CoolHead - medical cooling of migraine
|Coordinator||BrainCool AB (publ)|
|Funding from Vinnova||SEK 2 000 000|
|Project duration||December 2017 - December 2018|
|Venture||Innovationsprojekt i företag 2017|
|Call||innovationsprojekt i företag, Hösten 2017|
Purpose and goal
Develop the first medical device based on the concept of intra-nasal cooling for the self-treatment of migraine. CoolHead will be a small, easy-to-use, user-friendly on-the-go product which, via a nasal catheter, sprays a vaporizing coolant into the nasal cavity to effectively reduce the brain blood temperature to relieve pain. This project will deliver the final, clinically validated product and data package to obtain CE-marking for use in migraine.
Expected results and effects
With the compressor solution, sound level/vibration was on an unacceptable level. It was not possible to keep the size and weight of the control unit on an acceptable level with sound insulation and vibration minimizing solutions. The control unit became to big and heavy. This led us to further investigation. We found a completely different technical solution, an air pump with significant lower sound and vibration level. Initial tests show that this technical solution is capable to deliver required treatment setting. This technical solution is yet to be further analyzed and verified.
Planned approach and implementation
It was decided to not initiate a usability study (AP 4), as the developed prototype, with the compressor solution, was not to satisfaction. It is our aim to meet the requirements/findings (sound, vibration) before a user study is initiated. It is our aim to develop a full functional CoolHead alpha prototype, with the air pump solution, before entering the new EU project. With the EU grant, starting date 2019-04-01, it is our aim is to continue with all activities required for the CE-marking of a home care migraine device.