Sweden’s BrainCool Enters U.S. Market With FDA 510(k) Clearance for IQool System for Temperature Management

LUND, Sweden--(BUSINESS WIRE)--European medical device firm BrainCool AB has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its first product in the United States, the IQool^TM System, with an indication for use of temperature reduction in adult patients when clinically indicated.

“Precise and tolerable temperature management can be critical in achieving positive patient outcomes in a large variety of clinical settings. The patented IQool System is designed to work with both sedated and conscious patients, and works with several independent cooling zones of the body to maximize its effectiveness”

The IQool System is a next-generation precision surface cooling system intended for temperature management with a focus on three independent anatomical zones: head/neck, thigh and torso. The IQool System quickly and effectively cools adult patients when clinically indicated using easy-to-apply non-stick adhesive pads prefilled with BCCOOL (a non-toxic and bacteria-static cooling agent) that are attached to an automated chiller. The IQool engages within seconds, allowing clinicians in a variety of settings to manage patient temperature quickly and effectively.

“Precise and tolerable temperature management can be critical in achieving positive patient outcomes in a large variety of clinical settings. The patented IQool System is designed to work with both sedated and conscious patients, and works with several independent cooling zones of the body to maximize its effectiveness,” commented BrainCool CEO Martin Waleij.

Based in Lund, Sweden, Europe, BrainCool AB (publ) (AktieTorget: BRAIN) is a publicly traded medical device company focused on next-generation temperature management systems. The technology platform both cools and warms patients using focused anatomical zones as opposed to whole body applications such as cooling blankets. BrainCool dramatically advances the temperature management standard of care by delivering a physically-targeted, speed-driven temperature management system designed to be easy to use and effective. The company currently markets a number of CE-marked devices in Europe addressing therapeutic hypothermia for cardiac arrest and stroke (BrainCool^TM and RhinoChill^TM), with products focused on oncology, traumatic brain injury and pain management currently in development.

This information is information that BrainCool (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out herein, on May 17, 2017.