Chordate Medical is initiating a pre-study in the US as a first step in obtaining market authorisation from the FDA for its migraine treatment. The pre-study is expected to be completed in Q1 2021 and will provide clarity as to which pathway is appropriate to achieve market approval in the US. BioStock contacted CEO Anders Weilandt to learn more about the process leading up to FDA approval and the possibilities in the US for the company’s migraine treatment.
Medtech company Chordate Medical has developed Kinetic Oscillation Stimulation (K.O.S), a neuromodulating method for the treatment of both chronic nasal congestion (rhinitis) and chronic migraine. A very important milestone for the company was the CE mark in migraine obtained in May 2021, a year earlier than planned, which opened the door to the European market.
With the EU market approval in place, the company is looking to the US, where it is now launching a pre-study together with a reputable US consulting company. The pre-study is expected to provide the company with sufficient evidence to select the appropriate strategy to obtain market approval with the K.O.S migraine treatment in the US.
Preparations for De Novo application
Chordate Medical’s treatment system is classified as a medical device, which means that it must be approved by the Food and Drug Administration (FDA) in order to be marketed and sold in the US. There are several pathways to obtaining market approval, and the most appropriate route is determined by the classification under which the product falls, and whether there are any equivalent devices on the market.
In Chordate Medical’s case, the most appropriate pathway is probably a De Novo application, which is intended for low- or medium-risk medical devices without a launched equivalent on the US market.
Formal application in 2022
The company plans to complete the pre-study for market approval in the US during the first quarter of 2022 – only then can a decision on the choice of strategy be made. After that, a pre-submission step is carried out, and then finally the complete application is submitted to the FDA.
Weilandt comments on the announcement
Chordate Medical has previously announced that it plans to take market shares in a few select markets to establish market evidence and build corporate value for a future exit. In a press release regarding the plans for K.O.S in the US, CEO Anders Weilandt says that a market approval in the US does not alter the company’s marketing strategy:
»This ambition to procure a US market permit does not mean that we have changed the model on how we build our proof of market. However, our assessment is that an approved DeNovo application in the long run gives us a broader set of options and makes Chordate more interesting for the medtech industry in general.«
BioStock contacted Anders Weilandt to find out more about what this means and how he views the potential in the US for K.O.S.
You have now started the process of obtaining market approval in the United States. How long do you expect this process to take?
– It all depends on the steps that the pre-study concludes that we need to take. The FDA requirements differ in some respects from the requirements that needs to be fulfilled for market authorisations within the EU, so it may take more time or less time to get this in place.
Do you see that an FDA approval can further increase the company’s value ahead a future exit?
– Logically, it should. But the most important thing is that it gives the company more choices for future strategic decisions. This is also why we wanted to start the project as early as possible after obtaining the CE mark.
You are now in the final stages of your migraine study with K.O.S. Do you hope that the results of the study are sufficient to meet FDA requirements?
– This is one of the issues that needs to be investigated in the preliminary study. It may be that we need to collect more data, but it all depends on how the FDA assess the data that hopefully comes out of the ongoing study.
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