Since 2018, Chordate Medical has conducted a study on migraine patients to prove clinical efficacy and safety with the nerve modulating treatment method K.O.S. The patient study, conducted in Germany and Finland, is now in its final phase, and the goal is to have an article with the study results submitted to a scientific journal for publication in the spring of 2022.
For 10 years, medtech company Chordate Medical has developed Kinetic Oscillation Stimulation (K.O.S.), a CE-marked technology for the treatment of both chronic nasal congestion (rhinitis) and chronic migraine. Currently, the company sells its products in selected markets within the EU as well as in Israel and Saudi Arabia.
According to a recent market analysis, a strong growth trend is predicted in sales of Chordate Medical’s migraine treatment over the next five years, which can be supported by positive results from the ongoing migraine study with K.O.S.
The patient study provides content to scientific article
K.O.S. is currently being evaluated in a randomised, placebo-controlled and double-blind patient study with approximately 140 migraine patients at nine clinics across Germany and Finland. The purpose of the study was originally to gain scientific evidence for a CE mark in chronic migraine, but since an EU market approval has already been obtained, the goal with the study has shifted.
Instead, the idea is now that the patient study will form the basis of a scientific article that is expected to be completed and submitted for review in the spring of 2022. An article in a scientific journal is likely to promote the company’s sales work, according to CEO Anders Weilandt:
»An article in a scientific journal will support our market positioning and sales work in all selected markets, Including countries outside EU.«
Last patients to be treated
The patient study has resumed at an increasing rate from the beginning of 2021, after being paused in 2020 due to the Covid-19 pandemic. The next step in the study is to randomise the last patients, i.e., randomly place the patients into either the active treatment group or the placebo group.
In Chordate Medical’s migraine study, it takes approximately 10 weeks from the time the patient is included in the study to the completion of the treatment. The study evaluates K.O.S.’s effect on the number of headache days – with moderate to severe intensity – per month.
Positive interim analysis
The CE mark for K.O.S. in migraine was made possible thanks to a positive interim analysis presented in 2019. Data from the first 53 patients motivated the company to complete the study according to plan and that the number of patients did not need to be changed in order to achieve statistically significant results. Chordate Medical interpret these findings as a clear sign that the study design is correct and that the migraine study is likely to achieve the desired results.
If positive study results are achieved, it would not only provide a favourable starting point in the sale of K.O.S. as a migraine treatment, it could also enable market approval in the US and increase Chordate Medical’s attractiveness in the medtech sector.
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