1 company by Stanford University
When Neola Medical reports its third quarter, much focus is on the work of establishing itself in the US. Here, it recently reported good news after being designated as a so-called Impact1 company by Stanford UniversityStanford is a leader in neonatal care research and has launched the Impact1 program to foster innovation in the field. In addition to recognizing the technology as a significant innovation in neonatal intensive care, the company will also receive assistance in launching in the US market.
As an Impact1 company, Neola Medical will be part of a collaborative program partially funded by the US Food and Drug Administration FDAThe program provides access to expertise in medical device development, as well as advice from the FDA's own pediatricians and regulatory experts. The company has held meetings during the quarter to gain an understanding of the requirements for getting the product approved for market launch.
BioStock recently interviewed Neola Medical's CEO Hanna Sjöström to find out more about what this means for the company. Watch the interview here.
Promising results presented at congress
While much focus is on gaining a foothold in the US, Neola Medical has also celebrated successes on the scientific front. Results from the investigator-initiated clinical NIOMI study presented at the annual jENS congress, which was held this year in Rome. In the study, the Neola system was able to measure oxygen in the lungs of all newborns who participated in the study. The study also showed that the technology is stable and well tolerated.
Comments from the CEO
BioStock has contacted Hanna Sjöström in connection with the report to get her view on the past quarter and what lies ahead for the company.
First of all, Hanna, how would you describe the third quarter?
– It has been an important quarter for us where the results of our market strategy are now coming in. We have invested in collaborating with the very best in the care of premature babies internationally, and now we have established an extensive and significant collaboration with Stanford University, which is number one in neonatology and a major Key Opinion Leader in our field both in the US and internationally.
– At the same time, the final results from the independent clinical study on 100 newborns from University Hospital Cork, Ireland, have been presented. The results are very strong and show that Neola measures oxygen in the lungs of 100 percent of the participating patients and the researchers also conclude that our technology is excellent for lung monitoring even in premature babies.
You were recently selected as an Impact1 company by Stanford University. How important is this for your efforts in the US market?
– It is of great importance for our establishment in the American market. Our persistent work to expand the American network of key individuals in both academia and healthcare has really paid off. Stanford has selected Neola Medical because our medical technology has the potential to make a difference in the care of children from day one, hence the name Impact1.
– The fact that we are now the only European company to have been selected by Stanford as an Impact1 company means that we will receive market launch support from Stanford's doctors and regulatory specialists in an exclusive collaboration program that is partly funded by the US Food and Drug Administration (FDA) and the Bill & Melinda Gates Foundation.
– The purpose of the Impact1 program is to speed up the process of getting important medical technology innovation to children, and now Stanford and the FDA are joining forces to give us as a company the best possible conditions for this. The importance for us cannot be underestimated. The doors are opening for us in the USA.
You have had meetings with the FDA regarding the requirements for market launch. What requirements are the FDA pushing for and how do you meet them where you stand today?
– We plan to submit a so-called De Novo application to the US Food and Drug Administration, which is the regulatory path for completely new, groundbreaking technology like ours. Our formal meetings and contacts with the FDA have been frequent over the past year and we have developed a good picture of the requirements that need to be met to obtain market approval.
– Furthermore, through the Stanford collaboration, we have had the opportunity to have informal discussions with FDA pediatricians and regulatory experts regarding our regulatory strategy and our studies, together with Stanford neonatologists. It has been very educational and significant. We are now in dialogue about the details of our upcoming studies and look forward to starting the studies early next year.
– This is a preclinical study where we prove that our medical device measures correctly, which will be conducted in Copenhagen, followed by our first clinical study in the sensitive patient group of premature babies, which will take place in the USA. We will also conduct a Human Factor study in the USA to show that Neola works well for use in the care of premature babies.
Looking ahead, what activities will be in focus during the winter?
– We are now fully focused on preparations for our upcoming clinical, preclinical and Human Factor studies. We are in contract negotiations with US hospitals to conduct the studies, while our communication with the US Food and Drug Administration is being intensified with full support and participation from Stanford physicians and regulatory experts.
– We look forward to a very exciting end to the year and start to 2024, where we will also have the opportunity to welcome more colleagues to our development team.