All right, we're kicking off the next session here. My name is Young Li, one of the med tech analysts at Jefferies, and pleased to be joined by Hyperfine from the company. We have the CEO to my right, Maria Sainz. I guess I'll just pass the floor off to you for the presentation. Thank you.
Thank you, and thank you for inviting me. I'm very excited to be here. Here are our disclosures. I'm actually very excited to be here today. Hyperfine has brought to market the first and only to date AI-powered portable brain MRI. I'm more excited because just this past Monday, so three days ago, we announced the introduction in the market with FDA clearance of our next generation subsystem, which also incorporates a very recently cleared and exciting technology, which is our new AI-powered software, which has been branded Optiv AI. We are now entering for Hyperfine the era of our new subsystem powered by Optiv AI. The technology has been designed as platform technology so that it can be deployed across sites of care and across multiple neuro conditions, many of which have a significant burden clinically and economically on patients and society.
We are a revenue-generating business with attractive growth, solid gross margin, and terrific spending discipline. This is the new Swoop powered by Optiv AI. It is designed to improve access, equity, and affordability for brain MRI. It expands brain MRI to multiple sites of care, so you can basically safely perform brain MRIs in a neurology office, in an emergency room, or possibly in a community setting. It enables physicians to make timely and quick decisions on their patients, offering diagnostic quality images. It definitely, being a brain tool, holds a terrific promise to lower the burden of many devastating diseases such as stroke and neurodegenerative diseases. MRI is a very, very powerful diagnostic modality for conditions in the brain. However, conventional MRI has failed to make itself widely and readily and easily available to most of the population.
The statistics would say that less than 10% of the world population has ready access to MRI, leaving us with 90% that do not. Why is that? Primarily because of the cost and the complexity. It is costly to acquire. It is complex and costly to install with siting requirements, shielding, and operating costs that are expensive. It requires dedicated personnel in MR technologies. For certain types of patients, like those in critical care after a surgical procedure, it is potentially also risky, besides cumbersome, to take them downstairs to the conventional MRI. We're turning that a little bit upside down, not to compete with conventional MRI, but to expand the reach and the capacity of MRI across the world and across sites of care. We do provide diagnostic quality images at very low field strength. Our field strength is 64 milli-Tesla.
The lower field strength conventional MRI is 1.5 Tesla for comparison purposes. Have a very proprietary position with over 175 patents. As I said, it is platform technology that cuts across multiple clinical applications. It is really a new paradigm in terms of where and how you perform brain imaging being available at multiple sites of care. We have a very broad FDA indication. We can do pediatric all the way to adult patients, so no age restrictions. We also are covered by the same CPT reimbursement codes as conventional MRI. We are commercially available in the US through a direct team and outside of the US through a distributor network.
This is the new phase of MRI where you can actually perform brain MRI at multiple sites of care, a unit that can be easily wheeled down the hallway and through into elevators to actually go from critical care upstairs down to the emergency room in a matter of minutes. It is incredibly easy to use and intuitive with an iPad interface. As I said, I'm most excited to be able to talk today, three days after the clearance and announcement of clearance by FDA of our new scanner. It is the first time in the five years of commercial availability of the first scanner where we have really significantly improved and elevated the performance of the hardware.
The number of components in the hardware that have been designed for ease of use and patient comfort, but most importantly, there are several components in the hardware that also contribute to generating higher signal-to-noise ratio and higher electronics performance that also help with the image quality, which ultimately is the product of an MRI scanner. Optiv AI is actually our latest generation of software. It's AI-powered software. What we're able to do with AI is reduce the noise and the blur and create more clear and consistent images, and with that provide greater anatomical detail which support a more confident diagnosis. This is a little bit of the journey of image improvement we've been on in the last five years. The row on the bottom is where we started.
This is about nine years ago in the very, very early days of development of what was then a very ambitious, bullish, but lofty goal of really doing brain MRI on wheels. In a matter of less than 10 years, the images have been transformed to the upper row, and those are for each of the sequences that are offered in our scanner. A lot of people that have seen the latest images, all of those powered by Optiv AI, have unsolicitedly commented how close it looks to conventional 1.5 Tesla MRI. I would leave this slide up for a second only because I think images speak a thousand words.
This is what they mean when they say, "I think that doesn't look any different than some of the 1.5T scanners that I see." Clearly to the left is our latest scanner powered by Optiv AI, and to the right is a comparable sequence, not the same brain, but a comparable sequence in a 1.5 Tesla scanner. We also have amassed a very, very impressive set of publications and presentations and have conducted our own studies in some of the conditions that I've listed before: stroke, Alzheimer's disease, hydrocephalus, and several others. Our TAM is gigantic. Our mission is really to bring this portable AI-powered brain MRI into multiple sites of care. In the inpatient setting, we're talking about $1.5 billion. As we add to inpatient, the outpatient setting, our TAM grows north of $6 billion.
When we think about bringing it to the community setting, not any different than external defibrillators have done by actually bringing them to malls and train stations and airplanes these days, the size of our TAM grows north of $16 billion. Our footprint for growth has been all about this expansion into multiple sites of care while elevating with our technology improvements the image quality that we offer to make it a more confident tool for diagnosis of patients. We are on the verge at the midpoint of this year of really turning two significantly important growth catalysts into reality. As I said, just this past Monday, we announced the approval of the new subscanner powered by Optiv AI. That is the technology that we are taking forward with a significant leap and improvement in image quality. We are now in launch mode in an office.
That means we're adding to our hospital business, the neurology office setting, and I'll have a word about that in a second. We're not going to stop here on technology iteration, but we really are going to start seeing the growth in our business as we translate this growth catalyst into placements and quarter over quarter. We think about really our business with two sort of verticals in mind. The first one is the hospital. Clearly in the hospital, it's a compelling business proposition. First and foremost, our scans are reimbursed with the same CPT code as the conventional MRI. We have compelling clinical utility to actually offer scans to critical care patients without risk of transport to do emergency triage or routine follow-up, which takes us into the as well as the hospital-based clinics.
Our value proposition is strong when we just look at the amount of cost that we reduce when we do not have to convert a critical care patient into a patient that can be safely put into a conventional magnet. We're talking about a break-even point in the 12-18 month timeframe, which compares very favorably with most of the other capital equipment, which is three to four years. I've already mentioned the typical sites of care in which you find our Swoop system. Those would be critical care units, both adult and pediatrics, as well as ERs and hospital-based clinics. Of course, as we look at the world of IDNs, starting with a successful deployment opens doors so much more easily for other member hospitals. In the office, it's quite a different business, but it's still an incredibly strong business proposition.
When we look at the data, a typical neurologist that does not operate in the hospital, that operates out of an office, prescribes somewhere between 500-600 MRIs a year. Only 5% of neurology offices in the United States have imaging, so 95% do not. We have experienced a significantly shorter sales cycle with a more narrow set of decision makers and the ability to make both the clinical as well as the economic decision, usually within the practice leadership, which is also the clinician and their partners if they have partners. We've already completed one very important step, which is one that actually came November of last year with the update in the IAC guidelines that now include the use of portable brain MRI. For any office that would go through accreditation, CMS will then cover the scans that are performed in that office.
We've been running a pilot program, and throughout that pilot program, we have seen people go now through accreditation, training, installation, first scans, and also, really important, first payments from CMS for some of the first scans. As I said before, we are now moving from the pilot mode into the launch mode, and we continue to enroll in a study at two very large neurology practices, the Dent Neurologic Institute in Buffalo, New York, and Texas Neurology in Dallas, Texas, on a study to document all of the different use cases for which Swoop system can be used in an office setting. It really is a very, very straightforward tool and technology for an office. It's basically plug and play, plug and scan is what I like to say. They do not require a specialized siting. Very often, it sits behind an exam chair in an exam room.
There is no shielding. There is no infrastructure, and there is not a requirement that the technology be used by an MR technologist. From a commercialization perspective, about 180 is our number of installed systems on a global basis. We do have a direct sales force here in the U.S. It's relatively small, and we are also complementing the selling team with an implementation team that comes in and actually makes sure that the workflow works the way the hospital intends it or the office wants it and trains the personnel that will use the system. Globally and outside of the U.S., we operate primarily through distributors. I would say at this point, we have a network of distributors.
We have been getting CE Mark, UKCA approval for the different versions of the software, and we have also been working on local language translations for the user interface as well as documentation. We have checked all of those in about 10 markets outside of the U.S. I'm starting to see multiple sites in some of the markets which show the kind of depth that we can accomplish. From a pricing perspective, we have a model with pretty much selling the capital upfront and then recurring revenue for anywhere between two-four years based on three or five-year contracts. We have been increasing our MSRP with a new Swoop system. In July, we're moving our MSRP to $550,000 for the capital.
We will have anywhere between 10-12% of that amount as a recurring revenue starting year two, only because the first year software and service support are covered under a one-year warranty. Our business, given the large size of our TAM, can very, very quickly get to be very large. We're talking about relatively small penetration across the sites of care that I have described getting us to very high revenue numbers. About 1.5% penetration of the sites of care gets us to about $100 million. Of course, about 4.5% gets us to about $300 million. When I look at how de-risked these opportunities are, it feels very, very compelling as well. We do have the FDA clearance. We have reimbursement in place. Many of them were leveraging one hospital selling process.
In the case of the office, we do have that more streamlined selling process, selling cycle, and decision-making power. From a financial perspective, we did $12.9 million last year. We really believe this year is going to be a tale of two halves. We have guided to about 10%-20% and $5-$6 million in the first half. Our gross margin for capital equipment are very strong, guided for this year to 47%-50%. Our cash runway now extends, excuse me, all the way until the end of 2026. We are estimating our cash burn this year to be between $25-$28 million. As you see, we have been declining in cash burn in terms of operating efficiency and operating lean while still innovating, commercializing, and continuing to drive clinical and commercial evidence. I have a phenomenal team.
Some of them drive the business by vertical. Some of them are functional leaders with a lot of experience in medtech, in connected devices, and a lot of successful careers. I'll just leave you with this. Again, incredibly unique technology, but I'm excited that right now we're opening a new chapter with a new Swoop system powered by Optiv AI, commercial stage company with attractive growth, attractive gross margins, a prolific engine of iteration both now on the software as well as the hardware of components of our company and our technology. Clearly, the growth comes from expanding this technology so that the reach of MRI goes beyond really the basement of a hospital into multiple sites of care where our system can safely scan patients with a lot of infrastructure and without expensive dedicated personnel.
Solid financial profile and a terrific team that I am very happy to do this with. Thanks very much for your attention, and I'll take any questions. Are you building units? Okay. The commercial rollout for the new Swoop system that we just announced this week, basically, we're open for business, and at the same time, we are manufacturing units. I will be quite proud to say that we ended up getting approval a little bit earlier than we anticipated, which is a great problem to have. Yes, our team was trained earlier this week, and they're actively selling it. The manufacturing team is working on ramping manufacturing, going through those stages. It is the same contract manufacturer. The supply chain has been de-risked, but we're going through process qualifications, manufacturing transfer, and those things.
I would expect that we would have a steady manufacturing within a few months, but we should have units within several weeks. All right. Got it. Very helpful. I guess for the latest AI enhancements, will they be available for existing older generation installed systems as well? Right. Optiv AI is compatible with all of our Swoop systems. It is compatible backwards to the entire installed base. However, because of the changes in hardware that were specifically designed to create a better platform to drive image quality, the image quality will be more improved, further improved in the new scanner. We will launch Optiv AI alone, backward compatible to all of our installed base.
Okay. Got it. And then there's a healthy ASP uplift. Can you maybe talk a little bit about the margin differential as well?
It will be, and we've never talked that specifically.
We have started to manufacture, so you could expect that the margin today is not what the margin will be even within three to four months. I would expect that medium term and longer term, it will be comparable to favorable. Of course, in the early days, there's always the cost of starting and some fits and starts. I guess, what are the plans for the next-gen product to be launched internationally? The first thing we're going to do is take the new Optiv AI, so the software, and that will be available very possibly by the end of the year internationally. That would be through CE Mark, UKCA, and Canadian approval.
The new scanner, the new hardware is probably going to take us a little bit longer because there are some additional maybe technical work as well as regulatory work that needs to be undertaken. I would expect that to be sometime probably in the 12-18 month timeframe. All right. That's all for me. Thank you very much. Thank you. Thank you very much.