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.
Read also BioStock’s interview with CSO Jan Hermansson regarding the ongoing and planned studies.
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.