Earlier this month, cardiac technology company HeartBeam acquired the assets of digital health solutions company LIVMOR, including LIVMOR’s Halo+ Atrial Fibrillation (AF) Detection System.
HeartBeam’s move to acquire the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring aligns with its goals to improve patient outcomes and reduce healthcare system costs. But in a fast-moving ambulatory diagnostic cardiology space, will the LIVMOR deal be the disruptive ‘game changer’ that some observers believe?
The Signify View
The combination of HeartBeam’s so-called ‘world first’ AIMIGo 3D-vector ECG platform for heart attack detection technology, a credit card-sized device that can be slotted comfortably into a pocket, and LIVMOR’s Halo AF ‘smart watch’ monitoring system, is an exciting development. The combination promises to save lives and help keep patients out of hospital by intervening if they are identified as being at risk.
While the tie-up is a potentially powerful proposition, HeartBeam is not alone in its quest to disrupt the stranglehold of ‘traditional’ ambulatory diagnostic cardiology vendors.
We predict the overall value of the global ambulatory diagnostic cardiology market to reach $3.3B in 2026, from $2.5B in 2021. North America will account for $2.9B of the 2026 total. Of the three main segments of ambulatory diagnostic cardiology, Long-Term ECG and Mobile Cardiac Telemetry (MCT) will be the main growth engines, followed by Implantable Cardiac Monitors (ICMs), Short-Term ECG and Event Recorders (see below diagram).
Ambulatory Diagnostic Cardiology – Total – By Product Type – World
Source: Signify Health
Like so many facets of digital health in the US in the post-COVID era, value-based care (VBC) provides the underlying theme for vendors serving the ambulatory diagnostic cardiology market. The pandemic triggered a rush for virtual and remote care solutions, and that shows no signs of abating amid mounting pressure on hospitals to plug staffing gaps, reduce patient backlogs and cut costs. HeartBeam is one of many vendors positioning themselves to take advantage of this opportunity. Having taken ownership of LIVMOR’s FDA-cleared product, it can be confident in its ability to positively impact clinical workflows.
A Tale of M&As
Across its market reports on diagnostic cardiology and previous insights on the topic Signify Research has assessed the impact of health systems seeking to shift more healthcare services from acute to ambulatory settings, and whether traditional ambulatory diagnostic cardiology vendors risk being left behind in the old paradigms of care.
A flurry of mergers, acquisitions and partnerships have taken place as these vendors scramble to avoid that fate. Examples include Philips (which acquired BioTelemetry and Cardiologs in 2020 and 2021 respectively); Boston Scientific’s $925M acquisition of Long-Term ECG and MCT vendor Preventive Solutions; and Baxter’s $10.5B purchase of Hill-rom, both in 2021. Previously a large player in the short-term ECG market, in 2021 Hill-rom expanded into Long-Term ECG by acquiring BardyDx.
Although it will be mindful of the competitive strengths this brings to these more ‘traditional’ vendors, HeartBeam plays in a slightly different field where the competitive battle lines have yet to seriously overlap. On this side, iRhythm (the second-largest player in ambulatory diagnostic cardiology when excluding ICM revenues) is partnered with Alphabet-owned Verily to exploit the potential of ECG sensors in wearable devices. Last July, the two companies’ jointly-developed Zio Watch and Zeus System, which identifies and monitors AF by incorporating iRhythm’s continuous PPG, AI-based algorithm, secured FDA approval. Other companies in the race to gain share in this side of the market include multinationals Huawei and Samsung, specialist GPS technology company Garmin, and French connected health company Withings.
The ‘traditional’ vendors have yet to master ‘wearable’ technology at home, hence the relative lack of overlap at present. Until recently, the traditional cardiology vendors had focused on the hospital segment with solutions limited to the holter category.
Even where devices are practical and comfortable to wear – for example, Apple Watch or Google’s Fitbit – they fall far short of the capabilities of HeartBeam’s solution. With just a single-lead ECG for AF and with no detection for heart attack risk, these devices are far less sophisticated that HeartBeam’s 12-ECG lead capability.
AliveCor has been likened as a competitor for HeartBeam. We explore in this Insight how a collaboration with Biotronik to integrate AliveCor’s KardiaMobile 6L and KardiaMobile Card ECG technology with Biotronik’s BIOMONITOR Injectable Cardiac Monitor is among several initiatives shaping clinical diagnostic pathways for cardiac patients, setting an example of success that can come from further collaboration.
Hurdles to Adoption
There are several factors affecting global uptake for ambulatory cardiology solutions, including a lack of, or complexity around, reimbursement, component shortages (due to supply chain issues) and demands placed on existing hospital IT and workflows (for example how to manage the huge amounts of data generated, along with interoperability concerns).
As with many emerging healthcare technologies, reimbursement is crucial to market acceptance. It has proved complex and troublesome for some ambulatory monitoring vendors and their provider customers to navigate reimbursement provision for solutions being used outside the hospital. It is a similar picture around reimbursement structures for wearable devices and remote patient monitoring more generally. However, HeartBeam’s solution is covered by CMS reimbursement schemes.
Signify Research predicted last year in its Ambulatory Diagnostic Cardiology report that HeartBeam’s hand-held, 12-lead capability ECG device was one of a number of innovations that had the potential to disrupt the ambulatory diagnostic cardiology market in the short-to-medium term. We also noted other potential disruptors include multi-modality cardiac monitor Holter (Short-Term and Long-Term ECG, Event and MCT with built-in 4G connectivity) from Rhythmedix, whilst Indian vendor Dozee also released its ECG patch in 2022. A new cohort of vendors in Europe and the US are also looking to exploit the potential of AI for quicker and more accurate diagnosis.
We also believe ongoing advances in adjacent technologies and markets, such as Remote Patient Monitoring and consumer devices, will continue to influence the ambulatory diagnostic cardiology market. The Long-Term ECG market in particular, where reimbursement developments have lowered barriers to entry, will likely see a proliferation in vendors over the short-to-medium-term. However, as is the case in all healthcare technology and software markets, providers continue to favour dealing with a small number of large vendors who can offer enterprise-level solutions (including ongoing technical, administrative and in some cases, monitoring support). Without this protective umbrella, vendors supplying specialist, single-point solutions may struggle to achieve critical mass. This suggests yet more mergers, acquisitions and partnerships involving the large traditional vendors are on the way.
Big Tech Bets
The extent to which the boundaries between the various product categories of ambulatory diagnostic cardiology begin to overlap is unclear at this point, making any definitive claims around disruption difficult in the near-term.
Much will depend on whether big tech vendors decide to make a concerted play in this market. The Verily/iRhythm tie up previously mentioned indicates that at least Alphabet is certainly showing interest. If so, many of the new and emerging companies will come under their radar as acquisition targets. That could well include HeartBeam. With the LIVMOR intellectual property now under its control and two patented products HeartBeam AIMI software and the AIMIGo ECG device awaiting FDA approval, its attractiveness will be even more apparent.