Great. We're going to get started. My name is Ross Osborn of the MedTech and Diagnostics Analyst at Cantor, and today we have Organogenesis Holdings. With us, we have Gary Gillheeney and Dave Francisco. With that, Gary, you want to give us a brief background on yourself? Sure. I'm the Chairman, CEO, and President of Organogenesis. I've been with the company now for about 25 years. Organogenesis has been around for about 40 years. It's one of the oldest biotech companies in the space. And our company was formed really back in 1985 based on a spinoff out of MIT, Dr. Eugene Bell's lab, and did research all the way to 1998 when we launched our first product, Apligraf, which today is still the only product with two FDA-approved indications. And the company has continued to innovate over the years, and we've gone from a kind of below-the-knee one-product company to a head-to-toe wound care surgical organization. So it's been quite a transition over 40 years. Absolutely. Before we dive in, Dave, would you mind providing a brief background on yourself? Yeah, sure. I've been with Organogenesis for just over four years now. Before that, I spent 20 years at PerkinElmer Life Science Diagnostics and Tools Company. Great. Thank you. So maybe jumping right in to everyone's favorite question around the Physician Fee Schedule. Any updated thoughts here since we saw the initial proposal? How are you guys preparing for this, assuming it goes through January 1? So clearly a big change in the industry. It's really a watershed moment. Probably the biggest change in our space in over a decade. So we certainly support a lot of the points. We've lobbied for a lot of the components that are actually reflected in that proposed rule, which is one is to balance and have consistent reimbursement across sites of care. So all of the ASP sites of care, the doctor office, long-term care centers, home, and the outpatient setting now have consistent reimbursement. So it allows the patient and the doctor to treat where they best can get product and where the facility works best for that patient. So that's a huge change. The per square centimeter reimbursement in both sites of care, which means they're unbundling in the HOPD setting, is an enormous change, a real positive change, in my opinion. The tiers that CMS identified based on FDA classifications, they clearly identified PMA products as being clinically differentiated and recognizing that, as well as 510(k)s and 361s as three separate tiers. So we think that's a real positive step forward that just gives more access to PMA products with proven FDA indications that all patients will now have access to, where they really did not have access to that in certain sites of care based on the reimbursement model. So an enormous change, we think, for the better, better for patients, better for the market. It will bring stability to the market, eliminate the ASP plus 6 model, which has brought a lot of challenges to the space. The good news is the market has expanded. Since from 2021 to 2024, the market's doubled in volume, which is good. That means patients who really do need advanced care are getting it now, like in long-term care centers. Unfortunately, the costs have gone up by a multiple of 10, while the volume has gone up a multiple of 2. So with all that disruption now, should leave the market. There really is no financial incentive to use one product over another. It'll be based on clinical efficacy, service, and the overall brand support, which is where we live. That's the world we live in. So we feel very comfortable that a stable market is ahead of us. Great. And then I guess maybe to a lot of folks in the room, could you walk through your current product portfolio, areas of strength, maybe areas where you would like to grow or provide incremental data? Certainly, if the physician fee schedule holds, our PMA products become extremely valuable both to the patient and to the company. The relaunch of Dermograft, which we've announced with our facility expansion at Smithfield, Rhode Island, is a PMA product. That's certainly very positive for us. Our burn portfolio, which includes TransCyte, which is a PMA-approved product, will also be manufactured at our new site in Smithfield. That's exciting. We certainly will continue to build our surgical bag. As we move down the path with our ReNu product, if approved, we'll certainly be building out that channel as well. Great. And then I guess ahead of January 1, what does the second half of this year look like? Do you think physician behavior changes ahead of the PFS going through, assuming it goes through as is? Or is the second half going to be reflective of the first half in terms of product mix? I think I'll defer to Dave here. Yeah, sure. Obviously, the first half was pretty challenging for us, and we knew it, right, so I think we guided in a certain way. We executed against plan. We came in within those ranges in the first half. We always anticipated that the second half would be stronger, and there were a couple of things there: less disruption, customer disruption related to the LCD moving from go-live dates, and then also, we launched some new products in the second quarter, and those really gained momentum at the back half of the second quarter. That's continuing into the third quarter, and we expect to see that through the back half. The only thing we do anticipate is a little bit more pricing pressure as it gets to the end of Q4, because there'll be inventory on the shelves of some of these companies that'll be trying to move that forward before the 1/1/2026 deadline. So we've incorporated that all into our guidance. Great. And then you mentioned new product launches. Could we run through Vimatrix how that fits in your portfolio? I believe you launched in June, so early learnings there. Yeah, that's one of them. We launched two, actually, and both of them are gaining traction. So again, one of the reasons why we think the difference between the first half and the second half will be pretty strong. Great. And then how does that fit into your broader product portfolio Vimatrix? It's a dehydrated product, so it's one of the options that we've got in the portfolio. Those are the two that we introduced in the back half, which are both dehydrated products. They have different attributes, but they've got a place in this marketplace. So we're excited about the traction we're getting so far. Great. And then maybe switching to surgical and sports medicine side of the business. What's driving growth there? It seems like an exciting opportunity for you guys. Yeah, it really is. I mean, we grew 16% in the second quarter and 13% for the half. So we are excited about what we're seeing there. There's really kind of three things going on. One is we continue to see nice uptick in our PuraPly brand between the antimicrobial, the SX product, which we built specifically for the OR, and then the MZ, which is a particulate product. So those are doing well. We also launched Signature Matrix, so it's another opportunity to have a dehydrated placental-based product in the portfolio. And we also have launched an initiative within the commercial organization to have hybrid reps. So they're going both into the OR and advanced wound care centers. So that's added some value there too. How does the hybrid rep model play out over time? I guess what's a runway there versus completely having to bifurcate? The benefit is you're just following the doctor. So you've got the relationship with the doctor. You can either go to the wound center or you can go to the OR. And so we've seen some good traction from that. Perfect. And then maybe switching gears to ReNu. What's the latest update there? We finished the second phase three trial, and we expect to have the top-line data by the end of this month. If it's successful, we had a successful first phase three trial, as you know. If it's successful, we expect to file the BLA application by the end of this year and have approval by the end of 2026, one year. We would expect to commercialize the product in the second half of 2027 after we get coding and get on formularies, particularly with the commercial payers. We would expect to see traction in the second half of 2027 if it's approved. Got it. So assuming approval, what does that commercial launch look like? Will you guys need to generate incremental data? What is the sales force needed to commercialize that product? We certainly think we want to commercialize the product ourselves, so we'll have a direct sales force. Now, how we get ourselves into that channel, it could be that we build it. It could be that we acquire it, so we're looking at all options, certainly acquiring a channel, maybe the fastest path to revenue, and potentially add to the pain bag as well, so we think that that's certainly the optimal way to go, but if that's not an option, then we'll probably build our own sales force, which we think would be about 150-200 sales reps starting out. Got it. So what does that marketplace look like in terms of competitive offerings? Who do you think you can displace, or are you guys growing the market? It's an interesting market, the pain space. So today, the algorithm is NSAIDs, physical therapy, steroids, then hyaluronic acid is kind of the last resort before total knee replacement. Unfortunately, the gap in time with a lot of patients who are receiving hyaluronic acid and when they can get a total knee replacement is a long time. So it's a challenging time for them. So we think, if approved, that we would be attacking that hyaluronic acid space. And we're happy to be even after the hyaluronic acid assets if necessary, if that gives us better pricing, which it could. The further along you are in the algorithm and there's no other options, it gives you a bit of an opportunity with good data to get some better pricing. But the hyaluronic acid and after they've exhausted hyaluronic acid is where our space is, where our sweet spot is. Perfect. And then maybe touch base on the balance sheet. How are you guys feeling about it? Yeah, really good. So obviously, we did utilize some cash in the first half, but with $70-some-odd million of cash on the balance sheet and our forward-looking ability to generate profit in the back half, we feel quite comfortable with it. And then looking to 2026, what excites you the most? The PFS schedule excites us the most, quite honestly. A stable environment, competing on efficacy, competing on brand is a place that we like to live. Our portfolio is developed differently. Dehydrated amnions really dominate the market, but our portfolio is built on these stages of healing from the inflammatory stage all the way to the remodeling stage. We have products in each stage, and that's how our algorithms and how our reps are trained. And we have dehydrated as well as living technology, depending upon the comorbidities of the patient, the need. So we have the broadest portfolio, but it's not just similar products in a broad portfolio. It's different technologies. So we cross PMAs, 510(k)s, 361s. We think that's the right way to treat the patient. We think that's the right way the market should be looking at companies and portfolios that can solve all of the stages of healing, so not to get into the stages of healing too deeply, but the first stage is the inflammatory stage. Most wounds stall in that stage, and you can't move on to healing until you get out of it, so our PuraPly antimicrobial product prevents the reformation of biofilm and bioburden in the wound so it can move on to healing, and many times it will heal if they have other comorbidities in the patient where they need additional products or all the way ultimately to a living technology to get that wound to heal. We have it. Great. And then any questions from the audience? Great. If not, and lastly for me, any update on your RCT progress? Yeah, it's moving along. So we expect to have a publication by the 1st of November. And so that's in line with the expectations. And so we hope to have PuraPly available on the LCD in the 1st of January. Yes. Great. Looking forward to it. Well, thanks for being here. Appreciate the time. Thank you for the invitation. Appreciate it. Thank you. Thank you so much. Thank you.