A new invention may be on the verge of replacing expensive cranial surgery currently performed on some traffic accident victims and other patient groups. The ultrasound-based technology has now obtained CE approval for the European market.
“We went through the eye of the needle on this one,” says Tormod Selbekk. Selbekk is head of technology at spin-off company Nisonic AS. He is also the co-inventor of the new device and was previously a researcher in medical technology and ultrasound at SINTEF, where the idea was born.
“The increase in intracranial pressure (ICP) or brain pressure can lead to brain damage and can be caused by accidents or illness,” he says.
It is important in all cases to detect increases in brain pressure as early as possible, in order to make treatment easier and more effective. A treatment option can be as simple as the prompt administration of diuretic drugs.
Ultrasound can replace surgery
Brain pressure is currently measured directly using a sensor or through a drain that is inserted into the patient’s brain tissue through a hole in the skull. The procedure should be performed in an operating room. It is expensive, expensive and, not least, presents a low risk of side effects for the patient.
The new ultrasound scanner, called Nisonic P-100, can ease the burden on hospitals and provide patients with more sensitive treatment. It is equipped with a built-in software that automatically processes the ultrasound images. The device allows doctors to quickly determine if a patient can develop dangerous increases in brain pressure. The technology is based on an algorithm that interprets ultrasound images of the patient’s optic nerve sheath, which changes its dimensions in response to increases in intracranial pressure.
A demanding approval process
Obtaining CE mark approval for the Nisonic P-100 technology has been a demanding process, but the technology has recently been approved by various regulatory agencies and given the green light.
We are all very happy about it. This past year has been particularly difficult as the EU recently amended its legislation approving CE marking for medical equipment. On top of that, we had to deal with the effects of the Covid-19 pandemic. Despite these challenges, in just over two years we were able to advance our prototype and gain approval as medical equipment. “
Tormod Selbekk, Chief Technology Officer, Nisonic AS
This means that not only can the technology now be used in hospitals across the EU, but it will also be easier for us to access large and growing US markets in the future. The ICP detection and monitoring equipment market is expected to increase significantly in the coming years. Several reports have estimated a market valued at $ 270 million, with the highest levels of annual growth in ultrasound detection. Nisonic is thus ideally positioned to take advantage of a future growth sector.
Game changer possible
Eirik Helseth is Professor and Head of the Department of Neurosurgery at Oslo University Hospital, Ullevål. He is a principal investigator in a clinical research study, in which ultrasound images of the optic nerve are recorded in patients with severe head injuries. The collaboration in the research project allows Nisonic to receive anonymized ultrasound images and ICP measurements for further development of the methods.
As part of a standard procedure, these patients had a sensor surgically inserted into their brain to monitor intracranial pressure. The objective of the research project is to assess whether processed ultrasound images of the optic nerve captured by Nisonic technology can provide a reliable measurement of brain pressure.
Helseth calls the method a potential game changer:
“Current technology only allows us to make reliable measurements of intracranial pressure using a sensor, or via a drain, which is inserted into the patient’s cerebroventricular system (brain chamber),” explains Helseth. “Both methods require admission to the neurology department of a hospital and surgery to insert the pressure transducer or drain. If ultrasound images of the optic nerve prove to be a reliable method of measuring ICP, this will open up opportunities for the method to be applied not only in all other hospital wards, but also in GP surgeries and ambulances. . It will be fantastic – and a worldwide sensation, ”he says.
The more data, the better the result
However, Helseth would like to stress that the equipment can never be better than the data supplied to the algorithm.
“It’s critical that the equipment be used in many hospitals so that we can get even more patient data to work with,” he says. All healthcare professionals know that such equipment must be tested on a large number of patients before reliable measurement data can be obtained. For example, there may be differences in the structure of the optic nerve sheath between males and females, and between different age groups.
“This is why Ullevål’s neurological department is assisting Nisonic with his research and data collection. We have great confidence in the approach and the technology,” says Helseth.
Search for financial partners
Nisonic is now seeking more capital investments and business partners who can help the company realize its growth plans overseas.
“If we are successful in establishing our method of noninvasive surveillance of ICP, market assessments have indicated that there is significant interest among clinicians in hospitals in Europe and the United States, and high economic potential for the technology, ”says Selbekk.
The company has successfully developed the Nisonic P-100, working with several Norwegian contributors. These include the ultrasound company Vitacon AS, which provided key assistance in the CE mark approval process; Medistim ASA, specialized in ultrasound imaging related to cardiac surgery; and Aurotech AS, based in Tydal, which provided the equipment. Nisonic P-100 is generally a completely Norwegian product.
Used in Stockholm
The first Nisonic system is already on its way to the Bragée clinic in Stockholm, which collaborates with the Karolinska Institute in clinical research. Here, the equipment will be used for research on patients with chronic fatigue syndrome (CHD).
Swedish researchers are working with a theory that patients with ME also have high intracranial pressure. Nisonic’s equipment will be used to measure optic nerve sheath diameters in ME patients, as well as those in a control group. Selbekk specifies that these measurements will then be compared to diameters measured by magnetic resonance imaging (MRI).
This research will provide Nisonic with even more patient data, which will further improve the algorithms of the system.
“The more patient data we have, the better the equipment will be. Indeed, the method is based on deep learning and neural networks, which are branches of the field of machine learning and artificial intelligence, ”he said, adding;
“Our job will be much easier now that the equipment is CE approved. The CE mark allows us to capture anonymous data much faster than in the past. We hope to achieve even better results through systematic data analysis and to the formation of neural networks.