Jason Bednar : I want to shift gears. I don’t think it’s been touched on yet. Apologies if I missed it, but you mentioned your PR today, an assessment report from your European notified body, what does this mean for your European business? Does it affect at all your ability to sell in that market or get products approved in that market? When do you expect to hear an update from BSI? Just anything additional there because again, it could be important, just hard to tell if it is or not.
Linda Tharby : So let me start by saying that we are currently certified for sale in the EU. So no issue there. Every year, you go through an annual recertification process. They were in BSI as our auditor. They were in February to which we had zero non-conformances. So that’s awesome in our manufacturing and quality systems. We had one open technical file on one product and they recommended we had submitted our response to that open file to BSI, and we had been informed by them that they would come back with questions or that the file was closed. That was in March of 2023. So we were quite surprised when we got this report last week saying that they were not recommending our recertification due to this one product and open technical file.
We have launched an appeal as of last evening, they came back and acknowledge that they have received that appeal and we expect to resolve this in cooperation with them in the coming months. We expect little to no interruption in our sales in the European market. our products continue to remain certified, marketed and sold in the EU.
Jason Bednar : And Linda, again, I don’t want to throw out like the worst case, but just so we’re prepared. I mean, what’s that best case as we come back and there’s like no impact whatsoever or it’s de minimis or what’s worse case here just so we can prepare accordingly?
Linda Tharby : So best case is that there is no interruption at all. We are — well we work through this situation. Any product that we have in the market, we can continue to sell. So that’s best case. And worst case, what I would say, is a worst case would be that they say we are not — they stand by their original and do not accept our appeal. Again, I feel that’s highly unlikely given what we’ve sent them on their prior communication to us which is that’s why we’re appealing. But if they decide to uphold that then I would say it would take us several months to resolve, we feel we can resolve it on our end in several months. We feel it may take them some time to review the file. So you take all of those things into impact, I would say the worst-case scenario would be several months of not supply. I would cap that at probably 3 months in Europe of non-supply products.
Operator: This concludes our question-and-answer session. I would like to turn the conference back over to Linda for any closing remarks.
Linda Tharby : In closing, I just want to say thank you to the KORU team and to all of our investors for the continued progress in 2023, and we look forward to a great year in 2024. Thank you.
Operator: The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.
