Neola Medical is in full swing setting the stage for its medical device. While generating interest among neonatal intensive care units around Europe, technical verification is underway for clinical studies. BioStock has contacted CEO Hanna Sjöström to find out more about her take on the beginning of 2023.
“In the first quarter, we have taken great strides forward in the market preparation work for the launch of Neola”, Neola Medical’s CEO Hanna Sjöström opens the report for the first quarter of 2023.
The company has developed Neola, a medical device for continuous monitoring of premature babies’ lungs. With better monitoring, the company hopes that it can help detect lung complications faster, so that more children can survive and have a life without serious disabilities. The company also hopes that Neola will be able to free up important time for the staff, who today have to monitor each child visually.
Preparing for market launch
Neola Medical is currently preparing the product for market launch, where technical validation is being carried out for preclinical and clinical studies. Another important part of the market preparations is to create interest in the product. Here, the company’s clinical director Tetiana Kovtiukh has visited neonatal care clinics around Europe, where she seesgreat curiosity about the product. You can read more about her work here.
Europe will of course be an important market for Neola, but initially the focus will be on the US. Here too, the company has begun the marketing by participating in conferences and establishing important contacts with American neonatologists. Among other things, the company participated in the Pediatric Academic Societies conference in Washington, where the research team from University College Cork held a poster presentation about their study with the Neola technology.
Working towards a new target group
In addition to the main focus on premature infants, Neola Medical will also explore whether the technology could be used in other patient groups. The company was recently awarded Vinnova grants to collaborate with Skåne University Hospital and Lund University. Together, they will investigate the technology’s potential for continuous monitoring of older children’s lungs in intensive care and during surgery.
As with premature babies, it is important to be able to detect complications that may occur in a child who is in intensive care or during surgery. CEO Hanna Sjöström told us more in an interview with BioStock, which you can see here.
Looking at the financial part of the Q1 report, we see that Neola achieved an operating profit of approximately -2.4 MSEK. This can be compared with last year’s first quarter where the operating profit landed at -2.2 MSEK. At the end of the period, cash amounted to just over 34 MSEK. In the report, the company writes that on the one hand it expects the component shortage situation to improve going forward, but at the same time expects costs to increase.
BioStock contacted CEO Hanna Sjöström for a comment on the past quarter and to get her view on the rest of the year.
First of all, how would you describe the start of the year?
– In the first quarter, we initiated the market preparation work for the launch of Neola. We are forward-leaning and active with visits to neonatal intensive care clinics in both Sweden and Europe during the quarter where we create interest in our upcoming product for lung monitoring.
– We continue to protect our brand before launch and have previously registered Neola in Australia and Europe, and now also in China. We focus on every step of our product development and are now working intensively with technical verification and the regulatory process and planning of our upcoming studies.
You are currently conducting technical validation of the product. When can we expect it to be ready and what will then be the next step?
– We are in the middle of the work with technical verification that runs during the year. The next step is a preclinical study, which we will conduct in 2023, followed by a clinical study on premature infants that will take place in the US.
You will explore Neola’s potential in older children. Is it possible to say something about the market potential for that patient group?
– I am often asked about the company’s possibilities to also monitor the lungs of other important patient groups than premature babies, since the clinical need is so great. When children are to be anesthetized before an operation, and also in intensive care of children, there is a need to monitor their lungs to be able to quickly detect complications related to the ventilator.
– Children have much smaller margins than adults and it is important to quickly treat complications that may arise. Therefore, it is particularly exciting that we now have a collaborative project together with the intensive care doctors in Lund at Skåne University Hospital and Lund University, which will investigate the possibility and market potential of lung monitoring of children.
Looking ahead on the rest of the year, what milestones do you hope to report?
– We are now in a phase where we are focusing on technical verification and preparation for preclinical and clinical studies, important milestones that I look forward to telling you more about during the year. Of course, I also look forward to following the project for lung monitoring of children and the possibilities of expanding our patient group.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.