BrainCool AB has received an innovation loan of 500,000 SEK for the final phase in the process of CE certification and market approval of the semi-portable product – The Brain Cool System – that is to be launched for the indications stroke and cardiac arrest during 2015.
The product will be registered for market approval directly and not, as previously announced in the investment memorandum, in two stages, first for clinical studies and then for market approval after feedback from the EuroHYP study.
The company has booked tests at Intertech for electrical safety and EMC, and audit with a notified body for the issue of an EC certificate. This will take place after an inspection of the manufacturer’s quality system and assessment of the product documentation (“technical file”) for BrainCool AB, which will enable CE certification of the company’s products. The EC certificate does not mean that the product has been approved for CE marking; it is the manufacturer BrainCool AB that is certified, and has the right and responsibility of CE certify the company´s products.
During 2014 we have added new applications, for which patent protection has been sought, to create a stand-alone product that can give cooling down to lower target temperatures. This allows new conditions and opportunities for hypothermic treatment of stroke patients, and also for a market launch in cardiac arrest.
CEO Martin Waleij’s comments
Our original plan for the first year was to obtain a CE certificate for a product solely for clinical studies of hypothermic treatment of stroke patients. The further development of the product and the positive results of tests have now led us to decide to complete all technical documentation and have the product approved for launching on the market directly.
This means that we must delay the start of the EuroHYP study by about a quarter of a year, but this delay is more than compensated for by the fact that we gain several quarters and reduce costs significantly by having the market launch earlier. Another consequence is that we gain approval for the product not only for stroke but also for cardiac arrest.
The innovation loan, with a duration of 3 years, free of amortization for one year and at an interest of 4.5%, will help us to achieve this important milestone with our current financing. Moreover, the board and management of the company believe that there are good chances to seek further loans to finance our market launch and expansion. Export loans and market loans will be a high-priority form of finance parallel to our work of reaching partnership agreements for the coming launch of the BrainCool system.
As regards the portable product for ambulance care and oral mucositis (OM), it is ready for clinical studies, and the regulatory work and costs of obtaining CE certification for market approval will commence in the second half of 2015, parallel to the clinical study on OM.
For further information:
Martin Waleij – CEO
Telephone: 0733–93 70 76