Lund-based Neola Medical released its report for the third quarter last week. The company’s efforts to establish itself on the US market have begun to bear fruit and they have also presented promising clinical data that further strengthens their lung monitoring system Neola. BioStock has reached out to CEO Hanna Sjöström to get her thoughts on the past quarter and to find out what happens next.

Neola Medical has developed a non-invasive technology for continuous monitoring of lung function in premature babies. The Neola system uses probes that are placed on the skin, which means 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 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 and thus save more lives.

Selected as an Impact1 company by Stanford University

When Neola Medical reports its third quarter, a lot of emphasis is put on the work to establish the company in the US. Recently, they announced being named a so-called Impact1 company by Stanford University. Stanford is a leader in research for neonatal care and has launched the Impact1 program to drive innovation in the field. In addition to being seen as a recognition of the technology as a significant innovation in neonatal intensive care, the company will also get help in launching on the US market.

As an Impact1 company, Neola Medical will be part of a collaborative program co-funded by the U.S. Food and Drug Administration (FDA). The program provides access to expertise in medical device development, as well as advice from the FDA’s own pediatricians and regulatory experts. During the quarter, the company held meetings to get an understanding of the requirements to get market approval.

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 a lot of focus is on getting a foot in the door in the US, Neola Medical has also celebrated successes on the scientific front. Results from the investigator-initiated NIOMI clinical trial were presented at the annual jENS congress, which this year was held in Rome. The study showed that the Neola system was able to measure the oxygen in the lungs of all newborn babies 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, and the results of our marketing strategy are now coming in. We have invested in collaborating with the very best in the care of premature infants internationally, and now we have established an extensive and significant collaboration with Stanford University, which is number one in neonatology and major key opinion leaders in our field both in the US and internationally.

– At the same time, the final results from the independent clinical study on 100 newborn babies from the University Hospital in Cork, Ireland, have been presented. The results are very strong and show that Neola measures oxygen in the lungs of 100 per cent 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 push into the US market?

– This is of great importance for our establishment in the US market. Our persistent efforts to expand the US network of key people in both academia and healthcare have really paid off.  Stanford has chosen Neola Medical because our medical technology has the opportunity 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 be selected by Stanford as an Impact1 company means that we receive market launch support from Stanford’s physicians 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 bringing important medical technology innovation to children, and Stanford and the FDA are now joining forces to give us as a company the best possible conditions for this. The importance to us cannot be underestimated. The doors open for us in the US.

You have had meetings with the FDA regarding the requirements for market launch. What requirements is the FDA pushing and how do you meet them where you stand today?

– We plan to submit a De Novo application to the FDA, which is the regulatory pathway for brand new groundbreaking technology like ours. Our formal meetings and contacts with the FDA have been frequent over the past year and we have created a good picture of the requirements that need to be met in order to obtain market approval.

– Through the Stanford collaboration, we have also had the opportunity for unofficial discussions with the FDA’s pediatricians and regulatory experts regarding our regulatory strategy and our studies, together with Stanford’s neonatologists. It has been very instructive and significant. We are now in dialogue about the details of our upcoming studies and look forward to starting the studies at the beginning of 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 on the sensitive patient group of premature infants, which is taking place in the US. We will also conduct a Human Factor study in the US to show that Neola works well for use in the care of premature babies.

Looking ahead, what activities will you be focusing on during the winter?

– We are now fully focused on the preparations for the upcoming clinical, preclinical and human factor studies. We are in contract negotiations with US hospitals for the conducting of the studies, while our communication with the FDA is intensified with the full support and participation of Stanford’s physicians and regulatory experts.

– We look forward to a very exciting end to the year and start of 2024, where we will also have the opportunity to welcome more colleagues into our development team.

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