Chordate CEO Anders Weilandt explains study results at Aktiedagen on September 12th

On Monday, September 12th, 11:00, Chordate's CEO Anders Weilandt will participate on Aktiespararnas event Aktiedagen Stockholm. He will mainly talk about the subgroup result of the migraine study PM007 on the K.O.S treatment that was presented in London on September 8, and what it means for the company. The subgroup result shows a statistically significant reduction in the number of headache days.

“This event will be a good opportunity for me to explain the very positive result from the subgroup analysis, how it should be interpreted and what it means for the company going forward”, says Anders Weilandt, Chordate CEO.

Aktiedagen takes place at Hotel Birger Jarl in Stockholm. To attend on site, register here. The event is streamed live at www.aktiespararna.se/tv/live and on Aktiespararna’s Youtube channel. No registration is required to follow the event digitally.

After the presentation, Anders Weilandt will participate in a Q&A and questions can be asked by sending an SMS to +46 79-347 98 45 or an email to event@aktiespararna.se. Questions can be sent in now or during the presentation.

Statistically significant reduction in number of headache days shown in subgroup analysis of Chordate’s PM007 multicenter clinical study of K.O.S-stimulation for preventive treatment of chronic migraine

Chordate Medical Holding AB’s (publ) ("Chordate")(Nasdaq FirstNorth Stockholm: CMH), a specialty medtech company that focuses on developing neuromodulating systems for treating chronic migraine, today announces that an abstract entitled “Kinetic Oscillation Stimulation for the treatment of chronic migraine – a subgroup analysis of a randomised controlled clinical trial” by Hoffmann, J. et al, is presented as a poster at the Migraine Trust International Symposium 2022, London.

The poster reveals that the subgroup analysis of the 46 German subjects receiving active K.O.S-treatment demonstrated a significantly reduced number of monthly headache days (MHD) with moderate to severe intensity from baseline, when compared to the 46 subjects receiving the sham treatment. The difference shown by the least square means (LSQ) of the ANCOVA model between the 4-week baseline period and treatment weeks 3-6 was -2.52 MHD (CI95%=[-4.52; -0.52], p=0.0140 and by non-parametric, stratified van Elteren test p=0.0092). The 4-week follow-up period results – after ending six weeks of stimulation – showed a reduction in LSQ of -2.70 MHD (CI95%=[-4.73;-0.68], p=0.093; van Elteren test p=0.0151), demonstrating a sustained improvement during the observation period.

Response defined as ≥30% reduction in MHD with moderate to severe intensity from baseline was achieved in 41.4% of the subjects receiving active K.O.S vs. 14.9% in the group receiving sham treatment. The treatment was also reported as well-tolerated without severe adverse events.

The authors concludes that this trial thus far indicates that K.O.S is an effective and safe option for the preventive treatment of chronic migraine. And further that as the K.O.S is a non-pharma alternative it would constitute a valuable expansion of the current therapeutic arsenal, without the significant risk of unwanted side effects commonly seen with other preventive treatment alternatives.

“It is remarkable to learn about such stunning effect from the German part of the PM007 study. The demonstrated level of response with K.O.S is also remarkable. This will indeed be a great support for our marketing and sales ambitions. The opportunity to make this subgroup analysis presented itself as the German clinics completed their work early. Our near-term task is now to compile the data from the completed study, and to get it published in its entirety”, says Anders Weilandt, CEO of Chordate.

About the PM007 trial

This randomized, sham-controlled, double-blind, multicenter study was conducted at five neurology clinics in Germany and four in Finland. The study enrolled 132 subjects and was designed to evaluate the efficacy and safety of the K.O.S-treatment. Primary endpoint was to detect mean change from baseline (4-week screening period, 4-week follow-up period) in monthly headache days with moderate to severe intensity, following weekly treatments for six weeks. Fifty percent of the subjects received active K.O.S-treatment from the S211 investigative device, and fifty percent received a validated sham/placebo treatment from the same equipment. The study enrolled subjects with diagnosed chronic migraine (≥15 days/month of headache, whereof >8 days with migraine) and saw the last subject leaving the study at the beginning of August 2022.

Chordate Medical Holding (publ) Interim Report April-June 2022

Summary of the period April–June 2022

  • Net turnover was SEK 19,538 (165,699)
  • Cash flow from operating activities amounted to SEK -5,812,210 (-5,183,818)
  • Profit/loss after financial items was SEK -5,962,508 (-5,056,471)
  • Profit/loss after tax was SEK -5,962,508 (-5,056,471)
  • Earnings per share were SEK -0.04 (-0.05)

Summary of the period January–June 2022

  • Net turnover was SEK 88,170 (267,328)
  • Cash flow from operating activities was SEK -13,228,791 (-10,695,986)
  • Profit/loss after financial items was SEK -13,341,661 (-10,855,568)
  • Profit/loss after tax was SEK -13,341,661 (-10,855,568)
  • Earnings per share were SEK -0.08 (-0.10)

COMMENTS FROM CEO ANDERS WEILANDT

RESULTS FROM THE MIGRAINE STUDY ARE COMING

The migraine study is finally finished after all of the coronavirus-related delays. Subgroup results from the German patient group will be made public on September 8 in London. Very exciting times. We are continuing to deepen our work with the market through directly engaged experts and are moving away from the distributor model.

  • The migraine study is presenting subgroup results in September and has been closed at the clinic
  • Market access agreement for Germany and Israel
  • Second phase in the FDA project continues
  • Study plan for support studies presented

Clinical study on migraines is complete

We have all waited a long time, but the study is now completed. The final Finnish patient went through their final follow-up at the beginning of August. All of the study data is now undergoing a rigorous control process and statistical analysis in order to serve as a basis for the final report and scientific articles for publication.

Since the same process has already been applied to the study data from the German patient group in the spring, the study organization was able to perform a so-called subgroup analysis. The 97 German patients left the study, and the five study clinics were formally closed at the end of 2021. Now that the Finnish study patients are done, the study is complete, with a total of 132 patients.

A subgroup analysis shows the results from a sample of the study data, for example gender, age span, other illnesses or, like in this case, geography. A subgroup result should be viewed as independent from the final study results but is often viewed as in-depth and interesting.

The subgroup results will be presented as a poster at the scientific symposium Migraine Trust International Symposium 2022, September 8–11 in London.

There are not really any words to describe how exciting this is. A large percentage of the study sample is represented, 97 out of 132, and it is clear that the expectations are high. The interim analysis from May 2019 was clearly very strong, so it is logical to hope for an even better result now. As always, though, science is always science, and a lot can happen in a study — which is what makes it so unbelievably exciting.

Model with market consultants underway in Germany and Israel

We are adding Germany as a focus market for the introduction of migraine treatment. Preparations have been ongoing for some time, and starting with the subgroup results from the migraine study that will be presented soon, we will be moving into high gear. For this, we signed a consulting services agreement with MTIGER GmbH in Munich. MTIGER’s consultants are highly competent and very experienced in the area of migraines. We are applying the concept of market access consults to Israel as well and are progressing with a consulting assignment for market access with one of the owners of our former Israeli distributor. Pharmore PSR Ltd has more than 30 years’ experience and a valuable contact network from the Israeli neurology market.

FDA project continues

We continue to work with the second phase of the project to register the migraine treatment after a first round with the US authority. We need to adapt a number of technical matters since the requirements on tests and verifications are different from those in the EU. The study results that will be presented shortly are also crucial for the continued steps that may need to be taken in the project.

Two new studies

To support our marketing and sales work, we are starting a follow-up study of 200 patients in several countries and a smaller pilot study that will target the patients who did not obtain results from treatment with CGRP inhibitors.

In the cards for 2022

Everything is progressing according to plan so far. We continue to follow the marketing plan for 2022. This applies naturally to both the migraine and the rhinitis indications, but we will have a stronger focus on migraine.

Kista, August 2022 Anders Weilandt, CEO

Chordate Medical presents interim report for Q2 2022

Chordate Medical Holding (publ) publishes its interim report for Q2 2022 on Tuesday, August 30, 2022, 08:30. On Wednesday, August 31 at 11:00 am, the company invites you to a teleconference with CEO Anders Weilandt.

After the conference, there will be a question-and-answer session. The presentation is held in English. It is possible to follow the conference via computer or mobile devices.

To register for the web conference, register via the following link:

https://attendee.gotowebinar.com/register/3519820819663201294

The number of places is limited, so we recommend registering well in advance to secure a place.

A recording of the web conference will be available after the conference on the company's website www.chordate.com and on the Västra Hamnen Corporate Finance YouTube channel.

Chordate Medical launches market introduction of migraine treatment in Germany

Chordate Medical ("Chordate", the "Company") has entered into an agreement with MTIGER GmbH, Germany, to introduce the company's product for preventive migraine treatment, K.O.S, on the German market. Following a detailed market analysis carried out by MTIGER, the agreement runs for an initial period of one year.

MTIGER will introduce the K.O.S treatment to leading neurologists in Germany on behalf of Chordate in both the private and public healthcare market. The ambition is also to resolve questions regarding reimbursement opportunities for the treatment. MTIGER will locally support the German part of the follow-up study PM010 in a small number of clinics.

According to a recently published analysis, the prevalence of migraine is 14.8 percent for women and 6 percent for men in the German population. According to the same analysis, 1.2 percent, approximately 1 million people, meet the criteria for the diagnosis of chronic migraine in Germany.

Chordate has recently completed a clinical study of preventive treatment for chronic migraine in which 97 German patients were included and treated at five neurology clinics. As previously communicated, a subgroup analysis of the German part of the study will be presented on September 8-11 at the neurology congress MTIS 2022 in London.

“During the analysis and stratification work of the German migraine market, we have for a long time gotten to know MTIGER's competence and network. The German healthcare market is extensive, but at the same time both complex and fragmented. Just like for the markets in the UK, Israel, and the gulf area, with this agreement we want to establish a collaboration with market experts who works focused and dedicated – under our management”, says Anders Weilandt, CEO of Chordate.

Chordate Medical begins market introduction of migraine treatment in Israel

Chordate Medical ("Chordate", the "Company") has entered into an agreement with the market relations company Pharmore PSR LTD, Israel, to introduce the companys product for preventive migraine treatment on the Israeli market.

The agreement details that Pharmore will present the K.O.S treatment to opinion leaders within the neurology/migraine field and then develop a broader market position. The agreement also includes that Pharmore will manage the implementation of the companys previously communicated clinical follow-up study PM010 at two Israeli clinics. The agreement with Chordates former distributor has been terminated.

"Because we assess the conditions for achieving results faster, we have now chosen to work with a focused market access project in Israel, the same way as in the UK. The key people with neurology market expertise at our former distributor have formed Pharmore and are a natural contracting party for the continued assignment. According to our assessment, Pharmore possesses the necessary competence in the specialist area of neurology, the structure of the healthcare market, reimbursement matters and marketing", says Anders Weilandt, CEO of Chordate.

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

The following documents can be retrieved from beQuoted
Chordate-Medical-begins-market-introduction-of-migraine-trea.pdf

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.

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.

Subgroup results from Chordates PM007 multicenter clinical study of K.O.S-stimulation will be presented at Migraine symposium in London

Chordate Medical Holding ABs (publ) ("Chordate") (Nasdaq First North Stockholm: CMH), a specialty medtech company that focuses on developing neuromodulating systems for treating chronic migraine, today announces that an abstract entitled "Kinetic Oscillation Stimulation for the treatment of chronic migraine – a subgroup analysis of a randomised controlled clinical trial" by Hoffmann, J. et al, has been accepted as a poster by the Migraine Trust International Symposium 2022 [MTIS], September 8-11, 2022, London.

The abstract will present the results from the subgroup analysis performed of the 97 German subjects that left the PM007 study at the end of 2021, the poster is accepted by MTIS to be presented at the symposium. The study of a total of 132 subjects saw the last patient leave the study early August, and the completed data file is currently compiled for the final scientific article manuscript, anticipated to be submitted later this fall.

"It will be very exciting  to see the subgroup results of the PM007 study in a couple of weeks. If it is as good as we hope, this will immediately be a great support to our marketing and sales ambitions with the already CE-marked product. The fact that the German clinics completed their work early provided the opportunity to make this subgroup analysis, while waiting for their Finnish colleagues to catch up after all delays caused by Covid-19. Our near-term task is now to process the data from the completed study, and to get it published in its entirety", says Anders Weilandt, CEO of Chordate.

About the PM007 trial

This randomized, sham-controlled, double-blind, multicenter study was conducted at five neurology clinics in Germany and four in Finland. The study enrolled 132 subjects and is designed to evaluate the efficacy and safety of the K.O.S-treatment, with the primary endpoint to detect mean change from baseline (4-week screening period, 4-week follow-up period) in monthly headache days with moderate to severe intensity, following weekly treatments for six weeks. Fifty percent of the subjects received active K.O.S-treatment from the S211 investigative device, while the other half of the subjects received a validated sham/placebo treatment from the same equipment.

The study enrolled subjects with diagnosed chronic migraine (15 days/month of headache, whereof >8 days with migraine) and was completed at the beginning of August 2022.

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

The following documents can be retrieved from beQuoted
Subgroup-results-from-Chordates-clinical-study-will-be-prese.pdf

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.

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 has been notified of the granting of additional patent protection for headache treatment in the United States

Chordate Medical Holding AB (Publ.) announces that the US Patent Office has issued a decision that they intend to grant Chordates patent application US 16 / 938,383 from 2020. 

The patent application concerns the treatment of headaches with the focus on protecting the companys technology Kinetic Oscillation Stimulation (K.O.S). The granting of the application means that a third American patent is added to a growing patent family focused on headache treatment that the company has built since 2011.

"One of the three pillars of our strategy to build the company value for our shareholders is to pursue our patent strategy. The intellectual property defence of our technology in support of the business development is an essential part of what we consider core values in the company", says Anders Weilandt, CEO of Chordate Medical.

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

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.

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.

Chordate Medical updates on ongoing and planned clinical studies

Chordate Medical has two active studies, and another two that are in the planning stage. The purpose of the company's clinical development program is to support the ongoing market introduction of the K.O.S technology for chronic migraine in the EU and lay the foundation for regulatory market access in other markets such as the USA.

"Our clinical development strategy is aimed to conduct studies of specific nature and shorter duration ourselves, and to encourage and facilitate other independent external investigator-initiated studies once such opportunities arise", says Anders Weilandt, CEO Chordate.

The randomized controlled patient study PM007, that is being carried out at 9 clinics in Germany and Finland, will see the last subject leaving the study at the end of July 2022. A manuscript for a scientific article will be submitted for publication at the end of October 2022, at the earliest. This study will have recruited approximately 132 subjects with chronic migraine and the primary endpoint is the reduction of headache days.

The study on chronic rhinitis, PR008, will complete the clean data file June 2022, whereafter analysis and publication work will follow.

The planned study PM009 is an open pilot study to evaluate the efficacy of intranasal kinetic oscillation stimulation (K.O.S) in the preventive treatment of chronic migraine on subjects not responding to treatment with monoclonal antibodies targeting the CGRP pathway. The study's aim is to include 25-30 subjects to investigate the reduction of headache days using the K.O.S technology. Blood samples will be evaluated for relevant biomarkers. The study is conducted at King's College in London with three to four referring clinics assisting with the recruitment of suitable subjects for the study. The objective with this investigation is to detect a potential positive effect. Any level of positive result will likely mean a great opportunity for our company as this challenged patient group has very few options left.

PM010 is another planned study, which is an open post-marketing clinical follow-up investigation to follow long-term performance and safety of intranasal kinetic oscillation in subjects with chronic migraine during regular clinical treatment. The study will recruit 200 subjects and will be conducted at approximately 15 clinics in three to four European countries, the follow-up is 12 months. Data from this open study will be reported in intervals and used to fine-tune recommendations for the clinical regime.

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

The following documents can be retrieved from beQuoted
Chordate-Medical-pipeline.png
Chordate-Medical-updates-on-ongoing-and-planned-clinical-stu.pdf

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.

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) Interim Report Jan-March 2022

Summary of the period January-March 2022

COMMENTS FROM CEO ANDERS WEILANDT 

WHAT AN EXCITING START TO 2022

At the beginning of the year and up to now in May 2022, we are seeing growing international interest in Chordate as a company and our technology. The combination of the listing on Nasdaq First North and the CE marking for migraines seems to have increased our exposure internationally. We are constantly analyzing the marketing opportunities that potentially should be developed, for example the choice of the model to start our establishment in the UK.

Saudi Arabia will be the base for expansion in the region

In order to best develop Saudi Arabia and expand the operations to the other countries in the GCC (Gulf Cooperation Council), we are in the process of opening a representative office in Riyadh and have recruited Alain Durante to be the general manager. He has almost twenty years of experience in sales and marketing in medical technology in Saudi Arabia and has led the work with our products at our distributor for over two years. We thus have a very good set-up to develop the region.

Our new marketing consultants in the UK see potential for the migraine treatment

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 profit over time.

During the initial phase, the marketing activities in the UK will be focused on building up a network of opinion-leading neurologists, primarily among private care providers.

Listing on Nasdaq First North

The Companys share has been listed on NGM SME since March 2017. Following a decision by the Board to switch to the NASDAQ First North, the listing change went ahead on February 15. The Board of Directors makes the assessment that the listing change is positive for Chordates development and the fulfillment of our expressed exit strategy.

Project for US market approval from the FDA

The pre-study, which aims to find the right path for an application for marketing authorization for the migraine indication in the USA, resulted in the shift in March-April to a so-called DeNovo application. The project has now entered Phase 2, which, together with our US consultants at RQM+, is to obtain the FDAs view on how we have chosen to plan the final application.

The patient study on migraine is fully recruited

The remaining four Finnish clinics in the study have now recruited the last patient to start treatment. A patient spends ten weeks in the study in total. The scientific article from the study is expected to be completed as early as the end of the third quarter of this year. Since CE marking has already been obtained, the sole aim of the study in Germany and Finland is to support future marketing activities and gather data for the publication of a scientific article.

In the cards for 2022

Everything is progressing according to plan so far. We continue to follow the marketing plan for 2022. This applies naturally to both the migraine and the rhinitis indications, but we will have a stronger focus on migraine.

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 May 27th, 2022, at 08:30 a.m. CET.

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

The following documents can be retrieved from beQuoted
Chordate-Medical-Holding-publ-Interim-Report-JanMarch-202.pdf

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.

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.