Chordate Medical has received a CE marking that permits its Kinetic Oscillation Stimulation (KOS) technology to be marketed, sold and used for the treatment of chronic migraine within the European Union. This approval, which the company has described as a “very important milestone”, was achieved one year earlier than projected.
Swedish medical technology firm Chordate Medical’s KOS neuromodulation treatment method is already CE marked for the treatment of chronic nasal congestion, or rhinitis, but that clearance has now been extended to include its use as a preventive treatment for chronic migraine in adults over the age of 18. The CE marking applies to the current EU Medical Device Directive (MDD) and is “by far the most important event in the company’s history”, according to Chordate Medical CEO Anders Weilandt.
“The team has worked very hard for this, so surprised is not the right word,” said Weilandt. “However, we assessed early on that the probability of receiving CE marking based on the interim results was low. When something you work hard for is achieved, you are, above all, very happy. Everyone had, of course, visualised this goal and how we would get there—so euphoria is probably the most dominant feeling.”
Chordate Medical, according to a company press release, had previously assumed it must present complete study results from its ongoing migraine study in order to obtain a CE marking under the new EU Medical Device Regulation (MDR), which replaces the current MDD on 26 May 2021. However, it ultimately turned out that the interim results from 2019 for the migraine study were sufficient to obtain a CE marking under the current directive. The company’s MDD approval, and the CE marking KOS has received, will now remain valid until May 2024.
Chordate Medical’s KOS treatment method uses vibrations to stimulate the nerves in the mucous membranes of the nose, which is believed to balance the autonomic nervous system. This can help people with migraine who are believed to have an imbalance or irritation of the autonomic nervous system. According to the company, KOS has few or no side effects, especially in comparison to botox and other treatments for migraine.
Despite already gaining a CE mark, Chordate Medical will continue with its ongoing migraine study until it is completed—which is expected to be after the summer of 2021. And, while the final results of the study are now “not as decisive” due to the company having already received a CE marking for its KOS technology, they will nevertheless be published in a scientific journal, and serve as academic evidence of the clinical efficacy and safety of the treatment.