A new ultrasound system for non-invasive detection of raised intracranial pressure

Nisonic AS is a Norwegian medical ultrasound company originating from world-class research at SINTEF. The company develops an ultrasound system for non-invasive measurement of intracranial pressure. The company is currently funded by investors such as SINTEF Venture, Hadean Ventures, Investinor, Sarsia Seed and CoFounder. Increased intracranial pressure (ICP) can prevent blood flow through the brain and cause ischemia. Without early detection and early treatment, this can lead to permanent brain injury or death. Several neurological conditions are associated with increased ICP, e.g. traumatic brain injury (TBI), stroke, hydrocephalus, infections or brain tumor. ICP is currently measured invasively by inserting a pressure sensor through a cranial burr hole. The procedure is performed at neurosurgical operating rooms by specialized personnel, with high cost and risk of infection and bleeding. There is huge unmet global need for a simpler method for measuring ICP. Nisonic's ultrasound-based method can reduce costs for hospitals and society, reduce the risk of complications, and enable early diagnosis. The BIA project will help develop new technologies and methods to improve clinical accuracy and automate the measurement method. The main goal is therefore to achieve both high diagnostic accuracy and simplification of the measurements so that they can be carried out by health personnel without special competence.

Methods for automated processing of optic nerve sheath ultrasound images has been developed and implemented in software. The implemented methods and the software is the basis for the future business of Nisonic AS.

Raised intracranial pressure (ICP) may impede blood flow through the brain and cause ischemia. Without early detection and timely treatment, this can lead to permanent brain damage or death. Several neurological conditions are associated with raised ICP, e.g. traumatic brain injury (TBI), stroke, hydrocephalus, infections or brain tumour. For severe TBI patients, monitoring of ICP is mandatory. ICP is currently measured invasively by inserting a pressure sensor through a cranial burr hole. This is done in a neurosurgical operating room by highly specialized personnel, with high cost and a non-negligible risk of infection and bleeding. By the time a patient reaches the operating room, ischemic damage may already have occurred. There is therefore a large unmet clinical need for a simpler method for measuring the ICP. A non-invasive alternative for estimation of ICP will not only serve to reduce cost and risk of complications, but also provide diagnosis for patients with suspected raised ICP who are for some reason not eligible for invasive ICP measurement. This could eventually change the paradigm of diagnosing raised ICP, and the potential for improved patient welfare and reduced social cost is huge globally. The overall aim of the current project proposal is to reduce user-dependence, which is identified as a major challenge for both clinical accuracy and market penetration. Primary objective is therefore to achieve both high diagnostic accuracy and sufficient repeatability, i.e. small difference between users with different levels of expertise. Research partners in the project are SINTEF and Oslo University Hospital, Ullevål.