Project: A new multi-parameter neuromonitoring system to save patients` lives in stroke, brain injury, cardiac arrest and sleep apnea

BACKGROUND_x000D_ Market demand: Stroke and brain injury are leading factors for disabilities and death worldwide. In the EU, an estimated 7 mio people suffer from brain damage due to stroke, cardiac arrest and head trauma. The economic burden is among the highest of all diseases. The major goal in intensive and operative care is to avoid secondary brain damage after stroke, head trauma, cardiac arrest, in sleep apnea syndrome, and during cardiopulmonary bypass (CPB) surgery. Brain blood flow (cerebral blood flow; CBF) and oxygen supply are the most important parameters to detect secondary brain injuries and to guide treatment. CBF monitoring is a key instrument to improve therapy and outcome for these patients. The currently available methods to monitor CBF are unsuitable and technologies for measuring CBF rapidly, at the bedside are needed._x000D_ _x000D_ Technical need: Near infrared spectroscopy (NIRS ) is based upon the principle that light in the near infrared (NIR) region penetrates tissue and is absorbed by the blood containing deoxygenated and oxygenated hemoglobin. Conventional NIRS for brain oximetry applying patches with optodes over the skin are on the market and in clinical use. However, they have 3 major deficiencies: _x000D_ 1. They measure no CBF, which is crucial for diagnosis and treatment. _x000D_ 2. The NIRS signal obtained by plaster-based patches fixed on the skin is contaminated by extracerebral tissue (skin, skull, cerebrospinal fluid). Therefore no absolute values can be measured and no critical thresholds can be defined._x000D_ 3. They are large, expensive and cumbersome for clinicians to handle._x000D_ _x000D_ OBJECTIVE_x000D_ In OPTO-BRAIN, we will further develop NIRS to a unique multi-parameter neuromonitoring system (NeMo System) based on 4 components:_x000D_ 1. NIRS instruments, control unit: Based on refined optical technologies the measurement device is miniaturised, which allows manufacturing small, cheap and user-optimized instruments (Pocket NeMo). A light absorbing dye dilution mode applying indocyanine green (ICG) for CBF monitoring is introduced. _x000D_ 2. Probes, minimal invasive approach: Conventionally used for intracranial pressure (ICP) monitoring, our probe will be extended by optical fibres (NeMo Probe) to measure CBF and oxygen directly in the brain (without contamination from extracerebral tissues). For patients with severe brain injuries and stroke, where ICP probes are installed anyway due to elevated ICP, the NeMo Probe offers enhanced monitoring modalities without an additional surgical intervention. _x000D_ 3. Patches, non invasive approach: Measurements in parallel with the probe and patch allow developing new algorithms to purify the patch signal from extracerebral tissues. New materials and design of the plaster-based NeMo Patch, furthermore, will significantly decrease the susceptibility to artifacts. The strictly non invasive NeMo Patch will be applied in patients after cardiac arrest, during CPB surgery and in sleep apnea syndrome._x000D_ 4. Software: New algorithms and a graphical user interface (GUI) with intuitive user guidance will complete the NeMo System, which will enable a paradigm shift in intensive care medicine comparable to the one from visual flight to instrument flight._x000D_ _x000D_ APPROACH: _x000D_ Creaholic with expertise in innovative materials and product design will further develop the NeMo Patch from a functional model to a prototype. NEMO, IP holder for the NeMo System, will integrate the devices Patch, adapted Probe and Pocket NeMo into the NeMo System, while preparing the clinical trials in intensive care medicine and neurosciences. The clinical studies at and the user-input from 2 highly specialised university hospitals (MUG and ALU-FR) will provide data to develop the algorithms for the optimized software. To ensure the usability of the neuromonitoring system, use cases will be undertaken by Use-Lab, a leader in usability studies, and the GUI will be designed for different user groups in intensive and nursing care, anesthesiology and emergency medicine. The following programming, system optimization and on-going quality management will finally enable our interdisciplinary consortium of 3 R&D performing SMEs and 2 university hospitals from 3 countries to develop a market-oriented and user-friendly medical device._x000D_ _x000D_ EXPECTED IMPACT:_x000D_ OPTO-BRAIN will deliver an unprecedented neuromonitoring system for multi-parameter monitoring for more accurate clinical decisions, better outcome and cost reduction in health system. Market penetration will be enhanced through a business model based on a “razor and blades” approach: Small costs for the hardware (Pocket NeMo) allowing for fast decision processes in hospitals. NeMo Probe and NeMo Patch will be sold as disposables. The NeMo System will strengthen diagnosis, monitoring and prognosis of stroke easier, faster and more accurate. It will therefore improve the health and quality of life of European citizens and also promote development in photonics for life science markets in Europe.

Acronym OPTO-BRAIN (Reference Number: 6526)
Duration 01/01/2012 - 31/12/2013
Project Topic OPTO-BRAIN develops a revolutionary multi-parameter neuromonitoring system with 2 disposables: a minimal-invasive probe and a non-invasive patch. Thanks to advanced optoelectronic techniques, both are connected to the smallest instrument for near infrared spectroscopy in the brain ever constructed.
Project Results
(after finalisation)
Industrialized user-friendly prototypes have been finalized successfully, integrated into the NeMo System, and tested in clinical studies._x000D__x000D_Overall, data from 10 patients examined with the NeMo Probe (4 patients were measured in parallel with the NeMo Probe and NeMo Patch, 2 of these at the Universitätsklinik für Neurochirurgie of the Medizinische Universität Graz) and 10 healthy volunteers examined with the NeMo Patch is available to be submitted to the notified body Medcert, Hamburg._x000D__x000D_Please also see Final Report from NeMoDevices AG.
Network Eurostars
Call Eurostars Cut-Off 6

Project partner

Number Name Role Country
5 Universitätsklinik für Neurochirurgie, Medizinische Universität Graz Partner Austria
5 Use-Lab GmbH Partner Germany
5 Creaholic SA Partner Switzerland
5 NeMoDevices AG Coordinator Switzerland
5 Universität Freiburg Partner Germany