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Neola Medical continues towards market approval

Neola Medical marches towards the market

Neola Medical continues towards market approval

16 February, 2023

2022 was an intense year for Lund-based Neola Medical. A change of name was combined with positive clinical results, ISO certification and a successful capital raise. The company is now working to prepare the Neola lung monitoring system for launch in the US. BioStock contacted CEO Hanna Sjöström for  a comment on the year-end report released this week.

The Lund-based medical technology company Neola Medical has developed a product for continuous monitoring of premature babies’ lungs. The lungs of premature babies are sensitive and need constant monitoring.The Neola system has been developed to improve monitoring of these babies’ lungs.   Hopefully, doctors will be able to detect lung complications faster, so that more children will survive and live a life without serious disabilities. The hope is also for the system to free up important time for the staff, who today have to monitor each child visually.

Positive results published

One of the most important milestones last year was the results of the clinical study conducted at the University Hospital in Cork, Ireland. The technology appears to work as intended and the company aims to publish the results in scientific journals.

“This is a major step forward in the development of our lung monitoring product and also a significant step in building interest and acceptance for Neola among neonatal physicians worldwide,” writes Neola Medical’s CEO Hanna Sjöström in the Q4 report.

This autumn, reputable Pediatric Research published an article eoutlined the company’s technology. You can read more about it here.

Marketing of Neola initiated

Another important piece of the puzzle was laid in November, when the quality management system was certified according to the ISO 13485 standard. The certification means that Neola Medical complies with laws and requirements and is one step closer to a CE marking. In other words, the company is increasingly moving towards the market, where the main focus will be on launching the system in the US.

Going forward, the company will place much focus on marketing.  Neola Medical kicked off these increased marketing efforts in January by participating in the 2023 edition of the annual partnering conference JP Morgan Healthcare Conference. BioStock  asked Hanna Sjöström about her impression from the conference, in an interview  here.

Collaboration with 99NICU

So, the marketing has started and in early February a partnership was initiated with 99NICU – an international digital network for neonatologists. Neola Medical will present its technology to the network, in a webinar series called NEOvations. The Italian neonatologist MD Ph.D. Gianluca Lista has also been invited to talk about how non-invasive lung monitoring can improve the care of premature babies.

Increased investments in development and commercialisation

Looking at the finances, Neola Medical states that the costs were on average 1.7 MSEK per month in 2022. The company expects that costs will increase in the future, in line with accelerated product development and commercialisation. At the end of the period, cash and cash equivalents amounted to just over 40 MSEK.

Comments from the CEO

BioStock contacted Neola Medical’s CEO Hanna Sjöström to find out more about the past quarter and what she sees ahead.

Hanna Sjöström, CEO Neola Medical
Hanna Sjöström, CEO Neola Medical

First of all, Hanna, when you look back on 2022, how would you describe the past year?

– We are really in exciting times because we are in the final phase of the development of Neola. We have had a strong 2022 where we reached several significant milestones and took  major steps towards market launch. For example, the decision to change the company name to Neola Medical during the year has been an important step in positioning the company as a pioneering new player in the international market for neonatal intensive care equipment.

– The verification of our quality management system according to ISO 13485 was also an important milestone, just as the fact that the first interim data from the large clinical study in newborn babies was presented. In summary, 2022 has been an intense year for the company where we have put a number of important building blocks in place before launch.

You have now started the preparatory work for the launch of the Neola system, where you primarily target the US market. What will be important to ensure the best possible launch?

– We have done extensive market research that has given us important insights into the clinical perspectives that American neonatologists want to see in order to buy Neola. We are primarily aimed at neonatologists at the large American university hospitals, who are so-called “early adopters” of new technology. By getting the right key opinion leaders to use the product early on, our goal is to quickly build up a bank of independent scientific support through publications that in turn are significant in reaching a broad interest in Neola among neonatologists.

– We are now working on building a local network of contacts in the US, where we are targeting university hospitals as a first target group, as they more often invest in new equipment and are thus at the forefront of new technology.

Finally, what milestones do you hope to report on in 2023?

– We are now starting evaluation and testing of biocompatibility according to plan, which is part of the verification needed for regulatory approval. Demonstrating the safety of the product and meeting standards and regulations is necessary before both CE marking and market approval in the 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.

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