First patient included in Chordate Medical’s pilot study PM009

Chordate Medical Holding AB (publ) ("Chordate") announced today that the first patient has been included in the company's open pilot study PM009. The study aims to evaluate the effectiveness of Ozilia in the preventive treatment of patients with chronic migraine who do not respond to treatment with CGRP inhibitors and other migraine medications.

“PM009 is an important study with significant potential upside for the company. Every level of positive results from the study could represent a great opportunity for the company, as the patient group in question has very few treatment options left”, says Anders Weilandt, Chordate CEO.

PM009 is being conducted at King's College in London with three to four referring clinics and Dr. Jan Hoffmann as the responsible principal investigator. The goal is to include 25–30 patients in the study.

“PM009 is a pilot study where we can learn more about how Ozilia can help people with chronic migraine who have no other options left. The patients participating in the study have already tried at least three other preventive medications before being treated with CGRP inhibitors, and when they also do not respond to CGRP, there are not many more possibilities. Hopefully, Ozilia can have a positive effect for some of them”, says Jan Hermansson, Chordate CSO.

Chordate’s CEO on client visits in the Gulf region: ”A growing market with great potential for Ozilia”

Chordate Medical's CEO, Anders Weilandt, recently returned from Saudi Arabia and the United Arab Emirates, where he met with both existing and potential clients, and signed an agreement with a new marketing agent for the UAE.

"It has been a rewarding week where, together with our General Manager for GCC, Alain Durante, and Janin Medical, we met several healthcare organizations interested in Ozilia. We also visited IMC International Medical Center Jeddah, which has been treating rhinitis with Ozilia for a long time, and Nadicare Clinics with now six sites around Jeddah, which recently started using Ozilia on the first clinic," says Anders Weilandt.

The Gulf region has long been one of Chordate's priority markets to demonstrate proof of concept, and Ozilia has been used by several private hospitals for the treatment of rhinitis for an extended period.

"It is clear that the demand for treatments like Ozilia is significant in the region, and after the gradual establishment of the rhinitis treatment in the market, the next step is to launch Ozilia for chronic migraine and simultaneously bring in more clients on the rhinitis side," says Anders Weilandt.

Chordate Medical launches Ozilia migraine and rhinitis treatment in the United Arab Emirates

Chordate Medical ("Chordate," "the company") has contracted MEDSWAN MEDICAL SUPPLIES L.L.C, Dubai, as a market expert in the United Arab Emirates (UAE) for the introduction of the company's product Ozilia to the UAE market. As previously announced, the company intends to explore opportunities in the broader Gulf region based on the successes and experiences gained in Saudi Arabia, making the move into the UAE market a logical next step.

Medswan is owned and led by Hanna Hardwick, a Swedish Arabic-speaking businesswoman with 20 years of experience in leading sales and marketing positions within the medtech and pharma sectors in the MEA region. She has worked for global companies such as Sirtex, Terumo, Fresenius, Hilrom, and Siemens.

"Based on several important customer contacts for the UAE that we have collected at recent international congresses, we are expanding our focus primarily on chronic migraine in the Gulf region. Medswan will now register the products, a process estimated to take ten weeks, and concurrently launch and create market access for Ozilia. Hanna Hardwick has extensive experience in relevant specialist segments within medtech, a strong familiarity with market introductions, and a broad network," says Anders Weilandt, CEO of Chordate.

"The healthcare market in the UAE is almost entirely private and relatively straightforward to access. In recent days, we have visited four leading neurologists at as many hospitals here in Dubai – there is no doubt that Ozilia is a drug-free alternative that doctors here see a significant need to have access to."

Chordate Medical receives its first installation of the Ozilia migraine treatment at a private clinic in Hamburg

Chordate Medical has secured an agreement for the immediate installation of equipment and consumables for the Ozilia treatment for chronic migraines. The agreement was reached through the company's marketing consultants in Germany. The customer is a private specialist clinic in Hamburg.

“It is very satisfying to achieve a breakthrough in Germany as it is one of the markets we are focusing on. This will undoubtedly make it easier to continue converting prospects into orders in Germany. The agreement came about thanks to the skilled work of our German market experts,” says Anders Weilandt, CEO of Chordate.
Chronic migraines in Germany
Migraine is one of the most common diseases globally, with approximately 12.5 million people in Germany suffering from migraines in some form. That's about one in seven Germans. Globally, it affects around 1.2 billion people. Between 1.5 and 1.8 million Germans have chronic migraines. Migraine and headache care in the country are among the most advanced in Europe, and the market for migraine medications is one of the largest in the world. These conditions where part of the reason why Chordate conducted its recently concluded clinical study in Germany.

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)

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:

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 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.