The post-market study of Chordate’s Ozilia® migraine treatment has commenced in four different markets

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 Holding (publ) Interim Report July-September 2023

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

Chordate Medical presents interim report for Q3 2023 on Finwire TV

Chordate Medical Holding (publ) is releasing its interim report for Q3 2023 on Wednesday, November 1st, 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 www.chordate.com and on Finwire TV’s YouTube channel.

Chordate Medical receives registration of the trademark Ozilia®

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® replaces K.O.S as product name in all markets where the company operates.

Great Interest in Ozilia® Migraine at the Deutsche Schmerzkongress 2023 in Mannheim

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.

Chordate Medical selects analysis firm Kalqyl for analysis and ongoing monitoring

Chordate Medical has signed an agreement with Kalqyl for report monitoring and commissioned analyses. The collaboration includes independent monitoring of the company and its market potential with a valuation scenario from a potential buyer's perspective.

“Our ambition is for shareholders and stakeholders to have access to a relevant analysis of the company and the market potential that aligns with the company's strategy. Kalqyl's previous work demonstrates a deep understanding of the market and well-founded analyses of listed companies," says Anders Weilandt, CEO of Chordate Medical.

“Chordate is an exciting company. Starting from the perspective of a potential buyer of the company is a new way for us to do a company analysis, but at the same time, the most logical starting point," says David Uhrner, CEO of Kalqyl.

About Kalqyl
Kalqyl is an analysis company with a rapidly growing platform and a unique reach among Nordic investors. Kalqyl's analyses help companies clarify their business concepts and enable investors to better understand their operations. Kalqyl is a wholly owned subsidiary of Spotlight Group, acquired in August 2021.

Chordate Medical trains neurologists in Liverpool – initiating the introduction of Ozilia® Migraine

During a neurology symposium with around 60 participants at The Walton Centre NHS Foundation Trust in Liverpool on October 6-7, Chordate Medical conducted a separate training on the company's treatment method, Ozilia® Migraine (formerly K.O.S). The Walton Centre is a leading neurology hospital in the UK, serving an area of about four million people, and the medical team's intention is to begin implementing Ozilia® into their treatment arsenal, starting with their private clinic side.

“Together with our clinical application specialist, Petra Libert, I had the opportunity to train seven specialist doctors and nurses on the practical use of the Ozilia® migraine treatment. It is very rewarding to work directly with the specialists who actually performs the treatment and helps patients, while also taking the first practical steps towards increasing business," says Anders Weilandt, Chordate Medical CEO.

The Walton Centre is a specialist hospital providing comprehensive neurological, neurosurgical, pain management, and rehabilitation services. The hospital has about 1,450 employees and treats over 140,000 patients each year.

Chordate Medical at IHC 2023: ”Great Interest in Ozilia®”

Chordate Medical's booth was well-attended during the International Headache Congress in Seoul, which took place from September 14th to 17th, and CEO Anders Weilandt and Clinical Research & Medical Director Jan Hermansson were busy discussing Ozilia® Migraine (formerly K.O.S).

“Thanks to Dr. Hoffmann's poster and presentation, as well as other presenters mentioning Ozilia® Migraine as an alternative in their talks – combined with our marketing effort as a sponsor of the congress, the traffic to our booth was very satisfying," says Anders Weilandt, CEO of Chordate.

IHC 2023 marked the launch of Ozilia® Migraine, the new brand for Chordate Medical's migraine treatment. Ozilia® replaces K.O.S as the brand in all markets where Chordate is active.

“During the congress, we received clear confirmation that Ozilia® Migraine is seen as a relevant drug-free alternative, and awareness of our treatment technique was effectively disseminated among influential congress participants. We were able to establish valuable new contacts in both Europe and the USA that have the potential to lead to interesting developments of our business venture," says Anders Weilandt.

Chordate Medical introduces new trademark for Migraine Treatment: Ozilia® – Your Migraine Relief

During the International Headache Congress in Seoul from September 14 to 17, Chordate Medical is introducing the new brand Ozilia® Migraine for the company's migraine treatment. Ozilia® Migraine replaces K.O.S as the brand name in all markets where Chordate is active.

“This is the next step in the rollout and commercialization of the treatment in our focus markets. Migraine is predominantly a women's health matter, and the previous designation, K.O.S, has long felt as too technical and rather uninspiring as a brand. The meaning of the name Ozilia® revolves around her need for freedom – and that is also the core of what we want to offer to all people in the world who suffer from migraines”, says Anders Weilandt, CEO of Chordate.

Ozilia® Migraine will be showcased for the first time at the IHC in Seoul, the largest international platform for headache experts and migraine specialists.

“The interest in our study and its results is significant within the migraine field. Exhibiting at this congress is an excellent opportunity for us to introduce Ozilia® Migraine as a drug-free treatment option with a very favorable side effect profile and long-lasting preventive effects.”

Chordate Medical Holding (publ) Interim Report April-June 2023

Summary of the period April–June 2023

  • Net turnover was SEK 163,316 (19,538)
  • Cash flow from operating activities amounted to SEK -6,320,325 (-5,812,210)
  • Profit/loss after financial items was SEK -7,292,267 (-5,962,508)
  • Profit/loss after tax was SEK -7,292,267 (-5,962,508)
  • Earnings per share were SEK -0.03 (-0.04)

Summary of the period Jan–June 2023

  • Net turnover was SEK 283,737 (88,170)
  • Cash flow from operating activities amounted to SEK -14,800,251 (-13,228,791)
  • Profit/loss after financial items was SEK -14,405,401 (-13,341,661)
  • Profit/loss after tax was SEK -14,405,401 (-13,341,661)
  • Earnings per share were SEK -0.06 (-0.08)

INCREASED ACTIVITY ON SEVERAL KEY MARKETS
The second quarter of the year centered around the presentation of the final results from Chordate Medical’s crucial clinical study PM007 at international arenas for the industry in the USA and Germany. Interest in the study’s results is strong and growing, and when I meet doctors active in the migraine field it becomes clear that there is a considerable need for alternatives and complements to the medications that are normally used. We are also continuing to see strong and increasing activity in our key markets, where one highlight was that in May we received an order for rhinitis treatment from a private hospital chain in Jeddah, Saudi Arabia.

  • Presentation of study results in the USA and Germany
  • Breakthrough order from Saudi Arabia
  • Ethical approval from NHS for new migraine study
  • Fully subscribed incentive program for the Board of Directors and management
  • PM007 presentation at IHC2023 in Seoul – we will have an exhibition
  • Submission of article manuscript for PM007

Presentation of study results in the USA
The crucial clinical study PM007 was presented at the American Headache Society Scientific Meeting in Austin, Texas, by coordinating principal investigator Dr. Jan Hoffmann from Kings College in London. It was the first time the primary parts of the final results from the study were presented at a scientific congress, and Dr. Hoffmann’s lecture was attended by approximately 300 migraine specialists. Judging by the subsequent questions from the audience, the presentation was received with great interest. The questions asked mainly pertained to the study design, patient population, and the ease of use of the K.O.S product.
 
Article submitted for PM007
We are pleased to report that the authors of this crucial article have now submitted a manuscript to a prominent scientific journal. 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.
 
Breakthrough order from Saudi Arabia
At the beginning of May, our new distributor in Saudi Arabia, Janin Medical, received its first key order for equipment and supplies for the treatment method K.O.S for chronic rhinitis. The customer is the private healthcare company Nahdi Care Clinics, which has four hospitals located in the country’s second largest city, Jeddah.

In addition to the installations we already have in Saudi Arabia, three publicly owned hospitals in Jeddah, Makkah and Dammam have evaluated K.O.S, and Janin Medical is expecting orders from all three. In addition to the efforts to increase the business within chronic rhinitis, Janin Medical is also driving the process of registering a market authorization for K.O.S for chronic migraine.

Ethical approval from NHS for new migraine study
At the beginning of May, the ethics committee of the National Health Service (NHS) in the UK approved the study design for our upcoming scientific study PM009, which aims to evaluate the efficacy of K.O.S in the preventive treatment of chronic migraine on patients not responding to treatment with monoclonal antibodies targeting the CGRP pathway. Any level of positive outcome in the study will likely mean a great opportunity for the Company since the patient group in question has very few treatment options left. The first patient can be expected in mid-September.
 
Fully subscribed incentive program for the Board of Directors and management
The Company’s two newly established incentive programs were fully subscribed in May by management and the Board of Directors. The aim of the incentive programs is for current and future employees and consultants at Chordate Medical to be able to become long-term owners and benefit from and advocate for a positive value development in the share in the Company during the period covered by the proposed program and that the Company will be able to keep and recruit competent and engaged staff. Subscription to the programs entails an increase in share capital by SEK 1,000,000 and SEK 375,000, respectively if the warrants are fully used to subscribe shares in the subscription period.
 
Focus during the rest of the year
Through the end of the year, work will continue on sales in all our focus markets: Finland, Germany, UK, Italy, Israel and Saudi Arabia. Our marketing specialists are pursuing a number of prospects with the goal of receiving final orders. Marketing to support these efforts will primarily take the form of exhibitions at specialist congresses:

  • IHC2023, Seoul, South Korea, 9/14–17
  • Deutscher Schmerzkongress 2023, Mannheim, Germany, 10/18–21
  • Neurologdagarna 2023, Helsinki, Finland, 11/1–3
  • Regional symposiums and congresses

Kista, August 2023
Anders Weilandt, CEO