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BrainCool AB and University of Edinburgh Report Positive Results in Clinical Trial Testing New Medical Brain Cooling Device


LUND, Sweden and EDINBURGH, Scotland (May 7, 2014)—Positive results in a study conducted by the Centre for Clinical Brain Sciences and the Brain Imaging Research Centre at the University of Edinburgh investigating a new medical device for therapeutic brain cooling have allowed the Centre to end the pilot study on healthy volunteers early and move forward with a randomised study with healthy volunteers and further research on stroke patients. The medical device, developed by BrainCool AB, was developed primarily for the use in stroke patients and has promising implications for use with other patient groups as well. BrainCool uses a unique cooling method developed together with Dignitana, a world leader in scalp-cooling technology. The advanced technology used in the new BrainCool System allows cooling of the neck, which helps to speed perfusion and cooling of blood before it reaches the brain—potentially a critical intervention for patients suffering from stroke. BrainCool is the first medical device now available for clinical use to be tested for this purpose. By lowering brain temperature, therapeutic hypothermia may protect the brain from the injury which occurs following cardiac arrest, stroke, traumatic brain injury or neonatal asphyxia. Even a reduction in temperature to 35°C could be enough to protect the brain from stroke-induced damage. The Edinburgh pilot study was stopped early when a significant reduction in brain temperature of 0.6°C was observed. This would be an important addition to the cooling which can currently be achieved in awake stroke patients, and led the study committee to move to the next phase of testing with the conclusion of this study. “The results of our pilot study are very promising, and suggest that this approach could be useful for stroke patients,” said Dr. Malcolm Macleod, Professor of Neurology and Translational Neuroscience and Head of experimental neuroscience at the Centre for Clinical Brain Sciences at the University of Edinburgh. Stroke is the second largest cause of long-term disability in developed countries, and the second cause of death worldwide. Even in this advanced medical age, stroke patients today have limited access to immediate and effective therapy, thus, tragically, two-thirds of stroke patients remain disabled or die following a stroke. In Europe, nearly 1,000 people die from stroke related incidents every day. “An important advantage to brain cooling is that it may be used in most stroke patients, which is not the case for some other therapies such as clot-bursting drugs.” Dr. Macleod adds, “The technology that we are testing from BrainCool AB is designed to allow selective brain cooling that could be initiated at a very early phase. In addition to stroke, there are other potential uses such as in cardiac arrest and traumatic brain injury—perhaps with cooling initiated in the field or in an ambulance—that might help protect or lessen damage by cooling the brain.” Results from previous pilot studies suggest that even a small reduction of the brain temperature could be beneficial in treating stroke patients, and may even contribute to significantly reduced mortality rates and improved quality of life for stroke survivors. “Our studies are providing solid clinical evidence for the therapeutic use of medical brain cooling in stroke patients,” said Martin Waleij, CEO and President for BrainCool AB. “With nearly 150,000 individuals in the UK suffering a stroke each year, this technology could save lives and improve quality of life outcomes significantly. The findings in this University of Edinburgh study open the door to a new world of advanced healing options for people suffering from stroke, traumatic brain injury, cardiac arrest and neonatal asphyxia, but we will also investigate other medical cooling applications.” BrainCool’s ease of use provides a significantly more efficient and tolerable therapeutic cooling method than other devices currently being tested for cooling the brain. Unlike these other therapies, BrainCool offers flexibility and ease of use for both patient and clinician. The body remains completely free and unrestricted during use, and most patients are awake or resting calmly during treatment. An advanced BrainCool model that can be easily transported is currently in development in addition to the standard BrainCool System now available for clinical trials only. Portability and ease of use could make this new medical device particularly advantageous for stroke patients, for whom immediate intervention can be critical. In addition to the indication for use in stroke, new patent applications have also been submitted in the US complementary to the existing worldwide patents of Dignitana AB. About University of Edinburgh Centre for Clinical Brain Sciences The Centre for Clinical Brain Sciences (CCBS) was established in 2004 and is a part of University of Edinburgh. It is a multidisciplinary translational "centre without walls" combining basic and applied research to study the causes, consequences and treatment of major brain disorders. An explicit aim of the Centre is to discover and deliver novel therapies for brain disorders. About Brain Cool AB (publ) BrainCool AB is a Swedish medical device company focused on innovative technologies in the area of medical cooling, with an initial focus on stroke indication. BrainCool is being clinically tested in Sweden and the United Kingdom. BrainCool AB is listed on the Swedish smallcap stock exchange AktieTorget on May 7th 2014.(, share shortname BRAIN ) Caren Browning King + Company 00 1 212 561-7464 Martin Waleij CEO BrainCool AB +46 733 93 70 76 Eleanor Cowie Press & PR Officer, Univ. of Edinburgh 0131 650 6382 For more information visit