We’ve excised the excise tax

A couple of weeks ago, we announced that we were going to start adding a separate line item to invoices to cover our cost for the 2.3% medical device excise tax.

A few doctors responded with questions, so we decided to take one more look to make sure we we hadn't missed anything. Our attorneys and accountants dug deep into the murky depths of the federal tax code and returned with some excellent news. Based on the latest guidance from the IRS, as a dental lab manufacturing a Class II medical device, it looks like ClearCorrect is not required to pay the excise tax.

We'll refund the line-item fees that we've collected over the last two weeks, and you won't be seeing them on your invoices any more. We're just as happy about this as you are, and we apologize for the mixed messages. This is a brand-new law, and there is a lot of disagreement even between experts over exactly how to apply it.

Tell the ITC what you think

Notice of Commission Determination to Review the Final Initial Determination of the Administrative Law Judge; Schedule for Filing Written Submissions on Review

Good news!

The ITC has unanimously decided to review ALJ Rogers' initial determination. The commission is asking Align some tough questions, and we're optimistic that they'll end up deciding in our favor (like they did last time).

In the meantime, the ITC wants to hear from "interested parties" about whether granting Align's request to block us from using imported data would serve the public interest:

If the Commission contemplates some form of remedy, it must consider the effects of that remedy upon the public interest. The factors the Commission will consider include the effect that an exclusion order and/or cease and desist orders would have on (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.

This is a unique opportunity to make your voice heard. Send your thoughts to itc@clearcorrect.com by August 6, 2013, and we'll pass them along to the ITC.

Thanks for your support.

Sincerely,

Jarrett Pumphrey, CEO

ClearCorrect now accepts CEREC intraoral scans!

A few months ago, we started accepting intraoral scans exported in the STL format from a variety of scanners, including the 3M™ True Definition Scanner, 3Shape's TRIOS®, and even Align Technology's iTero™. Since then, we've been getting a steady stream of intraoral scans from doctors with these systems, which is great!

We've also recieved literally hundreds of requests from doctors to submit cases using Sirona's CEREC scanners, which can't export STL files. We made it our mission to find a way to make this work. We've been beta-testing the process with our PREP doctors, and now we're proud to announce that we can accept scans directly from CEREC's Omnicam and Bluecam via Sirona Connect!

Here's what the PREP doctors have had to say about using CEREC scanners with ClearCorrect:

“I have been a ClearCorrect provider for over three years now. During my time as a provider, I have always been impressed that ClearCorrect actually listens to feedback we suggest as providers and even incorporates these ideas into their product! The latest idea is the ability to use my CEREC Omnicam to take intraoral scans. I've always wanted to use my CEREC for clear aligners, and now I can. I've seen the control and accuracy that an all-digital workflow delivers first-hand. Every ClearCorrect case that I've submitted using my CEREC Omnicam has fit impeccably, right from the start.” —Dr. David Thurman
“I have been a ClearCorrect and CEREC user for about 3 years now. The CEREC has changed the way I practice dentistry by giving me an accurate and predictable treatment modality, providing the very best restorations for my patients. Similarly, ClearCorrect has really evolved over the past few years where now I'm getting the same predictability and outcomes in my orthodontic cases.  I am pleased to say that I've had to do minimal refinements on my cases, greatly enhancing the patient experience, expectation and outcomes. Needless to say I was thrilled at the opportunity to combine the digital accuracy of CEREC with the predictability and simplicity of ClearCorrect. As a Bluecam user I was able to image the entire mouth in about 8 minutes, quadrant by quadrant. The Phase Zero try-in fit perfectly and currently the case is progressing without any issues. I'm excited to be able to combine both technologies and get rid of PVS once and for all!” —Dr. Meena Barsoum

We want to thank our PREP doctors for helping us develop new techniques and for being a valuable part of ClearCorrect's future.

Medical device excise tax

As part of the Affordable Care Act, an excise tax is now being levied on certain medical devices. The tax went into effect on January 1, 2013, but we've been deducting the cost of the tax from your lab fees behind the scenes. Unfortunately, to avoid further price increases, it's become clear that we need to start itemizing the cost of the excise tax separately. Within the next few days, you'll see a new line item representing the cost of the 2.3% excise tax when you pay for each case.

We hate passing the tax on to you, but we'd hate raising our lab fees even more.

Until next time…

[Update: We are no longer adding this line item to our invoices. See this announcement for details.]

Tech Tip: Request retainers & view expiration dates on ClearComm

A couple of weeks ago, we reminded you that cases are automatically closed when you request a free final retainer, or one year after your last shipment, whichever comes first.

Starting today, you can add retainer requests to the list of new features available on ClearComm, along with case histories, intraoral scans, revisions, invoices, and treatment plans.

After the final phase has been delivered, you'll see "Request final retainer" at the top of the case page. You'll also see the expiration date for the case.

Request final retainer

From here, you can request a revision or close the case by requesting the final retainer. We can make retainers based on the last step, or you can submit new impressions or intraoral scans.

Closing case

If the retainer is based on an existing step, just click "Submit" and you're done. If you choose to send in impressions or scans, you'll be presented with options to upload or ship them after you submit your request. You can find cases that are ready for you to request a retainer under the in progress section of your case list.

In progress

Let us know what you think of the new features, and anything else you'd like to see. Until next time…

We’re moving to Round Rock!

You don't have to update your address book just yet, but we're so excited, we wanted to share the news a little early. After an extensive search, we've finalized plans to relocate our headquarters and manufacturing operations from Houston to a new improved facility in Round Rock, Texas (just north of Austin).

ClearCorrect key

If all goes according to plan, we expect to start the move in August, and finish up over Labor Day weekend. We'll update you with more details as the big day draws closer. We couldn't be happier with this move. Houston's been a great home for us so far, but the fun, high-tech Austin scene aligns even better with our core values, and we think it'll be the ideal environment for us to continue our long-term growth and prepare for international expansion.

Of course, we wouldn't be here without our providers, their patients, and everyone who we've worked with over the past six years. Thank you for all your support. It's been quite a ride, and we look forward to many more years of service in our new Round Rock facility. Until next time…

Tech Tip: Invoices & treatment plans available on ClearComm

Our technical team has been busy—the new ClearComm features just keep on coming. After introducing a new case history view, intraoral scans, and online revisions, today we're announcing that you can view invoices and case paperwork directly on ClearComm.

After we added payments to the case history view, some providers told us that they'd rather not see the specific lab fees there. In response, we've updated the description to just read "Payment received."

Payment received

Instead, you can now click the invoice icon to view a printable PDF with the full details of each transaction.

We've also added downloadable treatment plans for recent phases. (This is the same paperwork that comes in each aligner box.)

Phase 1 arrived

Same idea: just click the icon to download a PDF. Because this is a new feature, it's only available for phases that shipped in the last couple weeks. Over time, you'll start to see it on more and more phases. Don't forget that you can check the timeline at the top of each treatment plan to get a preview of what's coming up at future appointments.

Request revisions online

As promised, we've been adding new features to ClearComm on a regular basis. Last month, we introduced the new case history view. A few weeks ago, we started accepting intraoral scans. And today, we're pleased to announce that online case revisions are now available.

Phase 4 of 5 scheduled

When you select a case with a phase scheduled, you'll now see a blue "Revise" button in the action area. After you click that, the title will change to "Requesting revision."

Requesting revision

For each arch, you'll select the step that your patient is currently wearing. (Your patient should continue to wear the same step until the revised phase arrives, then switch directly to step A of the new phase.)

We can base the revision on existing models, on new impressions, or on new intraoral scans. If the aligners fit well, but you just want to request a change (for instance, adding engagers or requesting overcorrection), select "existing model." If you choose "new impression," you'll be presented with an option to ship it after you submit the revision request. If you choose "new intraoral scan," you can upload it along with the revision request, or submit the request first and upload the scans later.

Whichever option you choose, you'll need to provide some instructions explaining why you want a revision, and what you'd like us to change. Then just hit submit, and you're good to go. You don't need to send in a paper form, but if you want one for your records, you can download one by clicking the revision form icon in the case history.

Revision received

If you have any questions or feedback about this process, please let us know. Until next time…

ClearCorrect now accepts intraoral scans

Now you can choose whether to submit your cases with traditional PVS impressions or go all-digital with intraoral scans. We've been testing this feature with our PREP group for a while, and now we're ready to open it up to the public.

Naturally, we won't restrict you to any particular brand or model—we'll accept scans from any intraoral scanner, as long as they're in STL format. (STL is an open, industry-standard file format that can be exported by most popular scanners.)

We've already tested scans from a wide range of scanners, including the 3M™ True Definition Scanner, 3Shape's TRIOS®, and even Align Technology's iTero™. Please do your research before you buy a new scanner, though. Confirm whether you'll be able to export STL files with your reseller or manufacturer. Some models may require a service or software upgrade to enable STL export functionality.

You'll download your STL files from your scanner to your computer, and upload them just like your photos when you submit a case online. When you do, we can start working on your case immediately instead of waiting for your impressions to arrive. We expect all-digital cases to get turned around days faster, with more accuracy.

If you don't have a scanner yet, don't worry. You can just keep doing what you're doing. We're happy to accept impressions as well.

Exporting tips

We strongly recommend that you visually inspect your STL files before you submit them to us. Our favorite STL viewing application is netfabb Studio Basic, which is available free for Windows, Mac, and Linux. Other options include MiniMagics and FreeCAD.

Some scanners output several files, but the only ones we need are the upper and lower arches. The arches should be saved in separate files, with the arches oriented in occlusion.

We prefer "closed shell" models, but "open shell" models are acceptable too.

When you scan a patient with an iTero scanner, choose the iCast or iRecord format. The Invisalign format will not permit you to export STL files.

We can't provide support for your scanner software, but if you've got any other questions, as always, your account rep is here to help.

What happened this week at the ITC?

The rumor mill has been spinning overtime, so let's make a few things clear:

  • Align has not won any of their suits against us.
  • We are still making aligners.
  • Nothing has changed.

First, a quick recap. As you probably know, our good buddies at Align have a long history of suing their competitors. This doesn't usually work out that well for them—Align has had patent claims invalidated and they've paid out tens of millions of dollars in settlements.

But old habits die hard, and they've stuck to this strategy against us. In March 2011, Align sued us in California and Texas, and in March 2012, they filed two complaints with the ITC. These cases take a long time to play out: nothing significant has happened in the California case, and the Texas case is on hold. The first ITC complaint was decided in our favor this January.

This week, Administrative Law Judge (ALJ) Rogers issued his initial determination for the second ITC complaint. His opinion was that ClearCorrect did not violate Align's product claims, but Align's method claims were violated. Naturally, we disagree with that opinion. Regardless, here's what you need to know:

  1. This is not the final ruling on the case. The ALJ's initial determination will be reviewed by the ITC before they make their final decision, scheduled for September 2013. Then that decision is likely to be appealed in the U.S. Court of Appeals for the Federal Circuit. The ultimate conclusion is probably still years away.
  2. In the previous complaint, the ITC reversed this same judge's initial determination and ruled in our favor.
  3. We don't have to do anything differently right now. There's no effect on our day-to-day operations until the ITC makes their final decision.
  4. This initial determination has been incorrectly reported as "a ruling to block U.S. imports of a competing product by ClearCorrect." We make our aligners right here in Houston, Texas, so it's impossible for the ITC to block us from "importing" them. The only "imports" at stake in this case are digital files transmitted by diagnostic technicians in Pakistan. (We've argued that data transmissions shouldn't even be considered imports.)
  5. Align's legal VP recently claimed to investors that if the ITC ruling went their way, "ClearCorrect will be excluded from the domestic market." That's simply not true. Even if the ITC rules completely in Align's favor, we can continue manufacturing and selling aligners in the U.S. The only thing the ruling will determine is how and where we can stage the treatment plans.

In short, don't panic. We're sticking around. We've just invested in scaling up our production capacity by 30%, and we've got a really cool announcement to share with you tomorrow. Until next time…

Update: Align put out a second press release shortly after this was posted, but nothing has changed. The "cease and desist orders" they refer to are just the ALJ's recommendations from his initial determination. As explained above, the ITC is not expected to make a decision until September. If the ITC does issue cease & desist orders, they will apply only to imported data—our ability to design, manufacture, and sell aligners in the U.S. is not at risk.