LEGAL DISCLAMER
Hyposafe A/S has taken every care in the preparation of the content of this website. All information that it contains is provided by Hyposafe A/S in
good faith. There may, however, be inadvertent and occasional errors or omissions in respect of which Hyposafe A/S accepts no liability whatsoever.
EXCLUSION OF LIABILITY
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COPENHAGEN OFFICE
Hypo-Safe A/S
Diplomvej 381
DK-2800 Kgs. Lyngby
Denmark
Phone +45 2148 3588
Mail:
ODENSE OFFICE
Hypo-Safe A/S
Chr. Richardts Vej 26 B
DK- 5230 Odense M
Phone +45 6612 1478
Mail:
CVR: 29140774
HYPOGLYCEMIA
Hypoglycemia (also called an insulin reaction) occurs when blood glucose level falls too low, also resulting in a shortage of glucose in the brain (neuroglycopenia). During periods with brain glucose shortage, the function of the neurons is affected, altering the brain function and behavior. Hypoglycemia is, with good reason, feared by all insulin treated diabetics, due to the fact that it has some dramatic short-term effects, including shaking, sweating, nausea, inability to concentrate, cramps, unconsciousness, permanent brain damage or even death. Hypoglycemia can be caused by a number of factors: too much insulin, not enough food, too much exercise, eating late, or eating too little carbohydrates. In short, it happens when insulin and blood glucose are out of balance. Hypoglycemia can come abruptly and without warning. This can have serious consequences for the patient, especially if the timing is bad, for example, if the patient is driving a car. This can result in a number of derived effects such as third party person and property damage and constant social restrictions as a consequence of awkward or aggressive behavior. The number of severe hypoglycemia related incidents is estimated to be 50,000 per day, and explains death in 2-4% of insulin treated diabetics. The distribution of these severe attacks is uneven, and depends on the patients’ individual ability to sense the approach of hypoglycemia. Though all diabetics can be exposed to hypoglycemia, most cases will be registered in the 25% of the insulin users, normally categorized as the group with “unawareness” to hypoglycemia. The diabetics with unawareness are unable to sense and react to an upcoming hypoglycaemic event.
THE HYPOSAFE DEVICE
HypoSafe is the name of a new technology designed to detect and alert diabetics of hypoglycemia. Tests have shown that the human brain, which lives primarily on glucose, begins to demonstrate recognizable electric patterns approximately 20 minutes before hypoglycemia. By continuous measurement of the electrical activity within the brain (via EEG ), hypoglycemia can be detected, and the diabetic alerted before the situation becomes critical. When alerted, the diabetic can take the necessary action required to avoid hypoglycemia from occurring and thereafter adjust his/her glucose level to the appropriate interval.
HypoSafe is a device that is implanted under the diabetic’s skin on the side of the head. The device is implanted in the sub cutis layer, only a few millimeters below the skin, making the implant procedure rather simple. The implantation consists of the insertion of a 5 cm long, 0.5mm diameter electrode with a coin sized device attached to the end. The implant procedure takes up to 30 minutes and is performed under local anesthesia. The device can remain implanted for more than 10 years. The implanted part is soft and small and does not create inconvenience to the user. When implanted, there are no physical elements passing through the skin and the use of bandage/plaster is not required. Thus, there is no risk of infection or allergic reactions. Furthermore, as the device is hidden under the skin, the device has no implications for the users chosen lifestyle.
HypoSafe works because it uses the brain directly as a biosensor, measuring changes in EEG signals, monitoring for signs of hypoglycemia. By using EEG signals as the measuring principle there is a direct correlation between oncoming hypoglycemia and the signal that is measured. In this way, the measurement principle is not affected by delays and other unintended transition functions. Basing the measurement principle on the EEG signal further enhances robustness due to the fact that no calibration is required to identify the characteristic hypoglycemia pattern.
The Hypo-Safe technology has 5 major benefits that will greatly enhance the lives of insulin treated diabetics:
1) Provides a genuine protection against hypoglycemia by:
a. Ensuring the detection of all hypoglycemia events – this is possible due to the fact that the brain always emits a characteristic and recognizable EEG pattern, prior to the onset of hypoglycemia. This means that the user can feel secure that the device will alert before hypoglycemia arrives.
b. Provides alarms in time to react – our testing has demonstrated that by measuring EEG, hypoglycemia can be detected 10-20 minutes before the cognitive state starts to deteriorate. Receiving this warning gives the patient time to take positive steps to avoid hypoglycemia.
c. Does not stress the user with false positive alerts – the EEG measurement principle is very robust with respect to source of external interference, which creates an optimal signal for interpretation. Furthermore, the mathematical model used in the analysis is strong enough to ensure that we avoidance incorrect conclusions. This means that the user is not unnecessarily stressed by false positive alerts.
2) Does not require calibration – The measuring principle is based on changes in the EEG (delta) and doesn’t require a fixed reference value. This means that once implanted, the device does not need readjustments, despite individual differences in EEG.
3) Has no replacement parts – the internal device is based on electrical signals, and has therefore no moving parts or chemical reactions that can reduce the performance of the device. This means that once implanted, the device does not require maintenance.
4) Does not compromise the comfort of the user – as the device is hidden under the skin of the patient, there is no skin penetration and no risk of infection. This allows the user to engage in whatever lifestyle that the user wishes, without having to constantly take the device into account.
5) Is a simple, cheap and long lasting solution – the device is based on known and simple technologies, thus making the device relatively cheap to produce. The absence of mechanical and chemical components reduces the need for continual maintenance. Furthermore, the device is expected to have a lifetime of more than 10 years. This means that the device is very robust.
THE TECHNOLOGY PLATFORM
Though EEG and its potential has been known for many years, two major obstacles have restricted the further development for use in daily life purposes, primarily the lack of a convenient and accurate recording method and secondarily the difficulties in providing efficient methods of analysis.
Today EEG is monitored either by surface electrodes (widely used) or by sub cranial implanted electrodes (for diagnostics only). The sub cranial electrodes are very accurate, but are naturally combined with a lot of risk for the subject. The surface electrodes on the other hand are less accurate due to problems with pour skin contact and due to a high sensitivity towards movements, sweetening etc. Finally the loose wires in both recording methods are restricting the freedom of movement and are adding to a reduced quality of the signal.
The difficulties in providing efficient analysis are very much connected to the above. If no long time high quality EEG recordings are available, it is difficult to develop firm mathematical models. Naturally, also the computer power, size and the related software are making things possible today which were not imaginable just a few years back. This, combined with an enhanced scientific knowledge, makes it possible to make mathematical models and algorithms which can cope with even very complex challenges.
Hypo-Safe possesses and have access to the foremost scientific competences within mathematical models for complex data analysis.
The HypoSafe device is the first EEG device being made for implantation. The subcutaneous method of monitoring has demonstrated to provide a remarkable high quality of data which makes is possible to recognize typical EEG patterns that are unlikely to be detected with surface electrodes.
ABOUT HYPOSAFE
Hypo-Safe was founded by one of the world leading diabetes scientists, Professor Henning Beck-Nielsen in 2005, with a mission to help individuals suffering from hypoglycemic attacks. Through his research professor Beck-Nielsen found that hypoglycemia could be predicted timely and reliably from the EEG patterns in the brain. This insight led to the basic concept of the HypoSafe devise. Beck-Nielsen and CEO Rasmus Stig Jensen decided to turn the HypoSafe device into a product to help millions of diabetic patients.
In 2005 the company was a reality and now in 2008 the prototype device is completed and undergoing clinical trials.
OUR MISSION
Hypo-Safe’s purpose and existence is built on the foundation of the following mission statement:
Hypo-Safe A/S is committed to improve the lives of patients at risk from Hypoglycemia, by creating a symbiosis between the possibilities adherent in EEG measurement technologies and the ability to map and detect patterns in the human brain utilizing algorithms.
OUR VISION
Hypo-Safe’s vision for the future is as follows:
Hypo-Safe improves the lives of critically sick people, using the brain as biosensor, to detect and warn patients against the threat of critical events, resulting from their sickness. Hypo-Safe will closely follow the possibilities adherent within the market and follow a build-and-divest strategy, selling components of technology to interested acquires, while still retaining the core EEG measurement technology in order to allow the development of solutions for other attractive areas.
ORGANISATIONAL STRUCTURE
Hypo-Safe consists of a core team of directors and specialist. Between them, the core team possesses world-class competences within the areas of: diabetes, mathematics, project management and venture value creation. The core team works in close collaboration with a large number of stakeholders, all of whom are in possession of critical insight within a specific discipline. These stakeholders include: a Scientific Advisory Board, a number of participating hospitals, a technology network and major business partners within design and production.
HYPO-SAFE A/S CORE MANAGEMENT TEAM
Henning Beck-Nielsen (Chairman): Henning is a Professor and manager of the department of endocrinology at Odense University Hospital, and has been specializing in diabetes for the last 30 years. Henning has a high international reputation for his scientific work and has received a number of acknowledgements and prices. Latest he received The Hagedorn and Novo Nordisk prices. Henning is the original founder of Hypo-Safe A/S and is, with his strong scientific ballast, responsible for the precision and validity of the projects research related results. Renowned in the world of diabetes, Henning ensures a high level of interest around the project.
Rasmus Stig Jensen (CEO): Rasmus Stig Jensen is educated as an engineer from Aalborg Universitet. Rasmus has approximately 15 years experience with project management and execution of large scale, cross-border R&D projects and client contracts. Among those, Rasmus has five years of experience in line management and project portfolio management. In taking the role of CEO, Rasmus is responsible for all daily operations at Hypo-Safe A/S, with special focus on project management and delivery, and, managing relationships.
Claus Christiansen (Non-executive Director): Dr. Claus Henrik Christiansen holds a medical degree from the University of Copenhagen (1971) and has published more than 800 scientific articles. He is the executive director of Nordic Bioscience A/S, a company dedicated to the development, production and marketing of products within osteoporosis and diabetes. In addition, he is the founder of several biotechnology companies, including CCBR, Nordic Bioscience, Osteometer, MediTech and Synarc. Claus made last year alone exits for more than 200 mill USD. He also serves on the board of various biomedical companies and is a member of numerous scientific advisory boards. Renowned in the biotech-business Claus manages the market and investment strategies.
Kurt Christiansen (Non-executive Director): Kurt Christiansen has many years of experience in high-level positions in a number of industrial and market oriented companies. Kurt is currently CEO of Micromatic A/S, a company of more than 1000 employees with a worldwide presence and distribution channels. Based on his experience within top management Kurt manages the transformation of Hypo-Safe into an international market driven organization. Further to this, Kurt manages the strategic approach to contract, legal and patent issues.
Rasmus Elsborg Madsen (Scientific Specialist): Rasmus Elsborg Madsen (REM) has a Ph.D in mathematical modelling from the Institute for Mathematical Modelling (IMM), DTU. Furthermore, Rasmus has a degree as an electrical engineer from Århus Teknikum. Rasmus’s experience within the areas of neurological networks and pattern recognition, combined with his knowledge within the area of electronics, will ensure that the medical research results can be practically transferred to the commercial device. Rasmus provides a bridge between the medical findings and the technological solution.