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.
Analyst Group writes in a comment on Chordate Medical’s Q2 report that the company’s chosen strategy in the UK, which is now also being implemented in Germany and Israel, could result in a faster expansion.
“As we have previously written, we believe that Chordate’s chosen strategy in the UK could result in a faster expansion in the market, which would thus also be reflected in Chordate’s sales figures. We therefore view positively that the company has chosen to apply this strategy in Israel and Germany as well.”
Analyst Group also comments on the subgroup results that will be presented at the Migraine Trust International Symposium 2022 in London on September 8th.
“The subgroup results that will be presented next week could be a real value driver in Chordate’s share, given that the results are good. This as the results would constitute direct support for the company’s marketing of, and sales targets for, the K.O.S treatment for patients with chronic migraine. This is therefore something an investor should monitor.”
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.
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 the Nordics, Germany, the UK, Israel, and Saudi Arabia. Chordate Medical’s share is listed on Nasdaq First North Growth Market Stockholm (ticker: CMH). Read more at www.chordate.com/en/
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.
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 2022-08-30 08:30 CEST.
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 a.m., 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.
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.
For more information, please contact: Anders Weilandt, CEO Cell: +46 733-874277 e-mail: anders.weilandt@chordate.com
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 the Nordics, Germany, the UK, Israel, and Saudi Arabia. Chordate Medical’s share is listed on Nasdaq First North Growth Market Stockholm (ticker: CMH). Read more at www.chordate.com/en/
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 (“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.
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 AB 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.
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.
It has been an eventful first half of the year for Chordate Medical, including a list change to Nasdaq First North and an ongoing market introduction in Saudi Arabia and the UK. In addition, the company has fully recruited the migraine study and completed the first phase of the process to obtain market approval in the United States. BioStock had a chat with CEO Anders Weilandt about these events and his expectations for the autumn.
Chordate Medical has developed Kinetic Oscillation Stimulation (K.O.S), a neuromodulation treatment method that is CE marked for the treatment of both chronic nasal congestion (rhinitis) and migraine.
The main focus is primarily on chronic migraine, which became even more obvious at the beginning of 2022 when the company published “Den lilla migränboken” by author and journalist Kalle Dixelius.
List change to Nasdaq First North increases visibility
In February, Chordate also changed trading venue, from NGM Nordic SME to Nasdaq First North Growth Market. Since February 15, the Chordate stock is trading on First North which increases the company’s exposure to institutional and international investors.
Fully recruited migraine study
In April, Chordate achieved another milestone when the last patient was recruited to PM007, a large study with K.O.S in patients with migraine in Germany and Finland. The fact that the study is now fully recruited means that study data could be compiled in a scientific article before the end of the year. Chordate also plans to complete the data analysis of the rhinitis study PR008 shortly.
In May, the company announced that they are planning to start two more patient studies with K.O.S in migraine – PM009 and PM010. In PM009, the efficacy of K.O.S will be evaluated in patients with migraine who do not respond to treatment with CGRP inhibitors, while PM010 is a post-market surveillance study and part of the CE marking. PM010 will include 200 patients at approximately 15 clinics in 3-4 countries. The aim is to follow the long-term performance and safety of the K.O.S migraine treatment in clinical use.
Initiated FDA process and strengthened IP in the US
During the spring, a pre-study was completed in which the consulting company RQM+ investigated which route ismost suitable for obtaining market approval in the US for Chordate’s migraine treatment. The pre-study showed that Chordate should proceed with a DeNovo application to the FDA, which is an application process that is applicable to low- or medium-risk medical devices without already launched equivalents on the market.
According to Chordate, market approval in the US would be an important step in building company value for a futureexit. Another important building block is the patent protection of K.O.S, which was recently strengthened when the US Patent Office announced that they intend to grant a patent application for K.O.S for the treatment of headaches. This is the third patent relating to K.O.S for headaches to be approved in the US.
Market introduction in Saudi Arabia and the UK
In addition, during the spring, the market introduction in Saudi Arabia seems to have taken off. In March, Chordateannounced that they are opening a representative office in Riyadh to facilitate marketing activities in Saudi Arabiaand other Gulf countries. The rhinitis treatment has already been approved by the Ministry of Health and theinsurance reimbursement codes for the treatment are currently being implemented.
At the beginning of the year, the company also began a market introduction with the migraine treatment in the UK.The introduction is being carried out by Futures.Health which is currently introducing K.O.S to neurologists, primarily in the private sector, to increase awareness of the treatment and build a network.
Anders Weilandt sums up H1 and looks to the future
Chordate now enters the summer season with an expectation of an equally eventful second half of the year. The focus during the autumn will be to continue to build proof-of-concept in selected markets, complete the migraine study and continue to work on the market introduction in the UK and Saudi Arabia. In addition, they hope to progress in the market approval process in the US and China.
Chordate’s CEO Anders Weilandt tells us more in an interview with BioStock.
First of all, how would you sum up the first months of the year in three words?
– Exciting important events.
You still have a relatively low turnover – when do you expect the sales to kick-off?
– It depends on how you define ”kick-off”. On our recent trips to the UK and Italy, we can only conclude that the introduction and sales work is in full swing. Face masks are still required in healthcare facilities in both of these countries, but otherwise, the pandemic’s effect on sales has been manageable since mid-spring. All the work and results that were reached before the pandemic had to be restarted, but it looks good, even in Saudi Arabia. Our strategic goal is to show proof-of-concept in the market, i.e. show that we can sell. That is what we consider important for building company value.
Could you give us an update on how the market introduction is going in the UK and Saudi Arabia?
– In Saudi Arabia, work is now underway to get procurements under the NUPCO system approved. The Ministry of Health certificate has been in place since a while back, and now it remains to get the purchasing system to also process the orders that exist from several public hospitals. This so far only applies to the rhinitis indication. In the UK, the introduction of the migraine indication to leading neurologists has just begun. The clinicians who will participate in the PM010 post-market study are under recruitment. That study works very well as a tool in the initial stage of the market introduction.
If we focus instead on the U.S., what input have you received from the FDA so far?
– That is nothing I can comment on in detail other than that work is underway to understand the national requirements for a successful application for marketing authorization with the FDA.
Finally, what milestones await in the fall and beyond?
– The main thing is of course to report results from PM007, our big migraine study. We will also attend a number of congresses which we will inform you more about later.
The medtech company Chordate Medical currently has two patient studies that are in the final stages and two studies in the planning stage. Below, CSO Jan Hermansson talks more more about the studies and the company’s K.O.S technology for the treatment of migraine and rhinitis.
Chordate Medical has developed Kinetic Oscillation Stimulation (K.O.S), a neuromodulating intranasal treatment method for chronic migraine and chronic nasal congestion (rhinitis). K.O.S affects the autonomic nervous system by stimulating the nerve cells in the nose with vibrations, which is believed to provide a preventive treatment effect on both migraine and rhinitis.
The company’s products are sold in selected markets in Europe, Israel and Saudi Arabia.
Several studies with K.O.S
At present, the company has two studies with data analysis and reporting within reach – the migraine study PM007and the rhinitis study PM008 – as well as two planned studies with the K.O.S technology. The purpose of Chordate Medical’s clinical development program is primarily to support the market introduction of K.O.S for the treatment of chronic migraine in the EU, as well as lay the foundation for regulatory market approval in other markets such as theUS.
The studies are so far both initiated and financed by the company, according to the company’s CEO Anders Weilandt:
»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«
The migraine study will be completed in 2022
Since 2018, a randomised and placebo-controlled migraine study with K.O.S is being conducted at clinics in Germany and Finland. The study, called PM007, includes a total of approximately 132 patients with chronic migraine. The primary endpoint is the effect of treatment on the number of days of headaches of moderate to severe intensity per month.
Since a CE marking in migraine is already in place, the purpose of the migraine study is primarily to be able to publish scientific evidence for the treatment and thus support the company’s sales and marketing activities.
The last patient has been recruited and is expected to leave the study by the end of July 2022. This means that a scientific article is expected to be finished and ready to be submitted for review by the end of October 2022.
Planned migraine study at King’s College London
Chordate is also planning to start an open pilot study, PM009, at King’s College London with approximately 25-30 patients. The study aims to evaluate the efficacy of K.O.S in the preventive treatment of patients with chronic migraine who do not respond to treatment of CGRP inhibitors – a patient group with few treatment options available.
The ambition is that K.O.S will reduce the number of days with headaches. The study will also examine relevant biomarkers in blood samples from patients to evaluate the potential positive effects of the treatment.
Post-marketing study
The company has another study planned, PM010, which will be a so-called post-market surveillance study. The study aims to follow long-term results and safety of K.O.S in patients with chronic migraine during regular clinical treatment. About 200 patients will be recruited at 15 clinics in 3-4 European countries.
PM010 is an open study, i.e. both investigators and study participants know what treatment is being given. Data will be reported at intervals and used to fine-tune recommendations for the clinical treatment regimen.
Jan Hermansson, CSO Chordate Medical
The CSO tells us more about the studies
BioStock contacted Jan Hermansson, CSO at Chordate Medical, to learn more about the ongoing and planned studies. Hermansson is a dentist and has previously held managerial positions in the pharmaceutical industry at AstraZeneca, Pharmacia & Upjohn and Astra, among others. He has been CSO of Chordate Medical since 2012 and currently holds approximately 268,384 shares in the company.
Jan, what results do you hope to obtain in the ongoing study PM007 in migraine patients?
– Hopefully, we can prove that our treatment provides a statistically significant reduction in the number of headache days in this seriously ill patient group. The interim analysis of the study must have shown good results since we obtained marketing approval (CE marking) from it.
– However, the data is still blinded, only the notified body has been given access to this analysis. Now we hope and expect that the end result can confirm what we assume the interim analysis showed and that it can provide strong support for the marketing of our treatment.
When do you intend to start your two planned migraine studies PM009 and PM010?
–PM009 will first, the ethical assessment of the study has been completed and the contract with King’s College is being processed. The administration is extensive but we hope to get started with the first patients in August/September.
– For the PMS study PM010, it will be a gradual start depending on how long it takes to get the necessary approvals and contracts in the different countries. My hope is that some clinics can get started right after the summer, but it will probably take 6 months before all the clinics are up and running. Since this group of patients is really in need of new and better treatment for their chronic migraine, it should not be too difficult to find suitable patients.
What is the medical need for new treatment options for the PM009 patient group, i.e. patients that do not respond to CGRP inhibitors?
– These patients have already tried at least three other preventive medications before they are treated with CGRP inhibitors. If they do not get any effect with these new monoclonals, there are not many more options. We may not be able to help all patients in this study, but if we help a subset of them, we can greatly improve their quality of life! As a chronic migraine patient, you have at least 15 days of headache per month, of which at least 8 days with migraine.
Could you tell us a little more about the importance of conducting a post-market surveillance study like PM010?
– We are doing this study both to learn more about how to optimally treat this patient group and to meet the requirements of our reviewing body, Intertek. In this study, we follow the patients for 12 months. The patients will fill in a migraine diary every day and will be in contact with the treating clinic once a month. The treatments are planned together with the patients.
– Each patient receives a “starting dose” of 4 treatments in the first 6 weeks and then receives treatment as needed. We will thus be able to find the correlation between the number of headache and migraine days with the number of treatments the patients need. Knowing this, we will be able to give recommendations on treatment intervals etc. These observations are also important in negotiations with those who in the future will reimburse/pay for this treatment.
Could you also give us an update regarding the rhinitis study PM008?
– After many delays due to Covid-19 restrictions in the clinics, we were finally able to close the database at the end of May, and now the data has been transferred to statisticians for analysis. We hope to send a preliminary study report to participating clinicians over the summer so they can provide their comments and interpretations. After that, some of the doctors will write a manuscript for publication. All data are still withheld from us.
Finally, how are the ongoing and planned studies funded?
– Our studies are self-funded and within our plan. PM007 has also been financed by VINNOVA.
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.
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) publishes its interim report for Q1 2022 on Friday, May 27th, 2022, at 08:30. On Monday, May 30th at 14:00, the company invites the public to a livestreamed teleconference with CEO Anders Weilandt. The conference is followed by a Q&A session. You can follow the conference via computer or mobile devices.
The number of places is limited, so we recommend registering well in advance to secure a place.
After the conference, a recording of the web conference will be available on the companys website www.chordate.com and on the Västra Hamnen Corporate Finance YouTube channel.
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.
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