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Chordate Medical’s CEO comments on the terminated study

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Chordate Medical’s CEO comments on the terminated study

3 July, 2021

Chordate Medical has for a longer period of time conducted two parallel studies – one in rhinitis (chronic nasal congestion) and one in chronic migraine – with the company’s technology Kinetic Oscillation Stimulation. Chordate Medical has now chosen to suspend recruitment for the rhinitis study as an interim analysis has shown that it will probably not reach conclusive end results. BioStock has contacted Chordate Medical’s CEO Anders Weilandt, who points out that the migraine indication is the company’s main focus right now and that sales of the company’s product are not affected by the announcement.

Chordate Medical received a CE mark for its rhinitis treatment as early as 2011. Their product – Kinetic Oscillation Stimulation (K.O.S) – is approved for sale in the Nordic countries, the EU, Israel and Saudi Arabia and is sold through distributors in the Nordic countries, Italy and Israel. Now the company is working towards getting the K.O.S treatment CE-marked for chronic migraine as an indication.

The rhinitis study ends prematurely – the migraine study continues

Yesterday, Chordate Medical announced that they have chosen to terminate the ongoing clinical study of K.O.S in chronic rhinitis/nasal congestion. This because an interim analysis indicates that the study results will not be conclusive, which is why the company has been recommended to suspend the recruitment of new patients. However, the follow-up of already included patients in the study will be completed.

According to Chordate Medical, the migraine study and the sales activities continue unaffected despite yesterday’s announcement.

Chordate Medical’s view of the potential in both indications is still positive

Anders Weilandt, CEO Chordate Medical

BioStock has contacted Chordate Medical’s CEO, Anders Weilandt, to find out more about the terminated study and the company’s future plans.

Anders Weilandt, according to your press release, the intention of the rhinitis study was to extend the scientific basis from previously completed studies. Can you tell us more about the primary goal of the study and why you wanted to obtain new data?

– The study was intended to eventually deliver complementary scientific data that could be used in, e.g., compensation discussions with insurance structures in different markets. In practice, this could have happened sometime in 2022 after a scientific journal had then published an article based on the study. The purpose was never to support sales, as medical technology is rarely or never sold based on studies.

How come do the results deviate from the previous study? Did the design of this study differ from the previous study?

– The inclusion criteria were basically the same in both studies, but several changes were made during the previous study, which is why it is not particularly simple or relevant to try to make a direct comparison.

»There is always a lot of useful information to build upon even in studies that for some reason do not go as planned. We will therefore analyse the results carefully when we have access to study data.« – Anders Weilandt, CEO Chordate Medical

You will complete the follow-up of active patients for 12 months even though the study has been formally terminated. How do you plan to use the collected data?

– It would not be ethically correct not to complete the follow-up according to the study protocol, and this means that the study will not be formally terminated until all patients have left the study after 12 months. There is always a lot of useful information to build upon even in studies that for some reason do not go as planned. We will therefore analyse the results carefully when we have access to study data.

Chordate Medical’s product for chronic nasal congestion is already on the market today – does yesterday’s announcement mean that the product must be withdrawn?

–  The products for chronic nasal congestion as an indication are CE-marked based on previous studies. This means that the sales will continue despite a discontinued study. There are many products on the market that have both conclusive and non-conclusive studies in their luggage.

»I would like to emphasize that it is the migraine indication that is the main focus in our construction of company value. «

The stock market reacted strongly to the news that you have terminated your rhinitis study, and your share price fell by 40% yesterday. Do you think it is a reaction in proportion to the news’ impact on the company and the rhinitis product?

–  I do not comment on price movements on the stock market for reasons of principle. On the other hand, I would like to emphasize that it is the migraine indication that is the main focus in our construction of company value, which we have previously communicated.

– In general, there are probably a number of reasons why a share price moves radically, partly of a technical nature, or based on issues concerning shareholders’ views on investment horizons, etc. It does not by definition have to be about an exact valuation of the actual information given in e.g. a press release.

»The interim analysis confirmed that the study design is correct and that it is likely that the migraine study will achieve the desired result.«

In previous BioStock articles, it has been stated that you primarily intend to focus on your migraine product in the future. Is that project affected in any way by the fact that the rhinitis study has now been completed?

– The two indications, migraine and nasal congestion, are completely different disease states, and probably have different background causes. In addition, in May 2019, we communicated the results of the interim analysis from the migraine study. The interim analysis confirmed that the study design is correct and that it is likely that the migraine study will achieve the desired result. We perceive that answer as very positive. The conclusion is that these two studies have no mutual influence on each other.

Will you conduct more studies of K.O.S in rhinitis, or will chronic migraine be your main focus in the future?

– As previously communicated, our strategy is to gradually build up a stable scientific basis for our products. The main focus is still on the migraine indication, but it is possible that we will come to the conclusion that more should be done in rhinitis as well. There are different paths we can take there, but we will return to how it may look like when it becomes relevant.

If we look ahead, how do you assess the market potential for your respective products, and how does this play into your business model?

– Our view of the potentials in our two indications is unchanged and still positive. We assess that the migraine indication is more defined as a market and therefore is assumed to be faster to reach. The potential for rhinitis is also large but will take longer for us to process.

What will be the next step for Chordate Medical?

– In the near future, it is a matter of having the migraine study carried out and managing short-term effects from Covid-19. After that, we will complete the CE marking process for migraines within the new regulations, MDR, which will enter into force in the EU from May next year. In other respects, it is still important to build evidence in the market by selling more products in more markets.

 
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.

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