OrthoFX Co-Founder Talks New NiTime Clear Aligners

Alison Werner  

Hello and welcome to the Orthodontic Products podcast. I’m your host. Alison Warner, today I have with me Ren Menon, president and co-founder of OrthoFX, with over 20 years of experience in the clear aligner industry, including as global head of product and innovation at Invisalign for over a decade, Ren launched OrthoFX to innovate the aligner space. He’s here to talk about OrthoFX’s latest innovation. It’s NiTime, clear aligners, which changed the game when it comes to patient wear. Ren, thank you for joining me.

 

Ren Menon  

Thank you for having me. Alison, I’m looking forward to this conversation.

 

Alison Werner  

Well, to get started, I introduced you a bit there. But can you give our listeners a little more on your background in orthodontics and the clear aligner industry?

 

Ren Menon  

Oh, absolutely. Is it okay if I cover my team also?

 

Alison Werner  

Yeah, absolutely.

 

Ren Menon  

Okay. So OrthoFX was founded in 2018 from a founding day perspective. But a lot of the thought around OrthoFX and the problems that we were solving have been percolating in the industry since the very advent of this industry and since 1997 the team that I have is pretty much the team that built a lot of the founding technologies, foundational technologies in the space, starting with the polymers. Loc Phan is the inventor of the aligner polymer, and also the inventor of the most used polymer in the category, and the present generation polymer used by other brands. A trilaminate aligner material, which goes by brands like Zendura FLX and things like that. So he’s my co-founder. My other co-founder, Henry Chan, is the software pioneer that enabled a lot of things that are taken for granted today in this industry, including how you visualize a treatment plan moving from end to end, also called ClinCheck, by a brand name, if you may. But that capability, the combination of these two capabilities, the polymer and the software, enabled this industry, and we decided to come together in 2018 to create the next big step change in the category that we felt was needed, which we will get into NiTime as the example of the manifestation of that thought. But that’s the team behind this. There are several others. Collectively, we have about 200 years of R&D experience, product development and product launch experience. It’s a true team of insiders and innovators behind OrthoFX.

 

Alison Werner  

Great, so you mentioned that we’re going to talk about NiTime, but OrthoFX launched in 2019 correct? So what were you looking to bring to the space at that point?

 

Ren Menon  

Yeah. So OrthoFX launched. We were founded in 2018. Our first polymer got its approval in 2020 so in general, we wanted to bring about three changes, Alison. The first change that we wanted to do was to improve the polymer substantially to address the two unmet needs. One is predictability. Treatments were not tracking to the plan. You will see these plans on the 3D software, but in reality, those plans will not ever end up there in the promised time, and also will require a number of reboots. It created significant disruptions for the practice. An article published by AJODO by Dr Neil Kravitz, shows that 94% of treatments require some form of a reboot or a refinement. So it’s one of the lack of predictability is one of the founding unmet needs that we are trying to solve. The second thing that we were solving for is fitness or fitment within the patient’s lifestyle. Yes, aligners are a significant improvement over braces, but the fact that you’re to wear them for 22 hours a day and very unnatural for people to do that. People want to wear the aligner as minimally as possible. Ideally, we could invent a pill that you could take and then suddenly the teeth would get straight, perfect. Unfortunately, we’re not there. The best option that we have is an aligner that people can wear minimally, and also something that stimulates the biology of the bone to be able to accommodate that lesson wear time. So predictability, need for compliance, friendly solutions. And three, the need for an all in one solution where orthodontists can get all their needs addressed, for example, the need for financing, that need for remote monitoring, all that addressed from a single login and a single patient list. These are the three things that we wanted to invent in the world and we wanted to bring. We started with parts of it in 2020 with completing our rounded out portfolio in 2023 with the launch of NiTime at the AAO Meeting in New Orleans this year, earlier this year.

 

Alison Werner  

So let’s talk about NiTime clear aligners. This aligner is different from others on the market. Can you talk about those innovations that make it unique?

 

Ren Menon  

Oh, absolutely. So. This is the first and only aligner system that is FDA cleared for nine to 12 hours of wear, compared to traditional aligners that require up to 22 hours. Many of them are required. Some patients are required to wear it 24 hours, and as I was sharing earlier, Alison just a big disruption in somebody’s lifestyle. So this allows the sort of wear time, allows people to eat, drink, talk, hassle free, like we are doing right now. If you’re wearing a traditional liner, you lisp. It also creates the traditional aligner because of its design, because of the excessive forces it exerts up front. Traditional aligners exert a lot of force up front, and almost all the force disappears within three days. This means that those forces are really loaded up front, which means that patients have to endure a lot of pain. Many of them are on what is called a Tylenol diet the first few days as they get used to the aligner. So we wanted to make sure that these things are addressed with the NiTime aligner. And the way we are doing it, as you correctly point out, is through product differentiation. It is through a patented hyper elastic polymer with Air Shell Technology. This design is created to produce sustained optimal forces throughout the duration of the wear compared to the other aligners used in the category. Okay,

 

Alison Werner  

So can you talk a little bit more about that hyperelastic polymer and how that works, and then we’ll talk about the air shell polymer separately.

 

Ren Menon  

Yeah, no, I’d be delighted to so if you look at hyperelastic, hyperelasticity is a property where stress and strain remain consistent over long distances. So in other words, it’s not linearly or exponentially progressing like you would experience with a garden spring, where you stretch it more, it creates more stress, more stress, and then it gives out. What is needed is a flat curve on the stress strain curve, or a material that do not obey the Hooke’s law, which says that stress and strain are linearly proportional for some materials. So our intention or desire was to design a polymer that disobeys Hooke’s Law, and hyper elasticity is a function of that behavior as this as displayed by the NiTi wire in the braces world. So it is. It basically the aligner adjusts to the natural position of the tooth movement. And even in cases of slight deviation from plan, where it can deviate the stress strain curve, it is still able to exert the same force toward the duration of the moment that is required from that aligner. So if you think about the construction of the aligner, this is also where we have your close to 150 patents in different aspects of this aligner manufacturing, Alison right, from the design of the polymer to the manufacturing process that is involved. So the aligner itself has a flexible inner shell that has that is designed to follow the teeth closely. Think of it like a foot wrap if you made fits the align the teeth perfectly. That way it’s always engaged, which also means that you need fewer attachments, which is another benefit of this aligner. And then there’s a harder outer shell, which is made with a different polymer blend. And the aligner is just bonded at the edges, at strategic points, with a pocket of air in between, acting as a flexible transmission mechanism of that force so you air accommodates to to account the air moves to accommodate the shape of the tooth, or where that the deviation is, but at the same time maintains a constant pressure. That way the teeth that are moving respect to the position it’s in are able to always get that same constant force throughout the movement of that aligner. So this technology is what we call hyperelasticity, and the resulting property then creates a biologically friendly mechanism of tooth movement, which then allows the aligner to deliver the same results with far fewer hours of wear versus what is done with competition.

 

Alison Werner  

Okay, okay. And so now, can you talk about that air shell polymer you mentioned a little bit there. But how does that compare to a traditional clear aligner material?

 

Ren Menon  

Yeah. So if you think of a traditional clear aligner material, think of it as a single shell, where it has multiple polymers stacked together, but at the end of it, it’s still a single shell, if you may, like, you know, like this, like, like this. …

 

Alison Werner  

Just for the people who are listening, you’re holding up, like a piece of paper.

 

Ren Menon  

Yes, a piece of paper. And these papers are all fused. It’s all fused together into a single sheet of paper, okay? And it’s the entire forces distributed on that one surface, as opposed to what we have done. And the property that it’s able to deliver is limited to that one surface. What we are able to create is an infinite number of possibilities, because we use a flexible inner shell for contact or fit, and force producing outer shell, which then uses air, which is what creates these infinite force point and I would say, infinitely optimized force points, because each point has the only the required force, and no more, because the outer shell is maintaining the memory of the where what the force should be with the air acting as a conductor. So this is where the multi shell design is revolutionary and path breaking in its ability to deliver just the right forces for each point to every tooth, to make sure that we stimulate the right biological mechanism within the body.

 

Alison Werner  

Okay, so what specific malocclusions can NiTime aligners treat and can it handle complex cases?

 

Ren Menon  

Oh, absolutely. You should have seen our case presentation at the AAO meeting where two of our KOLs showed some very impressive cases, including some surgical cases, some cases of cases of all complexity and different indications, open bite, deep bite, class 2s. It is able to handle a wide range of cases. This is not just me saying it, but also you can see, look at the results. And also, this is also, FDA has cleared us based on a study that we did with over 6,000 data points that showed that the treatment indeed is efficacious for a wide range of cases. So our clearance is for all indications and for all teeth. So yes, it can handle everything from the most complex, the longest treatment, to the extremely simple.

 

Alison Werner  

And then, you know, patients are wearing this for less time. But is there any impact on the time in treatment?

 

Ren Menon  

No, absolutely not. So that’s something that we were really keen on our design parameters Allison, because an easy way out would have been to slow the velocity of the deep moment and then try this aligner, saying half the moment, so where half the time I am sorry, but that approach the body doesn’t work that way. That is a failed approach that was employed by some DTC companies, which is an absolutely irresponsible way to go about this innovation. With us, the treatment velocities are the same. You can test this out yourself, if you’re a doctor, by switching out the polymer, even at the last step where you approve the treatment plan. You can go from one polymer variation to the other at the same but also it’ll be the treatment plan assets as it was originally. There’s no change to that treatment duration because you change the polymer. So know that change is not by changing the treatment velocities, but by changing the very mechanics of how aligners move teeth. We stimulate bone biology differently to be able to create a shorter treatment time, which is foundationally and fundamentally different versus how competition approaches deep moment.

 

Alison Werner  

Okay? And then when it comes to treatment planning, what is the orthodontist experience and how does technology play in that process?

 

Ren Menon  

This is a great question, because if you think about aligners, I was just using this analogy with my team all the time. It’s like, if you think of a treatment plan that’s kind of like the playbook, and the polymer is the player, if you may. So just like you need both Bill Belichick and Tom Brady to win multiple Super Bowls, you need both, and you can see individually, they were not that great. So a treatment plan has to be designed and can’t be a great complement to the polymer. So our treatment planning approach is based on where we had the good fortune Alison to build our software platforms in the 2000 20s. Their AI could be used as a foundational approach on how technology and data can be leveraged. So you can see many of our treatment options include a retainer, which is we are using surveys to collect closed loop data, and then we are looking at the right patterns that results in the best outcome for any given scenario. So our treatment planning is initially guided by AI, where a certain treatment planning methodology is recommended. The design is then optimized by orthodontists, and then the treatment plan is completed and delivered to the doctor for their review, which means that when they see a treatment plan, they can hit Accept on it the first time with minimal number of back and forth needed, but if back and forth are needed, we have the ability to for them to do it themselves, if they want to. We have access to 3D controls. And if you are just extremely savvy in your clinical or picky in your clinical philosophies, it includes CBCT integration and all the advanced tools that you need if you’re not, if you are preferring a simpler, guided approach. We have options for that too, where you can turn on and off those features to be able to let us drive that, or have you drive that. So we customize the interface based on your preference and your expertise.

 

Alison Werner  

Okay, so what feedback have orthodontists and patients shared about the shorter wear time and kind of that overall experience with the NiTime clear aligners? (I keep wanting to say night time) NiTime clear aligners?

 

Ren Menon  

Yeah, I think the feedback is a couple of angles. One is the clinical angle of the feedback. I think in general, orthodontists like, you know, let’s be honest, many of them leaned in with the mindset of, let me give it a try. I’ll believe it when I see it. I am pleased to report that nine out of 10 orthodontists have used our platform, have continued to use it. Our churn rate on the orthodontist side, especially clinically minded orthodontists, have been very, very low, and you can look at the numbers on our refinements on seats. It’s a fraction of what the other industry players are offering today. The other aspect that is interesting, beyond the clinical aspect, is the patient comfort and patient preference aspect. Eight out of 10 patients, we are presenting the 22 hour side by side with a nine hour or a NiTime proposition. You are eight out of 10 patients, select the less wear time option. And here’s the kicker, they’re willing to pay up to 20% more for an aligner that they can wear fewer hours because it fits with their lifestyle. So what does that mean for the practice? It means offering a differentiated, premium product to drive patients to just those offices, plus create more revenue per sale. So this has been a clear winner, and we have data that shows doctor after doctor where, if they are following this approach to selling, they’re able to generate more revenue per sale than what they’re doing today, plus more patients come to those practices. We’ve looked at the CAC, the cost to acquire a customer for this proposition versus others. And again, this is about a fourth versus what you are able to get with traditional aligners. So in general, you know, if you have fewer refinements, fewer unplanned visits, an aligner that fits with your lifestyle, an aligner that patients love, it means that you’re going to get more referrals and better CSAT ratings, which all translates into better practice growth while reducing your unplanned visits, or improves improving your efficiency, which means better operating margins. So yeah, this is a bit of a this is, in my opinion, the way to think about this market, as opposed to what has been happening, which is a race to the bottom. No, that’s not the way to go about it. I keep repeating this the key, I think price competition is the least creative and the laziest way to compete. Real, original innovators compete on differentiation because they know the value that they bring to the practice or the value that they bring to the patient, and we are the perfect complement to a differentiated thinker, someone who’s truly interested in practice growth through maintaining or increasing prices. Is, as opposed to competing with a practice down the street on price, not the creative way and not the sustainable way for you to go, because that number can go down to zero. As you know, it’s a race to the bottom. Do not compete in that market, is my humble opinion.

 

Alison Werner  

So, how can doctors find more information about offering OrthoFX in their practice?

 

Ren Menon  

Yeah, thanks for allowing me to do a plug, if you may. Doctors can find information about OrthoFX by visiting orthofx.com There’s product information is included there, including some of the aspects of what I talked about. They can also sign up as a provider by choosing the join our network option on the website. You could also, yeah, it’s a button that’s just prominently there on the top right. We can also use social media for doctors. Just visit our LinkedIn page and just send us a DM . We’ll be able to take care of you, connect you to our training and onboarding team within 24 hours. They’re also on Instagram and Facebook, if you would like to see the work that we are doing on there, because a lot of the work that we are doing there is repeatable. We can provide you access. When you become a member with us, you get access to a marketing library of assets, which then helps you create time-relevant content that is prone and can generate traction. So all that’s available to you as a part of our All In One philosophy,

 

Alison Werner  

Great, I’m going to ask one more question, because you brought up something there about onboarding and training. Can you talk a little bit about that experience for doctors who are joining with using this?

 

Ren Menon  

Oh, absolutely, we have. Our approach in general has been to make that as seamless and as easy as possible, most of our orthodontists self onboard, they would be like, yeah, the button was here in that other platform, and that button is over here. The reason we recommend onboarding is not to get you started. You can start a treatment, a patient and a treatment plan with no guidance, but where, if you want to discover the bells and whistles, if you want to really take advantage of the power features of the platform, that is where the onboarding helps, and usually it is done over a one to two hour meeting. We also try not to load up too many things, because we have built a lot of things, it’s very feature rich. We try to create a pathway where we are. We are exposing a few relevant parts of the platform, or over meetings or a 90 day period. And then there’s reinforcement. We are also a CE education provider Alison, so if there is anyone interested in CE courses and things like that, we have it available online. That’s also a capability that comes free and included with our platform.

 

Alison Werner  

Great. Well, Ren, thank you so much for joining me and for talking us through the NiTime Aligner system. Appreciate it.

 

Ren Menon  

Yeah, thank you for having me. And this was delightful. You made it so easy on me and so stress free. So I appreciate you doing that. Thank you for being kind.

 

Alison Werner  

Good, good. Well, look forward to having you back with the next innovation. So thank you so much.

 

Ren Menon  

Indeed, thank you so much. 

 

Alison Werner  

As always. Thank you for joining us. Be sure to subscribe to the orthodontist products podcast to keep up with the latest episodes, and be sure to check out orthodontproductsonline.com to keep up with the latest industry news until next time, take care.

 

Transcribed by https://otter.ai