3D Systems Corporation (NYSE:DDD) Q4 2022 Earnings Call Transcript

Blake Keating: Understood. Thank you for the color.

Jeffrey Graves: Maybe one more question, Kevin, and then we’ll cut it off. Okay?

Operator: Certainly. Our final question today is coming from Ananda Baruah from Loop Capital. Your line is now live.

Ananda Baruah: Hey, guys, good morning. Appreciate it. Just real quick. Yes, I’m going to ask one thing just given the time. But just sticking with regenerative and you’ve given a lot of rich context today Jeff, is there anything — I don’t know, if you saw as you’ve seen this, you may have because you’re in the industry now. But end of last year over in the UK, it came out that some base editing technology has been used to cure certain types of cancers. What’s interesting is the technology isn’t yet approved sort of by the managing bodies, but if you’ll find the paperwork and if you can get access, you’re able to use it. And I guess the question is, do you think — yes, do you think before FDA approval, there are certain things that certain of the things that you’re working with in regenerative or even in orthopedics, that could come to market and be used — we could see proof of concept even prior to being FDA approved, that would help people kind of lay a trail of bread comes out to where that witness is going.

Jeffrey Graves: Yes. No. It’s an excellent question, because full and formal FDA approval obviously takes a lot of time, there’s breakthrough designations. There’s the — I’m spacing the term right now, but there’s the sympathetic approvals where a patient is going to die if they don’t get the treatment. There are those categories that the FDA and similar bodies overseas has in order to allow a new technology to get to market faster. Obviously, we go through all of the work to get full FDA approval, but wherever we can get breakthrough designation or early use designation, for example, this hospital in Austria, very early use of this Kumovis technology for an implant or scaling plant, which changes patients’ life. I mean and it was — and really from our perspective of printing, it was very low risk application for us.

And it was great to get it out there and get it used, so, that all helps in getting final regulatory approvals. But to your point, and it’s a good question, is there are pathways you can follow to get early designation if somebody is going to die or for other reasons, if you have breakthrough designation that you can get it in there. Part of the reason I wanted to really form our medical advisory board was to get guidance on that is where do we have an opportunity to go for early approvals for fast-tracking any of the technologies, obviously, balancing risk with patient outcomes to make sure we gather the right data. We’re spending a fair amount of money on animal testing now, which we haven’t talked about much at all publicly, but we’re doing a fair bit of animal testing on a variety of these technologies in order to gather data to know when we’re ready to go to the regulatory bodies and then, what kind of depth we have to go to in discussion.

So, we’re going through all the right steps to get there and hopefully — and we will get them to market as fast and as safe as we possibly can. Again, the first things to market I would expect will be the pharmaceutical applications for drug discovery. What we’re producing in these vascularized chips is remarkable. The ability to keep cells alive for months is an incredible step forward and the ability then to test to develop big statistics on new drugs. So that’s our goal, and it’s soon to be our capability here. That we’ll be talking about. After that, human body applications, either for tissue or to your point, orthopedics, and then beyond that in the future, obviously, organs. That’s where we’re headed. I think it’s a brand-new history and I feel great about our leadership position in it.