Good morning, everyone. Thank you for joining us at this year's Canaccord Genuity Musculoskeletal Conference. My name is Michaela Smith, and I'm on the Med Tech team here at Canaccord Genuity. I'm joined today by Carlsmed, a medical device company which uses patient data and digital technologies to create optimal surgical plans and its personalized aprevo spine fusion device for each patient. With me today is Mike Cordonnier, CEO. Thank you for joining me today, Mike. Before we begin, I want to remind everyone of any relevant disclosures which can be found on our conference and our firm website. With that said, I'll hand it over to Mike.
All right. Thank you, Michaela, thanks to the Canaccord team for having us back. This is our first time as a public company presenting, thrilled to introduce those of you that are new to the story to Carlsmed. Just to start, we're still a relatively young company, newly public. Started the company in 2018 on a mission, that mission is to improve outcomes and lower the cost of healthcare for spine surgery and beyond. What we do, which we'll talk a lot more about today, is ultimately reduce patient reoperation for spine fusion surgery. We built a preoperative, intraoperative, and postoperative technology platform to do that. With the data we'll go through, you'll see we're a rapidly scaling MedT ech company. We've operate at high gross margins.
We have great clinical validation and data that we'll go through, premium reimbursement, and in the early days, very strong customer traction. We just reported our Q4 earnings. We delivered in the Q4 north of $15 million in revenue, 76.5% gross margin with a year-on-year growth of 61% over the prior quarter in the Q4. When we look at our full- year results, we delivered $50.5 million in our first year as a public company, which is 86% year-on-year growth. With the proceeds from the IPO, we're in a very strong cash balance position, which gives us runway to cash flow break even. With our most recent guidance that we provided to the street, we're guiding to $70 million to $75.5 million in revenue this year.
Very strong growth representing 44% at the midpoint. We talked about our strong adoption. In the very early days, we grew our user base in the last year by nearly 70%, exited the year with 253 trained surgeon users rapidly adopting this technology. As we think about our commercial model, we've utilized a very traditional commercial model, which is a hybrid model.
Because we're quite differentiated, which we'll dive into, a little bit more deeply, we're able to leverage sales agents and distributors in the operating room to provide great level of service to the surgeons for the procedure and have our direct team really focus on customer acquisition, training, and support of the account, really focus preoperatively, which we'll talk a lot more about the importance of that really driving the outcomes needed for improvement in spine fusion. A lot of people know about the market. It is a giant market. We are deeply focused on the U.S. market, and we now serve two segments of this market with our recent cervical platform launch. For lumbar spine fusion, we see about 445,000 addressable procedures per year in the U.S., about 373,000 for cervical.
This gets us to a market north of 800,000 patients and procedures. Now I'll really dive into what makes us very different. We've developed what we call the aprevo® Technology Platform, and what this really allows us to do is to virtually model the patient's pathology preoperatively, create the optimal, patient-specific 3D surgical plan for that patient, including the personalized devices to achieve a very predictable outcome, give that information to the surgeon to review and approve, and then ultimately create build-on-demand personalized devices and single-use instruments for the procedure to achieve a very predictable alignment. Ultimately, we collect all post-op data from the patients, from the procedures in the aprevo® Intelligence Platform. What this does is it shows what was planned, what was achieved intraoperatively, and how that was maintained postoperatively.
That data is used to continuously train the platform, to continue to become more hyper-personalized to a patient population as well as to individual surgeons. The data speaks for itself. Very recently, our two-year data was published in the Global Spine Journal. That showed a 74% reduction in revision rate at the two-year time point for our patient population compared between the aprevo personalized surgery procedure and a traditional spine fusion procedure using stock devices. I'll give just a little bit of overview of how the platform works. Maybe if we press play. There we go. Ultimately, we take standard of care medical imaging from the patient, X-ray and CT scan data.
We take information about the surgeon, from that, we reconstruct the patient's anatomy in three dimensions and provide the optimal three-dimensional alignment for that patient based on clinical data, and create the optimal devices for the surgeon for their preferred approach and how they're trained to treat the patient. This data is then turned into the myaprevo® platform that the surgeon has to review the plan in three dimensions as well as the personalized devices to achieve the plan. It's very powerful. However, we keep it pretty simple. It shows their alignment targets, how the devices achieve the alignment targets, and the specifications for the devices that they'll receive.
Then, once this is approved, one of the recent innovations that we've launched is really our digital production system, which allows us to then produce the devices, sterile packed, and delivered within eight business days to the operating room. There's no trays, no inventory, everything's sterile packed. Then we collect the post-op data that shows what alignment was planned, how that was achieved intraoperatively, how that was maintained. The surgeon then has a dashboard of all of their patients. Ultimately, what this does is this gives surgeons a lot of confidence in really transitioning their practice from traditional spine surgery to really doing digital surgery. Bring that up several times because that is really where the magic happens, and that's what drives the optimal outcomes.
Part of adoption of any new technology really requires support from the payers, and we're in a really great position with the largest payer in the U.S., which is Medicare. Is the slide stopped? Did you fix it? All right. Well, I'll keep talking while they're fixing the slides.
Yeah, it's frozen.
I guess we can close that program and start again.
All right. I don't need the slides. It's for you guys. You know, one of the great things that we have, what we've been able to do with our technology is really take the data that we have. We submitted that to FDA to get Breakthrough Device Designation first for lumbar spine procedures. What that allowed us to do for lumbar is to get a New Technology Add-on Payment. Thank you. That was for the first three years of commercialization. We collected, continued to collect clinical data throughout the course, and ultimately submitted for permanent DRGs that went into place in late 2024 that give an incremental reimbursement for the lumbar fusion technology, for the aprevo technology as opposed to traditional stock devices.
This gives hospitals incentives to adopt this technology. Ultimately, that can improve outcomes and lower the cost of care for that patient population. All right, clicker works. We're winning. Now we started in lumbar. We have a huge amount of traction. We also recently expanded the platform to cervical. With cervical, one of the big challenges with the ACDF procedure, particularly when we look at the patient population that has osteoporosis, osteopenia, or soft bone, is that there's a high incidence of subsidence that ultimately leads to loss of correction and at the end of the day, a high rate of revision for this specific patient population.
You know, we see this about one- third of the cervical patients. We then developed a platform specifically for this patient population for the ACDF procedure, which is anterior cervical discectomy and fusion that allows us to very predictably determine the optimal alignment in the cervical spine, plan the correction for the cervical spine, and then produce patient-specific implants that fit the anatomy of the cervical. What's really unique about the cervical devices is for those that have seen a cervical ACDF procedure before, a typical interbody for cervical is wedge-shaped and requires drilling out of the end plates to place the device.
With our devices, they're wide, they fit out to the uncinate joint, which gives a huge surface area for that fits to the bone and allows a great surface area contact for soft bone. With the surgeons that are trained on the lumbar platform, it's easy for them to adopt the cervical platform because the underlying technology is the same. We take preoperative X-ray, CT imaging, create the personalized surgical plan. Ultimately, surgeon approves the plan. We 3D-print the interbody devices, sterile pack with single-use instruments delivered directly to the hospital. For the procedure itself, the ACDF procedure is very much the same as the traditional procedure. They get access, do the discectomy, this is where it's different.
They do not have to drill out the end plates and ultimately have a device that fits to the anatomy and delivers very predictable alignment. Again, we collect the post-op data for this, for every procedure, for every patient. We give the data back to the surgeons, and it really allows them access to be able to think about how to roll this out through their practice. We published our early data from our clinical evaluation at the CSRS meeting in December of last year, coincident with our product launch, that really showed our ability to deliver very specific intervertebral alignment, which ultimately will drive improved outcomes as we continue to scale. You know, just like with lumbar, it's really important to have a strong reimbursement profile. With the cervical technology, we also receive Breakthrough Device Designation.
We have a New Technology Add-on Payment that is active, that provides north of $21,000 incremental reimbursement to the hospital in addition to their current DRG payments in order to adopt this. Again, we are deeply focused on the patient population that is inpatient, typically an older patient population with osteoporotic bone. Really when we think about, you know, how we've continued to transform what ultimately spine surgery is and what we think of as a medical device company, it's really putting all of the key decision-making preoperatively using data to create a very predictable intraoperative experience. That's the deep integration between the pre-op digital planning and the post-op aprevo® Intelligence platform.
As we've continued to advance our portfolio, we think about providing access to all surgeons, so that they can provide this to their patients in the way that they've been trained to do the surgical approach. For lumbar, we initially started with anterior and lateral. For Anterior Column Realignment, we added in the transforaminal approach, initially for deformity and now with degenerative disc disease indications. Now with cervical, which just launched in December of last year, gaining very rapid market traction, we have the opportunity to support both a inner fixated approach without a plate, as well as a traditional ACDF procedure using external plate. Some of the most recent innovations that we just announced, we just completed the first posterior minimally invasive bilateral approach.
Now instead of a unilateral TLIF approach, the aprevo procedure can be done bilateral, and this allows a direct visualization, direct placement, anterior, posterior of the devices, again, using the same platform, allowing the surgeon really to improve the surface area contact significantly, and leverages a technique that is used about 8% of the total time in spine fusion today. We've been deeply focused inside the disc space, and we've had a lot of early market feedback and pull to move outside of the disc space. We just announced our CORRA personalized cervical plating platform, where we can, again, use the same aprevo pre-op planning and create the personalized alignment, the interbody devices to achieve that, as well as external plating. It's available either in a multi-level or segmental.
What this does, again, provides a zero inventory business for us. Very simple for the hospitals because it doesn't go through central processing. Everything is pre-planned, sterile packed, delivered on demand. We're really excited about this continuing to expand the already rapid adoption of the cervical platform. We really have a culture of patient-centric innovation and consider ourselves really the only pure play personalized surgery company, that really creates value, first for patients by giving a very predictable procedure, creates values for surgeons by moving the decision-making preoperatively and making the intraoperative experience very predictable and ultimately value for payers by using this technology that's going to ultimately reduce revisions, which are very costly to payers. Improving efficiency, improving outcomes of index surgery.
With that, just to wrap, and then I'll take a few questions. You know, we've grown very rapidly. We're in early days and, you know, very excited about what the future holds for personalized surgery. Thank you. Any questions from the audience?
Are you integrating any wearable technology on the post-op side?
We are not directly, but we are aware of several clinical studies that are being done with wearables that are tracking, you know, post-op recovery times.
Congrats on the growth. Looks like you're focused on cervical, but as you think about the fact that there's lots of expandable cages in the lumbar region, is that something that you're worried about?
I think it's something to continue to think about, just a bit about the procedure itself. You know, one of our, We really think about it as, you know, providing the technique and access, you know, with the TLIF and the now bilateral. You know, we can really address most all patients with a personalized approach, and I think our surgeons have been, you know, very happy with the ability to have a preplanned device that's self-distracting, that will fit into the natural anatomy of the patient. Yes.
Yes. From the picture of your product, I see some porous titanium. I'm curious about the processing technology you are having today.
Sorry, could you repeat the question?
From the picture of the spine product, there's some porous titanium. I'm curious about the processing technology you are having today. Some porous titanium. Is that what you said?
Yes. Okay. Yeah. The devices are porous, 3D printed, titanium alloy, which is very well studied for osseointegration.
Thank you.
Two questions. one, what's the lead time from when the doc orders the implant until it actually gets delivered? Number two, you guys have clearly done a really great job expanding throughout spine. Are you looking outside of spine at all? Are there any other segments you're interested or in consideration?
When we first launched, and focused deeply on teaching institutions and adult deformity, we were about eight weeks order to delivery. What we just announced, our most recent earnings call, is that we're now at six days, and we see that as material to be able to address the mass market. As far as our focus, our focus is deeply U.S. spine. The technology platform does have broader applications and, you know, we'll continue to add additional indications inside of spine before going outside of spine. All right. Thank you, everyone.