Cooral System is a medical device for prevention of oral mucositis (OM). OM affects 80% of all patients treated with chemotherapy or radiation, and is characterized by severe inflammations, sores and injuries in the oral mucosa.
Cooral is an oral cooling device for single use that connects to a portable cooling system and cools the oral mucosa. Cooral System is a unique product and has no competitor on the market today, which was affirmed by a very rapid patent approval. Against this background, the US FDA has chosen Cooral System to participate in the FDA Early Access Program (EAP), an access that is provided to products with the potential to address previously unmet medical needs for life-threatening or severe diseases.
Thus, the product represents a “breakthrough technology”, that means, new technology with significant clinical benefits over available products on the market. Cooral System is currently undergoing a multicenter clinical study in Sweden with a planned recruitment of a total of 180 patients. The clinical study is led by Karolinska University Hospital and forms the basis for a FDA approval.
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