The Innovation Fund has awarded Rehaler an Innobooster grant for the large scale clinical trial aiming to validate the effect of the Danish medtech company’s novel migraine treatment device. The trial will be carried out at specialty headache centres in the US, Germany, Italy and the UK. A positive outcome will open the path to FDA approval and global commercialization of the Rehaler treatment.
“This grant from the Innovation Fund provides important support for our technology which constitutes a ground-breaking new treatment for migraine. The funds will go towards a large-scale, randomized, controlled trial at a number of specialty headache centres in the US and Europe.” says Troels Johansen (M.Sc.Eng.,Ph.D.), Chief Executive Officer.
Rehaler’s device is a small drug-free inhaler that works by accurately controlling the inspired levels of CO2 and oxygen.
”It has been known since 1950 that CO2/oxygen mixtures inhibit migraine attacks but this is the first device that is able to deliver the correct mixture in a way which is both safe and practical in use”, said Troels Johansen.
The 10 gram device is developed from a prototype which demonstrated proof of concept in a 2017 pilot study at Aarhus University Hospital (Denmark). The results were published in Cephalalgia which is the highest ranked scientific headache journal in the world.
Rehaler’s first commercial target is migraine with aura which has a prevalence in the population of approximately 4%.
”Three out of four migraine patients are not satisfied with their current treatment, which shows a significant need for new effective treatments”, added Troels Johansen.
The clinical trial will start in October this year and is expected to finish early in 2024. If the results are positive this will open the path to FDA approval and global commercialization of the treatment.
For more information, please contact
Troels Johansen, CEO, Rehaler. Cell: +45 40 97 73 13. Email: tj@rehaler.com
About Rehaler
Rehaler is a private medical technology company developing and commercializing novel treatments based on modulation of CO2 and oxygen in the central nervous system. Rehaler has obtained proof-of-concept for its first product, the Rehaler device for treatment of migraine with aura. Rehaler is currently preparing a pivotal clinical registration study, which will be initiated in 2022 with the aim of obtaining market approval in the U.S. and support commercialization in the U.S. and Europe. The company’s technology platform has applications in several other neurological disorders which will be investigated alongside the registration study. Read more at www.rehaler.com.