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DATE
Nov. 5, 2026
CALL PARTICIPANTS
- Chief Executive Officer - Randy Mills
- Chief Financial Officer - Matthew Ferguson
TAKEAWAYS
- Net Sales -- $1.1 million, growing 20.4% year over year driven by increased performance in the cardiovascular business.
- Adjusted Gross Margin -- 85.5% versus 81.3% during the same period last year, excluding noncash amortization of intangibles.
- Research and Development Expense -- $3.0 million, representing a $1.9 million increase driven by investment in the NXT-41 and NXT-41x product development programs.
- Adjusted EBITDA -- Loss of $5.6 million compared to a loss of $3.4 million, reflecting higher spending on value-creating clinical and regulatory initiatives.
- Cash and Cash Equivalents -- $29.1 million as of Sept. 30, 2026, which does not include an $8 million payment received on Oct. 1.
- Total Nondilutive Funding -- $26 million, secured through three transactions over 51 days to fund operations through the anticipated first full year of commercial launch.
- Avenue Capital Loan -- $10 million, part of a $15 million facility with an additional $5 million available upon regulatory clearance of NXT-41x.
- SimpliDerm Sale Proceeds -- $8 million, received at the closing of the business divestiture to Cellution Biologics on Aug. 17, 2026.
- Boston Scientific Holdback -- $8 million, released from escrow on Oct. 1, 2026, without deductions following the 2025 sale of the bioenvelope business.
- Cardiovascular Segment Revenue -- $1.1 million, reflecting 20% growth year over year and a 65% increase for the first nine months of 2026.
- Cardiovascular Adjusted Gross Margin -- 85%, reflecting the segment's high profitability during its ongoing divestiture process.
- NXT-41x Revenue Capacity -- $300 million, supported by an automated drug-coating system positioned for commercial production.
- Target Gross Margin -- 80%, projected at scale for the NXT-41x product line due to manufacturing efficiencies.
- Sales Territory Plan -- 16 territories, targeting the primary United States markets that account for approximately 50% of the breast reconstruction market.
- Bacterial Eradication Study -- 0 viable bacteria, recovered from NXT-41x samples in a study challenging the matrix with an 8-log challenge of 100 million MRSA bacteria.
- Gram-Negative Performance -- 100% eradication, achieved against a 6-log challenge of 1 million E. coli bacteria in worst-case GLP study conditions.
- Antibiotic Coverage Duration -- 30 days, designed to provide localized protection through the critical period of surgical drain removal.
- Reported Infection Rates -- 17.6% to 23%, in women undergoing immediate implant-based surgery according to data presented by independent investigators.
- Antibiotic Failure Frequency -- 19.3% infection rate, in a study where all 419 breasts were treated with perioperative and postoperative systemic antibiotics.
- NXT-41 FDA Clearance -- Expected in the fourth quarter of 2026, serving as a regulatory foundation for the drug-eluting NXT-41x platform.
- GAAP Gross Margin -- 61.7%, an increase from 52.8% due to favorable product mix and segment performance.
- Net Loss -- $1.3 million compared to $3.9 million, as results were offset by income from discontinued operations related to business divestitures.
- Operating Loss -- $6.9 million versus $5.9 million, reflecting a shift in resources toward regulatory submissions and clinical validation.
- Potential Milestone Payments -- $3 million, contingent on technology transfer and commercial targets related to the SimpliDerm divestiture.
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RISKS
- Mills warned that because the company is dealing with a complex product and the Food and Drug Administration review process, the estimated regulatory clearance dates are projections rather than fixed timelines.
SUMMARY
Elutia Inc. (NASDAQ:ELUT) reported its third quarter financial results and provided a regulatory update regarding its lead drug-eluting program, NXT-41x. Management stated that the company secured $26 million in nondilutive capital through debt financing and asset divestitures, which is expected to fund operations through the anticipated commercial launch of NXT-41x in 2028. The company reported revenue growth in its cardiovascular segment while completing manufacturing preparations for its upcoming Food and Drug Administration submissions. Management indicated that the company is focusing on the development of its antibiotic-eluting biologic matrix to address unmet needs in infection prevention for reconstructive surgery.
- Management reported that extending systemic antibiotics beyond 24 hours does not effectively reduce infection risk at 30, 60, or 90 days.
- The company has initiated the recruitment process for sales leadership and direct representation for 16 major United States markets.
- CEO Mills noted that while 25 surgical matrices were showcased at the American Society of Plastic Surgeons meeting, none offered a commercial solution for infection.
- NXT-41x is designed to provide localized antibiotic elution through day 17, when surgical drains are typically removed.
- CFO Matthew Ferguson stated, "spending is shifting toward the programs that are creating value" as litigation costs decreased and development investments increased.
- The company reported significant interest from multiple parties regarding the divestiture of its cardiovascular business line, which remains on track for 2026.
INDUSTRY GLOSSARY
- NXT-41: A biologic surgical matrix designed for tissue reconstruction without an antibiotic coating.
- NXT-41x: A drug-eluting biologic matrix that delivers localized antibiotics directly to a surgical site.
- GLP: Good Laboratory Practice, a quality system for conducting non-clinical safety studies.
- MRSA: Methicillin-resistant Staphylococcus aureus, a bacterium that is resistant to many common antibiotics and causes surgical site infections.
- E. coli: Escherichia coli, a bacterium that can cause serious infection and sepsis in surgical environments.
- 510(k): A premarket submission to the FDA demonstrating that a medical device is safe and effective by comparison to a legally marketed device.
- VAC: Value Analysis Committee, the hospital body responsible for reviewing and approving new medical products for purchase.
- Acellular Dermal Matrix (ADM): A surgical mesh derived from human or animal skin that is processed to remove cells while preserving the extracellular matrix.
- Bioenvelope: A specialized surgical product used to hold implanted medical devices while delivering antibiotics to prevent infection.
Full Conference Call Transcript
Operator: Good day. Thank you for standing by. Welcome to the Elutia Third Quarter 2026 Financial Results Call. [Operator Instructions] Please be advised that today's call is being recorded. I would now like to hand it over to our first speaker, David Cherniak. Please go ahead.
Unknown Executive: Thank you, operator, and thank you all for participating in today's call. Earlier today, Elutia released financial results for the third quarter ended September 30, 2026. A copy of the press release is available on the company's website. Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the federal securities laws, which are pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that do not relate to matters of historical facts or relate to expectations or predictions of future events, results or performance are forward-looking statements.
All forward-looking statements, including, without limitation, those relating to our operating trends and future financial performance are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements.
For a list and descriptions of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our public filings with the SEC, including Elutia's annual report on Form 10-K for the year ended December 31, 2025, and in our subsequent periodic reports on Form 10-Q and current reports on Form 8-K accessible on the SEC's website at www.sec.gov. Such factors may be updated from time to time in Elutia's other filings with the SEC. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, November 5, 2026.
Elutia disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements because of new information, future events or otherwise. Also during this presentation, we refer to gross margin, excluding intangible asset amortization, which is a non-GAAP financial measure. A reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure is available on the company's financial results release for the third quarter ended September 30, 2026, which is accessible on the SEC's website and posted on the Investors page of the Elutia website at www.elutia.com. And with that, I will turn the call over to Elutia's CEO, Randy Mills.
C. Mills: Thank you, Bernadine, and thank you all for joining us today. It is an exceptionally busy and exciting time for us at Elutia, and I'm eager to get you up to speed on our progress. Here's how we'll spend our time. First, the need. It is serious and the lack of attention being paid to it by industry is astonishing. Infection was a major focus at last month's meeting of the American Society of Plastic Surgeons in Houston. It came up in every one of the 11 breast research sessions, yet there were no commercial products addressing it and no company on the exhibit floor was talking about a solution. That market dislocation has created a tremendous opportunity for Elutia.
Second, we'll review the great progress the team is making on NXT-41X. Our key GLP antimicrobial study met its predetermined endpoints. Surgeon feedback on the actual product was very favorable and NXT-41X is set to head to FDA this quarter. Then Matt will walk you through how we funded ourselves through launch without an equity offering. He'll also cover our cardiovascular business and its remarkable growth, take you through the third quarter results and end with the milestones ahead. Then we'll open the line for your questions, including the milestones ahead, including some that were actually brought in by you. Let me start with the need because that is where everything at Elutia begins.
Infection in plastic and reconstructive surgery is common. It is serious and it remains unsolved. Over the next few slides, I'll show you what surgeons themselves presented on at this year's national meeting because their data and insights make the case better than we ever could. The ASPS meeting was in Houston last month and to me, one of the most astonishing things that stood out above the rest was infection. There were 11 scientific sessions devoted to breast research. Infection risk and prevention were discussed in every one of them. Of the 135 research presentations, 70% or 52% addressed infection. Infection wasn't only covered in the research sessions, however.
The conference included an entire course called 28 years later, current strategies in salvaging the infected implant. Think about that. Surgeons have been fighting implant infection for decades, and it is still one of the biggest problems plastic and reconstructive surgeons face today. The data presented at the meeting were sobering. Investigators from UCSF reported on 1,094 breasts that underwent immediate implant-based surgery. In women who did not receive chemotherapy before surgery, 17.6% developed an infection. In women who did, it was 23%. That is nearly 1 in 4. A second study from Miami Cancer Institute looked at 419 breasts. Every one of those patients received antibiotics before and after surgery and 19.3% still developed an infection.
These are leading centers following current best practices and infection still approaches 1 in 4. And in most cases, these are women who are already fighting cancer. Think about that. So why not just do what we normally do and give patients more antibiotics because it doesn't work. A 20-year multicenter study presented at the meeting answered that question definitively. It looked at 4,647 patients across 170 health care organizations, extending antibiotics past 24 hours did not reduce infection at 30 days, 60 days or 90 days. And the biology explains why. Systemic antibiotics travel through the blood and mastectomy closes off the very blood vessels that would carry those drugs to the surgical site.
You can give more drug but it can't get to where it needs to go, which brings me back to what struck me most in Houston. In the session rooms, in the hallways at the receptions, surgeons were focused on infection, 70 presentations across all 11 breast research sessions. Then I walk into the exhibit floor and found a sea of commodity surgical matrices. There were literally 25 on the market and none are demonstrably different from the next but no commercial offering for infection. No one was even talking about it. On one side, you have surgeons and their patients living with this problem. On the other, an industry that hasn't offered them a solution.
That gap is the unmet need. It is the reason Elutia exists, and it is exactly what we intend to fix with NXT-41X. Now let me turn to how we intend to close that gap. NXT-41X is our lead drug delivery program. Our key GLP study is complete. Our manufacturing is set for commercial production, and we plan to submit NXT-41X to FDA this quarter. Let me walk you through where our programs stand. We currently have 2 product development programs and both are on track. I want to be clear that they are on separate submissions on independent time lines. First, NXT-41, our biological surgical matrix without drug. The 510(k) is submitted.
The review is progressing as expected, and we anticipate a clearance decision this quarter, and we have every reason to believe it will be favorable. However, it is largely academic at this point. NXT-41 has already done its job, which was to discover and answer FDA's questions about the base matrix. We have no intention of commercializing NXT-41. It broke the regulatory [indiscernible] for NXT-41X and everything that we learned from it has been built into the NXT-41X platform. The more material submission is NXT-41X, our lead drug delivery program. Our key GLP study met its predetermined endpoints, and we plan to submit NXT-41X to FDA this quarter.
From there, we anticipate a clearance decision in the second quarter of 2027, a commercial soft launch in the second half of 2027 and a full commercial launch in 2028. That timing reflects our current expectations and is, of course, subject to FDA review. But all in all, it is a very busy but exciting time in R&D and regulatory. This is the study that supports our submission, and it is pretty cool. In a GLP rabbit implant study, NXT-41X met its prespecified performance endpoints. We challenged it with MRSA, a drug-resistant gram-positive form of the most common pathogen in breast surgery, staph aureus.
And we then challenged it with E. coli, a particularly nasty gram-negative rod that can cause serious infection and lead to sepsis. And we didn't make this easy. We put the bacteria on the uncoated side of the matrix away from the drug and we added a lot of them. The MRSA challenge was 8 logs. That is 100 million bacteria. The E. coli challenge was 6 logs, 1 million bacteria. Both represent far more contamination than would normally be present in the operating room, creating true worst-case conditions. So the results after 7 days of implantation, we recovered 0 viable bacteria from the NXT-41X samples and surrounding tissue, 0. Contrast that with the matrix without antibiotics.
Every animal implanted with the matrix alone developed fulminant colonization by those same pathogens, 0 versus 100%, pretty cool. Data matter, but the surgeon's opinion matters, too, since they are the ultimate decision-maker. While we were in Houston, our NXT-41X surgeon steering committee met in person and their feedback on the design, handling and performance of NXT-41X was both informative and very positive. And while we talked about a number of different product attributes, 2 really stood out as the difference makers. And I wanted to share them with you since this is how a surgeon takes a look at a product like 41X.
They put it simply, it's about the drug being in the right place at the right time. The right place to them means powerful antibiotics that are uniformly distributed across the entire surgical site, that's exactly where systemic antibiotics fail to reach. The right time means 30 days of coverage. Why? Because that carries them through drain removal, which usually happens somewhere around day 17. It was simple and it was a powerful message for us to hear and it was gratifying for the team since that's what we designed NXT-41X to do. And we're ready to make it. Our automated drug coating system is set for commercial production.
It gives us at least $300 million in revenue capacity at launch and is designed to support a gross margin above 80% at scale. That matters for 2 obvious reasons. First, we certainly don't want to be supply constrained if the product is launching. Second, we want to be able to make money with this product and the margin profile we wanted was built into the manufacturing process from day 1.
So when you take a step back and you look at it, I hope you can see what we're creating here, a product for a true unmet medical need, one that already has been proven with our own technology that our own technology can answer and one that we can make money with. And we have the capital and team and intellectual property to see it through. And with that, I'll turn it over to Matt to close out and then be back with you for Q&A.
Matthew Ferguson: Okay. Thank you, Randy, and good afternoon, everyone. I'll start with our balance sheet because over the last 3 months, we did just what we said we would do. We added $26 million without an equity offering. We believe that funds Elutia through the anticipated clearance of NXT-41X and the first year of commercial launch. On our August call, we named 3 near-term funding milestones, and I'm pleased to report that all 3 are now complete. First, on August 11, we closed a $15 million loan facility with Avenue Capital Group. We received $10 million at closing and an additional $5 million becomes available following NXT-41X FDA clearance.
Second, on August 17, we closed the sale of our SimpliDerm business to Cellution Biologics and received $8 million at that closing. We're also eligible to receive up to $3 million in contingent technology transfer payments over the next 18 months. Third, on October 1, Boston Scientific released the full $8 million holdback from the 2025 sale of our bioenvelope business. That was with no claims and no deductions. Together, that's $26 million in just 51 days. That was a busy couple of months. We also have additional sources of capital that we expect will contribute to our runway.
There's a $5 million second tranche from Avenue Capital and up to $3 million in SimpliDerm milestones as well as proceeds from a potential cardiovascular transaction should that happen. As one of our remaining legacy businesses, I'd like now to focus a bit more on our cardiovascular business. Third quarter revenue there grew 20% year-over-year to $1.1 million. And for the first 9 months of 2026, revenue was up 65%. Third quarter adjusted gross margin was 85%. This business is performing well, but it is ultimately not where the company is going, where we're going as a company. As we've previously discussed, we've been pursuing a divestiture of this product line.
We believe the sale makes sense for the company, both as an additional source of nondilutive capital and to provide strategic focus as we get closer to the launch of NXT-41X. We've had significant interest in this asset from multiple parties and the strategic process remains on track. Now turning to a brief summary of our financial results. All the figures I'll go through are for continuing operations compared with the third quarter of 2025. Net sales were $1.1 million, up 20% from $0.9 million. Gross margin on a GAAP basis was 61.7% compared with 52.8%. Adjusted gross margin, which excludes noncash amortization of intangibles, was 85.5% compared with 81.3%. Total operating expenses were $7.6 million compared with $6.4 million.
The increase was driven by $1.9 million of higher research and development spending on NXT-41 and NXT-41X, partially offset by a $0.7 million reduction in net litigation costs. In other words, our spending is shifting toward the programs that are creating value. Loss from operations was $6.9 million compared with $5.9 million. Net loss from continuing operations was $6.5 million compared with $1.0 million. The prior year figure benefited from a $5.1 million noncash gain on the revaluation of warrant liabilities. Adjusted EBITDA was a loss of $5.6 million compared with a loss of $3.4 million. Reconciliations of our non-GAAP measures are included in today's press earnings release.
We ended the quarter with $29.1 million in cash and cash equivalents, and that balance does not include the $8 million -- $8 million Boston Scientific holdback, which we received 1 day following the end of the quarter on October 1. To close, here's where our capital is funding. We had 3 funding catalysts that are now behind us, the Avenue loan, the SimpliDerm sale and the $8 million Boston Scientific payment. Six catalysts lie still ahead. This quarter, we expect an FDA clearance decision on NXT-41. We plan to submit NXT-41X to the FDA, and we have the potential to complete a cardiovascular transaction. In the first half of 2027, we anticipate an FDA clearance decision on NXT-41X.
A commercial soft launch follows in the second half of 2027, and our full commercial launch hits in 2028. And in closing, I'd like to mention a couple of investor events that are coming up. The first is a fireside chat with Dr. Al Hassanein, Associate Professor of Plastic Surgery at Indiana University. Dr. Hassanein is a pioneer in local antibiotic delivery for prevention of infection risk in breast reconstruction. He's also very knowledgeable about our development process for NXT-41X and its most salient features. This event is taking place on November 20 and is being hosted by Frank Takkinen of Lake Street Capital Markets.
This event is open to Lake Street clients, so please contact Frank if you're interested in attending. And the second event is the Annual JPMorgan Healthcare Conference in San Francisco. We'll be hosting meetings there in our own space on January 11 and January 12. If you'll be there and you'd like to meet with us, please e-mail ir@elutia.com. And with that, operator, please open the line for questions.
Operator: [Operator Instructions] First question will come from the line of Frank Takkinen from Lake Street.
Unknown Analyst: This is [indiscernible] on for Frank Takkinen. Congrats on the quarter. I have a couple of questions for you guys. First, could you talk a little bit more about the barriers to entry in IP that you think will protect your competitive position? It would be interesting to hear where you think the strongest defenses exist, whether that be regulatory, product design, manufacturing know-how or a combination of all of the above. Any color would be appreciated.
C. Mills: Yes, Sam. So when sort of you look at the question of so why can't competitors come in and do this, there are two fundamental reasons that prevent that from happening. The first is we have built a very substantial intellectual property platform. Some of that we have chosen quite intentionally to keep as trade secrets. Some of that we have filed patent protection on, and actually, we continue to file and add patent protection to.
And while the idea of a drug delivery matrix is nowadays beyond patentability itself, we think the features that we have designed into 41x that we have intellectual property protection around that we have patent protection around are actually going to set what's going to be the only acceptable standard going forward and give us some really very meaningful protection in the marketplace. That's one. Two is the reality of it. It's been 25 years infection has been known to every relevant player in this field for the past 25 years, and no one's done anything about it. And the reason they haven't done anything about it is because it's really, really hard to do.
Our team here makes what we do look really easy. They are a group of flatout geniuses that have solved some very complex problems with some very sophisticated solutions. And sometimes perhaps I gloss over it a little bit too much, Sam, and almost make it sound too easy. It is not easy. This product platform has taken us 6 years to get to where we are today. And so even if there were somebody that we're going to decide to get involved in it, it is a long hard road to figure out how to get powerful antibiotics to uniformly elute off of a biological matrix in a delivery form that surgeons will accept.
And so we feel very, very confident that we have both an intellectual property and a regulatory barrier to entry that is going to keep us pretty much alone in this market for a while.
Unknown Analyst: That makes sense. I appreciate it. And then one other one. Once NXT-41X is submitted, how should we think about hiring expectations in advance of approval? I mean, how large of a commercial team will you hope to have in place at the time of the launch? And then maybe for Matt, in light of that, any initial thoughts on how we should think about OpEx going forward without SimpliDerm and the ramp-up investments in front of 41X?
C. Mills: Yes. So I'll do the play by play here. Matt will do color commentary on the financial implications for it. But Sam, at the end of 2027, heading into full -- the first full year of launch in 2028, we anticipate having the top 16 territories covered. The top 16 territories in the United States give us access to approximately 50% of the breast reconstruction market. We intend to do the vast majority of that through direct representation. We will use 1099 to fill in some of the spaces in between, but we really want to own the major markets. You may have seen -- I know we have gotten questions about and our HR department is flooded with applications.
We have started the recruitment process for both sales leadership as well as direct sales representation in these markets. The plan is, by the way, not to bring them in too early, but to identify the best candidates in the markets that we need and go through the proper according and vetting process to make sure that we're onboarding them when the time comes. So that recruitment process has started, but we don't anticipate it bringing on a real heavy share until really the second and the third quarters.
We don't have any need to bring them on too early since at least the third quarter of next year, if everything is on schedule, the third quarter of next year is going to be an exercise in VAC submissions. And sometimes VAC submissions are like watching paint dry, and there's no sense in having an elaborate and expensive commercial force sitting around with nothing to sell. So 16 is where we're going with that with the appropriate sales leadership. But we're not going to go crazy with it. We're not going to add too early. We think we're going to have great visibility into the 41x regulatory process as we begin to do that.
So if there is an unforeseen change in the time line, we'll have the ability to adjust. But that's the plan for the year, Sam. And do you want to talk about money?
Matthew Ferguson: Sam, yes, I think a lot of what Randy talked about really is the -- are the indicators for what spend will look like. And those relate to the concentrated market that we're entering into, the fact that there's no change to the physician workflow. So the sales cycle should not be particularly long, and we're really going to be standing alone in terms of offering a product that there's a great need for in the market right now. So all of that, we believe, translates to what should be a pretty rapid ramp once we launch with high gross margins and a relatively small organization, commercial organization needed in order to serve that market.
What that ultimately translates to, we're going through our 2027 budgeting process right now. So it's a little bit too early to speak in specifics. But our goal really is to not have our burn rate change that much if we go through next year and actually start launching the product. So we'll see how that plays out. We'll have a little bit more specificity that we probably can offer on our next call. But we feel good about where we are and the cash that we have in the bank and the ability for that to fund us through the launch of 41X.
Unknown Analyst: Awesome. I appreciate that. And then just one more. On 41X, what is left to be completed prior to the official submission? Is there any outstanding testing that could take a little longer? Or are you pretty much just packaging the final submission packet?
C. Mills: Yes. The heavy lifting testing for 41x is now complete. And what I mean by that are the pivotal performance studies, the studies that are the large animal studies that can go on for 6 months or longer. The product is up on stability testing now. This is when we do the final actual commercial-grade manufacturing of the product, take it through the entire cycle and then test it over periods of time for shelf life. That will be an ongoing program. And so that will actually -- that will actually continue to run, we hope, long after approval of the product as we continue to extend the date.
But the stability program is just an ongoing study that will continue to happen. The rest of the data for the product is done or is being packaged, but we have no more studies ongoing. So [indiscernible] around some of these things. We're talking about all GLP studies that are done for every one of these things. Every one of them requires numerous types of sign-offs from the contract testing laboratories that do them in order to meet GLP processes. And so those types of things take a little bit of time. They come in. It is a massive submission. So it's something -- it's thousands and thousands of pages.
And so it is a big deal for our team to put together. I'll make it sound really easy, but nothing big outstanding at this point, Sam. That's why we're pretty excited about it.
Unknown Analyst: Congratulations on the progress so far.
C. Mills: Thank you.
Matthew Ferguson: Thank you.
Operator: And now I'd like to turn it back over to Randy for closing remarks.
C. Mills: Okay. Thanks. And we actually are going to try something out here that I really like and that we received a number of questions ahead of the call and too many to go through. But I thought I'd take a couple of them and answer them, and this is something we'll do on future calls. So on a future call as long as you get your questions to us ahead of time, we'll be glad to throw it into the queue. Now a lot of questions we got -- basically, I'm going to pick a couple of questions here that were the most commonly asked questions because there seems to be some confusion around those things. That lies with me.
That's on me. So I need to do a better job communicating these. So let's start with the first one, which is, please clarify the time lines for NXT-41X and how they relate to the 41 regulatory process. Well, first, I hope that what we had in the presentation helped a little bit there and describe that they're both on independent tracks. I think that's the first really important point, 41 and 41X are on 2 separate development pathways. 41X is not dependent on NXT-41. So we will file 41x as soon as that regulatory file that Sam just mentioned is complete and it's ready to go.
So some sort of sub-questions like that, well, it seems like it's probably going to take like 9 months for 41 and we're anticipating 6 months for 41X, how do you reconcile those? Well, a couple of things. First is just to clear up some things on the timing of 41. 41 was submitted by us in February, but it actually wasn't accepted into FDA until later in March, believe it or not. And that is when they started their review clock. So just so everyone knows, there isn't -- it isn't taking some unusually long time. The FDA just gave themselves a little bit of time to check our 510(k) submission into their process. They're friends.
With regards to 41X, I also think it's important to say that we're anticipating a second quarter submission. Why? Because we don't have any big studies to do. We're not waiting on any data. So we think the second quarter is the most likely time. We think they're going to ask us some questions in the first quarter. We think we'll be able to answer those questions in the second quarter and have our clearance in the second quarter of that year. But you have to know that's an estimate. It could be earlier. It could be as short as 3 months and sometime come in April, maybe. It could come in sometime in September.
So it's our best guess at it, but there is certainly a range around it. We're dealing with a really complicated product, and we're dealing with the Food and Drug Administration. So I wouldn't be setting your watch by the exact day, but it is our best guess at this point on when it would be. So thank you for that question. A lot of the people who submitted it. And I hope that clarified some of those points. Okay. One more question, and that centers around the cardiovascular products, our process. So where are we on the sale of the cardiovascular business? If it's not sold, what are the plans going forward? This is a great question.
We have a great product with our cardiovascular product. In fact, it is the Cadillac of products that are out there for cardiovascular repair. It is a very sticky business. It is one that you've seen in our reporting. It's not just maintaining, but it's actually experiencing some very healthy growth since it returned back to the company from LeMaitre, and it has exceptional gross margins, right? So this is a product with 80%, 85% gross margins. We make money with this product. So as you would expect, we have received interest in it, but here's what we're not going to do. We're not going to do a bad deal.
If we have a serious acquirer that will complete a transaction, that could have value for us -- well, we'll have value for us, obviously, in terms of the cash that we bring in, but also value in terms of strategic focus, then we would do that. And we will do that as soon as we would be ready to do that deal, right? So if that happens this quarter, then we're ready to go. But we're not going to rush to get a bad deal done. I was just saying a friend of mine taught me, if you want a deal done badly, that's how you'll get it done.
And we're not in a rush to do it because it's a great business and it's a growing business. And frankly, it's not that big of a headache and it's not a distraction for us. And so it is a milestone that we will meet, but only if we end up with the transaction that makes sense for us to do. So I hope that clarified it. I encourage you to ask questions and submit questions ahead of time. We'll have information about how to do that in the next press release. But it's kind of fun. I like it.
And lets me know what you're thinking about and what you're worried about and frankly, what I'm doing a bad job communicating on. But with that, I think we are done, and I will turn it back to the operator to close the call.
Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.
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