BrainCool AB (publ) - market clearance in Europe for Cooral® Systems to prevent Oral Mukosit
BrainCool AB (publ) CE-marks Cooral® Systems, which means that market clearance for ehe European market is now in place, to prevent oral mucositis (OM). OM is a serious side effect that can arise from radiation and chemotherapy treatment of various cancers.
The approval for the Cooral® System is as an invasive product, which paves the way for a market launch as clinical data is now submitted for presentation at the ESMO conference on 18-22 September (European Society for Medical Oncology, reference 1).
Cooral® Systems has been assessed in a Nordic clinical trial on a total of 180 patients over a two-year period, with five university hospitals.
• We are proud that we will soon be able to start marketing Cooral® Systems in the European markets and contribute to a significantly improved cancer treatment by reducing the side effects, says Martin Waleij, CEO of BrainCool. Cooral® Systems is a safe and effective method of preventing OM and represents a milestone in cancer treatment.
Oral Mukositis is a serious side effect of chemotherapy. Inflammation and ulcers can occur in the palate and oral cavity, causing immense suffering for patients who, besides pain and singe, also have difficulty swallowing, eating and speaking.
Cooral® Systems consists of an oral cooling device for disposable cooling and is connected to a portable cooling system that cools the mucous membrane.
More than 3.7 million people suffer from cancer in Europe each year, according to WHO. In the United States, 1.7 million people were diagnosed with cancer in 2018, according to the National Cancer Institute. The market for therapies against OM was estimated at $ 2.2 billion in 2018 (reference 2).
Reference 1 - https://www.esmo.org/meetings/esmo-congress-2020, meeting to be as a digital meeting due to the current COVID 19 pandemic
For more information
Martin Waleij - CEO
+46 - 733 -93 70 76
About BrainCool AB (publ)
BrainCool AB (publ) is an innovative medical device company that develops, markets, and sells leading medical cooling systems for indications and areas with significant medical benefits within the healthcare sector. The company focuses on two business segments, Brain Cooling and Pain Management. BrainCool AB (publ) is based in Lund, Sweden, and its share is listed on Spotlight Stock Market.