The company has received CE mark approval for a neuromodulation treatment of Chronic Migraine.
The Swedish company’s existing EC-certificate for K.O.S has now been granted an extension with the indication Chronic Migraine and the intended use: Preventive treatment of chronic migraine in adults over 18 years.
The CE marking means that the K.O.S treatment meets the clinical efficacy and safety requirements for in the European Medical Devices Directive for the new indication. The approval allows Chordate to commercialize the migraine treatment within the EU, it states in a press release.
“Instead, the CE mark is now given within MDD which we considered less likely, i.e., on the interim results from 2019. The announcement is without comparison the most important event in Chordate’s history.”
The CE mark for preventive treatment of chronic migraine has been granted after examination of the medical efficacy and safety demonstrated by results from the interim analysis of the ongoing clinical patient study in Germany and Finland – which was the basis for the application submitted in May 2019. The CE mark applies to the current regulations for medical devices: MDD 93/42/EEC. Chordate has also been granted an extension of the company’s CE marks until May 2024, including rhinitis.
“Obtaining a CE mark for the migraine treatment has been our main objective and something we have worked several years to achieve, by two alternative processes. However, the most probable scenario was that we would have needed the complete results from the current clinical study, to apply under the new EU regulation MDR, that will replace MDD as of 2021-05-26. Instead, the CE mark is now given within MDD which we considered less likely, i.e., on the interim results from 2019. The announcement is without comparison the most important event in Chordate’s history,” says Anders Weilandt, CEO of Chordate Medical.
A big step forward strategically
The CE mark now obtained also means that Chordate has achieved the desired market position one year earlier than projected, it states.
“Of course, the ongoing migraine study will continue until it is completed, but the significance of the study has now shifted from being needed to obtain a critical approval to develop the market, to becoming a good sales support and an academically published proof of the clinical effect. By this, we are instantly taking a big step forward strategically, enabling us to establish sales in our selected markets in Europe,” says Weilandt.
The K.O.S treatment is since long CE marked for the treatment of chronic nasal congestion, rhinitis, which has also been introduced in selected EU markets and Saudi Arabia.
Photo of Anders Weilandt, CEO, Chordate Medical