QuickCool AB (publ) CE-marks Positioning Strap
QuickCool AB (publ) (the "Company") announces that the Positioning Strap, intended to keep catheters in place during treatment, is being registered at Läkemedelsverket i.e. the Swedish Medical Products Agency’s register for medical devices Class I products. The Positioning strap is part of the Company's Nasal Cooling Kit, i.e. disposable kit, which will be used during mild hypothermia treatments of cardiac arrest patients together with the QuickCool® SYSTEM.
During the year, the technical files for the remaining parts of the system will be submitted and reviewed by the Company's notified body, TÜV Süd, as part of the CE marking process for the QuickCool® SYSTEM.
QuickCool's Positioning Strap is classified as a Class I medical device according to both MDD (93/42/EEC) and MDR (2017/745). It is non-invasive and intended for single use and is used to fixate the balloon catheters that are placed in the nasal cavity of adult cardiac arrest patients during mild therapeutic hypothermia treatments. The Positioning Strap enables health care professionals to fixate the catheters, without using tape on the patient's face/head.
We have applied for additional IPR protection for the Positioning Strap in several countries in accordance with the European Patent Office announcement on 20 September 2018 that considered QuickCool's patent application via the Patent Cooperation Treaty (PCT) to be patentable.
"It's a milestone for QuickCool now that our Positioning Strap is being CE-marked and may be sold in a global market," says Fredrik Radencrantz, CEO of QuickCool AB.
For additional information, please contact:
Fredrik Radencrantz, CEO
Phone: 046-286 38 40
E-mail: fredrik.radencrantz@quickcool.se
Quickcool is a Swedish medical technology company, whose business concept is to save lives and prevent brain damage in acute ischemia (Inadequate blood supply to the brain) by developing and providing a unique and globally patented cooling system, the Quickcool SYSTEM. Quickcool is active in the fast-growing market, Targeted Temperature Management (TTM), for brain-protective cooling treatment of patients with e.g. acute cardiac arrest and stroke. QuickCool’s solution protects the brain by cooling in the nasal cavity and thus takes advantage of the innate heat exchanger in the nose. QuickCool’s Intranasal method offers gentle and uninterrupted cooling treatment for sedated patients. Quickcool is listed on Spotlight Stock Market and conducts its business at Ideon Science Park in Lund.
For more Information, please refer to www.quickcool.se