Neola’s CEO: “We are now preparing for a clinical study in the US”
After recently receiving a CB certificate for its medical device, intensive work is now underway at Neola Medical to prepare for the clinic. As part of this, a clinical pilot study will be carried out together with a neonatal ward in Sweden.
– This is a step to optimize the conditions for a successful clinical study in premature babies in the United States, CEO Hanna Sjöström tells BioStock.
Neola Medical develops Neola, a medical device for continuous monitoring of the lungs of premature infants. The product is designed to give neonatal departments the opportunity to better and faster detect complications in newborn babies. The hope is that more children will survive and have a life without serious disabilities.
After completing technical verification and obtaining a CB certificate, the company is now facing the clinical phase of development. This means that the product will be tested live on premature babies. The results from the upcoming clinical study in the US will then form the basis for a possible market approval, together with the international CB certificate and the results from the Human Factors study that was successfully conducted in the spring in Boston, USA. The company’s strategy is to start with a US focus, so this is where the clinical study on premature babies will be conducted.
High pace of development
– Having the opportunity to take advanced research from Lund University all the way from the lab to the clinic feels fantastic. That’s where we are now, Neola Medical’s CEO Hanna Sjöström tells BioStock.
– We have always had a strong focus on getting to the patient as soon as possible and have moved unusually fast for a completely new advanced technology. We started in 2016 with a research project and here we are now in 2024, ready for clinical studies. This is something we are very proud of.
Swedish pilot study streamlines
Good planning and careful preparation are two of the key factors for the company being able to maintain a high pace during development. Another such key is efficiency, something that will also be important during the clinical phase. An example of this is that Neola Medical will now conduct a clinical pilot study on premature babies together with a Swedish hospital. Contract negotiations are currently underway, and the goal is to start the study as soon as possible.
– This is a way for us to streamline the preparation for our US clinical study. The main goal of the clinical pilot study in Sweden is to learn as much as possible in order to be able to refine the study design and optimize the conditions for a successful clinical study in premature babies in the United States, which will form the basis as part of our application to the FDA for market approval.
– We will also get information about the differences that exist between the US and Europe in how the neonatal units practically care for the children.
Intensive preparations
In parallel with the pilot study, other preparations for the pivotal US study continue. The protocol is in place, and talks are being held with the FDA, while contract discussions are being held with US hospitals.
– A lot of planning is underway so that we can continue to keep up the pace and ensure that we reach our milestones. Ultimately, this is about cost control, where we want to get as smooth a process as possible and make sure that we follow our business plan, Hanna Sjöström tells BioStock.
Patent approved in the US
Neola also recently announced that the company had received patent approval in the US. The patent concerns a technical method that opens up for lung monitoring in patient groups other than premature infants. Corresponding patent applications are currently also being processed in Europe and China.
– The approval not only solidifies our competitive position in the American market but also protects a critical aspect of our technology pipeline. This patent is a cornerstone in our strategy to innovate and deliver next-generation lung monitoring solutions for patients in intensive care, including both children and adults.
(This is an updated article where the patent news was added after the original article was published)
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.
