PolarCool AB (publ.), the Swedish Med-Tech company behind PolarCap®, and the Hamburg Sea Devils of the European League of Football (ELF) have announced the launch of a clinical study investigating the neuroprotective efficacy of head and neck cooling following sub-concussive head impacts in American football players.

The pilot study, titled "Neuroprotective Efficacy of a Head-Neck Cooling Device Pertaining to the Cognitive and Somatic Sequelae from Subconcussive Impacts in European Participants of American Football" will be conducted by an esteemed panel of international experts in neurology, sports medicine, and physiotherapy. The research is led by Prof. Dr. Habil. Bernhard Elsner at the University of Lübeck in collaboration with Advocate Health Care (USA), HSD Hochschule Döpfer, and the Hamburg Sea Devils.

This study will focus on one of the most pressing challenges in contact sports: the long-term effects of repeated sub-concussive impacts-blows to the head that may not result in immediate symptoms but are increasingly recognized as contributors to cognitive and neurological decline. The study will investigate on whether PolarCap®, as a head and neck cooling device, can offer a neuroprotective effect in players routinely exposed to such impacts.

The study will involve 30 players from the Hamburg Sea Devils, including offensive and defensive linemen, linebackers, and tight ends - positions often exposed to high-impact collisions. The pilot study is randomized and will have three key assessments: pre-season, mid-season, and post-season. The primary endpoint is cognitive performance assessment using the ImPACT™ neurocognitive testing battery. The secondary endpoint is evaluating self-reported pain and functional impairments in daily and occupational activities through the Neck Disability Index (NDI).

The study is set to begin at the start of the 2025 ELF season. If the results show a positive correlation between the use of PolarCap® usage and reduced cognitive decline from sub-concussive impacts, the implications for PolarCool are far-reaching. PolarCap® would not only be established as a treatment for diagnosed concussions but also as a preventative solution for sub-concussive injury management-an area of increasing concern in contact sports. This would unlock a significant new market across American football alone, where thousands of teams at the youth, high school, collegiate, and professional levels are seeking proactive tools to safeguard athlete brain health.

Erik Andersson, PolarCool CEO comments:

-This study is highly relevant as repetitive impacts are a hidden but serious threat to the long-term health of contact sports athletes. A positive outcome would create additional potential for our method not only as a treatment for diagnosed concussions but also as a preventive solution for managing so-called sub-concussive injuries - an area that is receiving increasing attention within contact sports.

The company anticipates that the results of the study could influence policies and protocols surrounding athlete care and may drive adoption across a wide range of contact sports in the U.S. and globally.