I'd like to thank obviously all of our panelists for an excellent group of talks here and certainly open it up to the audience if there's any questions. I can start us off. This is a question for the panel at large, talking about one of the more practical aspects that we deal with every day in our clinics. Obviously these are treatments that hold tremendous promise for us as physicians, but there's a huge amount of misinformation and misleading marketing that's directed directly at our patients. How do each of you address unrealistic expectations in your patients? Yeah, that's the devil's in the details, right? I think if you're doing it right as a clinician, you probably ought to feel like you're talking more people out of these procedures than into them, because there's so much knowledge that you have to share with them, and you really have to educate them. These are not normal sports medicine office visits. These are 30-minute, 45-minute new patient visits, where after your normal H&P, you then go through these orthobiologic therapies and what they really mean, and you have to see what their baseline is. More and more people are coming in very educated, which helps, but there's so much in the marketing arena that's frankly just fraudulent in some examples that we have to reeducate in a relatively short time. So it's a great point. It's something we all have to strive to do. If I can mention, these are all off-label uses of a biologic choice, if you have it, and if 20%, 25% of drugs are used off-label, it requires, as a physician, responsibility, as you said, to have that conversation with your patient in part of that consultation. I have handouts. Here are the facts. Read them when you're not so nervous in front of the doctor, but clearly, you have a good consultation. You know, you really have to be transparent and honest, and you give them the latest of the science, keep up on it, and you're more of an educator than anything else, and certainly don't expect that your patients are going to do what they tell you. I've had patients continue to go get stem cell therapies after I've given them that discussion, but then when that happens and they come back to you and they're still hurting, don't be judgmental. Don't say, I told you. But really, rather, just say, okay, well, let's talk about how we're going to solve your problem. And, Ben, I think it's important, and Mike, to be objective about your own results and also about what you know from the literature, and I give them all that information, too, and Don, I agree. I talk more people out of it than we do. Yeah, I do. I do find it helpful to give them the literature. I have printouts of some of the best articles, the VSCO steroid PRP articles for the different applications. We're giving them a real scientific background. So, obviously, a growing field, I think, that we are learning about how to best set the appropriate expectations. So, Dr. Verma, yeah, question. Sure. Guys, thanks for a great session and keeping translational, which is really what we wanted to accomplish here. Two questions. Number one is, with the recent FDA guidance, I think there will still be some companies that try to sneak by. What's the legal risk to the physician if they continue to use these products? That's number one. Maybe, Donny, you can take that. And number two is, there are still graft-based placental products that are on the market, if I understand correctly. Can you just talk briefly about the difference in the regulatory pathway and why those are still permissible? Yeah. So, great question. The FDA, two days ago, published some question-and-answer type comments. And the bottom line, to keep everyone in the room safe, an IND, an investigational new drug that's approved by the FDA, simply gives a company the ability to then study that product in humans. Companies for the last three years have been taking, well, most of them don't even have INDs, but the ones that did have been taking those INDs and saying, we can now sell this to you, the doc, and you can use it on your patient. If you're not one of the principal investigators in that IND, you cannot do that. An IRB, an investigational or institutional review board, is another, you know, word salad that companies have used as a marketing tool, saying, we have an IRB, forgetting the fact that most of those were store-bought and funded by the companies themselves. An IRB's first job, really, is to see if an IND is necessary for a product. An IRB has nothing to do with the FDA. It doesn't give any company or any clinician the right to use a drug that's not approved. And then, finally, there's been this Q-code scandal that is now a multibillion-dollar the last numbers publisher to be believed, multibillion-dollar scandal that involves Medicare. And what has happened is one couple of companies got Q-codes through Medicare, kind of did an end-around around the FDA, and got a Q-code for a product, and then used that and built a whole marketing platform saying that we have a Q-code, Medicare has approved it, we're good to go. $2,000 per cc per need. You know, that's what you get. That was not legit. The FDA was forced to come out and make some comments, and they rarely like making specific comments, but Peter Marks came out and said, yeah, that was probably a mistake, we're working on that, which is FDA code for be ready for clawbacks. So any of you in the room that have done the Q-code routine, be careful, I would stop now and be ready. And hopefully there won't be anything beyond a clawback, but I think, from what I've heard, that's going to happen. Any ongoing use of those products puts you at significant risk, puts you on the FDA radar as a clinician. They usually like going after the supply side first, but they will come after the providers as well. And check your websites, because I've had people scrutinize our website, we've got a lot of problems with ours, we're having to change. So be careful about that. If you have stem cell on your website, take it off, that's an easy, right out of the gate. Maybe one more question from the side. I was just getting ready to say, could I ask, too, this may be the wrong question to ask at a biologics meeting, but has anybody had experience with percutaneous tenotomy for all the different degenerative tendon issues? Because that's paid for by insurance. And I've been doing it for a while, I've had some really good results, not perfect, but like I said, for tendinopathies, I think that might be a good option. But I was wondering if any of the panelists had had any experience, and are there any articles out there, because I've not been able to find any, that compare the results of PRP with percutaneous tenotomy? There's not much literature on that. You can for sure do a percutaneous tenotomy under ultrasound guidance. And I was at a dinner meeting at this meeting where we talked about that. It can obviously be done. I don't know that there's any literature with and without PRP or versus PRP. And then one more, back to Dr. Verma's question, a membrane, an amniotic membrane has approved uses in orthopedics, wound care, ulcers, things like that. So that's fine to use. You can use that off-label for whatever you want as a doc. But as soon as you blend it and make it an injectable, that's where there's a problem because there's not a non-label use. J.T. Toka showed a slick little device that's an implantable, so think about it. It's an injectable membrane, okay? So it's a membrane. It has an on-label use, but it's injectable. That splits the difference, I think, and I think J.T.'s got a great idea there. Great. Thank you so much over there for coming on Sunday over here. This is a great topic. You know, I think we have to move on, so thank you. So yeah.

unrealistic expectations

misleading marketing

orthobiologic treatments

educating patients

addressing misinformation