12 May, 2021
Chordate Medical has received a CE marking for K.O.S for the treatment of chronic migraine, meaning that the product can now be sold and marketed within the EU. The CE marking, which is a very important milestone for the company, got approved one year earlier than projected.
Medtech company Chordate Medical has developed a neuromodulation treatment method, Kinetic Oscillation Stimulation (K.O.S.), which is already CE marked for the treatment of chronic nasal congestion (rhinitis). The CE marking has now been extended to include the use of K.O.S 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 it is by far the most important event in the company’s history according to CEO Anders Weilandt. With the approved CE marking, Chordate Medical can begin the sales of K.O.S for the treatment of chronic migraine in the EU.
The CE marking means that the migraine treatment meets the clinical efficacy and safety requirements according to the current directive, MDD. The company has previously assumed that they must present complete study results from the ongoing migraine study in order to obtain a CE marking under the new EU regulation, MDR. However, it turned out that the interim results from 2019 for the migraine study were sufficient to obtain a CE marking under the current directive.
MDR, i.e. the new regulatory framework for medical devices, replaces the current regulatory framework MDD on 26 May 2021. In order to facilitate the transition for medtech companies, all certificates under MDD, including the CE marking for K.O.S, will be valid until 26 May 2024.
Chordate Medical’s treatment method K.O.S 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/irritation of the autonomic nervous system. According to the company, K.O.S has few or no side effects, especially in comparison to botox and other treatments for migraine.
Despite the CE marking, Chordate Medical will continue with the ongoing migraine study until it is completed, which is expected to be after the summer. However, the final results of the study are not as decisive anymore as the company has now received CE marking according to MDD with chronic migraine as an indication. However, the study results from the migraine study will be published in a scientific journal that will serve as academic evidence of the clinical efficacy and safety of the treatment. In addition, potential positive study results can serve as sales support for selling K.O.S. in selected European markets.
The CE marking also means that Chordate Medical has achieved the desired market position a year earlier than projected. Now the plan is to launch K.O.S as a treatment for chronic migraine in selected markets in theEU. A priority target group will be patients with chronic migraine who are currently treated with botox.
Chordate Medical’s CEO Anders Weilandt on the CE marking:
Anders, congratulations on the CE marking! Can you say anything about the importance of the CE marking for Chordate Medical?
– Thanks! This is very big for us and the whole company. It is without exaggerating the most important thing that has happened in the company’s history. A CE marked migraine treatment gives the company the market position we need to implement our strategy to establish business in selected markets.
Are you surprised that you have received a CE marking even before the migraine study is completed?
– The team has worked very hard for this, so surprised is not the right word. 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 visualized this goal and how we would get there – so euphoria is probably the most dominant feeling.
When do you plan to launch the migraine treatment and in which markets?
– We are starting this right away, as far as the pandemic restrictions allow. First up is Italy, followed by the Nordic countries and Israel. However, as we have said before, the ambition is to soon add additional markets.
Why have you chosen to focus primarily on the patients currently being treated with botox?
– We want to start there because we believe that patients who are used to coming to a clinic for botox treatment four times a year and in many cases pay privately can easily realise that K.O.S can be an attractive option from several perspectives. K.O.S is a treatment method with few or no known side effects.
How do you prepare to meet the requirements of the new medical device regulation, MDR?
– We now have three years to get it in place. Much of the work is already done since CE marking under MDR was our most likely option and what we worked for most until recently.
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