During 2021, Chordate Medical were able to ensure that several important pieces fell into place, such as the CE marking which allowed K.O.S to be marketed as a migraine treatment in the EU. Chordate is now looking forward to another eventful year that will include a list change to First North Growth Market and completion of the company’s migraine study. BioStock contacted CEO Anders Weilandt for a comment.
Chordate Medical has developed a preventive nerve-stimulating treatment for chronic nasal congestion (rhinitis) and chronic migraine. The Kinetic Oscillation Stimulation (K.O.S) treatment method uses vibrations to stimulate the nerves in the mucous membranes of the nose, which is believed to balance the autonomic nervous system.
Approaching the finish line in migraine study
2021 was an eventful year for Chordate Medical, not least in the migraine space where the long-awaited CEmarking was obtained. In addition, the company resumed the placebo-controlled and double-blinded migrainestudy, which started 2018 but had to be paused in 2020 due to the pandemic. The study evaluates K.O.S. in patients with chronic migraine at nine clinics in Germany and Finland.
The migraine study is now in its final stage and the treatment of the last patient is expected to start in the firstquarter of this year. When the study is completed, the results will be compiled in a scientific article that, in the event of positive results, can strengthen Chordate’s market positioning and sales work. The scientific report is expected to be completed and submitted for review in the third quarter of 2022.
A scientific article on Chordate’s rhinitis treatment was recently published in the American Journal of Surgeryand Clinical Case Report. Read the report here.
The CE marking was the highlight of the year
The main purpose of the migraine study was initially to generate scientific evidence for Chordate’s migraine treatment for the CE marking process, but it turned out that the interim results from 2019 were sufficient to obtain such marketing approval. The CE marking was obtained in May 2021, a year earlier than expected, which set the ball rolling for Chordate in a number of ways.
The CE marking means that the product may be sold within the EU, as it complies with the requirements of the EU Medical Devices Directive (MDD). The approval was undoubtedly the most important event in 2021, and in the company’s history, says CEO Anders Weilandt in an interview with BioStock:
»It is without exaggerating the most important thing that has happened in the company’s history. A CE marked migraine treatment gives the company the market position we need to implement our strategy to establish business in selected markets «
Chordate Medical’s distributors continued to be productive in 2021, despite the impact of the pandemic. With the CE marking, Vedise Hospital was able to introduce the migraine treatment to clinics in northern and central Italy, leading to the first commercial orders from Italy of the migraine treatment system. Vedise has been selling K.O.S as a rhinitis treatment in Italy since 2019 and has noticed a great interest in the treatment. In an interview with BioStock, Vedise’s CEO Valter Varano also pointed out how patients, especially professional athletes, have benefited from the treatment.
Almothihel Medical, Chordate’s distributor in Saudi Arabia, also made significant progress during 2021. The distributor managed to enter the public hospital market with Chordate’s rhinitis treatment thanks to a successful clinical evaluation at three public hospitals. Now, private and soon public healthcare providers can receive full reimbursement for performed K.O.S treatments, and in addition, the product will shortly be listed innational purchasing catalogues.
Aiming for the U.S. market
At the end of 2021, a pre-study was initiated to identify an appropriate strategy for obtaining marketingauthorisation in the US for the migraine treatment. The marketing authorisation work, which is carried out in collaboration with the globally leading consulting company RQM+, is expected to result in a so-called DeNovo application to the FDA. An approval would give the company more options and increase interest among other players in the medtech sector, thus representing an important step in building company value for an exit.
Chordate expects to be able to complete the pre-study in the first quarter of 2022 and to submit an application to the FDA in the second half of 2022.
Eyes also set on China
In 2021, Chordate also resumed the registration process in China, which is carried out together with Nanos Medical. Already in 2018, Chordate and Nanos Medical entered into a joint venture agreement and formed the joint venture Changyong Medical Technology to market the rhinitis treatment in China. In 2021, the agreement was renewed and Chordate received an order on two K.O.S units, worth SEK 167,000, to be used in the marketing authorisation process. Read BioStock’s interview with Nanos Medical CEO Terry Cui here.
List change to First North
In September, Chordate announced that they intend to change trading venue to Nasdaq First North GrowthMarket, after being listed on NGM Nordic SME since 2017. Chordate believes that the list change can increase awareness of the company and its product, both in Sweden and internationally, as well as make it easier for industrial investors to become shareholders.
The last trading day at NGM Nordic SME is expected to be 14 February, provided that trading in the company’s shares can be admitted on First North the following trading day. Chordate recently received preliminary approval from Nasdaq for admission to trading on the new trading venue.
Interview with Chordate’s CEO
BioStock contacted Chordate Medical’s CEO Anders Weilandt to find out more about 2021 and the plans for 2022.
How would you sum up 2021 in three words?
– Absolutely crucial progress.
Could you tell us a bit more about the possibilities and plans for K.O.S on the U.S market?
– We take it one step at a time. The results of the marketing authorisation work will determine which strategy we choose. The company is not currently funded for a market introduction in the U.S – but when we know more about the registration outcome with the FDA, we will get back to how to manage the market potential, which is of course significant.
You will soon complete a list change to Nasdaq First North Growth Market. What benefits do you expect this to bring?
– The main advantage is that international stakeholders will more easily find the company’s share. Although we will have basically the same regulatory environment as before, we also believe that some players in Sweden will be able to trade the share more easily.
»One or two new markets will be added to the markets we are currently focusing on. «
What can the market expect in terms of milestones in the coming year?
– First of all, we will complete the migraine study and eventually report its results. Also, one or two new markets will be added to the markets we are currently focusing on. Finally, we hope that the U.S market authorisation process can be initiated.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.