The complete study results from Chordate Medical’s migraine study 007 have today been submitted as a manuscript for publication in one of the three most prominent journals within the migraine field.

“This is a pivotal step, and once the scientific article is published, it will be a valuable tool for the company in marketing and sales efforts. Additionally, the article will be an important basis in upcoming reimbursement processes,” says Anders Weilandt, CEO of Chordate Medical.

Chordate Medical will announce when the authors have received approval for publication in the journal in question.

The final results from Chordate Medical’s PM007 study demonstrate that the company’s migraine treatment, K.O.S, exhibits a significant reduction in the number of headache days and migraine days in adult patients with moderate to severe chronic migraine. The results also show that K.O.S maintains a sustained therapeutic effect and is well-tolerated, with few unexpected side effects. This sets apart the unique treatment, which is non-pharmaceutical, from other preventative treatments in the market, also due to its favorable side effect profile.

After the results from Chordate Medical’s clinical study PM007 were presented at both the American Headache Society Scientific Meeting in the USA and at a congress in Berlin, Biostock interviewed the principal investigator, Dr. Jan Hoffmann, about the results and how the study has been received.

“For the attendees, the findings were of great interest as K.O.S. is based on an entirely new and non-pharmacological treatment concept. In addition, in contrast to some of the other available neuromodulation techniques, the efficacy of K.O.S. was demonstrated by a sham-controlled trial and not just by an open-label study.”

Read the full interview here

After the results of Chordate Medical’s migraine study PM007 were first presented at the American Headache Society Scientific Meeting, co-author Dr. Charly Gaul from the Headache Center Frankfurt will present the study at The German Migraine and Headache Society’s congress in Berlin on June 30th. Chordate Medical’s Clinical Research & Medical Director, Jan Hermansson, will be present in Berlin, where the company will participate in an exhibition alongside its German partner, MTIGER GmbH.

“The interest in the study and its results is significant within the migraine field, and this is a great opportunity for us to inform about K.O.S as a treatment method. Germany is one of the Chordate’s prioritized markets, and our partner, MTIGER GmbH, has made significant progress in introducing the K.O.S treatment to key neurologists and opinion leaders in the country,” says Anders Weilandt, CEO of Chordate.

The German Migraine and Headache Society (DMKG) was founded in 1979 by a group of dedicated headache scientists and today has more than 450 members, mainly Neurologists, Anaesthetists and General Practitioners, as well as Psychologists and Pharmacologists. One of the organization’s goals is to improve treatment options for patients with acute and chronic headaches.

Chordate Medical’s pivotal clinical study, PM007, was presented at the American Headache Society Scientific Meeting in Austin, Texas, by the coordinating principal investigator, Dr. Jan Hoffmann from King’s College, London. This is the first time the primary parts of the final results from the study have been presented at a scientific congress, and Dr. Hoffmann’s presentation 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. According to the physicians I spoke with after the lecture, the need for alternatives and complements to commonly used medications was confirmed. Having access to a therapy that does not entail drug side effects is seen as an important aspect in the migraine care sector”, says Anders Weilandt, Chordate CEO.

Dr. Jan Hoffmann at American Headache Society Scientific Meeting 2023.

In the abstract that forms the basis of Dr. Hoffmann’s lecture, the authors write “The findings of the 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 favorable side effect profile”.

“It is important to remember that our treatment method is a completely new concept for the world at large, and we are only at the beginning of disseminating knowledge about K.O.S. treatment. It is gratifying to have the opportunity to do so here in the United States, where approximately 39 million people suffer from migraines”, says Anders Weilandt.

In a new interview, Biostock talk with Otto Skolling, who was recently elected Vice Chairman of the Board of Chordate Medical. Otto Skolling has over 30 years of experience in product development, business development and project management within the pharmaceutical and medical technology industry.

“I am quite new to the company, so it is likely that I do not yet see all the opportunities and potential that the company has. However, it is clear to everyone that a new treatment in migraine for all those patients who do not respond to existing drugs, and it is a large group, with an effect on par with the best is of course very exciting. Here I believe that Chordate has an opportunity to become a serious alternative for those who today do not respond to existing drugs or who do not want to use these heavy drugs that are associated with today’s migraine treatment”, says Otto Skolling to Biostock.

Read the full interview

In a new interview with Biostock, principal investigator Dr. Lino Di Rienzo Businco discusses the new study titled “Effectiveness of Kinetic Oscillation Stimulation Treatment in Persistent Moderate-Severe Allergic Rhinitis Compared to Medical Therapy“. The study shows that Chordate’s K.O.S treatment improves nasal airflow more effectively than medical therapy alone in cases of persistent moderate to severe allergic rhinitis. Dr. Businco is an otolaryngologist, an expert in sports medicine, and has been treating patients with K.O.S for several years, including top athletes in Italy’s Olympic team.

“Key take away is the capability of K.O.S to complete the effectiveness of the standard medical care for allergic rhinitis with a very effective, non-invasive treatment and high patient compliance. Nasal obstruction, runny nose, nasal discharge, itching, and sneezing are better controlled when adding  an effective treatment against neurogenic inflammation. Otherwise, symptoms are not always well controlled in this special group of patients with moderate to severe allergic rhinitis,” says Dr. Businco to Biostock.

Chordate Medical has not previously investigated the effects of K.O.S on allergic rhinitis to a significant extent, which means that the study results open up new potential opportunities for the company.

“The innovative concept is that K.O.S not only has a positive effect on non-allergic patients, but even on allergic patients in an effective way to better control the symptoms and improve the efficiency of standard drugs such as nasal sprays, steroid sprays, and antihistamines, and perhaps even reduce the need for these medications with their associated side effects”, says Dr. Businco.

K.O.S is a CE-marked, neuromodulating, and drug-free treatment technique for chronic migraines and chronic nasal congestion (rhinitis). The treatment has proven efficacy and is marketed in Finland, Germany, the United Kingdom, Italy, Israel, and Saudi Arabia. Chordate Medical is listed on the Nasdaq First North Growth Market Stockholm (ticker symbol: CMH).

Watch the full interview with Dr. Lino Di Rienzo Businco below.

The results of the new investigator-initiated study titled “Effectiveness of Kinetic Oscillation Stimulation Treatment in Persistent Moderate-Severe Allergic Rhinitis Compared to Medical Therapy” demonstrate that Chordate’s K.O.S treatment improves nasal airflow more effectively than medical therapy alone in cases of persistent moderate to severe allergic rhinitis. Symptoms such as congestion, runny nose, itching, and sneezing significantly decreased in patients who received medical treatment in combination with K.O.S.

“We have not previously investigated the effects with K.O.S on allergic rhinitis in particular, so these results are very positive and potentially open up new opportunities for the company,” says Jan Hermansson, Chief Medical Officer of Chordate.

The patients in this study were diagnosed using skin prick tests on the arm or blood tests to confirm allergies, including allergies to dust mites, among others.

“This is important new information for physicians treating patients where allergens such as pollen and dust mites are frequently present. Patients with rhinitis often have a combination of allergic and non-allergic rhinitis, which may be a reason why a K.O.S-treatment combination provides the indicated improvement,”

The study was conducted by, among others, Dr. Lino Di Rienzo Businco, and was published in Journal of Otolaryngology Research & Reports.

The two incentive programs that were decided by Chordate Medical’s general meeting on May 11^th, 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 the Company will be able to retain and recruit competent and committed staff.

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

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 a neuromodulation and drug-free treatment technology for chronic migraine and chronic nasal congestion (rhinitis), Kinetic Oscillation Stimulation (K.O.S). 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 2023-05-25 08:30 CEST.