If you can just take the opportunity to go through maybe an introduction of the company and what are some key long-term growth drivers.
I would love to. co-founded Carlsmed in 2018 really with a mission to improve clinical outcomes and reduce the cost of healthcare for spine surgery and beyond. We built this technology platform that allows us to take preoperative data about patients, data about surgeons, create a three-dimensional digital model of the patient's pathology, the optimal surgical plan, and then 3D print all the devices that are needed for that surgery. It's a really different business model for a med tech company. We have a AI-enabled platform that allows us to do everything digitally for the surgery first, and then custom-make 3D printed devices for that surgery. We've developed this platform now for lumbar spine surgery and most recently cervical spine surgery.
What do you think that maybe the market is still underappreciating? 'Cause obviously it's a very clearly differentiated story.
Well, it's super early days, you know, we recently published our two-year outcome data on the lumbar platform showing that by using the aprevo platform, surgeons can reduce the revision rate for patients for lumbar spine fusion surgery by 74% at a two-year time point. It's really phenomenal because it's the first technology for this patient population that's meaningfully improved outcomes. When we talk about our mission of improving outcomes, reducing the cost of care, we're able to really achieve both of those because these are typically patients that are expensive for the healthcare system to treat, and by eliminating revisions, we're saving significantly dollars to the healthcare system.
One of the key drivers for us is to continue to broaden access to this technology. Really pleased about the preliminary inpatient rule that CMS put out.
That allows for us to broaden access and ultimately provide a very simple way for hospitals to get reimbursed for this technology.
Just since you are about two months out from the anniversary of your IPO, what has been the most positively surprised you and maybe over the next 12 to 24 months, how would you rank maybe surgeon adds, utilization, hospital access, mix, product attachment, how to think about those key growth drivers for you?
Well, one of the things that going public allowed us to do we raised just over $100 million in the IPO. It really allows us to reinvest in our core growth drivers and get us to a near-term path to profitability. With that, we think about our core growth drivers in operational excellence, commercial execution, education and clinical data, and we have a lot of exciting things that we've done just in the past few months since we've been public. For instance, we recently announced with our technology that we've built, we've been able to reduce the turnaround time down now to six days from initially when we went to market at eight weeks.
What that really allows us to do for surgeons that are trained is to deeply integrate into their practice, so that they can provide this to the broadest set of patients possible.
You're broadening out with corra and your cervical platform in 2026. What's changed most over the last year, and where do you see the biggest opportunity and gives you confidence in that, like scaling those products as well?
Thanks for bringing up corra. Our core technology platform, aprevo, has really been focused on taking patient data, surgeon data, turning that into three-dimensional surgical plans as well as the custom 3D printed interbody fusion devices. We've now been able to expand that to corra, where we've just done the first-in-human procedures. We're on track to launch in Q4 of this year, and this is our first foray into personalized fixation. With this, we're moving outside of the disc space.
have created a really robust platform where we can not only design the surgical correction and the interbody fusion devices but also fixation, which in this case is single level and multi-level cervical plates.
In order to provide a stable construct for that patient, through their fusion process.
Maybe also just to beyond the current cervical rollout, how should we think about maybe the next wave of products and platform that you can also expand your ecosystem with?
We've really broadened the ecosystem since we started. We started very narrowly focused with adult spinal deformity. Focused on teaching institutions, and we've created a very great solution for that for these long construct procedures. With our recent additions to the platform, we're really able to expand this to short construct procedures, which are typically degenerative disc disease procedures. We announced our first-in-human procedure with the posterior bilateral, which we can focus a minimally invasive procedure to actually increase the surface area of perfusion from the posterior in a bilateral approach, and we're on track to launch that in the fourth quarter. We see meaningful upside adoption for personalized surgery in 2027 and beyond with these growth catalysts.
It coincides really well with this preliminary ruling that Medicare put out, that would make reimbursement simpler for this procedure and really allow us to accelerate account access to this technology.
Maybe to double-click on the reimbursement, got a big bump with the proposed DRG, 523-525. Can you just sort of maybe walk us through the incremental benefit to either adoption and also pricing, and then maybe a little bit on what percentage of your patients are inpatient procedures and all that?
Would love to. T his is really for the aprevo lumbar procedure, and as we think about this procedure today, again, the majority of the value being done pre-operatively, where we can create the three-dimensional plan and then create the devices. What the new DRG allows us to do is to expand access to this technology and provide a very favorable reimbursement to hospitals for inpatient use. When we look at our patient population for lumbar, it is predominantly inpatient, and that is where we are focused, as well as for cervical. With cervical, we're in a very favorable position. We received Breakthrough Device designation for that from the FDA and currently have a New Technology Add-on Payment for inpatient procedures.
That's where we really see the predominance of the patient population for the cervical procedure, particularly for the Medicare-age population that has softer bone, that a personalized fusion device and procedure can really eliminate a lot of the common causes of revision, like subsidence.
Maybe how much of that benefit or potential upside could we see in 2026 and in 2027 if that goes through as proposed to guidance?
Well, we believe. For the IPPS ruling for the new DRG, you know, we see this as beneficial to hospitals that don't yet have access to this technology to make it very simple to understand not just the clinical benefits of adopting this technology, but also how this plays into the economics of the hospital which we anticipate to be very favorable and, you know, most importantly, to expand access to patients to this technology.
Since you reported your Q1 earnings had a very strong quarter, raised the guide by more than the beat. What did Q1 tell you about your underlying demand, and then what gives you confidence to maybe sustain that demand?
We feel really good about our performance, you know, for the prior three quarters since we've been a public company, and particularly in Q1. This was our first full quarter of the cervical launch, and we saw much more rapid adoption of the platform, particularly for surgeon users that are already trained on the lumbar platform. We outpaced our own expectation for new surgeon adds, and that really gives us a lot of confidence in our guide that we gave and our ability to continue to drive well above market growth with our technology.
You talked about the inpatient procedure with corra and cervical launch ramping. What has just been early adopter feedback, and how is that driving deeper utilization within the accounts as well?
Early feedback's been really phenomenal and really proud of the team for how we pulled this together. The cervical utilization, what we've really found is that with this personalized fusion technology, that surgeons are able to achieve very predictable alignment. This novel design that we came up with, which has wider implants that provide a very large surface area, have a very simple procedure intraoperatively because the devices themselves are tapered and fit anatomically and self-center and really give a alignment inside the disc space to the cervical spine.
Not typical, for this procedure.
As we see this continue to roll out some of the micro trends in the early days that we've seen is the ability to use this in a single level as well as a multi-level approach to deliver a very predictable alignment and continuing to work with some of the thought leaders on how this can be used to improve alignment algorithms for a broad patient population that suffers with cervical disc disease.
M aybe just the last couple minutes, switching over to margins and paths to profitability. Where do you think the biggest incremental margin upside could come from you? Obviously, you have a very asset-light model, so very attractive, but I think you've sort of on your recent convos to the public have seemed more constructive on a path to cash flow breakeven as well. Anything to signal there?
Key assumptions?
As we previously reported, we made a lot of investments in our technology, in our infrastructure, in our supply chain in order to drive the scale, that we're really building as a company. With that, with those technology advancements we've seen year-over-year more than a 200 basis point improvement in gross margin .
As we continue to roll out, next generation of our technology platform, we'll continue to see opportunities to maintain very high gross margins, which allow us to get to near-term profitability on the capital on hand. W hen we look at our core capital deployments today, across R&D and operations, and our professional education we're seeing sustainable growth that we anticipate will get us to be able to be cash flow breakeven in the near term.
Very exciting. Well, thank you for joining us, and thanks for a nice chat.
Thank you, Gracia.
To Bank of America for giving us the opportunity to present. My name is Joe DeVivo. I'm CEO of Butterfly Network, and I look forward to either introducing you or giving you an update to the overall story. We are a point-of-care ultrasound business. Point-of-care ultrasound is bringing ultrasound to where the patients are. Instead of a patient having to go into the hospital and have a radiology exam, doctors are educated to use a device, nurses, wherever the patient is, in the hospital or in the alt site, in the home, doctors would carry these devices to be able to manage patients. It's a whole new way of reducing the cost of care, democratizing ultrasound, because about two-thirds of the world doesn't have access to medical imaging.
They don't have that beautiful hospital where you just go in and get the overall image. We are bringing. Can I have the clicker? If you don't mind. We are a semiconductor-based ultrasound device, so that semiconductor acts very much like a TV screen, where we are able to program it to deliver all different types of sound dynamically. About 20% of patients with serious conditions are first misdiagnosed. About 80% of diagnostic dilemmas can be solved with simple imaging. The initial assessments with imaging results in changed medical diagnosis if they're imaged right up front. That means, like, at your primary care doctor. That means when you engage, instead of them taking your symptoms and then making, you know, the best decision with that data, giving them more data.
It's like we were the stethoscope salespeople 40 years ago who say, "Hey, Doc, it might be good for you to listen to the bowel sounds, listen to the fluid in the lungs, listen to the heart.
Now we're giving them a device that's only several thousand dollars to be able to see inside the body when they see the patient, and it's having massive impacts around the world. The way it works is, you know, supercomputers used to be huge. Now we all carry one in our pocket. Well, ultrasound machines are huge.
Now doctors and nurses are gonna be able to have a device in their pocket, and it's all made possible by the development of the semiconductor because whether you look at the heart, whether you look at the lungs, MSK, peripheral vascular, you would typically need a different probe for each one of those applications, or What we have now is the ability to just identify what part of the body you would like to scan, choose that part of the body, and then the settings of the chip change to be able to deliver the type of array and frequency necessary for that part of the body. What we are to classic ultrasound is what digital photography was to film. We are revolutionizing ultrasound through digital, the digital acquisition.
Ultrasound will do back-end digital processing, but they don't capture the image in a digital form where they can change and dynamically change those settings. It's a very, very powerful tool, and we're making a lot of progress. Much so that we're actually getting noticed in the world. We're getting noticed in You know, we are on The Pitt, we were on, just recently on Survivor, and then Virgin River, that I never watch that show, that's my wife's show, but she got excited when this particular person had a lower right quadrant pain and had to diagnose an appendectomy. Butterfly is making its mark in healthcare. We have over 150,000 devices sold to date. There are doctors in all different types of walks of life that have them for all their different use cases.
Now we're becoming a verb, "Did you Butterfly that patient?". It 's really a strong type of adoption, now we're working with large institutions about institutionalizing this into the main component of healthcare. As individual doctors walk around with individual ultrasound devices, in order to make this work for hospitals, they have to be able to capture the scan. We're one of the only companies in the only medical companies in the world to ever receive an Apple Design Award. We are architected in a cloud-based, app-based modern architecture with a modern SaaS platform that integrates into all the systems in the hospital.
We have hospitals now who have over 1,000 different devices, and all those devices stream data into the EMR, stream data into the DICOM, stream data into the revenue cycle management system, because in point-of-care ultrasound, hospitals only capture about 35% of their scans. That's 65% leakage on revenue, and also data compliance, as they need to have that data to be compliant. We've architected ourselves in a very modular way, in a very modern way. When I was running other device companies and I wanted to update my software on a device in a hospital, I'd have to send my rep in with a USB stick. Now I can push an update, just like iPhone, to all those devices around the world. We come up with a new concept, we push it.
Our architecture is actually one of our strategic advantages. What it allows us is in ultrasound, the hardest part about ultrasound is that it's hard. If you've had an MRI, if anyone has had an MRI or a CT, you go into the MRI lab and the tech puts you on the table and tells you not to hit your head on the way in. They go outside and initiate an automated protocol. Ultrasound is like an art. You have to actually search the anatomy, and then you have to understand what you've found. It's a much harder modality to do. It's kind of an enigma. You have this low-cost modality, but it's harder to do. How do you make it easier? AI.
There's over 30 companies now in Butterfly Garden developing LLM models to be able to make it easier for caregivers to do an ultrasound scan. At a minimum, make it easier to acquire the image. The two biggest challenges in ultrasound is image acquisition and image interpretation. If you make it easy for a nurse to go into a home and do a cardiac echo, which is the highest volume cardiac, image, taken, you can send that image to a cardiology clinic, they can make a decision, change the medications for that patient, keep them in the home, keep them in the nursing home, keep them where they're at, and stop the revolving door in and out of the hospital because they're not getting the appropriate management of care.
The amount of apps we have now and the amount of, whether it's cardiac echo or pulmonary or MFM, we just received the first FDA approval of a blind sweep of any company in the world just a month ago. FDA was so proud of it, they actually tweeted and posted on LinkedIn that this is the way AI should be approved with the appropriate safety and efficacy data. It's all based upon the apps and how we come into our ecosystem. That will change healthcare. They're just like the iPhone took over BlackBerry, we will take over all of the legacy handhelds when we have all of our applications easy and in a modern way.
We also now are helping work with at-risk providers to be able to show them how to use this in their practice and how to use this in order to be closer to patients. We're gonna be creating a whole new home care business that allows us to manage the logistics in order to move that part of this forward. That's another , we have our devices, we have software, and now we're building a service business. That'll be a very material contributor in 2027. There is a moment happening right now, and that moment is ultrasound is being seen as an amazing bridge into the human body by AI. A lot of different use cases. This is normalized from, for a growth rate standpoint.
There's about 13,000 to 16,000 studies on normal ultrasound a year, it's very flat. There's about 2,000 studies on point-of-care ultrasound a year, it's very flat. Now new applications on how ultrasound could be used in the brain for neuromodulation, how it could be used for deep brain stimulation, where literally, we are the only company in the world that has commercialized a digital ultrasound on a chip, we may be the next bridge between that chip and AI in the human body. There's a lot of use cases now. What we've made a decision is to start a business by licensing our chip to third-party companies who are not competitive with Butterfly in its core space, that's called our Embedded program.
We have solved a foundational problem in overall technology, and we're the only one who can put this chip and have this continuously evolving semiconductor-based ultrasound. What it does for us is our TAM for point-of-care ultrasound's just about $30 billion. Now by partnering with other companies in some very big use cases, our TAM goes from about $30 billion up to about $35 billion, because we can participate in all these different segments of the market. We've launched a program called Butterfly Embedded. For those looking at the slides, it looks a lot like Intel Inside, as you see in the bottom right, and that's exactly what it is that we have an ultrasound processor that can help third parties accelerate their ultrasound aspirations by using our tech platform.
F rom 1993 to 2005, NVIDIA was a video game company. They made processors for video games. What they did, they had a GPU, they had focus because they had to have this multidimensional activity, and then they had to have someone else have this multidimensional activity interact, and they constantly evolved that. It wasn't until 2005 when they launched something called CUDA. CUDA was their developer software, and that allowed third parties for the first time to go into the chip and change the settings for their particular applications. That's when the world started to change for them. If you listen, I've listened to the Joe Rogan podcast that had Jensen on for three hours. I've listened to him speak to Stanford students, where he said, "We had no idea what our next chip would be used for.
We just kept pushing the boundaries of technology. We're taking that same mindset. We're a point-of-care ultrasound company primarily, we now have opened our software up to third-party developers, and they are now finding all different types of new use cases for the technology, and that's turning into pretty potent revenue stream. A company that was purely point-of-care ultrasound and POCUS now has shots on goals for all these other markets, we are actively talking to companies in each of these markets. We are developing point-of-care ultrasound. We have a sales force. We have a marketing team. We have the cost of building that market. We can now participate in all these other markets without having to develop them, but by partnering with someone who's there who needs our core technology. We have 600 patents in this space.
It's cost us $300 million to make our first chip. We are now selling our third- generation chip. Our fourth generation is at TSMC, who is our partner. We are developing our fifth- generation chip. Here's our pipeline. We've never shown this before. We have four companies that are working with us that are, have been publicly disclosed. We have another five companies that don't wanna be unveiled yet. These are real early players in their space, and those are our partners. We have another 40 companies that we are actively talking to to license our chip. This, the ability to build our point-of-care ultrasound market and grow and see the dream of every doctor and every nurse having their own device is what our core mission is.
Being able to now leverage the technology for all different parts of healthcare to accelerate the benefit of human care, and then also to have our existing shareholders benefit from all that innovation, is why I think the next several years of Butterfly are gonna be absolutely insane. When these applications start going public, when these companies start bringing them out, and also when point-of-care properly adopts and inflects, this is gonna be one of the most exciting growth stories you guys are gonna watch. Just remember that you're here today, 'cause this is a real exciting time for us. The way our revenue as our company comes in, is both POCUS and Embedded. We are now breaking out the Embedded revenue. We sell hardware, services, and software in the POCUS segment.
Then on the embedded side or the chip side, we have a licensing fee, we sell chips, and we do a revenue share, depending upon different models, if they want exclusivity, et cetera. In this year, it's about 20%-25% of our revenue now, and I think it's gonna be a much bigger part. We're in the midst of a big turnaround. If anyone has seen Butterfly, we used to be a company with declining revenues, lower gross margins, burning a lot of cash. Over the last three years, we're now doubling our revenue. We're in the high 60% in gross margin. We have a strong balance sheet. We're using less and less cash.
We'll get to break even on our current cash, and we're gonna be generating a tremendous amount of value. Just last quarter, we grew 25%, improved our gross margins by 600 basis points, reduced our loss, and are really focusing on being very good shepherds of our cash. With that, I just wanna thank you for your attention, and again, for Bank of America for giving us this opportunity. Thank you very much.