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 Research. To 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.

About Signify Premium Insights

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 Research. To view other recent Premium Insights that are part of the service please click here