Swedish Chordate Medical receives CE mark approval for neuromodulation treatment of Chronic Migraine

Chordate Medical Holding AB (publ) ("the company, or "Chordate") is a Swedish medical technology company that has developed and patented an innovative treatment method: K.O.S. The 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. This CE marking comes one year ahead of the company's preliminary plan.

N.B. This English text is an in-house translation and adaption for language from the original Swedish text. Should there be any disparities between the Swedish and the English text, the original Swedish text shall prevail.

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.

The CE mark now obtained also means that Chordate has achieved the desired market position one year earlier than projected.

"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 Anders Weilandt, CEO of Chordate Medical.

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.

About the treatment method K.O.S

K.O.S, Kinetic Oscillation Stimulation, is a preventive neuromodulation treatment method for chronic migraine and chronic rhinits, with few or no unexpected side effects. K.O.S uses vibrations to stimulate the nerves in the mucous membranes of the nose, which is believed to balance the response of the autonomic nervous system with a positive effect on, for example, migraine.

K.O.S is an effective way to treat chronic migraine and chronic rhinitis. The treatment should be repeated with individual adjustment for best effect, as the full effect is achieved after several treatments. The treatment program for migraines involves more treatment sessions per year than for rhinitis. The treatment takes place in an out-patient clinic or doctor's office and can easily be performed by a registered nurse.

About the market for the treatment of migraines

The proportion of the population who have migraine globally is reported to be 15-18 percent of women and 6-8 percent of men. Chronic migraine, which affects about 2 percent of the population, means having a headache more than 15 days a month with at least eight days of migraine episodes. Sales of migraine pharmaceuticals is estimated to reach SEK 84 billion in 2026, with annual growth of just over 10 percent in the seven major markets.

Chronic migraine is usually treated with different types of medication. Many patients experience a fading effect over time and need to change medication, or that unwanted side effects no longer can be tolerated. Another type of treatment is injections with OnabotulinumtoxinA (Botox) in the face and around the head. The treatment is carried out at the clinic about four times a year and each treatment involve about 30-40 injection sites. The market for botox injections for migraines is expected to amount to approximately SEK 7 billion in 2023.

Patients treated with botox for migraine is a priority target group for the K.O.S treatment. Migraine patients who choose botox often pay privately for the treatment in many markets. Chordate expects to be able to gain market share in that segment more quickly, especially since K.O.S has few or no unexpected side effects compared to botox.

Chordate Medical webb site https://www.chordate.com/en/

For further information, please contact:

Anders Weilandt, CEO
anders.weilandt@chordate.com
Telefon: +46 (0) 733 87 42 77

About Chordate
Chordate Medical Holding AB (publ) is a medical technology company that for over ten years has developed, patented and CE-marked a new treatment method through nerve stimulation for chronic nasal congestion and chronic migraine. The company sells its product system including treatments via distributors to clinics and hospitals, which in turn treat patients. Chordate Medical is listed on the Nordic Growth Market NGM - SME (ticker: CMH). Read more at www.chordate.com.

Chordate Medical får de första kommersiella beställningarna för migränbehandlingssystemet från Italien

Chordate Medical Holding AB (publ) får via den italienska återförsäljaren Vedise Hospital den första kommersiella ordern för K.O.S systemet S220 för migränbehandling, till ett värde av cirka 125 000kr. Ordern omfattar två installationer som ska levereras till respektive klinik omgående.

De första kommersiella beställningarna på migräninstallationer kommer som en följd av att Chordates patenterade K.O.S-metod erhöll CE-märkning för behandling av kronisk migrän i maj-2021.


BioStock: Italian distributor expresses confidence in Chordate Medical's migraine treatment

Italy is Chordate Medical's most active market to date, in large part due to the distributor Vedise Hospital that has performed solid work regarding sales of K.O.S for the treatment of rhinitis. Now that Chordate has received CE marking in chronic migraine, K.O.S. will be launched as a migraine treatment in Italy. In an interview with BioStock, Vedise Hospital expresses high hopes for this launch and talks about its plans in connection with the launch.


BioStock: Italiensk distributör uttrycker förtroende för Chordate Medicals migränbehandling

Italien är Chordate Medicals hittills mest aktiva marknad, mycket tack vare distributören Vedise Hospital som har genomfört ett gediget försäljningsarbete av K.O.S för behandling av rinit. Nu när Chordate har erhållit CE-märkning inom kronisk migrän kommer K.O.S även kunna lanseras som migränbehandling i Italien, vilket Vedise Hospital har stora förhoppningar och planer för enligt en intervju med BioStock.  


Chordate Medical Holding AB:s (Publ) DELÅRSRAPPORT JANUARI-MARS 2021

Sammanfattning av perioden januari-mars 2021

· Nettoomsättningen uppgick till 101 626 SEK (463 168)

· Kassaflöde från den löpande verksamheten var -5 489 848 SEK (-4 196 529)

· Resultat efter finansiella poster var -5 799 097 SEK (-5 474 682)

· Resultat efter skatt var -5 799 097 SEK (-5 474 682)

· Resultat per aktie var -0,05 SEK (-0,13)


CHORDATE MEDICAL PRESENTERAR DELÅRSRAPPORT FÖR FÖRSTA KVARTALET 2021

Chordate Medical Holding (publ) offentliggör sin delårsrapport för första kvartalet 2021 torsdagen den 27 maj 2021. På fredagen den 28 maj klockan 10:00, bjuder bolaget in till en webbsänd telekonferens med vd Anders Weilandt. Efter konferensen följer en frågestund. Presentationen hålls på engelska. Det går att följa konferensen via dator eller mobila enheter.


Chordate Medical kommenterar marknadsstrategin efter beviljat CE-märke för behandling av kronisk migrän

Chordate Medical Holding AB (publ) (NGM - SME: ticker CMH) beviljades i maj 2021 CE-märkning för indikationen: förebyggande behandling av kronisk migrän hos vuxna över 18 år. CE-märkningen innebär att Chordate nu kan kommersialisera migränbehandlingen fritt inom EU. Eftersom medgivandet erhölls över ett år innan bolaget preliminärt väntade beskedet innebär det att Chordates marknadsstrategi för migränbehandlingen tidigareläggs.


Patientstudien om kronisk migrän återupptas även i Tyskland

Chordate Medical Holding AB (publ) (NGM - SME: ticker CMH) har sedan 2018 genomfört en internationell patientstudie på den patenterade behandlingsmetoden K.O.S mot kronisk migrän. Studien, som genomförs på ett flertal kliniker i Tyskland och Finland, fick på grund av covid-19-pandemin i stort sett pausas 2020. Nu meddelar även den största tyska kliniken att de kan återuppta sin del av patientstudien. Sedan tidigare har de finska klinikerna meddelat att de återupptagit arbetet. Hela studien beräknas nu att behandla de sista patienterna under tredje kvartalet 2021.


Swedish Chordate Medical receives CE mark approval for neuromodulation treatment of Chronic Migraine

Chordate Medical Holding AB (publ) ("the company, or "Chordate") is a Swedish medical technology company that has developed and patented an innovative treatment method: K.O.S. The 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. This CE marking comes one year ahead of the company's preliminary plan.


Chordate Medical erhåller CE-märkning för K.O.S-metoden mot kronisk migrän - ett år före plan

Chordate Medical Holding AB (publ) är ett svenskt medicintekniskt bolag som utvecklat och patenterat en innovativ behandlingsmetod, K.O.S, som nu beviljats tillägg av indikationen: förebyggande behandling av kronisk migrän hos vuxna över 18 år, till bolagets befintliga certifikat. CE-märkningen innebär att K.O.S uppfyller kraven på klinisk effekt och säkerhet för kronisk migrän i det europeiska direktivet för medicintekniska produkter. Medgivandet tillåter Chordate att kommersialisera migränbehandlingen fritt inom EU. CE-märkningen erhålls därmed ett år före bolagets preliminära plan.


Kommuniké från årsstämma i Chordate

Chordate Medical Holding AB (Publ) ("Chordate" eller "Bolaget") har den 15 april 2021 hållit årsstämma i Kista genom förhandspoströstning varvid aktieägarna, i enlighet med kallelsens förslag, i huvudsak fattade följande beslut.


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