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BrainCool Solution

Step 1 – RhinoChill™ – Proven Safe Efficacious Intra-Arrest Cooling

Early deployment of cooling with RhinoChill™ as soon as possible once at the scene of arrest and maintained throughout hospital until the switch to the BrainCool™ system protects the nerve cells from immune response to ischemia and reperfusion. Early, safe and efficient temperature management using RhinoChill™ provides neuro protection of the brain specifically in the ventricular fibrillation group.

Step 2 – BrainCool™ System – Advanced Temperature Management System

BrainCool™ System provides temperature management in the intensive care department using an intelligent, safe and simple method. The BrainCool™ System is the next generation precision surface cooling device that offers high flow rates resulting in an incredible heat exchange and precise temperature maintenance. The system is user friendly and provides a proactive approach to managing your patients with visible objective data.

Indications

Cardiac Arrest

Cardiac arrest occurs when the heart stops beating and prevents the circulation of blood in the body, which results in loss of consciousness and breathing. If this is unexpected it can be termed a sudden cardiac arrest or SCA. Brain injury is likely if cardiac arrest goes untreated for more than five minutes. Sudden cardiac arrest usually results from an electrical disturbance in the heart and is different from a heart attack. However, a heart attack can sometimes trigger an electrical disturbance that leads to sudden cardiac arrest.

Cardiac arrest is a severe medical emergency that, in certain situations, is potentially reversible if treated early. With fast, appropriate medical care, survival is possible.

Unconscious survivors of out-of-hospital cardiac arrest have a high risk of death or poor neurologic function. Therapeutic hypothermia is recommended by international guidelines

The most common cause of cardiac arrest is an arrhythmia called ventricular fibrillation — when rapid, erratic electrical impulses cause your ventricles to quiver uselessly instead of pumping blood and supply your vital organs.

Emergency treatments for ventricular fibrillation focus on restoring blood flow through your body as quickly as possible to prevent damage to your brain and other organs. After blood flow is restored through your heart, if necessary, you’ll have treatment options to help prevent future episodes of ventricular fibrillation.

The results of previous European clinical trial, the PRINCESS study showed that earlier cooling provided statically significant improvement which resulted in more neurological intact patients with (CPC 1) in the VF group

 

BrainSave Thrombectomy

BrainSave for Stroke – supporting a wide-spread market adoption, the combination of a sensor-controlled, combined therapeutic hypothermia device that allows for fast, seamless and continuous brain cooling of stroke patients to prevent brain damage.

First product on the market that addresses the need in stroke care for a safe and effective device that provides fast brain cooling from the emergency setting continuously through to post-treatment recovery.

Stroke

A stroke is the rapid loss of brain function resulting from an impeded blood supply to the brain. This can be due to lack of blood flow (ischemia) caused by an embolism or other thrombosis or it can be caused by a leakage of blood (hemorrhage). As a result of the lack of blood flow, the affected area of the brain is unable to function and this can lead to brain damage and cell death.
A stroke is a medical emergency that can cause permanent brain damage and even death. It is the leading cause of adult disability in the United States and Europe and it is the number two cause of death worldwide.
Because stroke incidence rises exponentially with age, the social and economic burden of stroke will rise further with the aging of the population.
In Sweden alone with a nine million population, 30,000 persons every year will experience a stroke and another 35,000 become victims of a cardiac arrest. The products are needed because considerable neuroprotection can be achieved through hypothermia, resulting in saved lives but also significantly improved quality of life for the surviving patients. Even small medical advantages in these two patient groups will give large health economic gains for society. There is also the potential for necessary technologies to be adopted at all hospitals with emergency care programs for these patients.

Market Overview

Unconscious survivors of out-of-hospital cardiac arrest have a high risk of death or poor neurologic function. Therapeutic hypothermia is recommended by international guidelines such as the European Resuscitation Council (ERC) and American Heart Association (AHA).

In US, according to the Boston MedTech Advisors survey (2016), more than 70% of hospitals use medical cooling, but the trend is increasing, and last year approximately 80,000 cardiac arrest patients were treated with therapeutic hypothermia “Heart Disease and Stroke Statistics — 2015 Update: A Report From the American Heart Association The annual report includes a chapter on Sudden Cardiac Arrest. According to the report, about 326,200 people experienced out-of-hospital cardiac arrests (OHCA) in the U.S. in 2011. (This compares with a reported incidence of 424,000 in the AHA´s Heart and Stroke Statistics– 2014 Update.)

The leading markets for the RhinoChill™ and the combination RhinoChill™/BrainCool™ System are US, Europe and Asia.