Oridion (provider of Sidestream Co2) with US import ban - implications?

[jelo68]

Dear all

I am disclosing that i am a financial analyst and i am covering Oridion, the pioneer and inventor of sidestream Microstream Co2 technology, as you certainly know.

Late December, the FDA issued an import ban on all of Oridion's products (so monitors and consumables) :angry:

Reasons were not very clear, the FDA action followed a warning letter from October, when the FDA said that quality control was not sufficient enough (simply spoken, of course everything is much more complicate).

However, it looks like Oridion is not able to supply anything to the USA right now, but of course its distributors will de-stock inventory, which can hold on for another 2 or 3 months. If the FDA issue is not fixed in that time frame, then no products will be available until it is fixed.

My question: is that an issue to you guys using that, or would you switch to a competitor, which i believe is Philips Novametrix technology, which i heard is not the best technology or do you just 'wait'? Is that possible for compliance reasons. Sorry for my questions, but i had the stock on a buy and i still like the company very much, but the stock lost some 40% after the FDA import alert.

Thanks so much for your inputs!

 

[46Young]

Dear all

I am disclosing that i am a financial analyst and i am covering Oridion, the pioneer and inventor of sidestream Microstream Co2 technology, as you certainly know.

Late December, the FDA issued an import ban on all of Oridion's products (so monitors and consumables) :angry:

Reasons were not very clear, the FDA action followed a warning letter from October, when the FDA said that quality control was not sufficient enough (simply spoken, of course everything is much more complicate).

However, it looks like Oridion is not able to supply anything to the USA right now, but of course its distributors will de-stock inventory, which can hold on for another 2 or 3 months. If the FDA issue is not fixed in that time frame, then no products will be available until it is fixed.

My question: is that an issue to you guys using that, or would you switch to a competitor, which i believe is Philips Novametrix technology, which i heard is not the best technology or do you just 'wait'? Is that possible for compliance reasons. Sorry for my questions, but i had the stock on a buy and i still like the company very much, but the stock lost some 40% after the FDA import alert.

Thanks so much for your inputs!

It's obvious that you're only posting here for possible financial gain. If they're going to resolve the issue, then I guess buy low, since their stock will go back up after the issue is resolved, just like Toyota with their recalls, for example.

Anyway, I located an article in regards to your post, contacted my EMS Capt, and advised that he suggest buying extra supplies or perhaps look into other vendors.

 

[BandageBrigade]

I actually like the phillips version and find it to be a superior product. Plus it has not had problems with the FDA. We switched to it very shortly after trialing a few other versions, and have no plans of switching to something else.

 

[mikie]

Is there any legitimacy to this?

I wonder how long it'll take for this to get locked...

 

[bigbaldguy]

The import ban appears to be legit, they have the article posted on their own website.

I imagine EMS departments will do everything they can to avoid having to buy Phillips if they already have Oridion equipment, that said many departments see this as very necessary technology so if the supply problem isn't handled fairly quickly I can see plenty of Oridion customers jumping ship if they can afford to do so.

 

[ffemt8978]

I wonder how long it'll take for this to get locked...

No reason for it to be locked yet.

 

[18G]

The OP was honest with why he is asking a simple question. What's the big deal?

 

[shfd739]

We use the Microstream stuff but it's incorporated into our Lifepak 12s. I can see materials management stocking up but it would be very difficult and exspensive to switch to another device. Hopefully Oridion can resolve the issues with the FDA soon enough to not have supply disruptions.