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

Chordate's Kinetic Oscillation Stimulation (K.O.S) method for the treatment of chronic rhinitis, and chronic migraine is currently sold via distributors in the Nordic countries, Italy and Saudi Arabia to clinics and hospitals, which in turn treat patients.

In the autumn of 2020, the distributor in Saudi Arabia managed to include the K.O.S treatment in a reimbursement code for insurance payment at private hospitals. Since then, the treatment has undergone a clinical evaluation at three major public hospitals in the country, where all three hospitals have now given their approval. Chordate's rhinitis treatment will thus receive a code in the national treatment catalogue, which means automatic compensation from the public health insurance when the treatment is given. The insurance compensation means that citizens of Saudi Arabia, who have free medical care, do not have to pay for treatment with K.O.S because the health insurance covers the cost.

"This is a major breakthrough in Saudi Arabia thanks to the sterling work of our local distributor. Now follows the work of generating sales and educating about the treatment method. In addition, since the K.O.S treatment is now approved for rhinitis, the distributor has announced the ambition to investigate the possibilities of also having the treatment for chronic migraine accepted," says Anders Weilandt, CEO of Chordate Medical.

This information was provided by the contact person below, for publication June 29, 2021 at 10:45 CEST.

For further information, please contact:

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

The following documents can be retrieved from beQuoted
Chordate-Approval-Saudi-Arabia-2021-06-29.pdf
Anders-Weilandt-vd-Chordate.jpg

Chordate-Approval-Saudi-Arabia-2021-06-29.pdf

Anders-Weilandt-vd-Chordate.jpg

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

The following documents can be retrieved from beQuoted
Chordate-CE-mark migraine-2021-05-11 eng.pdf

Chordate-CE-mark migraine-2021-05-11 eng.pdf

Interim results

Kista, Sweden, May 7, 2019 – Chordate Medical Holding AB's (publ) ("Chordate"), a specialty medtech company that focuses on developing neuromodulating systems for treating chronic migraine and non-allergic rhinitis, today announced the results of the interim analysis of the ongoing clinical study on migraine with an investigative product – Kinetic Oscillation Stimulation System S211 (K.O.S-treatment).  As part of the interim analysis, which was press released the 22nd of February, an independent data monitoring committee (DMC) conducted a statistical probability analysis focused on efficacy factors for the first 50 patients enrolled. Based on the results, the committee recommends continuation of the study, without a need for changing the number of patients for the final analysis.

"It is with great satisfaction I can conclude that the recommendation we have received confirms that the study is on track, as originally designed. The fact that the DMC recommend continuation with the same population size is a particularly strong message, which we interpret as a sign of probable efficacy. However, due to the limited number of subjects in the analysis this interim result is without statistical significance, thus far. The reader is therefore cautioned that this is an ongoing clinical study, and that its final result can only be judged once the study is completed and reported.

However, based on this confirmation we will now continue to prepare the registration process for a CE-mark of the migraine indication. We will also start to plan the market introduction for this treatment, that we believe can develop into a great non-pharmaceutical alternative for many chronic migraine patients in the world", says Anders Weilandt, CEO of Chordate.

The randomized, placebo-controlled, double-blind, multicenter study is being conducted at four neurology clinics in Germany. The study intends to enroll up to 140 subjects and is designed to evaluate the efficacy and safety of the K.O.S-treatment, with the primary endpoint to detect mean change from baseline (4-week screening period) in monthly headache days with moderate to severe intensity, in a 4-week performance assessment period. The fifty percent of the patients in the K.O.S arm are receiving active treatment from the S211, while the other half of the patients are receiving a validated sham/placebo treatment from the same equipment. The study enrolls patients with diagnosed chronic migraine (15 days/month of headache, whereof >8 days with migraine) and is planned to be completed during the late fall of 2019.

The Migraine Market

According to scientific literature, migraine, the seventh disabler, has a lifetime prevalence of around 15% of the population, of which around 1.4-2.2% suffer from chronic migraine. It can significantly limit the daily activities of sufferers as well as having considerable psychological and economic impacts, with accumulated costs amounting to 100 billion Euro in the European countries. Although chronic migraine is associated with substantial disability and costs, few treatments have been shown to be effective. The global migraine drugs market size has a forecasted value of  USD 7.7 billion in 2025 after showing a CAGR of approximately 18%. However, treatments with medicine is not all straight forward, many of the available products today comes with strong side effects, which for some patients are intolerable.

During the past couple of years, other more non-traditional ways to try and treat migraine, for example onabotulinumtoxinA (treatment with Botox), has been shown to reduce the frequency of headaches in patients with chronic migraine. Its benefits and potential use in migraine were observed incidentally while treating patients cosmetically for wrinkles. However, this type of treatment involves certain steps that many patients may find discomforting. For example, a single treatment could involve around thirty injections around the head area, alongside with multiple follow-up treatments.

At the same time, this shows that patients are willing to try new types of methods for treating migraine besides conventional medication. Chordate, with their Kinetic Oscillation Stimulation treatment, could play an important role and contribute with a new non-pharmaceutical alternative for chronic migraine patients.

For more information, please contact:
Anders Weilandt, CEO
anders.weilandt@chordate.com
Phone: +46 (0) 733 87 42 77 

Information:
This information is information that Chordate Medical Holding AB (publ) is required to disclose under the EU Market Abuse Regulation. The information was provided, through the contact person above for publication on May 7, 2019 at. 08:30 CET.

The following documents can be retrieved from beQuoted
Chordate Pressrelease 2019-05-07 English.pdf

Chordate Pressrelease 2019-05-07 English.pdf

Kista, Sweden, February 22, 2019 – Chordate Medical Holding AB's (publ) ("Chordate"), a specialty medtech company that focuses on developing and commercializing neuromodulating treatment systems for treating non-allergic rhinitis and chronic migraine, today announced the decision to conduct an interim analysis of the ongoing clinical study with Chordate's investigative product Kinetic Oscillation Stimulation System S211 (K.O.S-treatment).  The multicenter study conducted in Germany enrolls patients with diagnosed chronic migraine (15 days/month of headache, whereof >8 days with migraine).

"We have come to the point in the development of this study where it makes sense to – by common praxis – verify the validity of the underlying statistical calculations of needed study population, and to determine probability of its outcome. Chronic headache problems concern many patients around the world. We are continuing to explore what we believe can offer a great potential for remedy with our proprietary non-pharmaceutical preventive treatment method", said Anders Weilandt, CEO of Chordate.

The randomized, placebo-controlled, double-blind, multicenter study is being conducted at four neurology clinics in Germany. The study intends to enroll up to 140 subjects and is designed to evaluate the efficacy and safety of the K.O.S-treatment, with the primary endpoint to detect mean change from baseline (4-week screening period) in monthly headache days with moderate to severe intensity, in a 4-week performance assessment period. The fifty percent of the patients in the K.O.S arm are receiving active treatment from the S211, while the other half of the patients are receiving a validated sham/placebo treatment from the same equipment.

For more information, please contact:
Anders Weilandt, CEO
anders.weilandt@chordate.com
Phone: +46 (0) 733 87 42 77 

Information:
This information is information that Chordate Medical Holding AB (publ) is required to disclose under the EU Market Abuse Regulation. The information was provided, through the contact person above for publication on February 22, 2019 at. 08:30 CET.

The following documents can be retrieved from beQuoted
Chordate Pressrelease 2019-02-22 English.pdf

Chordate Pressrelease 2019-02-22 English.pdf

"We have previously communicated that we will initially target the Nordic, UK and the Middle East, which are mature markets. It is gratifying that we now can increase presence in UK and Ireland together with a strong company like the Severn. For a long time, Chordate has focused on UK, including through our major international rhinitis study where three British university hospitals are involved. However, we see that the marketing efforts needs to be considerably more aggressive. With Severn as a partner, we would gain access to experienced persons from a strong ENT company, which we believe will enable us to reach Chordate's full potential in the UK and Irish markets, "says Anders Weilandt, CEO of Chordate.

Transition to Severn will take place in the third quarter of 2018.

For more information, please contact:
Anders Weilandt, CEO
anders.weilandt@chordate.com
Phone: +46 (0) 733 87 42 77

Information: This information is information that Chordate Medical Holding AB (publ) is required to disclose under the EU Market Abuse Regulation. The information was provided through the contact of the above contact person for publication on August 14, 2018 at. 08:30 CET.

The following documents can be retrieved from beQuoted
Chordate Pressrelease 2018-08-14 English.pdf

PDF

" Chordate and Nanos Medical represents together a strong combination of patented technology and efficient market access competence. This long-term cooperation gives us a central position in the Chinese ear-nose-throat market (ENT), and freedom for Chordate to be focusing its own resources on building further market presence, primarily in the EU. Being able to take such a big and important step early in our international commercialization, is something that I deem as extremely valuable to our company," says Anders Weilandt, CEO of Chordate.

"Nanos Medical has ENT and cardio-vascular technology as the primary focus. Chordate's treatment method and product system is now added to our strong offer within ENT, where we already have well established channels. Initially we shall successfully manage the product registration process of Chordate's product in China, and parallel to that secure the production capacity, as well as important customer contacts to ensure a quick market introduction. We are looking forward to make this cooperation with Chordate into a great success for both parties, and for our respective shareholders," says Nanos Medical's CEO, Terry Cui.

Kista-Shanghai, 24 May 2018

For more information, please contact:
Anders Weilandt, CEO
anders.weilandt@chordate.com
Phone: +46 (0) 733 87 42 77

Terry Cui, CEO
terry@nanosmedical.com 
Phone: +86 (0) 21- 60433667

Information:
This information is such information that Chordate Medical Holding AB (publ) is required to disclose under the EU market abuse regulation. The information was provided, through the contact person above, for publication on the 24 May 2018 At. 15:45 CET.

The following documents can be retrieved from beQuoted
Chordate Pressrelease 2018-05-24 English.pdf

PDF

Data Anticipated Q4 2019
Kista, Sweden, May 08, 2018 – Chordate Medical Holding AB's (publ) ("Chordate"), a specialty medtech company that focuses on developing and commercializing neuromodulating treatment systems for treating non-allergic rhinitis and migraine, today announced that the first patients were enrolled in Chordate's clinical study of its Kinetic Oscillation Stimulation System S101 (KOS-treatment), an investigative product, in patients with diagnosed chronic non-allergic rhinitis.

"To now get started with the first patients at the University Hospitals in Helsinki and Kuopio, Finland, is very important in our long-term securing of scientific evidence. We know from previous studies, and our own and others' clinical experiences in practice, that we make significant difference for this very large patient group. We are now building further on this with the aim to produce a clear scientific basis for our continued business journey", says Anders Weilandt, CEO of Chordate.

The randomized, placebo-controlled, double-blind, multicenter study is being conducted at fourteen ENT university clinics in Finland, UK, The Netherlands, Italy and the Czech Republic. Coordinating investigator is Professor Claire Hopkins at Guys Hospital, London and study advisor is Professor Mats Holmström at the Karolinska Institute, Stockholm. The study intends to enroll up to 300 subjects and is designed to evaluate the efficacy and safety of the KOS-treatment. The primary endpoint is to detect weekly median change in a set of evaluation criteria from baseline, with a series of two consecutive treatments, until the third month follow-up visit. The total follow-up period of each patient is twelve months. Patients in the KOS arm will receive active treatment from the S101, while patients receiving placebo treatment will be given a validated sham treatment from the same equipment.

For more information, please contact:
Anders Weilandt, CEO
anders.weilandt@chordate.com 
Phone: +46 (0) 733 87 42 77

Information:
This information is information that Chordate Medical Holding AB (publ) is required to disclose under the EU Market Abuse Regulation. The information was provided, through the contact person above for publication on May 08, 2018 at. 14:45 CET.

The following documents can be retrieved from beQuoted
Chordate Pressrelease 2018-05-08 English.pdf

PDF

"Enrolling the first patient in our multicenter migraine study marks an important milestone for the company as we work our way towards bringing our S211 product to the market. I believe that our proprietary non- pharmaceutical preventive treatment method has great potential to make huge difference for many patients with chronic headache problems around the world", said Anders Weilandt, CEO of Chordate.

The randomized, placebo-controlled, double-blind, multicenter study is being conducted at four neurology clinics in Germany. The study intends to enroll up to 140 subjects and is designed to evaluate the efficacy and safety of the KOS-treatment, with the primary endpoint to detect mean change from baseline (4-week screening period) in monthly headache days with moderate to severe intensity, in a 4-week performance assessment period. Patients in the KOS arm will receive active treatment from the S211, while patients receiving placebo treatment will be given a validated sham treatment from the same equipment.

Kista, Sweden, March 23, 2018

For more information, please contact:
Anders Weilandt, CEO
anders.weilandt@chordate.com
Phone: +46 (0) 733 87 42 77

Information:
This information is information that Chordate Medical Holding AB (publ) is required to disclose under the EU Market Abuse Regulation. The information was provided, through the contact person above for publication on March 23, 2018 at. 08:30 CET.

The following documents can be retrieved from beQuoted
Chordate Pressrelease 2018-03-23 English.pdf

PDF

"We have a CE-marked and proven product system that currently is launched in the markets we can finance and manage, as stated earlier. Nanos Medical represents a fast growing and financially strong partner who immediately can start market preparations based on our eight Chinese patents. The joint venture adds resources and regional know-how that we cannot deploy ourselves, for the time being. This is in my opinion a big step for Chordate, "said Anders Weilandt, CEO of Chordate.

"Nanos Medical has ear-nose-throat (ENT) and cardiovascular medicine as focus areas. Chordate's treatment method and product system fits well into our business model, and will strengthen our range within ENT where we have already established marketing channels. We are very familiar with the product registration process in China, and have the required production capacity available. We look forward to implementing an efficient marketing process and rapid launch, as we consider this to be an important addition to our product portfolio", says Nanos Medical's CEO Terry Cui.

For more information, please contact:
Anders Weilandt, CEO
anders.weilandt@chordate.com
Phone: +46 (0) 733 87 42 77 

Terry Cui, CEO
terry@nanosmedical.com
Phone: +86 (0) 21- 60433667 

Information: 
This information is information that Chordate Medical Holding AB (publ.) is required to disclose under the EU Market Abuse Regulation. The information was provided by the above contact person for publication on 18th December 2017 at. 08:30 CET.

The following documents can be retrieved from beQuoted
Chordate Pressrelease 2017-12-18 English.pdf

PDF