Greetings. Welcome to the KORU Medical Systems third quarter 2026 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Louisa Smith, Investor Relations. Thank you, Louisa. You may begin.

Thank you, operator, and good afternoon, everyone. Joining me on the call today are Adam Kalbermatten, President and Chief Executive Officer of KORU Medical Systems, and Tom Adams, Chief Financial Officer. Earlier today, KORU released financial results for the third quarter ended September 30th, 2026. A copy of the press release is available on the company's website. I encourage listeners to have our press release in front of them, which includes our financial results and commentary on the quarter. Additionally, we will use slides to support further commentary in today's call, which are also available on the investor relations section of our website. During this call, we will make certain forward-looking statements regarding our business plans and other matters. These comments are based on our predictions and expectations as of today. Actual events or results could differ materially due to risks and uncertainties, including those mentioned in the associated press release and our most recent filings with the SEC. We assume no obligation to update any forward-looking statements. During the call, management will also discuss certain non-GAAP financial measures. You will find additional disclosures, including reconciliations of these non-GAAP measures with comparable GAAP measures in our press release, the accompanying investor presentation, and SEC filings. For the benefit of those listening to the replay, this call was held and recorded on Tuesday, November 10, 2026, at approximately 4.30 p.m. Eastern Time. Since then, the company may have made additional comments related to the topics discussed. I'd now like to turn the call over to Adam Kalbermatten, CEO. Adam, please go ahead.

Thank you, Louisa, and good afternoon, everyone. I'll first begin with commentary on this quarter's business highlights before handing the call over to Tom to discuss financial results and our updated guidance. Before diving into the results, I want to make several points. KORU has an incredible opportunity ahead of it, and we are working hard to capture it. I don't want to get ahead of ourselves, but I'd like to note the following. First, we are executing on the core business. As we guided in our Q2 call, are top line growth slowed in Q3 and we are on track to deliver high teens growth in Q4. We continue to grow our recurrent patient base ahead of the market and have made business profitability improvements and are pleased with the results. New initiatives take time and we are working on some big things that could significantly expand our patient base. We are progressing the business along multiple strategic dimensions opening new geographies, getting new drugs on label, addressing new indications, and adding new technologies. If we execute on these strategic priorities, the business will inflect. I won't put a precise date on that today, but in the meantime, you should expect us to run a healthy, profitable, growing business. Now I will dive into Q3. Revenue was $11.6 million. up 11% year over year, with margins expanding to 65.2%. Our top line this quarter reflects the timing we discussed last call. Our domestic core continued to perform well, while timing in international markets moderated our growth. What I want you to take away from this quarter is not the top line alone, but the quality of the underlying results and the direction we are heading. We achieved our second consecutive quarter of positive net income, and adjusted EBITDA made tangible progress on every strategic pillar we previously outlined that will drive our next phase of growth. With our current recurring revenue scale, profitability profile, and cash balance, we will fund the business while continuing to invest in growth. This quarter, we delivered proof points that will continue to fuel our growth. We signed new distribution partnerships in both Europe and Africa. Three U.S. specialty pharmacies are now dispensing KORU products to support the home administration of Restivio. And our new drug pipeline advanced across SEIG and oncology. KORU continues to be the global leader in large volume subcutaneous drug delivery. supporting the ongoing shift toward patient-administered therapies and home-based care in healthcare systems around the world. The IG market continues to grow in the high single digits annually, and our strategic priorities remain focused on bringing more drugs onto our label and capturing even larger markets, including patients with secondary immunodeficiencies, oncology, and rare disease indications. Let me discuss each in turn. We consistently deliver above-market growth domestically, and this quarter was no exception, with $8.1 million in domestic core revenues. KORU remains the market-leading solution in the United States, and we continue to see new patient starts in existing accounts while also onboarding new accounts. a strong underlying recurrent patient profile, and our ability to win new patient starts in an expanding IG market all contribute to our consistently strong top-line results. Specialty pharmacy sales of Restigio contributed to the increase in domestic core revenues. In the quarter, three US specialty pharmacies started dispensing KORU products for the home care of the drug, two of which use the complete KORU system and one using just our needle set. We expect Restigio to drive growth within the specialty pharmacy channel as new patient starts increase. We see the total Restigio market potential growing to around 100,000 infusions over the next three to five years. Internationally, our geographic expansion strategy continues to gain traction. and I am very excited about what we are accomplished this quarter. We signed a new sales and distribution agreement with a partner in one of Europe's largest markets to further support new patient starts across multiple countries with large patient populations. We received our first order under that newly signed sales and distribution agreement and expect to start seeing the benefits in the fourth quarter. This partnership is especially beneficial because of their position as a wholesaler, home care provider, and pharmacy within the healthcare system. All these components together create an integrated service network that will now use the KORU Freedom Infusion System. This positions us for continued scalable growth, focusing on new patient starts. In another exciting international milestone, We signed a sales and distribution agreement with a new partner in Africa and shipped our initial order this quarter. This is a meaningful step in broadening our global footprint and bringing subcutaneous infusion therapy to an entirely new patient population. Each new market we enter strengthens our foundation for long-term international growth. And the momentum we are building is exactly what we hope to see. As a reminder, international markets differ in how the device supplier is chosen for the health system. In tender-based markets, pharmaceutical companies bid to supply their pharmaceutical asset, and as part of that tender, they select which device will be used to deliver it. Winning the pharma relationship effectively wins the device volumes as well. This differs from distributor-based markets where there is no central tender Home care companies and hospitals drive the device decision independently, which means growth comes account by account rather than through a single tender win. KORU is active in both models. As anticipated, while our international sales slowed slightly as we navigated our launch into a competitive distributor-based market, the opportunity for growth in under-penetrated international markets remain intense. with the help of our new relationships, we will continue to build our revenues in OUS markets. We expect fourth quarter international performance to be strong. Partnerships like the additions in Europe and Africa are laying the foundations to strategically unlock these markets abroad and efficiently. We will continue with that same disciplined approach to the international markets and we'll keep looking for additional partnership opportunities that will drive enhanced market access internationally. Turning to our pipeline. You can think of our strategy here as focused on three elements. First, bringing additional drugs onto our label. Second, enhancing our existing technology. And three, building the foundation for connected health. I'll walk through where each of these stands today, starting with new drugs and novel therapies. As it relates to new drugs on label, as mentioned before, I want to make sure we manage expectations as these are closely tied to our pharmaceutical partnerships. We continue to make progress with existing commercial and additional pharma development partners, and the opportunities that we're working on are highly sensitive and other partners. Many involve multi-billion dollar drug assets and these opportunities are highly competitive. As a result, I will only share further detail when our pharma partners are prepared to disclose more information publicly or when we have launched a commercial partnership. We do have specific updates to share on one partnership across facilitated subcutaneous therapies. As many of you might have seen, detailed results from a pivotal 2-3 trial of an investigational facilitated subcutaneous immunoglobulin 20% therapy were presented by Takeda at ECID last month. The trial met its primary endpoint, and the data showed that compared with Hycuvia, the therapy delivered the same IgG dose in half the volume with infusion times shortened by more than 40% for a single infusion site while maintaining up to once monthly dosing. This is a compelling profile for patients and it reinforces the broader industry shift towards subcutaneous administration in the home setting. exactly the trend KORU is positioned to support. On the enzyme replacement therapy program in our pipeline, another promising milestone was reached. Patients are being dosed with the KORU Freedom Infusion System in our pharmaceutical partner's phase three clinical trial for this investigational drug. It has an estimated patient population of approximately 5,000 patients. Stead consistent progress like this is exactly what we want to see as these programs advance. Another pharmaceutical partner is approaching a phase three trial of their nephrology asset with the execution of a follow-on statement of work to support international clinical trials this quarter. The drug has an estimated patient population of approximately 10,000 patients and is a great signal of the growing scope in ambition of these collaborations. As a reminder, these collaborations are designed to navigate the multi-year pharmaceutical development pathway. While they often start with KORU providing clinical trial devices, we look at them as opportunities to serve as the engine fueling our long-term growth pipeline. We have also initiated discussions and provided samples with several new pharmaceutical companies. The pipeline is building just as we envisioned. Our 510K application for deferoxamine is still under review with the FDA. As you may recall, this drug is an iron chelating treatment, and the current infusion of this drug is with the CoRoot pump, which has been used off-label in the past. We are pursuing this label independent of a pharmaceutical partnership. We anticipate it will be a contributor in 2027 and beyond. We believe clearance could come in the near term, though timing rests with the agency, and we remain fully committed to getting deferoxamine on label. We are optimistic about where we stand and are excited about the next steps. Our conviction in oncology continues to be strong, and we believe this market represents a long-term growth inflection opportunity for KORU. We are mindful that these drugs represent high-value strategic assets to our pharma partners. And while we're making progress, we cannot provide explicit commentary on the details. We plan to share further details in the first half of 2027. On secondary immunodeficiency, we continue to expect pivotal trial endpoints toward the end of 2027. Many of those trials use SCIG drugs already on our CORU label. We are tracking them closely and speaking with pharma partners so that we are ready with the right channel and approach as US indications come online. Our focus is on disciplined execution against each of these pharmaceutical programs, and we plan to update you as we reach each milestone. As you can see, has a robust pipeline backing an already strong and continuously growing recurring core business. On the internal product development front, there is a great deal to be excited about. We continue to make excellent progress on our Freedom360 Next Generation pump, and we are finishing the final touches on our regulatory submission, which remains firmly on track for the end of the year. This is a significant milestone for the company, and the team has done an outstanding job getting us to where we are today. We believe Freedom360 will be a great addition to the portfolio, especially for the patients who have doses requiring multiple pre-filled syringes. Last quarter, we highlighted the acquisition of a connected monitoring technology asset. While it is still early, we now have functional prototypes that enable productive discussions with the pharmaceutical and specialty pharma companies. We are encouraged by these discussions and believe the technology will enhance the patient experience, deepen our value proposition, and provide meaningful real-time data insights to our pharmaceutical and specialty pharmacy partners. initial feedback from these partners is enthusiastic and very positive. They are helping us shape our connected vision for the future. Stepping back, the story of this quarter is simple. A growing business that is above market growth with the second consecutive quarter of positive net income and EBITDA. A live specialty pharmacy channel for Restigio a new distribution partnership unlocking Europe and another unlocking Africa, and a pipeline spanning facilitated SCIG, oncology, and connected health that widens our competitive moat every quarter. The foundation is built, the momentum is real, and we are executing with discipline. I am proud of this team and more confident than ever in the path we are on. With that, I'll turn the call over to Tom to discuss financial results. Tom? Thanks, Adam.

During the third quarter, we delivered quarterly revenue of $11.6 million, representing 11% growth year over year. Starting with domestic court, our largest segment, reported revenue grew 32% year over year, and on a normalized basis, it grew 10%. That normalized growth was driven by higher pumps and consumable volumes, new patient starts, and market share gains, all supported by a strong underlying SCIG market. One thing to keep in mind, the prior year quarter was adversely affected by one-time distributor impacts of approximately 1.2 million, which is why the reported and normalized figures diverged. International quarter looks different, and the rest. On a reported basis, it decreased 17% year-over-year, but that's entirely due to the same one-time distributor impacts in the prior year period. Normalized international growth increased 23%, driven by new patient starts within our existing markets, so the underlying trajectory here remains very healthy. Finally, pharma services and clinical trials declined 27% year-over-year reflecting lower orders of products for use in a customer's clinical trial program. This is a smaller, unpredictable part of the business and is inherently variable based on our customers' timing of their drug programs. So to summarize, $11.6 million in revenue this quarter and 11% in reported growth. The temporary distributor purchasing activities between geographies last year had zero net effect on the total core business. which is growing solidly in both geographies. And with that, let's move to the next slide. On gross margin, starting on the left side of the chart, we delivered 65.2% for the quarter versus 60.2% in the prior year period. That's a 500 basis point improvement over the prior year. And on the right, you can see we've been consistent in improving our gross margins this year. Three primary drivers of the improvement of gross margin include, first, lower manufacturing costs as we continue to improve production throughput efficiencies, and we benefited from lower tariffs. Second, we had higher average selling prices driven by a favorable geographical customer mix, not because we raised prices everywhere, but more so it's the mix of where we sold shifting towards higher price markets. and third, which is longer term, we extended our supply agreement in the second quarter with our CMO, which secures our pricing and volume efficiencies as we continue to grow our business. Now let's look at cash. We extended the quarter with $7.4 million, reflecting cash usage of $900,000 in the quarter. We were net income positive of $200,000 The usage was driven entirely by working capital for inventory purposes, supporting our fourth quarter acceleration of revenue to higher accounts receivable balance, putting us in good shape to return to cash flow positivity in Q4. And finally, adding non-cash items of $1.2 million, primarily stock compensation and depreciation, completes this bridge. We continue to have access to our unused $10 million debt facility, which provides additional financial flexibility for incremental opportunities, and we expect to end the fourth quarter with positive cash flow. Before we close out the quarter-by-quarter detail, let me zoom out to the year-to-date picture, because this table tells the story of 2026 in one view. Continued execution across every line of the P&L. Year-to-date revenue is 35.4 million versus 30.2 million last year. That's 17% growth. And as we saw earlier, that growth is coming from both of our core businesses. Gross margin is up 64% year-to-date, up 190 basis points from 62.1%. That reflects the manufacturing efficiencies, favorable geographic mix, and the CMO Supply Agreement we walked through a moment ago. On the expense side, operating expenses as a percentage of sales improved from 70.2% down to 64% at 620 basis point improvement. In plain terms, we're growing revenues 17% while holding spending well below that pace. That's operating leverage. The combination flows straight to the bottom line net loss narrowed from 2.2 million to just 300,000, an 84% improvement, and we've had positive net income for the past two quarters. Adjusted EBITDA grew from 100,000 to 2.2 million, roughly an 18 times improvement year over year. We are now operating at or near break even on a net income basis. Cash usage year to date was 1.5 million versus $1.1 million last year. I'd flag one item there. This includes roughly $1 million for the technology acquisition and recurring expense we completed in Q2. So excluding that investment, our underlying cash consumption actually improved year over year. So the year-to-date summary delivers double-digit revenue growth, expanding margins, discipline expenses, and a near break even bottom line. With that context, let's move to the outlook. We are updating our full-year 2026 guidance across all three metrics, revenue, gross margin, and profitability. Let me take them one at a time. First, revenue. We're raising the bottom end of our full-year guidance to $48 million to $48.5 million. representing 17% to 18% growth for the year, up from the prior range of $47.5 million to $48.5 million. Three factors are driving it. Continued U.S. and international share gains in our core business, PSP revenue from both ongoing and new collaborations, and revenue from new distribution agreements besides Europe and Africa. We are seeing revenue acceleration in Q4, putting us back on track for high-teens growth in the fourth quarter and the full year. Second, gross margin. We're raising the bottom of our range to 63% to 64% from the prior 62% to 64%. The manufacturing efficiencies and step-up in margin we discussed earlier are now baked into the profile under our new supplier contract. The one variable to watch is geographic mix. As we enter new markets and channels, mixed variability can move us within that range. Third, profitability. We expect positive adjusted EBITDA for the full year, and we're raising our year-end cash balance target to above $8 million from the prior $7.5 million. The drivers, accelerating revenue in Q4 full-year cash usage coming in under $900,000 and anticipated positive cash flow of at least $600,000 in Q4 itself. I note that acquisition costs and related operating expenses for the technology assets of about a million dollars in Q2 are absorbed within these targets. So the message on guidance, we're updating guidance positively across the board. and the Q4 setup of inventory in place, revenue accelerating, and positive cash flow expected supports these numbers. And with that, let me turn it back over to Adam for closing comments. Adam? Thanks, Tom.

Before we open the call to questions, let me bring it together. Revenue growth of 11% was below where we want it to be. though this is consistent with the trajectory we outlined last quarter. International growth slowed as anticipated, and we are expecting to build back in the fourth quarter. As Tom described, the year prior year period comparison was affected by distributor timing items. Normalized for those, domestic core grew approximately 10%, and international core grew 23%. and the progress we made on our initial non-tender market arrangements gave us greater clarity as we head into the fourth quarter and we are seeing the momentum as indicated by our revised guidance. The Business Foundation is a highly recurrent revenue business, which is healthy. Gross margins expanded 500 basis points to 65.2% and we've delivered back-to-back quarters of positive adjusted EBITDA. We ended the quarter with $7.4 million in cash and an undrawn $10 million credit facility. We expect cash flow to be positive in the fourth quarter and to finish the year with more than $8 million in cash, which gives us the flexibility to keep investing in growth. We also added building blocks for the next phase of growth. We signed new distribution partners in Europe and Africa three specialty pharmacies are now supporting home administration of Restigio, and our pharma pipeline is advancing across facilitated SCIG, deferoxamine, enzyme replacement, and nephrology, alongside Freedom360 and Connected Health new product developments. All of this is anchored by approximately 60,000 chronic recurring immunoglobulin patients who rely on the Freedom system every single day. That durable, recurrent revenue base is what allows us to invest in the future. Our long-term targets remain unchanged, $100 million in revenue, gross margins above 65%, and EBITDA margins of 20% or greater. Our results this quarter, with gross margin already at 65.2%, and the second consecutive quarter of profitability, show the model is working. We are executing with discipline against each of our strategic pillars, and we will keep you updated as we reach each milestone. With that, operator, please open the line for questions.

Thank you. We will now be conducting a question and answer session. We ask that you please limit yourself to one question and one follow-up. If you would like to ask a question, please press star 1 on your telephone keypad. Confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question is from Caitlin Roberts with Canaccord Genuity. Please proceed with your question.

Hey guys, it's Michaela. And for Caitlin, thanks for taking the questions and congrats on a good quarter. Our first one is with the new sales and distribution agreement signed in Europe and Africa, can you provide some more color maybe on the cadence of 2027 international revenue?

Hi Michaela, it's Adam. Thanks for the question. We're really excited about the new sales and distribution agreement. As we think about it today, we look at it as we've done the work to execute that agreement. We've got the initial orders in place, and we're going to start delivering those in Q4. It's actually part of the reason we are quite excited about our Q4 opportunities as we've resolved some of those challenges that we highlighted in Q3 with getting the new agreement in place. As we think about 27, You know, this is certainly going to be something that we see new patients starts continuing to move forward there. I wouldn't want to call out something specific related to this new agreement as we're still trying to work through our budgeting process for 27. And we'll comment a little bit more on that towards the end of the year when we release those results. But clearly, this is something that we've been excited about as it gets into the fourth quarter here and then continuing with that growth momentum into 27 as well.

That's great. Thanks. And then maybe just a follow up. Can you talk more about the SCIG market health this quarter and what you're seeing into the fourth quarter and maybe for both domestic and international?

Yeah, absolutely. We actually just got kind of a highlight in the last week of how the overall SCIG market is doing. You know, we see continued growth there. and Joseph Pazdan. still continuing to have that healthy growth that we see in both the domestic and international market overall, that 8% to 10% on the Skig side.

Awesome. Thank you.

You're welcome.

Our next question is from Jason Bednar with Piper Sandler. Please proceed with your question.

Hi, this is Andrea, on for Jason. Thank you so much for taking the question. As we look ahead to 2027, what elements of the strategy do you guys have the most confidence in? Is it the U.S. growing above the SEIG market, growth in established international markets, adding new international markets, it seems like, or converting the novel therapies business into core?

Hi, Andrea. Thanks for the question. You know, as we think about 2027, You know, we're really relating it back to kind of the strategic pillars and growth plan that we have. We have a lot of really good things going well, not only in IG, but you're asking about some of the other PST and new drugs there. You know, we talked a bit about Restigo earlier on the call. That's something going quite well for us. We mentioned deferoxamine. That's still under agency review, but we're hoping to get some positive news shortly there. And then on the new product development side, you know, we'll be launching our Freedom 360 as we're expecting to do filing towards the end of this year and then have an approval next year as well. You know, as we noted in the prepared remarks, we're not going to comment on oncology until kind of the first half of 27. So I'm going to hold off on that. High level on the P&L. We're doing really well on gross margin, second consecutive quarter. We're expecting that to continue into 27 as well. In terms of the budgeting process, we're still in that for 27 and trying to work through those details. And we'll be issuing guidance when we report Q4 as we normally do. But thanks for the question.

Yeah, I appreciate it. And then maybe just as a follow-up, are there any assumptions that can be made for the fourth quarter just regards to the split between the U.S. and international?

Andrea, this is Tom. I'll take that question. Yeah, as we look at the fourth quarter, as we mentioned, we anticipate reacceleration with high teens growth. as Q3, as we mentioned in the last call, was sort of our trough. We expected a lower quarter in Q3, but we're bouncing out of that. And we expect, you know, really to finish the year from a guidance perspective, you know, with the core revenue. I won't get into the specifics of the breakdown by business, but we do expect the core revenue to be between 17% and 19% to finish out the year in growth.

Thank you.

Our next question is from Frank Takanan with Lake Street Capital Market. Please proceed with your question.

Great. Thanks for taking the questions and appreciate the time and congrats on the quarter. Apologies if these got asked and hop in between a few. Just wanted to think about OUS. Can you maybe just refresh us on the amount of new geographies you're thinking about launching into either between now and year end or into 2027? and then give us a feel for if those are tender markets versus non-tender markets so we have an understanding on how to think about the ramp up of those new geographies. Thanks.

Hey, Frank. You know, I'll start by saying across the board, we continue to operate both in tender and competitive markets that operate on a non-tender basis. We're overall seeing growth across all of those markets at a pretty high level, which is encouraging. When we were talking about some of the challenges that we were working through in Q3, we overcame those. And that's behind us now, right? We mentioned earlier we signed the distribution and sales agreement with a pan-European supplier. So that's going to be a partner we're working with across multiple different geographies in Europe, so different countries there. We're expecting those new orders and new patients to start coming through in the fourth quarter here and carrying into 27. As we continue to look a bit further through this down kind of quarter we had in Q3, we expect that to continue going forward. We signed another distribution and sales agreement with a partner in Africa. So you can see we're also focused on expanding outside of Europe and moving into Africa as well. We're going to see how that one goes. I'd say that was one that really came up opportunistically that we're excited about. We think there's probably going to be more opportunities for us to do this as we get into 27, but we're continuing to get our products out there, start new patients on our therapies, and really look at where are all those opportunities for us to continue going. One other thing to note is in the past, we've largely been focused on kind of the pre-filled syringe rollouts, creating that fertile ground. We're continuing to look into other areas where we could continue to expand as well, even where pre-filled syringes may not be as adopted as they have in some countries. So I'll kind of leave it at that, but a lot of things to really be excited about internationally as we continue to grow in the fourth quarter and in the 27.

Got it. very helpful and maybe I'll take a initial shot at 2027 not expecting to get full clarity but I think we've we've thought about kind of U.S. core as in the in the neighborhood of a 10 to 15 percent grower and then we've seen OUS even even with some of the the slowdown more recently still in the kind of 20 to 30 percent range do you think that's a fair working assumption as we start to build out 2027 given some of the other newer indications or maybe kind of back half of year into 2028 it's just Thank you, Adam. Thank you.

also a little bit dependent on kind of our distributors and how their inventory gets backfilled as they have their own targets that they manage as well. Internationally, that business continues to grow. I think we're going to continue to see above market growth there as well. I don't want to give a specific range there now as we're still trying to work through exactly what 27 looks like. But I think it's fair to say we're going to continue to capture those opportunities that are out there and see above market growth.

Great. Thanks for taking the questions.

Our next question is from Chase Knickerbocker with Craig Hallam Capital Group. Please proceed with your question.

Good afternoon. Thanks for taking the questions and congrats on the progress. First, Adam, maybe just wanted to start on trying to understand what you can sort of do to influence initial traction in some of these non-tender markets in Europe. Is there any markets in which you're kind of doing marketably better in those non-tender markets? I guess just kind of how international performance is kind of delineated by market, again, those non-tender markets. And then second, if you could just update us on where your current European market share is and how you see that progressing over the next couple of years.

Great question. Hey, Chase. So I'll start with, you know, internationally, we still see ourselves having a pretty large opportunity there. You know, if we were to guess our market share, We're probably in that 20% type range, give or take. That's an approximation. We're going to continue growing that into the future as we're picking up new patient starts in those markets, in those geographies. Overall, we see ourselves performing well in the overall geographies where there's a focus on the cost of overall care. where we can go in and provide an economic solution that perhaps not only saves the healthcare system some money, but also allows patients the convenience of using our products, which are a little bit easier for them to manipulate and self-administer their medications compared to some of the other standards out there, which are different market to market. We're also very focused on some of the larger markets there where we see the ability to set up arrangements with companies that kind of span the drug wholesaler, the home care provider, and the pharmacy all in kind of one form. That was something that we really wanted to do with this partnership that we just talked about earlier for a pan-European partner. We see it as an opportunity where we could streamline a lot of the things that we're going to be working with them as they're also distributing the drug. They're also providing the home care experience to train the patients and support them. So I think that's a key theme that we're going to try to look at as we continue to look at all of those individual markets and try to bring new patients with our products serving them.

Got it. And then maybe just kind of upon launch, how we should think about Freedom360 being a driver for growth. Do you think this is kind of allowing for kind of dominant share in patients on high volumes of SCIG and maybe already on the 50s? Or do you think it further share kind of across the patient continuum and allows you to kind of accelerate your share gains? Thanks.

Yeah, great question. Overall, the Freedom360, we're hearing a lot of positive feedback and excitement for it. where we're really seeing the most interest is those patients that have volumes that go across multiple different syringe volumes. It's something where it allows them to kind of swap out different syringes and have a very quick changeover without having to go through a reloading from a vial or anything else. So it really follows on the patient experience in trying to make it as seamless and easy for patients to administer their medications. as we're looking at it, it's really about launching into the US where we're seeking our first approval. That's something that standard 510K timelines are 90 to 180 days. Following that, each specialty pharmacy kind of has their own clinical evaluation protocols. The good news is we have a lot of those discussions ongoing with them, but we can't formally start those processes with them until after we have that 510K approval. looking at that as we're trying to get this in towards the end of this year. I think we're going to see some things in the back half of next year that'll help bring some additional value out there to capture.

Great. Thanks, Adam.

You're welcome.

We have reached the end of the question and answer session. I would like to turn the floor back over to Adam Kalbermatten for closing comments.

Thank you. So just want to wrap up the quarter here. Very excited with our continued progress, signing new agreements, making continued progress across our domestic and international markets. A number of new activities to be excited across on our pipeline as well. We're looking forward to setting ourselves up for a very strong close in Q4 and looking forward to updating everybody with those results.

Thank you, everybody.

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.