Yesterday, Chordate Medical announced that the company’s migraine study has resumed in Finland after being paused for a number of months due to the Covid-19 pandemic. The goal is now to complete the migraine study in July so that Chordate Medical’s method can be CE marked as a treatment for chronic migraine.
Medtech company Chordate Medical has developed a treatment method for chronic nasal congestion (rhinitis) called Kinetic Oscillation Stimulation (K.O.S). Since 2018, Chordate Medical has conducted a study with K.O.S in patients with migraine at nine clinics in Germany and Finland. During large parts of the ongoing pandemic, the study has been paused, but yesterday Chordate Medical was able to announce that it has restarted in Finland and that two patients have been enrolled.
Resumed earlier than expected
In January, the study management in Finland decided that the care staff must be vaccinated against Covid-19 before the migraine study could be resumed. Read more here. The company’s previous prediction was that the migraine study would be resumed in March, but now it has started earlier than expected to the great joy of Chordate Medical’s CEO Anders Weilandt:
»Admittedly, the announcement was expected, but it comes earlier than we thought, which is extra gratifying« – Anders Weilandt, CEO Chordate Medical
Study clinics in Finland and Germany
The migraine study was initiated already in 2018 with the goal of evaluating the effect of K.O.S on the number of headache days per month with moderate to severe intensity. In 2018, the study was conducted at four neurology clinics in Germany and since then, four Finnish clinics and another German clinic have also been included in the study.
Due to the pandemic, study activities have had to be suspended in both Finland and Germany, and the study is still suspended at the German study clinics. However, the German study clinics managed to treat a large number of patients before the pandemic, and according to CEO Anders Weilandt, the German study clinics account for two thirds of the study population.
40 patients remain
Over the next few weeks, the four clinics in Finland will recruit the remaining 40 patients required to complete the study. The goal is that the last patient can leave the study by July 2021. When the study is completed, a shorter period of data processing and statistical analysis will take place before the results can be presented. According to Anders Weilandt, the study clinics are well prepared to carry out the last part of the study in a short time:
»The four Finnish clinics have long been well prepared to implement this in a short time, mainly through their organisational affiliation with a common database containing over 70,000 migraine patients«
CE marking in case of positive study outcome
Chordate Medical’s treatment method for chronic nasal congestion is already CE-marked and marketed in the EU and Saudi Arabia, among other places. The company’s goal is to also CE mark the product as treatment for chronic migraine and to do this, the statistical outcome from the migraine study is required. The CE marking is a prerequisite for being able to launch the migraine treatment in the EU, a market that would open the door to significant revenue for Chordate Medical.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.