It has been just over two years since Nasdaq’s listing bell rang at Medicon Village and Neola Medical entered the stock market. A lot has happened since then and the company’s focus is now all on preparing for market launch in the US. BioStock contacted Neola Medical’s CEO Hanna Sjöström to find out more about where the company is today and how she views the journey ahead.
Neola Medical, or GPX Medical as the company was called until the name change this summer, has developed a medical device for monitoring the lungs of premature babies. About 140 million babies are born worldwide every year. Of these circa one in ten is born prematurely, i.e. at week 37 or earlier. A premature baby is very sensitive, as the body is not quite ready for a life outside the womb yet.
Lungs are particularly sensitive in premature babies
In a premature baby, the lungs are particularly sensitive and an important part of the work in a so-called NICU ward (intensive care unit for newborns) is to ensure that the baby breathes and that the blood is well oxygenated. The most common cause of death among premature babies is so-called respiratory distress syndrome (RDS). To avoid this, ventilators are used to help the child breathe and keep the lung open. However, long-term respiratory care is not good for these sensitive children, which is why there is a desire to minimise the use of ventilators in this patient group.
Therefore, the most important course of action is to monitor the child, closely follow its condition and provide the necessary care when the need arises. Today, this is done manually with the help of X-rays, blood tests and ECGs, as well as visual monitoring by healthcare professionals. The procedures are often painful for the child, increase the risk of developing cancer later in life and entail high costs for the healthcare system.
Identifies complications before they occur
Neola Medical wants to change this with its patented medical device Neola. Through probes attached to the skin, the product can continuously monitor both lung volume changes and the free oxygen concentration in the lung. This allows you to identify trend changes in a non-invasive way and gives the caregiver the opportunity to act before something serious happens, which is what distinguishes Neola from today’s methods, such as routine X-rays and blood sampling.
Preparing for market launch
Neola Medical is currently preparing for market launch, where the main focus is on the US. The company is working on an FDA application that it aims to submit in 2023 or early 2024. The company also plans to conduct another clinical validation study in the country starting next year, to further appease the regulatory authorities. However, Neola’s function and effect is already well documented. Among other things, positive interim data from an ongoing study initiated by leading neonatal researchers in Ireland were recently presented.
As Neola Medical is now approaching market launch, BioStock took the opportunity to contact CEO Hanna Sjöström to find out more about her and how she sees the company’s future.
First of all Hanna, for those who do not know you, could you tell us a little more about your professional background?
– I have a master’s degree in economics with a degree from the Technology Management program at Lund University. I have 18 years of experience from leading positions primarily in sales, marketing and product development from The Coca-Cola Company, L’Oréal and TePe and have been CEO of Neola Medical since 2019. I am a certified board member in Life Science and work on the boards of Alteco Medical and Selcis.
How would you say that your past experiences benefit Neola Medical?
– As the first full-time CEO of Neola Medical, I came in with a strong business mindset early in the company’s development. This meant that we quickly identified a clear strategy for the company, with a clearly identified target group to which we provide real benefit, and a limited but very large and profitable market where we have a great opportunity to take a significant share.
– We are a strong and experienced team with various key competencies. The importance of sharing a clear vision and strategy cannot be underestimated. I contribute a clear vision for the company, a strong commercial focus and a forward-thinking spirit that means that we have succeeded in recruiting and retaining an extremely strong team.
If we turn to Neola, your product is designed to simplify and improve the monitoring of premature babies. What are the advantages of it, as you see it?
– Our medical device, Neola, means faster detection of lung complications and this can prevent more serious complications in premature babies. With Neola, results can be shown in under a second and the number of days premature babies must be monitored in expensive neonatal intensive care can therefore probably be reduced.
– At the same time, we are reducing the time that nurses have to spend observing the children, which is also an advantage of Neola. This is a big difference from today’s methods that are slow, potentially harmful and that bother the child. In addition, Neola is non-invasive and thus safe for the baby’s sensitive skin.
You are primarily targeting the US market. What is the strategy for bringing the product to market?
– We follow a clear strategy where we prepare for commercialisation and market introduction of Neola. This means certifying our quality management system according to ISO 13485 and working on the issue of cost reimbursement from the US healthcare system as well as pricing.
– An important step is the application for market approval in the US, from the FDA, and CE marking of the product. The next step is launch, where we primarily target the US, and more specifically the 48 university hospitals we have identified, to catch “early adopters”.
You recently received positive results from your first major study in Ireland. What did the data show?
– The results confirm that the technology works well for measurements on newborn babies’ lungs, which strengthens our perception of Neola’s future in neonatal intensive care. We look forward to the overall results expected later this year. Clinical results are crucial for successful commercialisation and therefore it was particularly significant that the results from the first 50 out of a total of 100 patients in the investigator-initiated clinical study at the University Hospital in Cork, Ireland, were presented earlier this year.
The study was started on the initiative of the reputable University Cork College, who bought a system from you even before market approval, which is a bit unusual. What prompted that?
– There is currently a great need for new technology because today’s monitoring methods are insufficient due to them being invasive, slow and potentially harmful. Neonatologists lack modern technology, as the market is underinvested and is estimated to be ten years behind in development. Professor Dempsey, who is leading the work at the neonatal intensive care clinic at Cork University Hospital, sees the potential of our new technology and believes it has the potential to completely change the way premature babies are monitored in the future. With this support, a local approval has been obtained for research studies with Neola even before CE marking.
What is the next step in the study and what is the data to contribute with?
– So far, results from the first 50 children have been reported, and the results of the entire study on 100 children are expected by the end of 2022. In the study, the gas volume in the lungs is measured using our medical device for continuous lung monitoring, Neola. The impact of the location of the probes on the signals is examined, providing information on how to optimally position the probes on the chest of the infant for the best monitoring performance.
– The extensive data that comes out of this study will be important for the continued product development and the research articles that will be published with data from the study will probably further increase the interest from neonatal intensive care physicians worldwide.
You aim to submit the application to the FDA next year. What activities will be important in order to be able to do that?
– An important part of the application to the FDA is to have the quality management system approved according to ISO 13485. There is a regulatory plan and an ongoing process to reach an agreement with the FDA, but to carry out studies both for technical verification and clinical validation are important activities in order to be able to see this through.
If everything goes your way, when will we see the Neola system on the market?
– If everything goes our way, we can see Neola on the market in 2024. Before that, we look forward to continuing to follow the ongoing clinical study in Ireland, where results from the entire study in 100 children are expected by the end of 2022.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.