After a long pandemic break, scientific congresses are now resumed globally in Life science. For Chordate Medical, INS 2022 is the first in a series of congresses where the company demonstrates its technology K.O.S. INS stands for International Neuromodulation Society and is focused on innovation and investments in neuromodulation.

“This is one of our most important platforms to be exposed to, both to meet doctors who are at the forefront of clinical development, and as exposure to industrial and financial actors. The interest in new treatment methods for chronic migraine that are not invasive or based on drugs is significantly high”, says Anders Weilandt, CEO of Chordate.

INS 2022 this year gathers around 950 participants from 52 countries and has 32 exhibitors. The scientific program is aimed at clinics and researchers in neuromodulation with a focus on the latest technical developments and new treatment methods.

Chordate Medical’s CEO Anders Weilandt will participate on BioStock Life Science Spring Summit on June 8^th, at 11:20. He will present the latest developments in the company, such as the recently completed first phase of the marketing authorization process in the United States, the upcoming representative office in Saudi Arabia and the marketing efforts in the United Kingdom.

“Biostocks Life Science Summit events is an important platform for Nordic innovation companies such as Chordate. I look forward to talking about what we have done so far in 2022 and what we have planned for the rest of the year and beyond,” says Anders Weilandt, Chordate CEO.

BioStock Life Science Spring Summit will be livestreamed at Biostocks Youtube channel:

• Link to Livestream June 8^th (day 1)
• Link to Livestream June 9^th (day 2)

Read more about the event: https://www.biostock.se/en/2022/04/biostock-life-science-spring-summit-june-8-9/

For more information, please contact:
Anders Weilandt, CEO
anders.weilandt@chordate.com
Cell: +46 733-874277

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 Medicals share is listed on Nasdaq First North Growth Market Stockholm (ticker: CMH). Read more at www.chordate.com

Chordate’s Certified Adviser on Nasdaq First North Growth Market Stockholm is Västra Hamnen Corporate Finance AB, +46 40 200 250, ca@vhcorp.se.

On Thursday, June 9th, 14:10 CET, Chordates CEO Anders Weilandt will participate on an investment event hosted by Västra Hamnen Corporate Finance. He will present the latest developments in the company, such as the recently completed first phase of the marketing authorization process in the United States, the upcoming representative office in Saudi Arabia and the marketing efforts in the United Kingdom.

The event is a hybrid event that is held for an audience in Studio Malmö and livestreamed on Västra Hamnens Youtube channel.

Time: June 9^th, 14:10 – 14:35
Registration for physical participation
Registration for online participation

A recording of the broadcast will be available afterwards on Chordates website and on the Västra Hamnen Corporate Finance YouTube channel.

About Västra Hamnen Corporate Finance
Västra Hamnen Corporate Finance is an independent advisor who assists companies and owners with, for example, raising capital and advising in connection with corporate transactions. The company currently employs 8 people and operates from Malmö. Västra Hamnen Corporate Finance is under the supervision of the Swedish Financial Supervisory Authority.

For more information, please contact:
Anders Weilandt, CEO
Cell: +46 733-874277
e-mail: anders.weilandt@chordate.com

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 Medicals share is listed on Nasdaq First North Growth Market Stockholm (ticker: CMH). Read more at www.chordate.com/en/

Chordates Certified Adviser on Nasdaq First North Growth Market Stockholm is Västra Hamnen Corporate Finance AB, +46 40 200 250, ca@vhcorp.se.

N.B. The English text is an in-house translation of the original Swedish text. Should there be any disparities between the Swedish and the English text, the Swedish text shall prevail.

Chordate Medical estimates that a sufficient number of patients have been recruited for the study on migraine which is being carried out in Germany and Finland – and that the number of patients prescribed by the study design has thus been met.

The main purpose of the patient study, which began in 2018, was from the beginning to enable a CE marking of the company’s preventive treatment of chronic migraine. Since Chordate already in May 2021 received the CE marking on interim data from the same study, the main purpose was fulfilled, however, a positive result from the patient study is still extremely important for the continued marketing activities. The goal is to get a scientific article published. The article is expected to be completed and submitted for scientific review no earlier than the end of the third quarter of 2022, as the last patient will now leave the study in July.

“An article in a scientific journal will support our market positioning and our sales work in all selected markets, including countries outside the EU”, says Anders Weilandt, CEO of Chordate.

The international patient study on the patented treatment method K.O.S against chronic migraine began in 2018. The study, which is carried out at nine clinics in Germany and Finland, was paused due to the covid-19 pandemic in 2020 but resumed intermittently in 2021 when the pandemic progression allowed.

For more information, please contact:
Anders Weilandt, CEO
anders.weilandt@chordate.com
Cell: +46 733-874277

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 Nasdaq First North Growth Market Stockholm (ticker: CMH). Read more at www.chordate.com. Chordate’s Certified Adviser on Nasdaq First North Growth Market Stockholm is Västra Hamnen Corporate Finance AB, +46 40 200 250, ca@vhcorp.se.

N.B. The English text is an in-house translation of the original Swedish text. Should there be any disparities between the Swedish and the English text, the Swedish text shall prevail.

On Monday 2 May, 11:00, Chordate’s CEO Anders Weilandt will participate on Aktiespararnas event Aktiedagen Stockholm. He will present the latest developments in the company, such as the recently completed first phase of the marketing authorization process in the United States, the upcoming representative office in Saudi Arabia and the marketing efforts in the United Kingdom.

“It is important for us to meet both existing and potential new shareholders. We want to take every opportunity to inform the market and Aktiespararna is an important platform with professional events. They know how to guide their members to good companies and good investments, and it will be extra fun to have a live audience again,” says Anders Weilandt, Chordate CEO.

Aktiedagen is a hybrid event that is held for an audience on Operaterassen and livestreamed on Aktiespararna’s Youtube channel and on http://www.aktiespararna.se/tv/live. The event is open to everyone and does not require membership in Aktiespararna. No registration is required to follow the event digitally.

Read more about the event and register for the physical event here: https://www.aktiespararna.se/aktiviteter/aktiedagen-stockholm-6

For more information, please contact:
Anders Weilandt, CEO
Cell: +46 733-874277
e-mail: anders.weilandt@chordate.com

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 Nasdaq First North Growth Market Stockholm (ticker: CMH). Read more at www.chordate.com/en/

Chordate’s Certified Adviser on Nasdaq First North Growth Market Stockholm is Västra Hamnen Corporate Finance AB, +46 40 200 250, ca@vhcorp.se.

N.B. The English text is an in-house translation of the original Swedish text. Should there be any disparities between the Swedish and the English text, the Swedish text shall prevail.

Chordate Medical Holding (publ) has together with regulatory quality consulting firm RQM + completed the pre-study to apply for a marketing authorization for the K.O.S treatment for chronic migraine at the US Food and Drug Administration, FDA. Based on the results, Chordate chooses to initiate a so-called De Novo application. The next phase has begun and includes a pre-submission meeting with the FDA to get the agency’s preliminary view on how the final application should be designed.

“The pre-study shows that the most advantageous strategy for Chordate and our treatment is a De Novo application, which involves an application process that is adapted to medical devices with low or medium risk without already launched equivalents in the US market”, says Anders Weilandt, CEO of Chordate Medical.

Chordate announced in October 2021 that the company had made a strategic decision to initiate a pre-study to apply for a marketing authorization for the K.O.S treatment for chronic migraine at the FDA. Following the completion of the pre-study, Chordate will now carry out a pre-submission step to understand the perspective of the FDA on a tentative submission, after which the complete De Novo application will be submitted.

“It is satisfying that we are done with the first phase and following the schedule. A market condition in the USA is an important step in our strategy to build company value and it will give the company greater choice for future strategic decisions”, says Anders Weilandt.

For more information, please contact:
Anders Weilandt, CEO
Cell: +46 733-874277
e-mail: anders.weilandt@chordate.com

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 Nasdaq First North Growth Market Stockholm (ticker: CMH). Read more at www.chordate.com/en/

Chordate’s Certified Adviser on Nasdaq First North Growth Market Stockholm is Västra Hamnen Corporate Finance AB, +46 40 200 250, ca@vhcorp.se.

N.B. The English text is an in-house translation of the original Swedish text. Should there be any disparities between the Swedish and the English text, the Swedish text shall prevail.

Chordate Medical is certified to sell its rhinitis treatment to both private and public hospitals and clinics in Saudi Arabia. In addition, the caregivers can receive full reimbursement for the treatment, which can benefit sales according to the company. Chordate Medical is now establishing a representative office in Saudi Arabia to enhance the conditions for a successful market establishment and expand its operations to other countries in the Gulf Cooperation Council, GCC.

Advancement in Saudi Arabia

Saudi Arabia is one of the countries that Chordate Medical has selected to prove the market potential of K.O.S. It is also one of the markets in which Chordate has made the greatest progress over the past year, particularly in terms of insurance reimbursement. In November 2020, private health insurance companies approved an insurance code for K.O.S that can be used by private healthcare providers in Saudi Arabia for the treatment of rhinitis. The first insured K.O.S treatment was carried out at the end of 2021.

Today, both private and public healthcare providers can receive full compensation for performed K.O.S treatments through the patients’ general health insurance or private health insurance.

BioStock has previously reported on Chordate Medical’s visits at clinics and the 26th Saudi Otorhinolaryngology (SORL) Society Conference in Saudi Arabia. Read the article here.

Appointed General Manager of the representative office

The company’s distributor Al Mothihel received national permission to sell K.O.S to public hospitals in Saudi Arabia after the clinical evaluation of K.O.S at three public hospitals was approved in June 2021. To build on this progress, and support the distributor’s work, Chordate Medical has decided to establish a representative office in Riyadh. The registration process for the representative office is underway and is expected to be completed within six months.

The operations of the representative office will be led by Alain Durante in the role of General Manager. Durante has nearly 20 years of experience in sales and marketing in medical technology in Saudi Arabia and has previously been responsible for the market introduction of K.O.S as an employee at Al Mothihel. Alain will continue working with Al Mothihel but also identify new opportunities for K.O.S in the region.

Want to reach more markets in GCC

Chordates Medical’s CEO Anders Weilandt regards it as a natural first step to establish a presence in Saudi Arabia as the country constitutes a large part of the medtech market in the Gulf region, but he also sees potential in other markets within the GCC:

»We want to build on our market position for rhinitis in Saudi Arabia as early as possible and expand it to other countries in the immediate area. Saudi Arabia accounts for 55 percent of the medtech market in the Gulf region according to external analyses, so it is natural that we now establish a local presence there – Anders Weilandt, CEO Chordate Medical.«

Chordate Medical will therefore not only build on the market position in Saudi Arabia, but they will also try to establish the rhinitis treatment in other countries in the region, such as Qatar, Kuwait, Bahrain and the United Arab Emirates. According to the company, the process to obtain compensation codes can be facilitated thanks to the ongoing implementation of insurance compensation in Saudi Arabia and an established cooperation between the member states.

BioStock contacted the company’s CEO Anders Weilandt to find out more.

In what way will the representative office benefit sales and market establishment in Saudi Arabia and other GCC countries?

– We want to be as close and familiar with the market as possible in order to be able to work with first-hand information and quick action. It is a challenge to be far away in a different cultural environment and try to remotely control a market introduction. In this way, we will be more agile and be more cost efficient.

According to your press release, such an office has a special status in Saudi Arabia because it doesnot handle trade or transactions. Could you tell us a little more about what that means?

– It works a bit like an embassy; facilitating trade but is not an active part of it. The aim is to lead national distributors-but with greater proximity than if we were to do so from Sweden. A representative office is ar registered form of operation in Saudi Arabia but with limited administrative and accounting requirements.

Finally, can you also give us an update on the work of introducing K.O.S in the two nationalprocurement systems in Saudi Arabia?

– It is one thing to have the product/treatment approved for use with compensation in public healthcare, another to offer products for sale. Saudi Arabia has two comparatively very modern national catalogue systems that public healthcare providers can use. The same is also found in Sweden, but here it is then divided into all our regions. There has been a lot of work to get the products introduced, and some work remains to be done. However, once this is in place, all affiliated healthcare providers under the Ministry of Health can easily order our products.

– In addition, there is a collaboration within the GCC that in the long run could lead to our products being introduced in a simpler and faster way in other GCC countries’ procurement systems. If and when we succeed with that, it will of course be a great advantage for us.

Read the original article at Biostock

Chordate Medical Holding (publ) is opening a representative office in Riyadh, via Chordate Medical AB, to continue to grow in Saudi Arabia and expand its operations to the other countries in the GCC (Gulf Cooperation Council). The general manager of the office will be Alain Durante, who has almost 20 years of sales and marketing experience in medical technology in Saudi Arabia.

“The ongoing implementation of insurance compensation in Saudi Arabia has the potential to lead more quickly to corresponding compensation codes in other countries within the GCC as there is an established cooperation between them. We want to build on our market position for rhinitis in Saudi Arabia as early as possible and expand it to other countries in the immediate area. Saudi Arabia accounts for 55 percent of the medtech market in the Gulf region according to external analyzes, so it is natural that we now establish a local presence there”, says Anders Weilandt, CEO of Chordate Medical.

Saudi Arabia is one of the markets that Chordate Medical has selected to prove the market potential of K.O.S treatment in order to enable growth and attract buyers of the company. In November 2020, private health insurance companies in Saudi Arabia approved the insurance code that can be used by private care providers in the country when treating with K.O.S for chronic rhinitis, and at the end of 2021, the first insured K.O.S treatment was carried out in the country.

“With the establishment of a representative office in Riyadh, we are taking the next step to grow further. We see that we have the same potential in other markets in the GCC, such as Qatar, Kuwait, Bahrain and the United Arab Emirates”.

The registration process for the establishment of the representative office is underway and can take up to six months. Such an office has a special status in Saudi Arabia because it does not handle trade or transactions, and in Chordate’s case it will consist of Alain Durante in the role of General Manager.

“Alain has been responsible for the successful work so far as an employee of our distributor Al Mothihel Trading in Jeddah. In his new role, Alain will continue working with Al Mothihel but also gradually find new opportunities for Chordate in the region”, says Anders Weilandt.

For more information, please contact:
Anders Weilandt, CEO
Cell: +46 733-874277
e-mail: anders.weilandt@chordate.com

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 Nasdaq First North Growth Market Stockholm (ticker: CMH). Read more at www.chordate.com/en/

Chordate’s Certified Adviser on Nasdaq First North Growth Market Stockholm is Västra Hamnen Corporate Finance AB, +46 40 200 250, ca@vhcorp.se.

N.B. The English text is an in-house translation of the original Swedish text. Should there be any disparities between the Swedish and the English text, the Swedish text shall prevail.

2022 is expected to be a very important and exciting year for medtech company Chordate Medical, according to CEO Anders Weilandt’s statement in the year-end report. The company is fully committed on pursuing the market plan for 2022, for both  the migraine and the rhinitis treatments, but with stronger focus on migraine. They also aim to add one or more new markets during the year. BioStock contacted Weilandt to find out more about the marketing plans and his expectations for sales in 2022.

Additional markets – The UK is next

Chordate Medical is also aiming to add one or more markets during the year, as was proven recently when the company was able to announce that the UK is the next target market for the K.O.S migraine treatment. A market analysis, conducted by the consulting firm Futures.Health (FH), has identified the appropriate approach for the UK market introduction with the migraine treatment. FH is now ready to start introducing the treatment to leading neurologists in private health care and then also the publicly financed specialist care.

Chordate Medical is also collaborating with the American consulting company RQM+ to reach market approval in the US with the migraine treatment. A pre-study is currently being conducted to identify the right approach for a marketing authorisation application to the FDA. The pre-study is expected to be completed during the first quarter.

Completion and reporting of the migraine study

To support the marketing and sales activities in the migraine indication, Chordate Medical will also focus on completing and presenting the results of the ongoing migraine study. The people responsible for the trial are making the assessment that the last patient can start treatment during the first quarter and then follows a 10-week period before the patient’s participation in the trial is completed. This should mean that a scientific article with the study results can be completed in the third quarter of this year.

The sales work for the rhinitis treatment continues

Chordate Medical will not, however, put all its focus on the migraine indication in 2022 – sales work for the company’s rhinitis treatment is also progressing. The focus is mainly on Italy and Saudi Arabia, where pandemic restrictions are now being eased.

In addition, the company’s joint venture partner Nanos Medical has resumed the product registration process for the rhinitis treatment in China, with the goal of obtaining market approval in 2023.

Financed for the rest of the year

In summary, Chordate Medical has a lot going on in 2022, which they seem to be prepared for financially. The current cash position is expected to be sufficient to finance the company’s plans for 2022 and part of 2023. At year-end, their cash balance amounted to 29 MSEK.

The cash position was strengthened in October thanks to strong support from the shareholders in the redemption of warrants TO7. The exercise period for TO7 ended in October and a total of 99.23 percent of the warrants were redeemed. Chordate Medical thereby received SEK 35.6 million before issue costs. The capital injection enabled Chordate to repay a bridge loan of SEK 7.125 million to five of the company’s major shareholders.

The CEO about the sales in 2022

According to the Q4 report, net turnover amounted to 0.4 MSEK in the fourth quarter and 0.8 MSEK for the full year. The revenue is derived from sale of systems and treatments in Sweden, Saudi Arabia, China and Italy.

Anders Weilandt, were the sales figures for 2021 in line with your expectations?

– Yes, I would say they were in line with our expectations. We are still in early stage and have of course also been affected by the pandemic.

How would you create conditions for a good sales development in 2022?

– By supporting our marketing partners in their sales activities in every possible way. Much is about introducing our product end customers with well-founded arguments. Here we can make a clear difference.

Finally, are Chordate Medical’s market introductions and study activities in any way affected by the current situation in Europe?

– We have not seen any impact so far, neither for our production or customers.

Read the original article at Biostock here

Summary of the period October–December 2021

• Net turnover amounted to SEK 403,257 (81,015)
• Cash flow from operating activities amounted to SEK -6,578,027 (-5,252,419)
• Profit/loss after financial items was SEK -7,191,338 (-5,587,828)
• Profit/loss after tax was SEK -7,191,338 (-5,587,828)
• Earnings per share were SEK -0.05 (-0.05)

Summary of the period January–December 2021

• Net turnover amounted to SEK 882,046 (618,007)
• Cash flow from operating activities amounted to SEK -20,225,217 (-17,190,817)
• Profit/loss after financial items was SEK -21,766,276 (-19,758,879)
• Profit/loss after tax was SEK -21,766,276 (-19,758,879)
• Earnings per share were SEK -0.19 (-0.32)

COMMENTS FROM CEO ANDERS WEILANDT

KEY EVENTS IN 2021 PAVE THE WAY FOR AN UNBELIEVABLY EXCITING 2022

When I look back on everything that happened in 2021, I am struck by how important and exciting 2022 will be.

• CE marking for the migraine indication was finalized, well over one year earlier than we had hoped
• The migraine trial now appears to be approaching completion after a number of pandemic-related delays
• Cash is strong from the outcome of TO7, which generated SEK 35.6 million before expenses. Our owners showed exceptional support, redeeming 99 percent of the warrants.
• Renewed agreement for our joint venture company in Shanghai
• Our share switched to NASDAQ First North, which improves visibility and service to our shareholders

In 2022, we will continue the market introduction of our product for chronic migraine after receiving CE marking in May of last year. The ambition is to find an approach that is highly effective and has the best possible control at as low a cost as possible. As previously communicated, we have the ambition to add more favorable markets to the market plan. Once the agreement renewal with our joint venture partner Nanos Medical was finalized, the product registration process for the rhinitis indication in China was restarted. Nanos makes the assessment that the market approval can be obtained in 2023.

At the same time, the sales work continues for the rhinitis indication primarily in Italy and Saudi Arabia, where the pandemic restrictions are once again relaxed and normal sales work can be resumed.

Introduction of the migraine treatment in England

During the second half of 2021, the consultancy firm Futures. Health (FH) completed the market analysis we commissioned to find the best way into the UK market. FH has now also received the assignment to handle the market introduction of the migraine treatment on the market. FH is starting with leading neurologists in private health care and intends later to also raise interest from the publicly financed specialist care. The market potential is significant with around 10 million migraine patients in the country according to the NHS. This is a long-term project that we assess could generate results over time.

Financing

With the generation of SEK 35.6 million before expenses from warrant series TO7, of which 99.23 percent was redeemed, there is cash to finance the plan for 2022 and part of 2023. This very strong support from our owners allows us to focus fully on developing the market, for which I am very grateful.

Change to NASDAQ First North

The company’s share has been listed on NGM SME since March 2017. After a decision by the Board of Directors to switch to NASDAQ First North Growth Market, the listing change was implemented on February 15. The Board of Directors makes the assessment that the listing change is positive for Chordate’s development and the fulfillment of our expressed exit strategy.

Project for US market approval from the FDA

The pre-study with the aim of finding the right approach for an application for marketing authorization for the migraine indica-tion in the USA that was previously communicated is now under way in a project together with the US consulting firm RQM+. The pre-study is expected to be completed in Q1 2022.

Clinical trial on migraine in its final stage

Since CE marking has already been obtained, the sole aim of the trial in Germany and Finland is to support future marketing activities and gather data for the publication of a scientific article. Patient recruitment, which once again slowed, this time by the spread of the omikron variant in Finland, is now at a point where the people responsible for the trial are making the assessment that the last patient can start treatment during the first quarter of the year. A patient spends ten weeks in the trial in total. It is estimated that the scientific article can be completed during the third quarter of the year.

Focus 2022

With all of the important prerequisites delivered last year now in place, we are fully focused on pursuing the market plan for 2022. This applies naturally to both the migraine and the rhinitis indications, but we will have a stronger focus on migraine. In particular, this entails the potential addition of important markets that we hope to be able to activate.

At the same time, we are continuing to support our existing market partners in every way, regardless of the indication focus they currently have.

Read the full report here

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 February 25th, 2022, at 08:30 a.m. CET.

For more information, please contact:
Anders Weilandt, CEO
Cell: +46 733-874277
e-mail: anders.weilandt@chordate.com

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/

Vastra Hamnen Corporate Finance AB, +46 40 200 250, ca@vhcorp.se, is Chordate’s Certified Adviser.