Ozilia has now been installed at the private healthcare company Nahdi Care Clinics’ hospital in Jeddah, Saudi Arabia. Chordate Medical received the order through the company’s distributor in Saudi Arabia, Janin Medical, in May 2023, and Nahdi Care Clinics is now offering Ozilia to its rhinitis patients.

“It’s a great feeling that the equipment is in place and operational, and Nahdi Care Clinics can now treat their patients with Ozilia. The installation also included training for the clinic staff. The next step is to take orders for Ozilia from one or more of Nahdi Care’s other three hospitals. It shouldn’t normally take this long between order and delivery; the delay is due to the fact that Janin Medical has undergone a fundamental restructuring, with the owning family taking over the company’s management – something we view positively, says Anders Weilandt, CEO of Chordate Medical”, says Anders Weilandt, CEO of Chordate Medical.

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.

“Alain Durante, the general manager of our representative office in Saudi Arabia, has, together with Janin Medical, done a great job in promoting Ozilia for rhinitis, in addition to the four installations we already have. The introduction of migraine is also being prepared while waiting for product registration to be completed”, says Anders Weilandt.

Biostock interviews Chordate Medical’s Medical Director Jan Hermansson about the company’s post-market study PM010, which was recently initiated.

“Since this is an open study, we will be able to analyse the results on an ongoing basis. When we have a sufficient number of patients who have been on treatment long enough, we will conduct interim analyses […] We have selected clinics with a higher patient flow that did not participate in 007. Recognizing the challenges of patient recruitment for studies, we sought clinics with a substantial pool of patients to choose from. Additionally, it has been crucial that both the clinic’s management and healthcare team express a clear interest in our drug-free treatment alternative”, says Jan Hermansson to Biostock.

Read the full interview

The clinical post-market study, PM010, for Chordate’s migraine treatment Ozilia® (formerly K.O.S) has started. The study is designed for 200 patients across up to 15 clinics in the United Kingdom, Germany, Italy, and Israel. It is an open observational study with a 12-month follow-up.

Post-Market Surveillance, a part of the regulatory requirements for the CE marking of the migraine product, is crucial for providing information to treating physicians on how often the treatment needs to be administered to different types of patients.

The first clinic to start is Hull University Teaching Hospitals NHS Trust in Hull, UK, where Professor Fayyaz Ahmed is the investigator in the study, which has begun recruiting approximately 10 patients. Ethical approvals and agreements with other clinics and countries are in place.

“It is satisfying that we are now underway with PM010 after hard work in selecting the right clinics and managing ethics and study agreements in each region where the study will be conducted. It has been important to involve clinics with a relatively large patient flow, focusing on normal clinical operations rather than study-related activities,” says Jan Hermansson, Medical Director at Chordate.

Chordate Medical’s Ozilia® (formerly K.O.S) migraine treatment is a new and alternative method for chronic migraine. Ozilia® has been CE-marked since May 2021 for the preventive treatment of chronic migraine in adults over 18 years old and is marketed in selected European markets and Israel.

Read more about the completed, ongoing, and planned studies on the Ozilia® treatment

Chordate Medical’s third quarter of 2023 marked the beginning of the autumn series of scientific congresses, where the company also launched the new brand Ozilia®, replacing K.O.S in all markets where the treatment is offered. The period began with a scientific poster presenting the results of the pivotal migraine study PM007 at the International Headache Congress in Seoul. Ozilia® was highlighted by several other speakers as a potential valuable treatment alternative when medication is not suitable or desired.

On Wednesday, November 1^st, Chordate’s CEO Anders Weilandt presented the company’s Q3 report and provided information on the focus for the remainder of the year on Finwire TV. He also answered questions from viewers, discussing topics such as the global market for neurostimulation solutions, including Ozilia®.

“We belong to a large industry segment known as neurostimulation, and a significant amount of money is being invested in it. It also generates substantial revenue in the market. We belong to the chronic pain segment, with our two indications being a subset. This would help an observer understand that a significant amount of money is being invested in this segment by the industry. There is great interest, and it is growing rapidly in this industry segment. So, there is a strong focus from major industrial players globally.”

Anders Weilandt also talked about the importance of new treatment options like Ozilia® for migraine care.

“Every migraine specialist or neurologist has a toolbox that includes a variety of medications and alternatives. None of these existing treatment options work for more than half of the patients. And none of the existing drug alternatives work for a lifetime; they have an effect for a few years, then the effect starts to diminish, and a change in treatment is required for that reason. Or side effects emerge that the patient can no longer tolerate. Ozilia® is another alternative, and the lack of alternatives is a problem for healthcare and for patients.”

Read more about the migraine market

Read about Chordate Medical’s business case

Chordate Medical is currently in Helsinki to present the migraine treatment Ozilia® at the Finnish Neurology Association’s congress, taking place from November 1st to 3rd. The congress is gathering 450 delegates from across Finland.

“We are met with significant interest from numerous migraine specialists and neurologists. The Ozilia® treatment is considered a necessary and welcome drug-free addition to the treatment arsenal. The Finnish clinics that participated in the migraine study PM007 are a big asset and help in spreading awareness of Ozilia® in the country,” says Anders Weilandt, CEO of Chordate Medical.

Ozilia® is a CE-marked nerve-stimulating treatment method that offers a drug-free alternative for chronic migraine. The treatment has clinically proven efficacy according to a recent study, and is marketed in Finland, Germany, the UK, Italy, Israel, and Saudi Arabia.

Summary of the period July–September 2023

• Net turnover was SEK 210,947 (0)
• Cash flow from operating activities was SEK -4,961,395 (-5,623,481)
• Profit/loss after financial items was SEK -4,938,361 (-6,139,836)
• Profit/loss after tax was SEK -4,938,361 (-6,139,836)
• Earnings per share were SEK -0.02 (-0.04)

Summary of the period January–September 2023

• Net turnover was SEK 494,684 (88,170)
• Cash flow from operating activities was SEK -19,761,647 (-18,852,271)
• Profit/loss after financial items was SEK -19,343,762 (-19,481,497)
• Profit/loss after tax was SEK -19,343,762 (-19,481,497)
• Earnings per share were SEK -0.08 (-0.12)

INTERNATIONAL INTEREST AND NEW BRAND NAME
The third year of the quarter marked the start of the fall’s series of scientific congresses where we also launched the new brand name Ozilia® that now replaces K.O.S on all markets where the treatment is offered. The period started with a poster presentation at the International Headache Congress in Seoul of the results from our crucial migraine study PM007. Ozilia® was mentioned by several other lecturers as a potentially valuable alternative when medication is not appropriate or desirable.

• Study results presented at IHC2023 in Seoul
• Submission of article manuscript for PM007
• Presentation in Berlin of case study from the migraine study
• Launch of new brand name Ozilia®
• New commission analysis

Study results presented at IHC2023 in Seoul
After the first presentations in Austin and Berlin in July, the clinical study results from PM007 were also presented to basically the global leaders in migraine care, research and the industry at the International Headache Congress in Seoul September 14–17. This was the first time Chordate exhibited at an international level, which clearly indicated that Ozilia® is viewed as a relevant medicine-free alternative and knowledge about our treatment technique was properly disseminated among key congress participants. We were able to connect with valuable new contacts in both Europe and the USA that have the potential to lead the development of our business in an interesting direction.

Presentation in Berlin of case study from the migraine study
Dr. Tim Jürgens presented a case study from the migraine study PM007 at The German Migraine and Headache Society congress on June 30 in Berlin. The case study described one of the patients in the study with a headache that was very difficult to treat. After treatment with Ozilia®, the patient showed a sharp reduction in the number of migraine episodes, from 18 to 8 days. The positive effect lasted for four months without further treatment sessions. This is a single case with a remarkable effect. Given that the patient had few functional medical alternatives due to other illnesses, the report shows the value of Ozilia® as an alternative when other existing treatments are ineffective.

Article submitted for PM007
The authors of the PM007 study announced that they had submitted a manuscript to a prominent scientific journal at the end of August. After publication, the article will be a valuable tool in our marketing and sales effort. Published results are also a necessary basis for success in various reimbursement processes.

Launch of new brand name Ozilia®
Our treatment is now marketed under the name Ozilia® or Ozilia® Migraine. The new brand name is the next step in the rollout and commercialization of the treatment on our key markets. The name has been warmly received, with special attention given to the fact that it is a female name since around 70 percent of migraine patients are women.

New commission analysis
Of more than 900 listed companies in Sweden, it is estimated that one-third offer so-called commission analyses to facilitate the assessment of the company for its owners and stakeholders. Chordate is now ordering a commission analysis from Kalqyl for the same reason. We are taking steps toward the long-term goal of being able to offer our owners a bid from an international actor who is interested in adding our technology to their product portfolio. The value of the company should then theoretically be the same as the value that the buyer sees in marketing and selling the technology where it is active, often globally. We assume in principle that such hypothetical bids reasonably should constitute part of the theoretical value for the technology, but not all of it. Traditional equity or corporate analysis is often based on present value calculations of unrestricted cash flow; in other words, the value in the new few years of the profit that a business can generate itself that is not needed for some other activity in the business. The analysis principle, which is the most common and in most cases the proper tool, becomes problematic when the strategy in the company that is being analyzed instead is about showing a value in a buyer’s assessment—where the technology can have a much larger value for another party than what the company itself can achieve through profit generation from its own sales. We have therefore signed an agreement for a commissioned analysis from Kalqyl, which we, like most other small companies, will pay for. Kalqyl and other analysis firms conduct and publish their analyses at their own risk and independent from the client to preserve their reputation, which for them is crucial for their existence. We make the assessment that Kalqyl has the capacity and interest to perform a strategy-based analysis and publish it as part of the basis for the market’s assessment of Chordate.

Focus during the rest of the year
During the last part of the year, work will continue in our focus markets Finland, Germany, the UK, Italy, (Israel, unfortunately temporarily halted) and Saudi Arabia. The list of prospective clients is growing, and we are approaching our targets on several points. Marketing is in the form of exhibitions at specialist congresses:

• IHC2023, Seoul, South Korea, 9/14–17
• Deutscher Schmerzkongress 2023, Mannheim, 10/18–21
• Neurologdagarna 2023, Helsinki, Finland, 11/1–3
• EHC2023, Barcelona, 12/6–9

Kista, October 2023
Anders Weilandt, CEO

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 has developed, patented and CE-marked Ozilia® Migraine (formerly K.O.S), a neuromodulation and drug-free treatment technology for chronic migraine and chronic rhinitis. The treatment has clinically proven efficacy according to a recent study, and is marketed in Finland, Germany, the UK, Italy, Israel, and Saudi Arabia. Chordate Medical is listed on Nasdaq First North Growth Market Stockholm (ticker: CMH). Read more at www.chordate.com

The company’s Certified Adviser on Nasdaq First North Growth Market Stockholm is Västra Hamnen Corporate Finance AB.
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.

This information is information that Chordate Medical Holding is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2023-11-01 08:30 CET.

Attachments
Chordate Medical Holding (publ) Interim Report July September 2023

Chordate Medical Holding (publ) is releasing its interim report for Q3 2023 on Wednesday, November 1^st, at 08:30. On the same day, at 10:00, the company invites you to a webcast presentation of the report with CEO Anders Weilandt on Finwire TV.

The presentation can be viewed through the following link: https://www.finwire.tv/webcast/chordate-medical/q3-2023/

Following the presentation, there will be a Q&A session where viewers can submit questions.

A recording of the presentation will be made available afterwards on the company’s website http://www.chordate.com and on Finwire TV’s YouTube channel.

Chordate Medical has obtained the registration of the trademark Ozilia® in the EU from EUIPO (EU Intellectual Property Office) in trademark classes 9 and 10. The company is now proceeding with applications in other suitable countries based on the priority period allowed by the registration.

The new trademark represents a strategic step in the roll-out and commercialization of the migraine treatment in Chordate Medical’s focus markets. Ozilia® will replace K.O.S as a trademark in all markets where the company operates.

Read more about Ozilia®

Biostock interviews Chordate Medical CEO Anders Weilandt about Chordate’s participation at the prominent pain congress Deutsche Schmerzkongress in Mannheim, and why Germany is an important market for the company.

“The market introduction in Germany is going according to plan, and it is now a matter of getting a small number of clinics that want to get started. At the same time, we are working on various solutions so that the patient will eventually be able to receive insurance compensation for the treatment. The German market for headache is the best developed in Europe, by far. Generally, a migraine patient has very good access to structured care and specialists”, says Anders Weilandt.

Read the full interview

Chordate presents Ozilia® (formerly K.O.S) and the migraine study PM007 at the Deutsche Schmerzkongress from October 18 to 21 in Mannheim, an annual congress for the German Pain Physicians Association with approximately 3,500 members.

“Germany is an important focus market for the company, and we are noticing an entirely new level of interest from the delegates at the congress. It is evident that awareness of Ozilia® is spreading more and more, and our offering is highly relevant,” says Anders Weilandt, CEO of Chordate Medical.

The study is being presented at the congress as posters by Dr. Charly Gaul and Dr. Florian Rimmele, two of the five study leaders in the German part of the study. Dr. Gaul also introduced Ozilia® as a drug-free alternative in his lecture.

“We continuously receive numerous leads from clinics that want to learn more about Ozilia® and also wish to start offering the treatment to their patients, both in Germany and on our other key markets,” says Anders Weilandt.