Carlsmed, Inc. Common Stock Bank of America SMID Cap Virtual Conference
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Hi, everyone. Thanks for joining. Just wanted to come on to say welcome. Thanks for joining one of the sessions of day 2 of our Small and Mid-Cap virtual event. Great opportunity to hear from corporates across the small and mid-cap space where our analysts have really great breadth of coverage, about 1,000 small and mid-caps that they cover in the U.S. Feel free to reach out if you need the schedule for the rest of the day, any additional sessions you want to join. But wanted to pass it over to Travis.
Thank you. Hi, everybody. Travis D, the MedTech analyst here at Bank of America.
We welcome Carlsmed up next. We've got the full team, Mike, Leo, and Stephanie recently joined as investor relations. Maybe I'll turn it over to you, Mike, and maybe start with an introduction, the business, for those unfamiliar with the story here.
Thanks, Travis, and thanks Jill for having us today. Really thrilled to be here. Just a little bit about Carlsmed. We are an AI-enabled MedTech company and really founded on a mission to improve outcomes, decrease the cost of healthcare for spine surgery and beyond. We developed this Breakthrough Technology designation that allows us to take imaging from patients, data from surgeons, create a 3D virtual model of the patient's spinal pathology, the optimal 3D surgical plan for that patient, and then the perfect fit three-dimensional devices that are 3D printed that go into the disc space of the patient and create three-dimensional alignment. We received this Breakthrough Technology designation for lumbar spine fusion as well as cervical spine fusion. With our platform technology, we've been able to meaningfully improve outcomes in this patient population.
What's really unique about our business in the MedTech space is that we are digital first. We actually have no inventory, and so we're able to model the surgery digitally, build-on-demand the devices specifically for the surgery, and collect post-op data for every surgeon, every patient that continues to improve the platform.
Maybe to lay the groundwork, what are some of the biggest challenges with traditional spine surgery today, and whether for patients, surgeons, hospitals, payers, all the different customers, if you will, and how you're uniquely positioned to solve those problems?
Yeah. When we started the company, we were narrowly focused on this really big problem with spine surgery in that, particularly for complex spinal deformity surgery, it's really difficult to create a three-dimensional surgical plan that the surgeon can implement in surgery and the patient can maintain that correction post-operatively. Traditionally, for that patient population, there's a really high revision rate. This is a challenge for patients, it's a challenge for surgeons, and ultimately, it's a challenge for payers because these are really expensive procedures. What we've been able to do is to build a different kind of business where we're deeply focused on delivering the right surgical plan for the patient and the surgeon, and build those devices specifically for that patient, for that surgeon.
What we've been able to prove is that we've improved outcomes and ultimately, lowered the cost of treating that patient population.
One of the things that helped validate the approach here is the clinical data you've published and generated. Maybe for especially those newer to the story, walk through some of the clinical findings and how surgeons have responded to the evidence that you've built.
When we talked about our deep focus on patient population, we've done most of the clinical data studies on the most complex patients. We look at adult spinal deformity. These are patients that have a complex curvature of the spine, very degenerative disc spaces. With our technology, we're able to restore alignment and actually deliver the alignment in the disc space. Most recent data that was published in The Global Spine Journal showed for patients that received our technology with the 3D surgical plan, the 3D fusion devices versus traditional spine fusion, that there was a 74% reduction in reoperations in that patient population. That's really significant tool that's now available for surgeons to deliver to their patients.
How should we think about the market opportunity that you're addressing today and whether procedure volumes and growth, et cetera?
When we look at the market, we play today in two distinct but similar markets, lumbar spine fusion, cervical spine fusion. We look at both of these markets right around 400,000 addressable procedures, which takes us north of a $10 billion market opportunity in the U.S. With our early stage, we're growing very rapidly and continuing to train surgeons, accelerate hospital access so that we can make this available to all patients.
When you think about the difference between lumbar and cervical, anything different to call it from a commercial perspective or clinical perspective?
Absolutely. The great thing about the market itself is there's a really large overlap, hospitals, surgeons that perform both lumbar and cervical fusion procedures. For the markets themselves and the clinical benefit, there's a lot of overlap in our technology. We started with lumbar. We just launched cervical in December of last year. With lumbar, our lumbar platform using the AI-enabled medical device to automate the surgical plan, the patient-specific model, we're able to actually precisely deliver 3-dimensional alignment, which is really important for giving a stable construct that maintains durability post-operatively. For the platform for cervical, we really engineered it focused on patients with poor bone quality, which is a really big challenge with the ACDF procedure, that a large percentage of patients have poor bone quality.
We're able to not only personalize the alignment, but engineer each individual device in a way that supports the fusion with a very high surface area that puts it in a great position for fusion, even if the patient has compromised bone quality. Early clinical experience with that's been really phenomenal because surgeons now have a tool for this more challenging patient population in cervical.
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