Chordate Medical’s two incentive programs fully subscribed by the board and management

The two incentive programs that were decided by Chordate Medical’s general meeting on May 11th, 2023, have today been signed in full by the company's board and management. This involves the subscription of 4,000,000 warrants of series 2023/2025:1, and thus an increase in the share capital by SEK 1,000,000, as well as 1,500,000 warrants of series 2023/2025:2, and thus an increase in the share capital by SEK 375,000.

The purpose of the incentive programs is that current and future employees and consultants in the Company will be able to become long-term shareholders and work for, and take part of, a positive value development of the share in the Company during the period covered by the proposed program, and that Chordate Medical will be able to retain and recruit competent and committed staff.

Chordate Medical Holding (publ) Interim Report January-March 2023

Summary of the period January–March 2023

  • Net turnover was SEK 120,421 (68,633)
  • Cash flow from operating activities was SEK -6,499,823 (-6,765,843)
  • Profit/loss after financial items was SEK -7,133,134 (-7,379,153)
  • Profit/loss after tax was SEK -7,133,134 (-7,379,153)
  • Earnings per share were SEK -0.03 (-0.04)

INCREASED ACTIVITY ON SEVERAL KEY MARKETS
From the start of the year through May 2023, we have seen increased activity on all key markets, both from us and from potential and existing customers. We recently received a breakthrough order in Saudi Arabia for the rhinitis treatment, British NHS approved the design of our pending migraine study, 11 clinics in Italy are now offering K.O.S treatment for chronic rhinitis, and the American Headache Society’s (AHS) scientific conference in June accepted the study results from PM007 for presentation in a lecture format. In addition, we started the year with a rights issue that was subscribed to approximately 72 percent, which shows continued strong confidence from our shareholders.

  • Abstract with completed study results from the migraine study accepted for presentation in lecture format at AHS.
  • Yet another step on the path to product registration in China.
  • New patent granted by the European Patent Office—reinforces the company’s position on the market.
  • Cash reinforced by SEK 37.3 million before expenses following the rights issue.

Several successes in Saudi Arabia
At the end of February, the Saudi Food and Drug Authority approved Janin Medical as our authorized representative in the country. Since then, we have received a breakthrough order for rhinitis systems from the private healthcare company NahdiCare Clinics for the first of their four clinics, and our distributor Janin Medical is simultaneously pursuing registration for marketing authorization for the migraine indication. While we wait for this authorization, Janin’s sales staff are busy increasing the number of rhinitis installations in both private and public clinics that are on our target list.

AHS has accepted the migraine study for presentation
The primary results from migraine study PM007 – “Kinetic Oscillation Stimulation (K.O.S) for the preventive treatment of chronic migraine: results from a randomized-controlled trial” – were published as an abstract on the AHS website in April. Dr. Jan Hoffmann, Kings College, will present the study’s results at the AHS congress in Austin, Texas, in mid-June this year.

This is very important for us; only select scientific works are invited for presentation in lecture form, which we can only interpret to mean that the scientific committee at AHS has judged the material to be very interesting.

Key advancement on the Chinese market
In February, our Chinese joint venture company Changyong Medical Technology Co. submitted an application for product registration in China for the K.O.S treatment for chronic rhinitis. This is a key step forward toward entry into the Chinese market.

Another patent reinforces our market position
The European Patent Office approved at the beginning of the year another patent application regarding development of the K.O.S treatment. Continuing to expand the patent portfolio makes it more difficult for a potential competitor to enter our market and enables exclusive access to the market, which is a pillar in the ownership value the company is building.

Focus during the rest of the year
We are continuing to follow up on the established sales and marketing plan in our select markets, with a special focus on the migraine area.
 
Kista, May 2023
Anders Weilandt, CEO

Chordate Medical presents interim report for Q1 2023

Chordate Medical Holding (publ) publishes its interim report for Q1 2023 on Thursday, May 25th, 2023, 08:30 a.m. On Friday, May 26th, 10:00 a.m., the company invites you to a live-streamed teleconference with CEO Anders Weilandt.

After the conference, there will be a question-and-answer session. The presentation is held in Swedish. It is possible to follow the conference via computer or mobile devices.

Register for the web conference here: https://attendee.gotowebinar.com/register/6316614468544567648

The number of places is limited, so we recommend registering well in advance to secure a place.

A recording of the web conference will be available after the conference on the company’s website www.chordate.com and on the Västra Hamnen Corporate Finance YouTube channel.

New investigator-initiated study on chronic rhinitis shows positive results with K.O.S treatment from Chordate

The investigator-initiated study The effect of single kinetic oscillation stimulation treatment on nonallergic rhinitis from the University of Helsinki was published in March 2023 and the results show that Chordate's K.O.S treatment provides patients with non-allergic rhinitis with a subjective symptom improvement for at least 1 year, thus possibly decreasing the need for invasive treatment methods.

"This is another investigator-initiated study that, completely independent of Chordate, shows good results one year after rhinitis treatment with K.O.S. The study results show that K.O.S significantly reduced symptoms for a significant proportion of the 49 patients who participated in the study. This is, of course, another important proof that the treatment can help many people around the world who suffer from chronic rhinitis," says Anders Weilandt, CEO of Chordate.

The study was published in the scientific journal Laryngoscope Investigative Otolaryngology and is the fourth publication in the author Sara Sainio's doctoral thesis Efficacy and Safety of Novel Medical Devices in Rhinology.

Read more about the completed, ongoing, and planned studies on the K.O.S treatment

Communique from the Annual General Meeting in Chordate Medical (publ)

Chordate Medical Holding AB (Publ.) (“Chordate” or “the Company”) held the Annual General Meeting on May 11th, 2023, whereby the following main resolutions were made.

Resolution on the dispositions in respect of the company’s profit and loss pursuant to the adopted balance sheet

The General Meeting decided that no dividend shall be distributed for the financial year 2022 and that the company’s result shall be carried forward in the new accounts

Determination of the number of directors, deputy directors, auditors and deputy auditors, fees to the board of directors and the auditor, and election of the board of directors and auditors

Fees to the board of directors, for the period running until the end of the next annual general meeting, shall amount to a total of SEK 620,000 with the following distribution: SEK 180,000 to the chairman of the board, SEK 140,000 to the vice chairman of the board and SEK 100,000 to each of the other members of the board who are not employed by the company.

Re-election of the members of the board of directors Henrik Rammer, Tommy Hedberg, Caroline Lundgren Brandberg and Gunilla Lundmark for the period running until the end of the next annual general meeting.

Election of Otto Skolling as a new vice chairman of the board of directors for the period running until the end of the next annual general meeting.

Re-election of Henrik Rammer as the chairman of the board of directors for the period running until the end of the next annual general meeting.

Re-election of Öhrlings PricewaterhouseCoopers AB as auditor for the period running until the end of the next annual general meeting. Öhrlings PricewaterhouseCoopers AB has announced that the authorized public accountant, Henrik Boman, will be the responsible auditor.

Authorization for the board of directors to resolve on issuances

The general meeting decided to authorize the board of directors, on one or more occasions, until the next annual general meeting, with or without preferential rights for the shareholders, to resolve upon issue of shares, convertibles and/or warrants. Such new issue resolutions may include provisions of payment in cash and/or payment by way of contribution of non-cash consideration or by set-off of a claim or that subscription shall be subject to other conditions. The terms and conditions for the issue shall be customary to market practice with the possibility to a customary issue discount and shares, warrants and/or convertibles may be issued up to a volume corresponding to in total not more than 40,000,000 shares.

Resolution on an incentive program to the management

Resolution on the implementation of a long-term incentive program 2023 (”LTIP 2023:1”), in accordance with the notice. The proposal is divided into the following items.

A. Resolution regarding issue and approval of transfer of warrants, series 2023/2025:1

B. Other matters in relation to LTIP 2023:1

A. Issue of warrants, series 2023/2025:1

The Board of Directors of the Company proposes that the general meeting resolve to carry out a private placement in respect of not more than 4,000,000 warrants of series 2023/2025:1, entailing an increase in the share capital of not more than SEK 1,000,000 if the private placement is fully taken up.

1. The resolution according to the above shall otherwise be governed by the following terms and conditions

1.1 The right to subscribe for the warrants, with derogation from the shareholders’ pre- emption rights, shall vest in the Company, with right and obligation to transfer the warrants to employees and consultants in the Company and its subsidiaries in accordance with below.

No oversubscription is allowed.

1.2 The reason for the derogation from the shareholders’ pre-emption rights is to implement an incentive program through which employees and consultants in the Company and its subsidiaries shall be able to become long-term owners and participate in and work for a positive growth of value of the Company’s share for the period that the program covers, and to ensure that the Company and its subsidiaries can keep and recruit qualified and motivated personnel.

1.3 The warrants shall be issued at no consideration.

1.4 Subscription for the warrants shall take place on the same day as the date of the resolution to issue warrants. The Board of Directors shall be entitled to extend the subscription period.

1.5 Each warrant entitles the holder to subscribe for one new share in the Company.

1.6 The warrants may be exercised for subscription of new shares during the period commencing on November 1, 2025, up to and including November 30, 2025.

1.7 The subscription price per share shall correspond to 150 percent of the volume- weighted average price according to Nasdaq First North Growth Market’s official price list for the share during the ten trading days immediately preceding the Annual General Meeting.

1.8 Any share premium shall be transferred to the unrestricted premium reserve.

1.9 The shares subscribed for based on the warrants shall carry a right to participate in dividends for the first time on the next record date for dividends, which occurs after subscription is completed.

1.10 Other terms and conditions according to the complete terms and conditions for series 2023/2025:1.

2. Approval of transfer of warrants, series 2023/2025:1

2.1 The Board of Directors proposes that the general meeting approves the Company’s transfer of warrants of series 2023/2025:1 in accordance with the following.

2.2 The right to acquire warrants from the Company shall vest in three categories of participants (the ”Participants”) in accordance with the table below.

Category Number of
Participants
Number of warrants
per Participant
Total number of
warrants
CEO Max. 1 Max. 2,000,000 Max. 2,000,000
Senior executives Max. 2 Max. 750,000 Max. 1,500,000
Consultants Max. 2 Max. 250,000 Max. 500,000

2.3 The warrants of series 2023/2025:1 shall be transferred on market terms at a price (premium) based on an estimated market value of the warrants that has been calculated by an independent valuation institute using the Black & Scholes valuation model.

2.4 The value for warrants of series 2023/2025:1 has, during March 2023, preliminary been calculated to SEK 0.05 per warrant based on a share price of SEK 0.53, a subscription price per share of SEK 0.80, a term of approximately 2.68 years, a risk-free interest rate of 2.8 percent and a volatility of 32 percent.

2.5 The final valuation of the warrants of series 2023/2025:1 takes place in connection with the Participants' acquisition of the warrants and will be based on market conditions at that time.

2.6 Transfer to Participants requires that the warrants can be legally acquired and that, in the Board of Director’s opinion, such acquisition can take place using a reasonable amount of administrative and financial resources. Transfer to each Participant assume that such Participant enters into an agreement regarding, among other things, right of first refusal with the Company.

2.7 Application for acquisition of warrants shall take place on May 18, 2023. The Board of Directors is authorized to extend the application period.

2.8 Payment for warrants that are acquired must be made no later than on May 18, 2023. The board has the right to extend the time for payment.

2.9 The Company reserves the right to repurchase warrants if the Participant’s employment with or assignment for the Company or its subsidiaries ceases or if the Participant in turn wishes to transfer warrants. The warrants shall otherwise be governed by market terms.

2.10 Warrants held by the Company that are not transferred to Participants or that are repurchased from Participants, may be cancelled by the Company through a decision by the Board of Directors. The cancellation shall be notified to the Swedish Companies Registration Office.

B. Other matters in relation to LTIP 2023:1

1.1 Effects on key figures and costs
The Company’s earnings per share will not be affected by the issue, since the warrants’ strike price exceeds the current market value of the shares at the time of

the issue. The Company’s future earnings per share may be affected by the potential dilutive effect of the warrants in the event the Company reports a positive result and the strike price is lower than the market value. The warrants will be transferred at market value, which means that no taxable benefit value will arise and thus no social fees for the Company. In addition, the warrant program will give rise to certain limited costs in the form of external consulting fees and administration of the warrant program.

1.2 Dilution of existing shares and votes
Based on the number of shares and votes outstanding in the Company, LTIP 2023:1 implies, upon exercise of all 4,000,000 warrants, a full dilution corresponding to approximately 1.69 percent of the total number of shares and votes outstanding in the Company on a fully diluted basis, however, subject to the recalculation of the number of shares that each warrant entitles to subscribe for that may occur as a result of certain issues etc.

Exercise of all warrants within the framework of all outstanding and proposed incentive programs in the Company would correspond to a aggregated dilution of approximately 4.52 percent of the total numbers of shares and votes in the Company on a fully diluted basis, however, subject to the recalculation of the number of shares that each warrant entitles to subscribe for that may occur as a result of certain issues etc.

1.3 Calculation of the market value
The market value has, during March 2023, preliminary been established based on a calculated market value for the warrants, applying the Black & Scholes valuation model calculated by Mazars Financial Advisory. The preliminary calculated market value is set out above in item A.2.4.

1.4 Other share-related incentive programs
In addition to the proposed incentive program for the board of directors set out under item 15 below, the Company’s share-related incentive programs are described on pages 25 and 29 in the company’s annual report.

1.5 Authorizations for the Board of Directors
The General Meeting authorizes the Board of Directors to execute the resolution under item A.2. above. In addition, the Board of Directors, or a person appointed by the Board of Directors, shall be authorized to make minor adjustments to the resolutions above that may be necessary in connection with the registration with the Swedish Companies Registration Office and Euroclear Sweden AB, respectively.

1.6 The background and rationale for the proposal
The Board of Directors wishes to implement an incentive program through which employees and consultants in the Company and its subsidiaries shall be able to become long-term owners and participate in and work for a positive growth of value of the Company’s share for the period that the program covers, and to ensure that the Company and its subsidiaries can keep and recruit qualified and motivated personnel.

The Board of Directors have proposed that the term of the warrants shall be less than three years. The reason hereof is that the Board of Directors wishes to introduce an incentive program for employees and consultants in the Company and its subsidiaries with a term that corresponds to the term in the long-term incentive program 2021, which was decided by the extraordinary general meeting on October 5, 2021. The Board of Directors considers that it is of great value for the Company that participants in all of the Company’s incentive programs have the same structure and maturity on their respective instruments.

1.7 Preparation of the proposal
The basis for LTIP 2023:1 has been prepared by the Board of Directors of the Company. The work has been supported by external advisors and has been made in consultation with shareholders. The Board of Directors has thereafter decided to present this proposal for the general meeting. Except for the staff that have prepared the matter upon instruction from the Board of Directors, no employee that may be a Participant of the program has participated in the preparations of the program’s terms.

1.8 Majority requirements
The resolution by the general meeting regarding the implementation LTIP 2023:1 in accordance with the above requires that shareholders representing not less than nine-tenths of the votes cast as well as the shares represented at the general meeting approve the resolution.

Resolution on an incentive program to the board of directors

Resolution on the implementation of a long-term incentive program 2023 (”LTIP 2023:2”) for current and acceding board members in Chordate Medical Holding AB (publ) (the ”Company”), in accordance with the Notice. The proposal is divided into the following items.

A. Resolution regarding issue and approval of transfer of warrants, series 2023/2025:2

B. Other matters in relation to LTIP 2023:2

A. Issue of warrants, series 2023/2025:2

The Proposers proposes that the general meeting resolve to carry out a private placement in respect of not more than 1,500,000 warrants of series 2023/2025:2, entailing an increase in the share capital of not more than SEK 375,000 if the private placement is fully taken up.

1. The resolution according to the above shall otherwise be governed by the following terms and conditions

1.1 The right to subscribe for the warrants, with derogation from the shareholders’ pre- emption rights, shall vest in the Company, with right and obligation to transfer the warrants to the current and acceding board members in the Company in accordance with below.

No oversubscription is allowed.

1.2 The reason for the derogation from the shareholders' pre-emption rights is that the Proposers wishes to implement an incentive program which provides current and acceding board members the opportunity to take part in the Company's long-term value development. The Proposers’ considers that the introduction of an incentive program promotes participation in the Company’s operations and creates the conditions to keep and recruit competent board members in the Company. A long- term ownership commitment through the incentive program is also expected to contribute to long-term value creation in the Company and to create a shared interest between the Company’s board members and its shareholders.

1.3 The warrants shall be issued at no consideration.

1.4 Subscription for the warrants shall take place on the same day as the date of the resolution to issue warrants. The Board of Directors shall be entitled to extend the subscription period.

1.5 Each warrant entitles the holder to subscribe for one new share in the Company.

1.6 The warrants may be exercised for subscription of new shares during the period commencing on November 1, 2025, up to and including November 30, 2025.

1.7 The subscription price per share shall correspond to 150 percent of the volume- weighted average price according to Nasdaq First North Growth Market’s official price list for the share during the ten trading days immediately preceding the Annual General Meeting.

1.8 Any share premium shall be transferred to the unrestricted premium reserve.

1.9 The shares subscribed for based on the warrants shall carry a right to participate in dividends for the first time on the next record date for dividends, which occurs after subscription is completed.

1.10 Other terms and conditions according to the complete terms and conditions for series 2023/2025:2.

2. Approval of transfer of warrants, series 2023/2025:2

2.1 The Proposers propose that the general meeting approves the Company’s transfer of warrants of series 2023/2025:2 in accordance with the following.

2.2 The right to acquire warrants from the Company shall vest in participant (the ”Participants”) in accordance with the table below.

Participants Number of warrants per
Participant
Chair and independent directors Max. 350,000
Other directors Max. 225,000

2.3 The warrants of series 2023/2025:2 shall be transferred on market terms at a price (premium) based on an estimated market value of the warrants that has been calculated by an independent valuation institute using the Black & Scholes valuation model.

2.4 The value for warrants of series 2023/2025:2 has, during March 2023, preliminary been calculated to SEK 0.05 per warrant based on a share price of SEK 0.53, a subscription price per share of SEK 0.80, a term of approximately 2.68 years, a risk-free interest rate of 2.8 percent and a volatility of 32 percent.

2.5 The final valuation of the warrants takes place in connection with the Participants' acquisition of the warrants and will be based on market conditions at that time.

2.6 Transfer to Participants requires that the warrants can be legally acquired and that, in the Board of Director’s opinion, such acquisition can take place using a reasonable amount of administrative and financial resources. Transfer to each Participant assume that such Participant enters into an agreement regarding, among other things, right of first refusal with the Company.

2.7 Application for acquisition of warrants shall take place on May 18, 2023. The Board of Directors is authorized to extend the application period.

2.8 Payment for warrants that are acquired must be made no later than on May 18, 2023. The board has the right to extend the time for payment.

2.9 The Company reserves the right to repurchase warrants if the assignment as board member for the Company ceases or if the Participant in turn wishes to transfer warrants. The warrants shall otherwise be governed by market terms.

2.10 Warrants held by the Company that are not transferred to Participants or that are repurchased from Participants, may be cancelled by the Company through a decision by the Board of Directors. The cancellation shall be notified to the Swedish Companies Registration Office.

B. Other matters in relation to LTIP 2023:2

1.1 Effects on key figures and costs
The Company’s earnings per share will not be affected by the issue, since the warrants’ strike price exceeds the current market value of the shares at the time of the issue. The Company’s future earnings per share may be affected by the potential dilutive effect of the warrants in the event the Company reports a positive result and the strike price is lower than the market value. The warrants will be transferred at market value, which means that no taxable benefit value will arise and thus no social fees for the Company. In addition, the warrant program will give rise to certain limited costs in the form of external consulting fees and administration of the warrant program.

1.2 Dilution of existing shares and votes
Based on the number of shares and votes outstanding in the Company, LTIP 2023:2 implies, upon exercise of all 1,500,000 warrants, a full dilution corresponding to approximately 0.64 percent of the total number of shares and votes outstanding in the Company on a fully diluted basis, however, subject to the recalculation of the number of shares that each warrant entitles to subscribe for that may occur as a result of certain issues etc.

Exercise of all warrants within the framework of all outstanding and proposed incentive programs in the Company would correspond to an aggregated dilution of approximately 4.52 percent of the total numbers of shares and votes in the Company on a fully diluted basis, however, subject to the recalculation of the number of shares that each warrant entitles to subscribe for that may occur as a result of certain issues etc.

1.3 Calculation of the market value
The market value has, during March 2023, preliminary been established based on a calculated market value for the warrants, applying the Black & Scholes valuation model calculated by Mazars Financial Advisory. The preliminary calculated market value is set out above in item A.2.4 above.

1.4 Other share-related incentive programs
In addition to the proposed incentive program for the management set out above in item 14, the Company’s share-related incentive programs are described on pages 25 and 29 in the company’s annual report.

1.5 Authorizations for the Board of Directors
The general meeting authorizes the Board of Directors to execute the resolution in item A.2. above. In addition, the Board of Directors, or a person appointed by the Board of Directors, shall be authorized to make minor adjustments to the resolutions above that may be necessary in connection with the registration with the Swedish Companies Registration Office and Euroclear Sweden AB, respectively.

1.6 The background and rationale for the proposal
The Proposers wishes to implement an incentive program which provides current and acceding board members the opportunity to take part in the Company's long- term value development. The Proposers’ considers that the introduction of an incentive program promotes participation in the Company’s operations and creates the conditions to keep and recruit competent board members in the Company. A long-term ownership commitment through the incentive program is also expected to contribute to long-term value creation in the Company and to create a shared interest between the Company’s board members and its shareholders.

The Proposers have proposed that the term of the warrants shall be less than three years. The reason hereof is that the Proposers wishes to introduce an incentive program for current and acceding board members in the Company with a term that corresponds to the term in the long-term incentive program 2021, which was decided by the extraordinary general meeting on October 5, 2021. The Proposers considers that it is of great value for the Company that participants in all of the

Company’s incentive programs have the same structure and maturity on their respective instruments.

1.7 Preparation of the proposal
The proposal on LTIP 2023:2 has been prepared by the Proposers. The work has been prepared by staff at the Company at the instruction of the Proposers and with support by external advisors. The Proposers has thereafter decided to present this proposal for the general meeting. No board member that may be a Participant of the program has participated in the preparation of the proposal.

1.8 Majority requirements
The resolution by the general meeting regarding the implementation LTIP 2023:2 in accordance with the above requires that shareholders representing not less than nine-tenths of the votes cast as well as the shares represented at the general meeting approve the resolution.

Complete documentation regarding the resolutions made at the General Meeting can be downloaded from the company's website, https://www.chordate.com/en/investor-relations-2/corporate-governance/general-meeting/

NHS gives ethical approval for Chordate’s new migraine study

The ethics committee of the National Health Service in the UK has approved the study design for Chordate Medical's upcoming migraine study PM009, which aims to evaluate the efficacy of K.O.S in the preventive treatment of chronic migraine on subjects not responding to treatment with monoclonal antibodies targeting the CGRP pathway.

Approval of the study design was the final formal obstacle for study to be initiated at King's College London. Chordate estimates that the screening process at the earliest can start in the beginning of July 2023.

"PM009 is an important and exciting study with significant potential for us. Any level of positive outcome will likely mean a great opportunity for our company as this challenged patient group has very few options left," says Anders Weilandt, CEO of Chordate.

About PM009

The PM009 study is a planned, open pilot study to evaluate the efficacy of intranasal kinetic oscillation stimulation (K.O.S) in the preventive treatment of chronic migraine on subjects not responding to treatment with monoclonal antibodies targeting the CGRP pathway. The study aimed to include 25-30 subjects to investigate the reduction of headache days using the KOS technology. The study is conducted at King’s College in London with three to four referring clinics assisting with the recruitment of suitable subjects for the study.

Chordate’s market in Saudi Arabia – position and potential

Saudi Arabia is one of the markets in which Chordate has been active for the longest time. Already in November 2020, private health insurance companies in Saudi Arabia approved the insurance code that can be used by private healthcare providers in the treatment of chronic rhinitis using K.O.S. By the end of 2021, the first insurance-covered K.O.S treatment was carried out in the country.

Chronic rhinitis is a major health problem in the country due to air pollution in larger cities, high prevalence of dust mites and mold spores, combined with constantly changing between high outdoor temperatures and chilled indoor environments.

Healthcare in Saudi Arabia

Healthcare in Saudi Arabia is provided through three main sectors: the Saudi Ministry of Health, which consists of hospitals and primary care centers throughout the country, other government institutions, and the private sector. Publicly funded healthcare is free for all Saudi citizens.

In the early 2000s, Saudi Arabia adopted a new law requiring private employers to provide health insurance coverage to non-Saudi employees. This has contributed to significant changes in how healthcare services are provided and paid for in the country, with a strong growth in the private healthcare sector's capacity and the number of health insurance companies.

Bupa Arabia is the leading health insurance provider in Saudi Arabia, offering health insurance to both companies and individuals. Bupa Arabia is part of the international health insurance and healthcare company Bupa Group, which provides healthcare services to more than 40 million people in 190 countries.

“Saudi Arabia has two very modern national catalog systems that public healthcare providers can use. Therefore, all connected healthcare providers under the Ministry of Health can easily order or request bids for our products. A similar system exists in Sweden, but it is divided among all of our regions”, says Anders Weilandt, Chordate CEO.

Chordates position on the market

Chordate Medical's distributor, Janin Medical, is licensed to offer K.O.S treatment for chronic rhinitis to both private and public hospitals and Chordate received an insurance code for insurance payment at the end of 2020. The insurance code means that patients with private health insurance have the costs or part of the costs paid for a treatment. The reimbursement code covers the cost at private hospitals and clinics belonging to the VIP, Class A, and Class B categories in Saudi Arabia. For VIP and Class A, the K.O.S treatment for chronic rhinitis is fully covered by medical insurance, while Class B has a cost sharing of 10 to 15 percent.

Saudi Arabia has 415 public and 127 private hospitals, of which about 30 hospitals belong to categories A and B. In addition to the treatments for chronic rhinitis, Janin Medical is also driving the process of registering a market authorization for K.O.S for chronic migraine, where the processing time is at least two months.

In March 2022, Chordate opened a representation office in Saudi Arabia to increase the chances of a successful market establishment and expand the business to other countries in the Gulf Cooperation Council, GCC. In December 2022, Chordate entered into an agreement with Janin Medical, one of Saudi Arabia's leading medical equipment companies, to function as new exclusive distributor in Saudi Arabia and Bahrain for both migraine and rhinitis indications from the turn of the year. The company is a pure importer and distributor of advanced medical technology products in neurology, pulmonology, cardiology, speech therapy/audiology, and urology. Janin Medical also has the status of offering public procurement, currently supplying medical devices to Saudi Arabia’s government biddings, so called Nupco tenders (National Unified Procurement Company, Saudi Arabia’s largest centralized health care procurement, storage, and distribution organization for pharmaceuticals, medical equipment, and supplies).

Chordate assesses that there is potential for expanded market activities in the GCC area – not least in the United Arab Emirates and Qatar.

Chordate Medical receives rhinitis-order from private hospital chain in Jeddah

Chordate Medical has received an initial order for equipment and supplies to the treatment method K.O.S for chronic rhinitis via the company's distributor in Saudi Arabia, Janin Medical. The customer is the private healthcare company Nahdi Care Clinics, with four hospitals located in the country's second largest city, Jeddah.

“The healthcare company has evaluated K.O.S for some time and treated approximately 30 patients. They have now placed a small initial order worth around SEK 120,000 for one of their hospitals, and we expect that they will shortly place orders for two more of their four care facilities. In most cases, the treatments at NadiCare are reimbursed by insurance from the private healthcare insurance company BUPA Arabia. One can roughly expect that a patient in Saudi Arabia means an average annual revenue from end-user sales stage of around SEK 10,000”, says Anders Weilandt, CEO of Chordate.

Three publicly owned hospitals in Jeddah, Makkah and Dammam have also evaluated K.O.S and Janin Medical expects incoming orders from all three. In addition to incoming orders for K.O.S for rhinitis, Janin Medical is also driving the process of registering a market authorization for K.O.S for chronic migraine, where the registration process will take at least two months.

“Since we’ll receive more and more orders for the rhinitis treatment, the road to a market permit for the migraine indication is shorter and less difficult than before.”

The Saudi Food and Drug Authority (SFDA) has previously approved Janin Medical as Chordate's new authorized representative in the country, and transfer of the market authorization for the rhinitis treatment to Janin.

Chronic rhinitis in Saudi Arabia

The prevalence of chronic rhinitis is high in Saudi Arabia due to air pollution in major cities, high incidence of mites and mold spores, combined with constant alternation between high outdoor temperatures and cold indoor environments. Chronic rhinitis is considered a major health problem that has been given a lot of attention. The overall picture is that treatment should be given 2-3 times more often than in Northern Europe due to the low air quality. Excessive long-term use of nasal spray is also very common and is seen as a very urgent problem to overcome, even here the K.O.S treatment is seen as a valuable therapeutic tool.

Interview: specialist in neurology dr. Emilia Tauriala on Chordate’s migraine treatment

Dr. Emilia Tauriala is a specialist in neurology, Chief Medical Officer at Terveystalo – one of Finland's largest private healthcare companies, and one of the trial leaders in Chordate Medical's study PM-007 in Finland. In an interview with Biostock, she talks about the study work, the benefits of K.O.S and the great need for new treatments for chronic migraine.

”The headache days were significantly reduced when comparing the real internasal stimulation to sham stimulation. The side effect profile is very different. K.O.S mostly gives side effects during those 20 minutes when you receive the treatment, but the rest of the week you’re “free to go” so to speak. Currently, available treatments for migraine prevention include medication mostly. So, we have blood pressure medication, anti-depressants, and anti-epileptic drugs available for most patients. While they can be effective for some individuals, they’re not always successful in reducing migraine days or the severity of the attacks, and they may also have unwanted side effects. It is actually quite common that the side effects prevent use of those treatments”, says Dr. Emilia Tauriala in the interview.

Watch the interview with Dr. Emilia Tauriala, Specialist in neurology and CMO at Terveystalo.

The primary final results from Chordate Medical's PM-007 study will be presented at the American Headache Society's Scientific Meeting in mid-June. The results show that K.O.S has a significant effect in the preventive treatment of chronic migraine. Chordate CEO Anders Weilandt has previously commented on the study results:

"The fact that AHS invites the researchers in the study to present the study results in a lecture format confirms the importance of the study results, which show that K.O.S has a significant clear effect for the preventive treatment of chronic migraine. We see the customary publication of the abstract as very positive because it will contribute to the knowledge about the treatment method spreading faster both in the USA and the rest of the world," says Chordate CEO Anders Weilandt in a Biostock article.

Read more about The migraine market in Finland and Chordate’s outlook

Chordate announces that the American Headache Society has accepted a presentation of the final results of the PM007 study at the AHS-congress in June 2023

Chordate Medical Holding AB (publ.) ("Chordate" or "the Company") (ticker: CMH) would like to inform the market that the primary results from the migraine study PM007 – Kinetic Oscillation Stimulation for the treatment of chronic migraine – a subgroup analysis of a randomised controlled clinical trial – have now been published in the form of an abstract on the American Headache Society's (AHS) website. The results confirm the abstract with subgroup results from the German part of PM007 presented at the Migraine Trust International Symposium 2022 London in September last year. The final results do not differ significantly from the results already reported from the subgroup analysis.

– The fact that AHS invites the researchers in the study to present the study results in a lecture format confirms the importance of the study results, which show that K.O.S has a significant clear effect for the preventive treatment of chronic migraine. We see the customary publication of the abstract as very positive because it will contribute to the knowledge about the treatment method spreading faster both in the USA and the rest of the world. As a sponsor of a study, we have no influence over, nor control of, such occurrence, says Anders Weilandt, CEO of Chordate.

The abstract reports the analysis of a selection of primary endpoints from all 132 patients in the study, where the 67 patients who received active K.O.S treatment showed a significant reduction in the number of monthly headache days (MHD) with moderate to severe intensity from baseline, compared to the 65 patients who received the sham treatment. The difference demonstrated by the least squares means (LSQ) in ANCOVA analysis between the 4-week baseline period and treatment week 3-6 was -2.23 MHD (CI95% =[-3.95; -0.51], p=0.0132). The results from the 4-week follow-up period – after completing six weeks of stimulation – showed a reduction of LSQ by -2.68 MHD (CI95% =[-4.32; -1.04], p=0.0014), thereby showing a sustained improvement during this observation period. The treatment was well-tolerated with no severe adverse events.

The authors conclude that: " The findings of the randomized, sham-controlled clinical trial show that intranasal K.O.S is an effective and safe option for the preventive treatment of chronic migraine. The non-pharmacological nature of the treatment option positions K.O.S as a valuable addition to the current therapeutic portfolio for the management of chronic migraine as beyond having a solid and sustained treatment effect, it stands out from other preventive treatments by its favourable side effect profile."

Chordate informed about the subgroup results from the clinical study PM007 in September 2022.

Agenda and more information about the AHS annual scientific meeting.

AHS is an American professional society of researchers and physicians dedicated to the study and treatment of headache and facial pain. The Society's goal is to promote the exchange of information and ideas about the causes and treatment of headache and related painful disorders. AHS's activities include a scientific annual meeting, a comprehensive headache symposium, regional symposia for neurologists and family physicians, publication of the journal Headache, and sponsorship of the American Migraine Foundation.

About PM007

The randomized, sham/placebo-controlled, double-blind multicenter study was conducted at five neurological clinics in Germany and four in Finland. The study included 132 patients and was designed to evaluate the effectiveness and safety of K.O.S treatment, with the primary efficacy endpoint being to detect the average change from baseline (4-week screening period, 4-week follow-up period) of monthly headache days with moderate to severe intensity, after weekly treatments for six weeks. Fifty percent of the patients received active K.O.S treatment from the study equipment S211, while the other half of the patients received a validated sham/placebo treatment from the same equipment. The study included patients with the diagnosis of chronic migraine (15 days/month with headache, of which >8 days with migraine) and was completed in early August 2022.