Credit: PolarCool LUND, Sweden--May 11, 2021--PolarCool AB (publ), a Swedish medical device company focusing on treatment of sports-related traumatic brain injury (TBI) and whiplash, today announced that it has submitted a 510(k) pre-market notification to the U.S. Food and Drug Administration (FDA) for the PolarCap® System. This submission follows publication of statistically significant clinical results in the scientific journal Concussion, showing clear benefit for use of the PolarCap® System in the treatment of concussions among players of 15 elite Swedish Ice-Hockey teams in the Swedish Hockey Leagues (SHL). The incidence of sports-related concussions is a significant national health concern in Sweden, as it is here in the U.S., and there is growing evidence that repetitive traumatic brain injury can cause long-term changes in brain structure and function. This is of particular concern in the field of contact sports, such as ice hockey, where available treatment options are limited.