Quarterly report brought forward in Chordate Medical Holding AB (publ)

Chordate Medical Holding AB (publ) ("Chordate" or "the Company") hereby announces that the Board has today decided to bring forward the company's report for Q3 2021 to give owners and stakeholders in the outstanding warrant TO7 the opportunity to view the quarterly report before trading in the option ends October 27, 2021, and before October 29, 2021, which is the last day for redemption of TO7. The report for the period July-September 2021 will be published on October 25 2021 instead of November 19 as previously communicated.

The company's financial calendar has been updated and can be found at https://www.chordate.com/en/investor-relations/financial-calendar/

This disclosure was submitted for publication, through the contact person below, on September 23rd, 2021, at 16:00 pm CET.

For more information, please contact:

Anders Weilandt
Managing Director
Cell: +46 733-874277, e-mail: anders.weilandt@chordate.com

The following documents can be retrieved from beQuoted
Chordate-Tidigarelagd-delarsrapport-Q3-21-EN.pdf

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 neuromodulation treatment technology for chronic nasal congestion (rhinitis) and chronic migraine. The company offers its product via distributors to clinics and hospitals in selected European markets, Israel and Saudi Arabia. Chordate Medical's share is listed on the Nordic Growth Market NGM – SME (ticker: CMH). Read more at
https://www.chordate.com/en/

Notice of Extraordinary General Meeting of Chordate Medical Holding AB (publ)

N.B. The English text is an in-house translated summary of the original Swedish text and should only be construed as a brief notification service to non-domestic shareholders. Should there be any disparities between the Swedish and the English text, the Swedish text shall prevail.

The shareholders of Chordate Medical Holding AB (publ) are hereby summoned to the Extraordinary General Meeting on October 5th, 2021.

Matters of the Extraordinary General Meeting are listed below. The notice in its entirety and postal voting form will be made available in English on the company website.

  1. Election of chairman
  2. Establishment and approval of the ballot paper
  3. Selection of one or two adjusters
  4. Examination of whether the Extraordinary General Meeting has been duly convened
  5. Approval of agenda
  6. Determination of fees to the board
  7. Election of a board member
  8. The Board's proposal for a long-term incentive program 2021
  9. Establishment of a nomination committee

For more information about the full Notice of Extraordinary General Meeting, please read the Swedish version (or the English version, when made available on the company website), or contact the company.

This disclosure was submitted for publication, through the contact person below, on September 20th, 2021, at 14:30 am CET.

For more information, please contact:

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

The following documents can be retrieved from beQuoted
Notice-of-Extraordinary-General-Meeting-of-Chordate-Medical-.pdf

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 neuromodulation treatment technology for chronic nasal congestion (rhinitis) and chronic migraine. The company offers its product via distributors to clinics and hospitals in selected European markets, Israel and Saudi Arabia. Chordate Medical's share is listed on the Nordic Growth Market NGM – SME (ticker: CMH). Read more at
https://www.chordate.com/en/

The Board decides to convene an Extraordinary General Meeting

Chordate Medical Holding AB's (publ) ("Chordate") Board of Directors has today decided to convene an Extraordinary General Meeting. The reason for the Extraordinary General Meeting is to decide on the election of a new Board member, Caroline Lundgren Brandberg, a decision on the establishment of a Nomination Committee and a decision on a new option program for key persons in the company. The formal notice must be published no later than September 21st, where full information on each decision point will be included.

The Board's decision to convene an Extraordinary General Meeting relates to three matters. Shareholders representing more than 50 percent of the ownership propose that Caroline Lundgren Brandberg take a seat on the board. The matter of the Nomination Committee intends to formalize such a review body before the next Annual General Meeting. The option program is intended to give the company the opportunity to be able to attract and retain the right competence in the company.

This disclosure was submitted for publication, through the contact person below, on September 14th 2021 at 16:40 am CET.

For more information, please contact:

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

The following documents can be retrieved from beQuoted
The-Board-decides-to-convene-an-Extraordinary-General-Meetin.pdf

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 neuromodulation treatment technology for chronic nasal congestion (rhinitis) and chronic migraine. The company offers its product via distributors to clinics and hospitals in selected European markets, Israel and Saudi Arabia. Chordate Medical's share is listed on the Nordic Growth Market NGM – SME (ticker: CMH). Read more at
https://www.chordate.com/en/

Chordate intends to change trading venue to Nasdaq First North Growth Market

The board of Chordate Medical Holding AB (publ) ("Chordate") has today decided to start the process of changing trading venue to Nasdaq First North Growth Market in Stockholm. The company's shares are currently traded on NGM Nordic SME.

The Board believes that a change of trading venue for the company's shares to Nasdaq First North Growth Market will increase the knowledge of the company both in Sweden and internationally, making it easier for industrial investors to become shareholders, and have a positive impact on the company's relationships with partners and potential customers.

Overall, a change of trading venue is considered to be positive for Chordate's development and completion of the stated exit strategy. Nasdaq First North Growth Market is Nasdaq's European growth market, with the same legal status as NGM Nordic SME. Shareholders in Chordate will not have to take any action in the event of a change of trading venue.

We are grateful for the cooperation and the good dialogue between the company and NGM during the period the company's share has been listed on NGM Nordic SME.

Advisor
Västra Hamnen Corporate Finance AB is Chordate's advisor regarding the planned list change and Certified Adviser.
Wistrand Advokatbyrå AB is Chordate's legal advisor.

This disclosure was submitted for publication, through the contact person below, on September 14th, 2021, at 16:30 am CET.

For more information, please contact:

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

The following documents can be retrieved from beQuoted
Chordate-intends-to-change-trading-venue-to-Nasdaq.pdf

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 neuromodulation treatment technology for chronic nasal congestion (rhinitis) and chronic migraine. The company offers its product via distributors to clinics and hospitals in selected European markets, Israel and Saudi Arabia. Chordate Medical's share is listed on the Nordic Growth Market NGM – SME (ticker: CMH). Read more at
https://www.chordate.com/en/

Chordate secures bridge loans of SEK 7,125 million from five owners

Chordate Medical Holding AB's (publ) ("Chordate") has today procured bridge loans of SEK 7,125 million, in five different agreements, from the main owners Magnus Brandberg, Hawoc Invest AB, Sifonen AB, Bevaclean AB and related board member Tommy Hedberg. The purpose of the bridge loans is to strengthen the company's liquidity and working capital for the upcoming redemption period of warrant TO7. The loans can be offset against TO7, which is due to be redeemed in October 2021, but has a maturity of 12 months and is admitted at market rate.

"We have chosen to take advantage of a standing offer of support before the TO7 redemption period and believe that the time is now appropriate to strengthen our cash holdings. We are incredibly grateful for the support shown by the long-term owners – which is important in this type of enterprise," says Anders Weilandt, CEO of Chordate.

Information:
This disclosure contains information that Chordate Medical Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person below, on September 7, 2021 at 08:15 a.m. CET.

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

The following documents can be retrieved from beQuoted
Chordate-bridge-loans eng.pdf

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 neuromodulation treatment technology for chronic nasal congestion (rhinitis) and chronic migraine. The company offers its product via distributors to clinics and hospitals in selected European markets, Israel and Saudi Arabia. Chordate Medical's share is listed on the Nordic Growth Market NGM – SME (ticker: CMH). Read more at
https://www.chordate.com/en/

The first migraine patients undergo K.O.S treatment in Sweden

Clinics in Malmö and Solna in Sweden have now started treating migraine patients with Chordate Medical Holding AB's (publ) ("Chordate") K.O.S treatment. It is the first time K.O.S. treatment has been used to treat chronic migraines in regular clinical practice.

"The clinics see a great interest and many people seek the treatment spontaneously. Within a few days, our collaborating clinic in Gothenburg will also be able to offer K.O.S. treatment for chronic migraines.

"The work to establish sales in our selected markets in Europe continues, and the fact that we now have patients undergoing the treatment is very satisfactory," says Anders Weilandt, CEO of Chordate.

Chordate received CE marking of the K.O.S method for treatment of chronic migraines in May 2021. The CE marking means that K.O.S meets the clinical efficacy and safety requirements for chronic migraines in the European Medical Devices Directive. This approval allows Chordate to commercialize migraine treatment freely within the EU, and now the first patients have started treatment in Sweden.

 

 

 

This disclosure was submitted for publication, through the contact person below, on August 19th 2021 at 11.50 am CET.

 

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
the-first-migraine-patients-2021-08-19-eng.pdf

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 neuromodulation treatment technology for chronic nasal congestion (rhinitis) and chronic migraine. The company offers its product via distributors to clinics and hospitals in selected European markets, Israel and Saudi Arabia. Chordate Medical's share is listed on the Nordic Growth Market NGM – SME (ticker: CMH). Read more at
https://www.chordate.com/en/

Chordate receives a first order from China worth SEK 167,000, a new jv-agreement is negotiated with Nanos

Chordate Medical Holding AB (publ) ("Chordate") has received a prepaid order for two new generation K.O.S machines, for immediate delivery to Changyong Medical Technology Co. Ltd., the joint venture company co-owned with Nanos Medical (Shanghai) Ltd. The K.O.S machines will be used in the process to obtain a market permit for Chordate's technology for rhinitis treatment in the Chinese market. A new joint venture agreement is currently being negotiated with Nanos, which is expected to be concluded soon.

Chordate and the Chinese company Nanos Medical began a joint venture in 2018 and then formed a jointly owned company in Shanghai with the intention to market the K.O.S technology in the Chinese market. Nanos Medical owns 2/3 of this company and is the party that finances marketing and sales, Chordate will for its 1/3 contribute the Chinese patents once product registration is in place. After that the covid pandemic has blocked all non-priority clinical trials in China, the stop of new product registrations before the country's new medical technology legislation came into force at the turn of 2021, and that Chordate's newly launched treatment unit called for a reset of the registration process, Nanos Medical has now restarted the initiative to begin the marketing of K.O.S. The prepaid order pertains to two K.O.S machines to a value of SEK 167,000. The equipment is necessary to carry out the product registration process required by the authorities to market the K.O.S treatment. Nanos estimates that the permit process should be completed within 15 months.

A new agreement regulating the cooperation for the jointly owned company Changyong Medical Technology Co. is being finalized and is expected to be presented to the market soon.

"I see this order as a confirmation of that both our partner and the Chinese market are handling the pandemic well, and also that we have a partner with capital strength who invests in the K.O.S treatment.

The project to secure access to the Chinese market is severely delayed compared to the original plan. However, I note that the root causes for that lies largely beyond the control of the parties. Therefore, it is extra gratifying that the process now accelerates again", says Anders Weilandt, CEO of Chordate.

Chordate Medical has developed a CE-marked treatment method called Kinetic Oscillation Stimulation (K.O.S) for the treatment of chronic rhinitis (nasal congestion) and chronic migraine. The product system is currently sold via distributors in the Nordic countries, Italy and Saudi Arabia to clinics and hospitals which in turn treat patients.

This disclosure contains information that Chordate Medical Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the contact person below, on August 18th 2021 at 8.30 am CET.

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

The following documents can be retrieved from beQuoted
Order-and-jv-agreement-China-2021-08-18-eng.pdf

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 neuromodulation treatment technology for chronic nasal congestion (rhinitis) and chronic migraine. The company offers its product via distributors to clinics and hospitals in selected European markets, Israel and Saudi Arabia. Chordate Medical's share is listed on the Nordic Growth Market NGM – SME (ticker: CMH). Read more at
https://www.chordate.com/en/

Clinical evaluation of Chordates K.O.S treatment for rhinitis in public hospitals in Saudi Arabia now approved

Chordate Medical Holding AB's (publ) ("Chordate") treatment has now been approved in a clinical evaluation at three major hospitals in Saudi Arabia, ordered by the Ministry of Health in the country. This means that the cost of the treatment will automatically be covered by the public health insurance and Chordate's distributor will be given access to offer the treatment to the country's public hospitals.

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

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 https://www.chordate.com/en/

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

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

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 successfully completes Interim Analysis for ongoing multicenter clinical study of intranasal kinetic oscillation stimulation for preventive treatment of chronic migraine

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

TO THE EDITORS
About Chordate
Chordate Medical Holding AB (publ) is a medical technology company that during ten years has developed, patented and CE-marked a new treatment method for chronic migraine and non-allergic rhinitis through neuromodulation. The company sells its product system including treatments through its own sales organization as well as distributors to clinics and hospitals, which in their turn treat patients. Read more at www.chordate.com. Mangold Fondkommission AB, tel. +46 8 5030 1550, is the company's mentor and liquidity guarantee at NGM Nordic MTF.