Hanna Sjöström, CEO Neola Medical Photo: Roger Nellsjö

Av Anders Göransson den 19 februari 2025 15:30

The Lund-based company has developed what it describes as the world's first medical technology for continuous monitoring of the lungs in premature infants. The goal is to detect complications faster than is currently possible. The standard method now used is chest X-ray – but by the time this is done, it is often too late to save the child.

Based on research from Lund University, Neola has developed an entirely new method that measures volume changes and free oxygen in the lungs in real-time and warns if life-threatening complications arise. The measurements are made via probes placed on the child's skin, which send a weak infrared light through the lung.

The measurement system, called Neola, has previously been clinically tested on newborns. Now, the Swedish Medical Products Agency and the ethical committee have given the company the green light to start a clinical study on premature infants. It will be conducted at Södra Älvsborg Hospital in Borås in Western Sweden and will include ten children, starting in the spring.

"It's significant. Generally, it is difficult to conduct studies on preterm born infants for ethical reasons. You could say that we are now in the final step where we will see that our technology works also on the patient group that needs it the most," says Neola's CEO Hanna Sjöström, who believes that the non-invasive nature of the method was key to the study application being approved.

Although the current study will be conducted in Sweden, the company's initial focus is on the US market. The Swedish study is intended to be followed by a clinical study on premature infants in the US, which will form the basis for the company's application for approval by the US Food and Drug Administration (FDA).

"We are seeking FDA approval first because the demand for paediatric medical technology is very high in the US. The FDA itself has assessed that medical technology innovation for children is severely lacking and has launched special initiatives to promote it."

Neola is one of the few companies selected to receive support from Stanford University's programme for technological innovation in child and maternal care. This means that the company receives significant support from the FDA, which co-finances the programme.

"In this way, we have a fast track into the US market, which we do not really see in Europe."

Hanna Sjöström is one of the speakers at the conference "The Future of Swedish & Danish Life Science" taking place in Lund in southern Sweden on 15 May. There, she will talk about the company's efforts to establish a foothold in the US.

"I will talk about the path to the US market, our experiences of establishing a subsidiary in the US, how important it is to connect with the right Key Opinion Leaders, and how we have gone about doing this. I will also look at some of the pitfalls, such as payment models and the regulatory process."

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