Tag Archives: Cleerly

Signify Premium Insight: Reimbursement Raises Prospects for Cardiac Plaque AI

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Cleerly recently joined the very exclusive club of medical imaging AI vendors whose solutions are now deemed eligible for reimbursement, with the CMS adding an OPPS code for AI-based coronary plaque assessments.

The move means that Cleerly’s plaque AI solution, as well as similar approved solutions from other vendors, now qualify for reimbursement of between $900 and $1,000, when used with Medicare patients scanned in hospital outpatient settings.

The provisioning of a reimbursement code means that Cleerly joins some of medical imaging AI’s most esteemed vendors, such as HeartFlow, and Perspectum, which are increasingly eroding one of the central barriers to the adoption of medical imaging AI: a clear return on investment for adopters.

The Signify View

In one of his works, playwright, poet and author Oscar Wilde once lamented “cynics” who “know the cost of everything and the value of nothing”. Given Wilde died in 1900, he was unlikely to have been thinking of US healthcare providers when he recorded such an utterance. However, his sentiment may resonate with the medical imaging AI vendors who are desperately trying to convince such providers to take a chance on their solutions.

These vendors have a challenging task ahead of them. One of the most pervasive barriers stymieing the adoption of medical imaging AI in hospitals is the questionable return on investment that some solutions offer. There are, for instance, solutions that offer limited value to providers, perhaps shaving only seconds off the completion of relatively menial tasks, or offering assistance in l low volume niche applications that are far too specialised to be commercially viable.

One of the ways those vendors which do offer clinically valuable solutions can convince hospitals of the worth of their solutions is focusing on demonstrating their value. This is a route taken by the likes of Perspectum, which recently published a study highlighting the cost-effectiveness of its LiverMultiScan software by demonstrating “significant” cost savings when the solution is used.

Other developments, however, focus on the other side of this Wildean balance, and instead of demonstrating value, aim to effectively negate, or at least minimise the cost the provider pays to use a tool.

Of Price and Value

At present, bar a handful of exceptions, providers must pay out of pocket for any AI solutions that they choose to utilise. Given the limited budgets and resources available to devote to a potentially intensive and time-consuming deployment of an AI solution, paying out of their own pocket is an unappealing prospect if they can’t be assured a return. The decision of the CMS to reimburse a solution, however, can assuage these concerns, allowing providers to enjoy the purported benefits of a solution, largely at another’s expense.

Even in cases where reimbursement doesn’t cover the entire cost of a tool’s use, such as that of HeartFlow FFR-CT, which is reimbursed at around $950 even though using the tool costs around $1,500, for a provider, paying $550 out of pocket is much more palatable than having to pay $1,500, especially given HeartFlow’s now well-established credentials.

Although Cleerly, like HeartFlow, targets cardiovascular disease, it offers value in a different way. Heartflow’s FFR-CT solution, can in some circumstances, replace an invasive diagnostic procedure which assesses blood flow within a coronary artery. Cleerly’s solution meanwhile measures the actual blockage of coronary arteries. As such, like HeartFlow, using Cleerly’s solution can avoid the need for an invasive procedure, and instead monitor biomarkers of cardiac disease non-invasively.

Now such assessment can be accomplished by providers, while being paid for by CMS, using Cleerly’s plaque solution is a clear opportunity, and one which comes without any obvious downsides.

Commercial Objectives

For Cleerly, this further bolsters its strong position in the medical imaging AI market. The vendor emerged from stealth mode in June 2021 with a $43m series B funding round, since then it secured a $223m series C round in July 2022. In the Premium Insight evaluating that funding round, we highlighted that the vendor should use that money to push for reimbursement and look to expand its commercial reach. Now, with the former objective achieved, it can better focus on the latter. Its hefty funding rounds gave the vendor the financial firepower to establish effective sales networks, while the reimbursement gives providers a reason to pull the trigger. The use of Cleerly’s tool has, after all, quickly grown from a capable solution, to a capable solution that offers a competitive return on investment.

More broadly, the reimbursement also illustrates the guiding hand of the CMS. Reimbursement has the potential to be transformative for a valuable, yet underutilised solution, instantly removing the biggest barrier to its use. As such, the CMS can offer a boost to any vendors or solutions which it believes are particularly worthy, or any avenues which particularly merit further development. It also has the power to revise reimbursement over time, upping or lowering reimbursement in line with the scale of use and relative “value” of the solution. The body must still be discerning, so almost without exception reimbursement has been granted to vendors which already have mindshare and cachet in the market, but, as it has done with Optellum, it can propel smaller, lesser-known vendors to relative stardom.

Furthermore, reimbursement not only makes certain specific products more appealing, it also can improve the prospects of particular use cases, with vendors offering solutions similar to those which have been approved likely to refine or further develop their own products in order to be able to capitalise on that reimbursement. In this way, the CMS can help shape development of the medical imaging AI market.

Heartfelt Progress

At present, this development is leaning further towards cardiac imaging than radiology. Tools that assist in cardiac imaging, from vendors such as HeartFlow and now Cleerly offer significant value to providers, changing patient care pathways, and in the case of Cleerly in particular, offering the opportunity to improve the health of entire populations. This aligns to forecasts made in Signify Research’s AI in Medical Imaging World Market Analysis 2022 – Core Report, which identifies cardiac imaging as the largest medical imaging AI segment over the forecast period.

Compared to cardiac imaging, radiology is somewhat lagging behind. This is largely a result of the nature of many radiology tools. While there are numerous radiology tools on the market, many of them represent limited value propositions. These tools may, for instance, only offer incremental gains, such as marginally increasing the speed at which findings are detected, or fractionally increasing the rate at which measurements are taken. In cardiology, on the other hand, solutions often have far more significant value, shifting a diagnostic pathway or providing earlier diagnosis for example. There are also radiology vendors with similar aims, but in most cases, the benefits are less clear cut than in cardiac imaging.

Another facet of the CMS decision to reimburse the use of Cleerly’s plaque detection solution is the fact it has assigned the vendor an OPPS code, for reimbursement in an outpatient setting. Such a move suggests the body aims to push forward the use of AI in outpatient settings. This makes sense. Outpatient settings represent an attractive setting for AI assistance and keeps pace with the growing preponderance in the US for use of outpatient imaging for non-emergency imaging a more cost-effective setting versus hospitals.

Above all though, the decision by the CMS to provision an OPPS code for Cleerly highlights an important step for the company, propelling it into the upper echelon of medical imaging AI vendors. It does, after all, offer a valuable solution with regulatory clearance, it is well funded and has won the confidence of investors, and now qualifies for reimbursement, incentivising providers to adopt it. More significantly however, it represents a milestone for medical imaging AI as a whole. In this and other recent moves, the CMS has shown that it will support vendors which offer value to providers and will incentivise the use of solutions that can materially improve outcomes for patients.

With its provisioning of a code for Cleerly, the CMS has shown that it is making a more concerted effort to forward the adoption of medical imaging AI. One might even say it has realised the importance of being earnest.

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Signify Premium Insight: Cleerly Exceptional: $223m Funding lets Heart Health Specialist Join AI’s Top Table

This Insight is part of your subscription to Signify Premium Insights – Medical ImagingThis content is only available to individuals with an active account for this paid-for service and is the copyright of Signify Research. Content cannot be shared or distributed to non-subscribers or other third parties without express written consent from Signify ResearchTo view other recent Premium Insights that are part of the service please click here.

Co-written by Dr Sanjay Parekh

Cleerly, the cardiac AI vendor which emerged from stealth last year with a $43m Series B funding round, has seen its total funding increase five-fold thanks to a bumper Series C round. The vendor, which had previously raised a total of $56m, closed its Series C financing round of $223m in late July, taking its total funding to $279m.

The round, which places Cleerly among the very upper echelon of AI vendors in terms of funding, will allow the vendor to expand its team, while also allowing the AI outfit to extend its commercial reach, granting more providers and patients access to the tool. Despite investors’ confidence, however, does Cleerly, still a very young and unproven vendor, really warrant such financial backing?

The Signify View

Cleerly is unusual. Aside from the fact that it has taken one of the largest ever sums in a single funding round for a medical imaging AI vendor, and that it has done so at an unprecedented pace, it does not easily fit into the same categories as other vendors with similar funding totals. For the most part, vendors which can boast of more than $100m in total funding fall into one of two categories. Either they offer multiple or divested products, offering providers a breadth of capability, or a depth of capability along a clinical use case, or they are from China. Cleerly, like HeartFlow which has raised more than $550m in funding, does not fit easily into either, currently offering only a single cardiac tool.

This, however, is a tool which could have a significant impact. Heart disease is one of the world’s greatest health burdens, but all too frequently it is only discovered when a patient suffers a major cardiac event. If the patient survives, treatment usually involves expensive invasive and/or pharmaceutical interventions. Assessing heart health before a patient experiences serious symptoms can also be difficult, and is usually dependent on tests for surrogate biomarkers (e.g., cholesterol), or sequelae of the disease (e.g., ischaemia or stenosis). Cleerly’s solution aims to end this shaky reliance and instead, directly measure, quantify, and classify atherosclerosis itself.

Individual Symptoms

This can, in the first instance, provide value by aiding diagnosis. A patient may present with chest pain, for example, and Cleerly’s solution would be able to ascertain whether that patient has an increased risk of cardiovascular disease, which results in the patient having an elevated risk of a more serious cardiac event in the future, or whether it was a single transient incident that required lifestyle management rather than pharmaceutical or surgical intervention. Being able to accurately determine a symptomatic patient’s cardiovascular health would therefore be highly valuable to a provider.

This value looks liable to increase in the short term too. Optellum, a vendor focused on lung nodule malignancy detection recently demonstrated that its Virtual Nodule Clinic solution qualifies for CPT code 0721T for quantitative CT tissue characterisation, thereby granting reimbursement for the solution’s use. Cleerly’s tool is in some ways similar, quantifying tissue from a CT scan in order to assess a patient’s risk of a serious pathology (measuring, quantifying, and classifying plaque). It may therefore be likely that Cleerly will pursue use of this CPT code, deeming its solution eligible for reimbursement and pushing for this in the near future. This would overcome one of the main obstacles holding back the use of AI solutions, at hospitals making sales look even more promising. As such, working to attain such reimbursement should be among Cleerly’s priorities.

This however misses the true potential of Cleerly’s solution, the potential that prompted investors to pull out their cheque books so readily.

A Bolder Vision

Cleerly states that it envisions “a world without heart attacks”. This will not be achieved by the better management of patients showing up at emergency rooms with chest pain. Instead, this vision ties into the more significant opportunity offered by solutions such as that developed by Cleerly, which helps explain investors’ enthusiasm.

Instead of looking to only help in the diagnosis of symptomatic patients (on an individual case basis), Cleerly’s solution may be used to help manage the health of entire populations. Instead of waiting for patients to present with symptoms related to heart health, Cleery’s solution could be used for opportunistic screening, and used in the background for every patient that has  a chest CT. In doing so, those at a high risk of cardiovascular disease, even in the absence of immediate symptoms, could be given help sooner, and their yet-to-manifest serious cardiac event could be tempered or even averted through lifestyle changes or preventative medicine.

The real prize from such an approach, however, is realised when providers are able to not only treat  those who have been scanned in response to symptoms or surrogate biomarkers, but when the use of a solution such as Cleerly’s on similar patient cohorts can determine at-risk patients that would benefit from earlier intervention.

To achieve this, the detailed quantification profiles provided by Cleerly need to be fed back into the EMR or an enterprise data warehouse (EDW). Once in the EMR/EDW, vendors specialising in risk stratification such as Innovaccer, Health Catalyst and Arcadia would be able to utilise the data in their own algorithms to identify and guide the management of these specific patient cohorts. In this way, patients within the EMR, who may have never had any cardiac symptoms or any related condition, could be identified as a high risk and have their health proactively managed.

Action from a Distance

There are currently barriers to such an approach. Some of these are centred around technical challenges or issues to do with implementation. For instance, there needs to be closer integration of radiology data into the EMR/EDW, with the results of Cleerly’s quantification being not only collected in the radiologist’s report, but also imported into a structured data field within the EMR/EDW. For EMR/EDW vendors to focus on such a feature there needs to be demand from customers, and cardiac plaque scores to be collected widely enough to be worth the developmental cost. The lack of established cardiac screening programmes makes this even more challenging. The same is true for the risk stratification specialists, which will only start considering scores from the likes of Cleerly when they are proven enough to have meaningful impact. Although, of course, having an impact is one of the factors that will drive adoption.

Other factors are financial. In the key US market, without adoption of value-based care payment models, providers could face lost revenue if such tools reduce volumes of lucrative interventional procedures. These value-based care payments are increasing in prevalence, accounting for 41% share in 2020, up from just 23% in 2015, but there is still some way to go. Cleerly may also argue that such adoption of its tool could offset loss of revenue from valuable interventions and prescriptions for providers. It could, for instance, highlight that its tool may identify greater numbers of patients that require lower cost treatments, as well as some that may still benefit from surgical or pharmaceutical intervention. Cleerly might also explain that many lucrative procedures would ultimately be delayed rather than completely averted.

Benefit and Burden

These, however, are questions for the future. In the near term there is clearly enough value for providers to consider the adoption of the company’s solutions, this will be especially true if its solution receives reimbursement. For investors, this clinical value is a good indicator of an AI vendor that is worth funding. This, in combination with other longer-term opportunities such as adoption in a comprehensive population health management programme, and the vendor’s involvement in large-scale international, long-term clinical studies of cardiovascular disease mean the vendor is ensuring it harbours significant revenue-generating potential in the future.

There are challenges. Both from within, if it fails to maintain its pace of development, for example, and externally. These outward challenges include increased competition with comparable solutions from the burgeoning range of AI specialists focused on heart health such as HeartFlow, Keya Medical, Artrya, and Caristo Diagnostics, as well as the barriers that, at present, prevent Cleerly’s tool maximising its utility in population health management deployments. Another, more nuanced concern is related to the valuation of the company conferred on it by such an enormous funding round. HeartFlow failed in its attempt to list publicly, in part because of disagreements over the company’s true worth. Securing such sizable funding could be necessary for Cleerly to grow, while other factors such as the extensive international clinical study Cleerly is funding could prove to be a veritable goldmine in years to come, but in the near to mid-term, when revenues and especially profits will be slender, such significant funding at such an early stage could quickly become a burden.

Cleerly’s ascent has been remarkable. The speed at which it has travelled from an unknown developer in stealth-mode to join the ranks of the best-funded AI companies in the industry has been unprecedented. That makes sense if the vendor one day can, as it hopes, make heart attacks a thing of the past. Until then, it highlights what more the vendor has to prove.

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Signify Premium Insight: Artrya: AI & the Art of Going Public Punctually

This Insight is part of your subscription to Signify Premium Insights – Medical ImagingThis content is only available to individuals with an active account for this paid-for service and is the copyright of Signify Research. Content cannot be shared or distributed to non-subscribers or other third parties without express written consent from Signify ResearchTo view other recent Premium Insights that are part of the service please click here.

Australian cardiac AI developer Artrya recently announced that it is set to list on the Australian Stock Exchange this month, at an enterprise value of more than AUD 105m (US$77m). The cardiac imaging specialist plans to raise AUD 40m in an initial public offering of 29.6m shares, at AUD 1.35 a share.

The money will add to the AUD 19m in start-up funding the vendor has so far received and will primarily be used to meet costs associated with product development, clinical R&D and regulatory clearance. The vendor’s core solution, Salix, has been admitted by Australia’s Therapeutic Goods Administration (TGA) as a Class 1 product, allowing it to be commercialised in that country, and Artrya has filed an application with the US-FDA. The float will, however, also fund global expansion, and allow other regulatory filings to be made in Canada, the EU (CE Mark) and the UK.

The Signify View

Heart disease is the world’s leading cause of death. As such, any tool which can aid in the relief of such a global health burden has significant market potential. Artrya is the latest company to utilise AI to capitalise on this potential and address a health problem that is responsible for, according to the World Health Organisation 32% of all deaths each year.

Aside from potentially saving millions of lives, software tools that can address heart disease can also bring about sizable economic benefits. Many patients only realise they have heart disease when they experience a heart attack or other significant cardiac event. Those patients, if they survive, often require expensive interventional procedures, extensive rehabilitation programmes, and costly courses of drugs. Solutions which help identify and manage at-risk patients sooner, enabling them to be treated with lifestyle changes and preventative medicine, could save billions of dollars and therefore be an attractive proposition for providers.

Artrya hopes to offer such benefits with its Salix suite of solutions which aims to improve the detection and treatment in two ways. Firstly, the developer aims to automate the analysis and diagnosis of heart CT scans, and secondly, in adopting more of a population health approach and improving the identification and management of patients at risk of coronary arterial disease. It does so by assessing certain types of arterial plaques (namely vulnerable plaque, not easily discernible on CT scans by the human eye), which are linked to heart disease. Like American heart health software developer Cleerly, which also focuses on the identification and classification of arterial plaques, this approach deviates from more typical assessments which focus on arterial calcification, a surrogate, rather than direct marker of heart disease.

Deep in Development

Despite the promise of this approach, however, Artrya’s suite is still very much in development. While the vendor’s Salix Coronary Anatomy (SCA) product, which detects the vulnerable plaque and other biomarkers, is in the process of securing regulatory clearance in the US and Europe, the other key component in the suite, Salix Coronary Flow (SCF), a ‘non-invasive whole-heart blood flow assessment’ is still in development. Meanwhile, development for several of the suite’s other constituent products has not yet even begun.

This begs the question of why the vendor has chosen to list now. Most AI vendors to date have tended to rely on private funding as they continued to work on their products, only going public when their offering is more mature. Cleerly, for example, raised significantly more in its recent Series B funding round, than Artrya will net from its listing. While the market potential for Cleerly, in the near term at least, is arguably higher given it has already secured FDA approval, the vendors are still at similar stages. Both vendors will, for instance, seek to use the benefits of their recent funding rounds for the commercialisation of their products. Cleerly however appears to be treading a path more similar to that of HeartFlow, the most well-funded of all medical imaging AI vendors. When HeartFlow listed in July 2021, it had already raised more than $550m in private funding, had already become well established in many hospitals, including beyond the US, was generating revenue, and even reimbursement (in the US, UK, and Japan) for its solution. Artrya’s approach of listing publicly before it has achieved any of this may grant the vendor a greater degree of exposure, at least in the short term, and help the vendor as it tries to promote itself. However, unlike Cleerly whose backers are perhaps more nurturing and invested in the longer term, Artrya will now have to deal with a multitude of shareholders, potentially pushing the vendor in different directions, and perhaps being rather less understanding in their quest for accelerated returns.

Growth to be had

Artrya’s decision could be influenced by several factors. As highlighted in Signify Research’s analysis of VC funding in 2020, it is becoming increasingly difficult for smaller, less established AI vendors to secure VC funding, especially as market leaders are emerging. This lack of forthcoming funding, as well as impending time pressures as vendors look to secure segments of the market for themselves, making it harder for other vendors to thrive, could also have driven Artrya to accelerate its plans. Floating in the future may not have been an option if the developer had waited until it had grown and found that it had missed its opportunity, with the market consolidating around competitor vendors. Given the market Artrya is targeting, the vendor does have potential to grow significantly. This is particularly true given the American College of Cardiology and American Heart Association’s recent changes to their guidelines that emphasise CT Angiography (CTA), an imaging exam necessary for the use of Artrya’s suite, as a first-line test for evaluating patients. Securing US-FDA clearance will enable it to gain traction on the back of these new guidelines. Further, the value of the vendor’s offering is also seen by the UK’s National Health Service, which has added it to the provider’s list of approved and prequalified suppliers. This could bolster the vendor’s fortunes in the near future, with Artrya anticipating UKCA regulatory approval, enabling the solution to be purchased in the UK, in mid-2022.

In addition to the commercial considerations there are also issues surrounding the integration of the solutions and how they are used in practice. One of the possibilities, for example, is improving the integration of the AI results into the provider’s workflow. At present, the process for the use of these tools is to conduct a scan, which is then analysed by the AI algorithm, and then the results are returned in a report. This could be improved if the results of the scan could be more efficiently brought into the workflow, even going as far as reporting results in real time. Such advances could bring disruption to the market, enabling Artrya, or whichever vendor was able to achieve such a feat to have a distinct technical advantage compared to competitors.

Early or Excellence?

Ultimately, Artrya’s decision to list could prove a smart move. If the vendor can capitalise on the cash injection to successfully win regulatory approval in the United States and Europe, commercialise its suite and win a few large deals it could become part of a rapidly growing segment. Artrya could establish itself as one of a handful of key, high-profile AI developers that specialise in heart health, and grow along with the market. Like others such as Cleerly and Zebra Medical Vision, for example, Artrya’s population health tools could also prove lucrative as opportunistic screening becomes a more important feature of the market. This is particularly true given Artrya’s identification of direct biomarkers, rather than surrogate biomarkers, which are used by some competitors, such as Zebra Medical Vison.

However, this upside carries considerable risk. Artrya will, every quarter, have to share its performance and share progress with investors. Unlike vendors that are able to develop in the dark until launching, as its closest competitor Cleerly was able to do, Artrya will have to perpetually convince investors of its value. This will at present and for the foreseeable future, prove a difficult task. Artrya is not generating revenue, and for all the opportunity before it, this potential is at present almost wholly unrealised. How swiftly and how significantly that changes will be a measure of how successful this unconventional play proves to be.

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This Insight is part of your subscription to Signify Premium Insights – Medical Imaging. This content is only available to individuals with an active account for this paid-for service and is the copyright of Signify Research. Content cannot be shared or distributed to non-subscribers or other third parties without express written consent from Signify ResearchTo view other recent Premium Insights that are part of the service please click here