PolarCool AB has announced the submission of a De Novo application to the U.S. Food and Drug Administration (FDA) for its PolarCap System. This marks a crucial step towards launching the innovative medical device in the United States, targeting the significant market for concussion treatment.
The De Novo application is supported by clinical results from a 5-year study, enabling the PolarCap System to be considered for approval as a novel treatment for concussions. The company aims to initiate a full-scale investment in the U.S. market in 2025-2026, with preparations already underway, including stationing an employee in the U.S. to manage the launch.
Market Opportunity
The U.S. market presents a substantial opportunity for PolarCool, with approximately 3.8 million concussions occurring annually. The North American market for concussion treatment is valued at around SEK 3.4 billion annually. The presence of numerous universities and colleges with extensive sports programs further enhances the potential for implementing the PolarCap System, with over 3,500 such institutions.
Management Perspective
"One of our most important goals is to launch the PolarCap® System in the US," said PolarCool CEO Erik Andersson. "Therefore, it feels fantastic that today we submitted a formal application to the FDA and thus took an important step forward to achieve this. The US market has large potential and is a key market for our expansion. Above all, we look at the biggest sports such as American football and ice hockey, where the incidence of concussion is high and the need for solutions is large. Already today, we notice a great interest in the PolarCap® System both from universities and medical representatives. Therefore, I have very high hopes for our upcoming launch."
Regulatory and Clinical Foundation
PolarCool's decision to pursue a De Novo application followed consultation with the FDA and was based on strong clinical results from the 5-year study of the PolarCap System. These results support the potential approval of the system as a treatment for concussion, positioning it as a first-mover in the market. In late 2023, PolarCool received an MDR certificate for both its quality management system (QMS) and the PolarCap System, which, along with recent financing, enabled the completion of the FDA application. PolarCool will now work with the FDA to secure approval while simultaneously preparing for the upcoming launch.
