PolarCool chooses new opportunity for stronger approval in the US
PolarCool AB (publ), after consultation with the US Food and Drug Administration (FDA), has today decided to submit a De Novo application for the product PolarCap® System. The reason is the recently published strong clinical data for PolarCap® and the decision on a CPT® 3 code from the American Medical Association. The fact that PolarCool now chooses to focus on a De Novo approval is because the recently published 5-year clinical study enables an approval of the PolarCap® System for treatment against a purely medical indication, "concussion". The fact that the American Medical