As Neola Medical reports its second quarter of 2023, much of the focus is on market preparations. Intensive work is underway with technical verification studies while the company is also preparing for both a preclinical and a clinical study. BioStock contacted CEO Hanna Sjöström to find out more about how she views the development during the quarter.
Lund-based Neola Medical has developed the medical device Neola, to monitor the lungs of premature babies. While today’s monitoring methods require painful and sometimes risky procedures such as X-rays and blood sampling, Neola offers a non-invasive solution.
With sensors attached directly to the skin, the system can continuously monitor lung volume changes and oxygen concentration. It gives caregivers the ability to detect and act on potential complications before they become serious. With Neola, Neola Medical not only hopes to save lives, but also to free up time for healthcare professionals.
Aiming at the U.S.
Right now, Neola Medical is in the midst of preparing the product for market launch, where the main focus is on the US market. Neola Medical’s CEO Hanna Sjöström visited BioStock’s studio at the beginning of the summer to talk about the newly opened office in Palo Alto, Silicon Valley. It is one of many important steps in achieving commercial success. You can watch the interview here.
Turning to the development work, technical verification studies with the product are now underway. Preparations are also being made for a preclinical and a clinical study in premature infants. On the business development side, strategy work is underway that looks at pricing and reimbursement from the US healthcare and insurance systems.
Preparing the market
At the same time, the company is actively preparing the market for launch. During the spring, it participated in the Pediatric Academic Societies in Washington, USA – an important forum for neonatologists worldwide. At the meeting, the research team from University College Cork presented the results of their study using the Neola technology. In connection with the conference, the company also published a white paper summarising results from technical, preclinical and clinical studies, an important tool in marketing efforts.
During the spring, Neola Medical also announced that it had begun work to potentially broaden the use, to include other patient groups than just premature babies. That is made possible by placing the light source of the system inside the body. Together with Skåne University Hospital and Lund University, the company will investigate whether the technology can be used for continuous monitoring of older children’s lungs in intensive care and during surgery.
Continued stable finances
Looking at the financial side, cash flow during the quarter amounted to -4.5 MSEK, which can be compared with -5.8 for the corresponding quarter last year. The company left the period with cash of approximately 30 MSEK.
BioStock contacted Neola Medical’s CEO Hanna Sjöström, for a comment on the past quarter and to get her thoughts on the autumn.
First of all, Hanna. How would you describe the first half of 2023?
– The first half of 2023 has marked the start of our market preparation activities ahead of the launch of our medical device for continuous monitoring of premature infants, Neola. During the second quarter, we increased the pace of the pre-launch work, which includes both regulatory processes, visits to conferences and active work to strengthen our IP portfolio.
– The product development work continues according to plan. We are now working intensively with technical verification studies of Neola and we are also preparing for a preclinical study and a clinical study on premature infants, which will take place in the US.
One of the activities you mentioned are the so-called technical verification studies with Neola. What is the aim of these studies?
– The technical verification studies are carried out in collaboration with external test institutes and include, among other things, tests for electrical safety. They aim to ensure that Neola and the technology in the product are safe to use in measurement and monitoring in neonatal intensive care units.
– The results from the studies will be used as part of the documentation we will submit to authorities to obtain approval for the start of sales.
You are preparing for more studies, both preclinical and clinical. Can you tell us a little more about them?
– We are currently preparing for a preclinical study in Copenhagen, where we will show that Neola monitors in accordance with set requirements. We are also preparing for a user study with healthcare professionals working in US neonatal intensive care units. We plan to initiate it later in 2023. In addition, we are preparing for a clinical study in the US in 2024, which will be the first clinical study in premature infants to be conducted with Neola.
Looking ahead to autumn, what milestones do you hope to report on going forward?
– We are in the middle of technical verification studies with Neola. We have come a long way in these studies and these tests are planned to be completed in the autumn. In addition, we look forward to receiving the results of the large clinical study in 100 newborn infants conducted by the INFANT Centre at the University Hospital of Cork, Ireland in 2022.
– They will be presented at one of Europe’s most important neonatal conferences, jENS, in Rome in September. We really have an exciting autumn ahead of us!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.