Cleerly
B2B per-study service. A site sends a coronary CTA to Cleerly LABS, which returns a quantified plaque / stenosis / ischemia-likelihood analysis; the ordering physician or facility bills CPT 75577 (and previously the deleted Category III family 0623T–0626T) and Cleerly is paid per analysis. Revenue therefore rides on reimbursed CCTA volume at a price the payer sets, not on a negotiated software subscription — a structurally different economic engine from enterprise health-IT SaaS.
Earnings, margins, COGS & capex
Cleerly is the purest expression of a thesis the QAI board tests and then declines to be long: a reimbursement moat. It won the sector's best payment pathway — a Category I CPT code, five of seven MACs with a finalised coverage determination, and seven commercial payers covering '86+ million Americans' — and the reward for winning it was a rate that did not move. CPT 0625T paid $950.50 in CY2024 and CY2025; the Category III to Category I upgrade renamed it 75577 and it still pays $950.50 in CY2026; CMS proposes $950.50 again for CY2027. Delta: exactly $0.00 (canon REG-CPT-003, four Addendum B vintages). Worse for the moat narrative, 75577 is a CATEGORY code — HeartFlow's plaque product, Cleerly's AI-QCT and any future entrant all bill it at the same price. So the financial question is not price, which CMS owns, but volume: and the CY2024 Medicare OPPS claim count on the Cleerly-era code was 22. Everything bullish about Cleerly is an argument that 2026 is the year that number stops being 22.
Income statement — where each revenue dollar goes
% of revenueOf every $1 of revenue, ~0¢ is cost of goods and ~98¢ operating expense, leaving ~2¢ of operating profit.
Revenue trend
Margins
software-like per study; capped on the sell side by an administratively-set price, pressured on the cost side by GPU inference plus clinical over-read
two large prospective trials plus national payer contracting run far ahead of per-study revenue
equity-funded; no round disclosed since Dec 2024
COGS structure
Per-study, not per-seat. Each analysis consumes GPU inference across a multi-hundred-slice CT volume (segmentation, vessel labelling, lumen-wall and plaque characterisation), cloud storage and PHI-compliant transfer, plus a human quality step on output that a cardiologist will act on. That last item is the one that does not fall with GPU prices, and it is why AI-QCT gross margin should be modelled below classic SaaS even as inference costs decline. Two further structural cost/price facts: (1) the price side is fixed by CMS, so falling compute cost accrues to Cleerly rather than being competed away — but only until a rival with the same code undercuts on service; (2) canon flags an ESTIMATED 50% multiple-procedure reduction when 75577 is billed alongside the CTA it rides on — explicitly UNVERIFIED at primary in the board's own record, so it must be carried as a modelling risk, not a fact.
Capex
Immaterial. No owned imaging fleet, no data centres disclosed; compute is consumed as cloud opex. The capital-intensive asset in this value chain — the CT scanner — belongs to GE HealthCare, Siemens Healthineers, Canon Medical or Philips and sits in the customer's building.
Latest earnings
n/a
None. Company-side directional signals only: '86+ million Americans' covered as of 6 Jan 2026; evidence base of 'millions of images from over 40,000 patients'; 'over 50 peer-reviewed manuscripts' in the two years to April 2026; 'substantial growth' asserted without a figure (Cleerly, 17 Apr 2026).
- CPT 75577 rate (hospital outpatient)
- $950.50, APC 1511, SI 'O1' as proposed for CY2027 — flat across CY2024–CY2027 (canon REG-CPT-003)
- CPT 75577 rate (imaging centre / physician office)
- $1,021 national average — a DIFFERENT setting; never compare with the APC figure (canon PB-039)
- MAC coverage
- 5 of 7 Medicare Administrative Contractors with a finalised determination (canon CM-PRIV-CL-01)
- Commercial covered lives
- '86+ million Americans' across 7 named payers (Cleerly, 6 Jan 2026)
- CY2024 Medicare OPPS claims, 0625T
- 22 (CMS; 81 across all three flagship AI services — only the 22 are cardiac; Perspectum's 0698T 55 and 0724T 4 make up the other 59)
- FDA authorisations
- 4 (FDA AI-Enabled Medical Device List, corporate-family roll-up, list vintage 2026-06-16 — canon REG-FDA-018; quote only on this basis)
- Disclosed funding
- $223M Series C (Jul 2022, T. Rowe Price-led) + $106M Series C extension (4 Dec 2024, Insight Partners-led); ~$578M cumulative per Tracxn (unverified)
- Last post-money valuation
- not disclosed — no negotiated mark is public, and none may be inferred from round size
Growth drivers
- CPT Category I code 75577 effective 1 January 2026 — the first year the service bills under a permanent Category I code rather than a Category III placeholder, though the rate under it is still set one year at a time (canon CM-PRIV-CL-01 / REG-CPT-003 / REG-CPT-007)
- Five of seven Medicare Administrative Contractors with a finalised coverage determination (canon CM-PRIV-CL-01) plus seven named commercial payers — Aetna, UnitedHealthcare, Cigna, Humana, BCBS Kansas City, Excellus BCBS and EviCore — covering '86+ million Americans', Aetna alone >20M lives (Cleerly press release, 6 Jan 2026)
- The imaging-centre / physician-office setting pays a $1,021 national average versus $950.50 in hospital outpatient (canon PB-039), so site-of-service mix shift toward outpatient imaging centres is accretive per study
- CCTA-first chest-pain pathways displacing functional stress testing, which expands the addressable scan base Cleerly analyses
- Workflow and administrative products that attack the real adoption bottleneck rather than the algorithm: Cleerly PREVIEW (case prioritisation and prior-authorisation support, debuted at ACC.26, 28–30 Mar 2026) and the customisable Full Text Report (SCCT2026, 9–12 Jul 2026)
- Evidence flywheel and adjacency — the CONFIRM2 registry (international observational, ~30,000 target, >10,750 enrolled) and the Allelica partnership launching a Cleerly Polygenic Cardiovascular Risk Score Test extend the franchise from a single read to a risk-stratification pathway
Bull & bear
Cleerly holds the cleanest nationally-priced payment pathway for the diagnostic test that is displacing functional stress testing — permanent as a code, reset annually as a rate, and 2026 is the first year it can actually be billed at scale: a Category I code, five of seven MACs finalised, seven commercial payers and 86M+ covered lives, against a CY2024 Medicare claim base of 22. Price is fixed — so every dollar of falling compute cost is retained, and the entire return is a volume ramp off a base near zero.
- A Category I CPT code is the hardest asset to acquire in US medtech, and 75577's rate has held at $950.50 across four Addendum B vintages (canon REG-CPT-003). Read it precisely: the payment sits in New Technology APC 1511 (Level 11, $901–$1,000), not a clinical APC, and CMS proposes moving it to SI 'O1' for CY2027 — the rate is stable by CMS practice, not protected by structure
- The volume base is so low it is almost all upside: 22 CY2024 OPPS claims on the Cleerly-era code, against 86M+ commercially covered lives from 6 January 2026 and five of seven MACs finalised. This is not a market-share fight; it is category creation with the payment already in place
- Fixed price plus falling inference cost is an unusually clean margin structure. CMS is not going to claw back a compute saving it cannot observe, and HeartFlow's 80.2% GAAP / ~81% guided non-GAAP gross margin on the adjacent code proves the shape is reachable
- Site-of-service mix is a free rate increase: $1,021 national average in the imaging-centre / physician-office setting versus $950.50 in hospital outpatient (different settings, never to be compared directly) means outpatient CCTA growth lifts realised revenue per study without any CMS action
- The evidence programme is genuinely differentiating and hard to replicate — CONFIRM2 (>10,750 enrolled toward ~30,000) plus a 7,500-patient randomised primary-prevention trial in TRANSFORM is a scale of prospective data no CT OEM's console feature will match, and it is the raw material for guideline inclusion
- Cleerly owns the workflow layer around the read (PREVIEW for prior authorisation and case prioritisation, customisable Full Text Reports) and an adjacency into inherited risk via the Allelica polygenic score — turning a per-study analysis into a repeat-use preventive-cardiology pathway
Cleerly is the cleanest available proof that a reimbursement moat is a toll booth someone else owns. It spent five years converting a Category III placeholder into a Category I code and the rate moved by exactly $0.00; the code it won is shared with HeartFlow and Elucid at an identical CMS-set price; its demonstrated Medicare volume was 22 claims in CY2024; and its listed rival is now seeking a permanent injunction against three of its products. The QAI board's response to this business model is to be SHORT the listed instance of it, not to hunt for a way to be long the private one.
- The upgrade paid nothing. $950.50 as 0625T in CY2024 and CY2025, $950.50 as 75577 in CY2026, $950.50 proposed for CY2027 — a $0.00 delta across four Addendum B vintages (canon REG-CPT-003). The single most-cited bull fact about this company is, on the primary source, rate stasis
- Non-excludable by construction: 75577 is a category code that HeartFlow's plaque product, Cleerly's AI-QCT and any future entrant all bill at the same rate, so vendors compete on service inside a price the payer sets. Exclusivity is decaying inside Addendum B, not the preamble — three new Category III placeholders (X567T, X668T, X669T) already sit at 75580's proposed rate
- Volume, not price, was always the binding constraint, and volume was 22 CY2024 OPPS claims on 0625T (81 across all three flagship AI services — only the 22 are cardiac; Perspectum's 0698T 55 and 0724T 4 make up the other 59). CMS pooled standalone with add-on because 'the standalone service and add-on services are identical'. A pathway with no claims through it is a permit, not a business
- The adjacent code shows where this goes: 75580 was cut 13.8% in one year and is proposed down another 3.1% into SI 'O1' — and 75577 is proposed into 'O1' too for CY2027. Canon also flags an ESTIMATED 50% multiple-procedure reduction when 75577 is billed with the CTA it rides on (UNVERIFIED at primary), which if real halves the realised rate in the most common billing pattern
- Litigation risk is asymmetric and product-level: six HeartFlow patents with 2012–2018 priority dates, filed 13 April 2026 in the Eastern District of Texas, seeking a permanent injunction against ISCHEMIA, Plaque Analysis and Compare. Cleerly calls the claims baseless and has not counter-sued. A well-capitalised listed plaintiff can outlast a private defendant on legal spend alone
- There is nothing to buy and nothing to price. No post-money valuation was disclosed at the December 2024 round, no round since, no revenue, no burn, no filings — and the board carries no valuation for the name precisely because inferring one from a raise size would be fabrication
What it is worth
No valuation is carried for this name, by decision. Cleerly is private, no post-money was disclosed at its last round (the $106M Series C extension of 4 December 2024, led by Insight Partners), and there is no negotiated mark to quote — so unlike a private peer with a published round price, there is not even a stale figure to stamp. A valuation must NOT be inferred from the raise size. What can be framed is the economic envelope, which is unusually legible because CMS publishes the price: revenue is (reimbursed AI-QCT studies) × (a rate CMS sets — $950.50 in APC 1511 hospital outpatient, $1,021 national average in the imaging-centre / physician-office setting, two different settings that must never be compared as one number), less an estimated multiple-procedure reduction of ~50% when 75577 is billed with the CTA it rides on (UNVERIFIED at primary — canon flags it as such). Against that, the CY2024 Medicare OPPS claim count on the Cleerly-era code 0625T was 22. The correct output of this dossier is not a number; it is a volume question with a published price.
CMS does to 75577 what it has already done to 75580 — a 13.8% one-year cut is the precedent, on a rate now held by a discretionary authority CMS itself calls interim — while three new Category III algorithmic placeholders and Elucid's rising 0712T show entrants arriving faster than volume. The HeartFlow injunction lands, or the defence consumes a funding round. Volume stalls short of the level that makes a per-study, administratively-priced business profitable, and the Viz.ai precedent repeats: the first AI software granted an NTAP was paid up to $1,040 per case in the FY2021 IPPS final rule, extended once, and appears zero times in the FY2023 rule. A first-mover payment pathway does not compound. In this branch there is no down-round to observe, only a private mark that never becomes a print.
The code works as a permit and not as a moat. Volume grows materially off a near-zero base as coverage converts, but is shared with HeartFlow and Elucid and capped by CCTA capacity, prior-auth friction and the multiple-procedure reduction; the rate stays at $950.50 into CY2027 as proposed while drifting into the discretionary 'O1' bucket; the litigation settles or narrows with a licence and a cash cost; and Cleerly raises again privately at a mark that is negotiated rather than discovered. No public price exists to re-rate, so the value question stays unresolved until an IPO or a trade sale forces it.
TRANSFORM reads out with an outcome benefit, guidelines move CCTA-plus-plaque-quantification into the recommended pathway, and the CY2024 claim base of 22 compounds into six figures of annual reimbursed studies against 86M+ covered lives at a rate CMS never cut. Compute cost falls while the price stays fixed, so incremental gross margin approaches the ~80% the listed comparator already prints; the HeartFlow suit resolves without an injunction; and an IPO clears at a multiple that reflects a nationally-priced, permanently-coded diagnostic. In this branch the shared code stops mattering because Cleerly owns the evidence that made the pathway worth using.
Framing, not a recommendation, and not investment advice. The board's position is explicit: Cleerly is on the watchlist with a lean of 'watch — but read HeartFlow first', and the reimbursed-diagnostics view is expressed as a SHORT of the listed instance (HTFL) rather than as a hunt for a way to be long the private one (canon PB-039). The reason is structural: 75577 is a category code, so any long thesis on Cleerly's moat is simultaneously a long thesis on its two closest rivals' access to the same rent. WHAT WOULD MAKE IT INVESTABLE: an IPO — at which point the first question is not the code, it is what happens to the rate at the next OPPS rule. Per the board's own deployment discipline, a new private-turned-listed name is sized at 3–5% only on the FIRST print that discloses the AI revenue line separately, never on listing day; a listed acquirer absorbing Cleerly into a $30B+ diversified platform would dilute the moat to noise and would not qualify. Cleerly also sits inside the board's standing 'investability gap' regime: six disclosed private marks dated Jun 2025 to May 2026, summed, total ~$33.05B — last-round marks, not marks-to-market, and not uniformly post-money — against the entire 17-name listed pure-play cohort at ~$33.90B of market cap at the 31 Jul 2026 close, directional only, with the moat-owners — Epic, Aidoc, RapidAI, Viz.ai and Cleerly as holder of the Category I plaque code — on the private side of the line.
SWOT
Strengths
- First mover and category definer in AI-QCT — first FDA clearance for AI quantification and characterisation of coronary plaque (2020), and the company whose Category III codes (0623T–0626T) became the Category I code the whole category now bills
- The sector's cleanest reimbursement pathway — Category I 75577 effective 1 Jan 2026, 5 of 7 MACs finalised, seven commercial payers, '86+ million Americans' covered (canon CM-PRIV-CL-01 + Cleerly 6 Jan 2026)
- Deep clinical-evidence programme — CONFIRM2 international registry (>10,750 of a ~30,000 target enrolled) and the randomised TRANSFORM trial (7,500 asymptomatic pre-diabetic / T2D / metabolic-syndrome patients), plus 50+ peer-reviewed manuscripts in two years
- Physician-founder credibility — James K. Min, MD, a cardiac-imaging academic, sells to the cardiologists and radiologists who must trust the output
- Asset-light: no scanner capital, no owned data centres; the expensive hardware in the value chain is the customer's
Weaknesses
- Winning the code moved the price by exactly $0.00 — 0625T $950.50 (CY2024/25) to 75577 $950.50 (CY2026) to $950.50 proposed (CY2027) (canon REG-CPT-003). The reward for a five-year reimbursement campaign was rate stasis
- 75577 is a CATEGORY code, not a company code — HeartFlow, Cleerly and Elucid all bill it at the same CMS-set rate (canon PB-039). The moat is a pathway for a procedure, not an exclusive licence
- Demonstrated Medicare volume was de minimis — 22 CY2024 OPPS claims on 0625T; the entire three-code flagship pool was 81 claims
- Facing a six-patent infringement suit from its listed rival with priority dates 2012–2018, seeking a PERMANENT INJUNCTION against Cleerly ISCHEMIA, Plaque Analysis and Compare (HeartFlow, filed 13 Apr 2026, E.D. Texas)
- No liquidity and no visibility — no post-money valuation disclosed, no round since Dec 2024, no revenue, no burn — an outside investor cannot size the runway or the mark
Opportunities
- CY2026 is the first year the volume thesis is testable — a Category I code plus 86M+ covered lives against a CY2024 Medicare claim base of 22 is enormous headroom if adoption converts
- Site-of-service mix — the imaging-centre / physician-office national average is $1,021 versus $950.50 hospital outpatient, so growth in freestanding outpatient CCTA is accretive per study
- Attacking the actual bottleneck — PREVIEW's prior-authorisation and case-prioritisation support addresses administrative friction, which is a larger drag on CCTA volume than algorithm accuracy
- Adjacency into risk stratification via the Allelica polygenic-risk-score partnership — moving from one read to a longitudinal preventive-cardiology pathway with repeat economics
- An IPO is the only event that makes the name investable at all (canon PB-039 / board watchlist), and a listed acquirer taking the plaque code in-house is the board's own named tranche-5 trigger
Threats
- CMS rate risk is the whole thesis — 75577 moves into SI 'O1' for CY2027 as proposed, the same New Technology-adjacent bucket CMS itself describes as an interim, transitional policy renewed one year at a time — and the adjacent FFR-CT code 75580 was cut 13.8% in a single year, $1,017.39 (CY2025) to $877.34 (CY2026), with $850.50 proposed for CY2027 (canon)
- The HeartFlow injunction — a granted permanent injunction against ISCHEMIA / Plaque Analysis / Compare is an existential product risk, not a damages line item
- Non-excludability is worsening, visibly, in Addendum B — three new Category III algorithmic placeholders (X567T, X668T, X669T) sit in APC 1510 at exactly 75580's proposed rate, and Elucid's 0712T is the one code in the cohort RISING — $88.05 (CY2025) to $220.60 (CY2026) to $250.50 proposed (CY2027) (canon REG-CPT-009)
- A crowded FDA-cleared field — HeartFlow, Elucid, Circle Cardiovascular Imaging, Caristo Diagnostics, Artrya and Keya Medical all hold CCTA-AI clearances, and the CT OEMs (GE HealthCare, Siemens Healthineers, Canon, Philips) can bundle plaque analytics into the scanner console
- The Viz.ai precedent for payment-pathway decay — the first AI software granted a Medicare New Technology Add-on Payment was approved in the FY2021 IPPS final rule at a maximum $1,040 per case, extended one year for FY2022, and then appears ZERO times in the FY2023 final rule. A first-mover payment pathway does not compound (canon)
Moats, dependencies & bottlenecks
Moats
Strong as a barrier to entry, zero as an exclusivity the code is permanent, the RATE is annual The cleanest reimbursement pathway in the sector and a real gate a new entrant must clear. But it is a CATEGORY code: HeartFlow, Cleerly and Elucid all bill it at the same $950.50 in APC 1511. Reimbursement is still a barrier to entry; the rent is being levelled across everyone who clears it (canon PB-039 / REG-CPT-003).
5 of 7 MACs with a finalised coverage determination plus seven commercial payers and '86+ million Americans' covered (Cleerly, 6 Jan 2026). Contracting takes years to build — but the coverage attaches to the CODE and the service, so a rival billing 75577 inherits much of the benefit.
if TRANSFORM reads out positive CONFIRM2 (>10,750 of ~30,000 enrolled) is observational — association, not causation — and 50+ manuscripts in two years is publication volume, not proof of outcome benefit. TRANSFORM, randomised over 7,500 asymptomatic metabolic-risk patients, is the asset that could become guideline-grade. Unread as of Aug 2026: no efficacy claim is supportable today.
4 authorisations on the FDA AI-Enabled Medical Device List corporate-family roll-up basis (list vintage 2026-06-16, canon REG-FDA-018 — quote only on that basis). These are 510(k) CLEARANCES, not PMA approvals and not De Novo grants; clearance establishes substantial equivalence, not demonstrated clinical benefit. Six other vendors hold CCTA-AI clearances.
Physician-founder credibility, society-meeting presence (ACC.26, SCCT2026), and increasing embedment via PREVIEW's prior-auth and prioritisation workflow plus configurable reports. Switching cost is real but modest — a per-study send-out is far easier to re-route than an EHR-embedded enterprise platform.
litigated Cleerly asserts confidence in its portfolio and 'original research... over the past two decades' (17 Apr 2026). HeartFlow asserts six patents against three Cleerly products and seeks a permanent injunction. Until this resolves, IP is a liability line, not a moat.
Dependencies
CMS rate-setting (OPPS Addendum B and the Physician Fee Schedule) Price-setter for the core service CMS sets the sell-side price outright: $950.50 in APC 1511 hospital outpatient, $1,021 national average in the imaging-centre / physician-office setting. The CY2027 NPRM (CMS-1850-P) proposes 75577 flat but in SI 'O1'; the adjacent 75580 has already been cut 13.8% in one year. Rate risk is not a sensitivity — it is the business.
Coverage gatekeepers A priced code with no coverage determination pays nothing. 5 of 7 MACs are finalised (canon); the remaining two, plus policy retrenchment by any of Aetna / UnitedHealthcare / Cigna / Humana / BCBS KC / Excellus / EviCore, directly moves addressable volume.
Siemens Healthineers, Canon Medical, Philips) Cleerly cannot exist without someone else's scan Every unit of revenue requires a coronary CTA already acquired on hardware Cleerly does not own. The OEMs are simultaneously the source of supply and the most credible bundlers of a competing plaque-analytics feature at the console.
Legal / product continuity Six patents, 2012–2018 priority dates, against ISCHEMIA / Plaque Analysis / Compare, with permanent injunctive relief sought. Cleerly denies infringement and has not counter-sued. Injunction risk is product-level, and legal spend is asymmetric against a listed plaintiff.
Pre-profit with no round disclosed since the $106M Series C extension of 4 December 2024 and no cash disclosure. Neither a valuation mark nor a runway is observable from outside — an information gap, and gaps in private credit-worthiness resolve unhelpfully.
Per-study inference over large CT volumes. Falling compute cost is retained margin because the price is administratively fixed — the one place the fixed rate works in Cleerly's favour.
Advantages
- Holder of the sector's cleanest reimbursement pathway — Category I 75577 from 1 Jan 2026, 5 of 7 MACs finalised, 86M+ commercially covered lives
- First mover: first FDA clearance for AI plaque quantification and characterisation (2020), and the vendor whose Category III family became the category's Category I code
- The largest prospective AI-QCT evidence programme — CONFIRM2 registry plus the randomised 7,500-patient TRANSFORM trial
- Asset-light per-study model with a CMS-fixed price, so falling inference cost accrues to Cleerly rather than being competed away on price
- Site-of-service optionality — the imaging-centre / physician-office setting pays a $1,021 national average versus $950.50 hospital outpatient
- Workflow and adjacency expansion (PREVIEW prior-auth support, configurable reports, Allelica polygenic risk score) that deepens use beyond a single read
Weaknesses
- The Category III to Category I upgrade moved the rate by exactly $0.00 — the headline achievement produced no pricing gain
- 75577 is shared, not exclusive: HeartFlow and Elucid bill the same code at the same CMS-set rate
- Demonstrated Medicare volume was de minimis — 22 CY2024 OPPS claims on the Cleerly-era code
- Six-patent infringement suit from a listed rival seeking a permanent injunction against three named Cleerly products
- No disclosed valuation, no round since December 2024, no revenue, no burn — unpriceable and unmonitorable from outside
- No outcome-benefit claim is supportable yet — clearances are 510(k), CONFIRM2 is observational, TRANSFORM is unread
Bottlenecks
- Claims volume, not pricing — 22 CY2024 Medicare OPPS claims on 0625T is the base the whole bull case must multiply
- Prior authorisation and administrative friction on CCTA — the constraint Cleerly PREVIEW was built to attack, which is an admission of where the drag actually sits
- CCTA capacity and cardiology/radiology reading workflow — scanner time, protocol standardisation and image quality gate every downstream analysis
- The estimated 50% multiple-procedure reduction when 75577 is billed with the CTA it rides on — UNVERIFIED at primary in the board's own canon, and therefore an unquantified haircut on realised rate
- Per-study clinical over-read / QA cost, which does not fall with GPU prices and caps gross margin below classic SaaS
- Evidence-to-guideline lag — TRANSFORM has not read out, so no outcome-benefit claim is available to force adoption
- No liquidity path — private, no disclosed mark, and the board's own trigger for investability is an IPO that has not happened
Top signals & trends
Top signals
A Category I payment identity rather than a Category III placeholder — the real gate a new entrant must clear (canon CM-PRIV-CL-01). The code is permanent; the payment is not, sitting in New Technology APC 1511 under an interim, one-year-at-a-time CMS policy (canon REG-OPPS-009 / REG-CPT-007).
Four Addendum B vintages, verified at primary (canon REG-CPT-003). The moat was granted and the rent did not rise.
Cleerly press release, 6 Jan 2026. Coverage breadth is the precondition for any volume ramp — though it attaches to the code, so rivals inherit much of it.
CMS pooled standalone with add-on because the services are identical. The pool is too small to be a pool — a priced pathway with almost no claims through it.
Priority dates 2012–2018. Cleerly's 17 Apr 2026 statement calls the claims baseless and promises uninterrupted service; no counterclaim disclosed. Product-level, not merely financial, risk.
Canon REG-CPT-009 — the only AI imaging code in the cohort rising, and it belongs to a competitor. CMS is willing to move rates; it just is not moving Cleerly's.
Movement toward the bucket CMS itself describes as interim and transitional, with standard ratesetting suspended one year at a time. The adjacent 75580 lost 13.8% in a single year.
Product motion aimed at prior-auth friction and repeat use rather than incremental algorithm accuracy — the right target if volume is the constraint.
Not evidence of distress, but it removes the only external mark and any runway visibility. The board carries no valuation for this name and none should be inferred (canon CM-PRIV-CL-01).
Trends
Expands the scan base every AI-QCT vendor analyses. The single most important secular driver for the category, and it is independent of Cleerly's execution.
Four vendor-specific Category III codes collapsed into one shared Category I code at $950.50; three new Category III placeholders (X567T, X668T, X669T) seated in APC 1510 at exactly 75580's proposed $850.50. Exclusivity decays in the addenda.
CMS describes the regime as an interim payment policy and a transitional period under section 1833(t)(2)(E) equitable-adjustment authority. A rate held by fiat can be released by fiat.
GE HealthCare, Siemens Healthineers, Canon Medical and Philips control the acquisition point and lead the FDA authorisation leaderboard by a wide margin — a 'good enough, already paid for' path that pressures per-study send-out economics.
A newly-listed HeartFlow with public-market capital suing a private rival for injunctive relief sets the pattern: where the code is shared and the price is fixed, patents become the only remaining exclusion mechanism.
Seven commercial payers plus 5 of 7 MACs by early 2026 normalises the service in utilisation-management policy — the precondition for volume, even if the benefit is shared across code-holders.
Polygenic risk scoring, serial plaque progression tracking and prior-auth automation convert a one-off analysis into repeat use — the only credible route to revenue growth that does not depend on a CMS rate increase.
Ecosystem & competitor graph
Suppliers feed the company; customers pull from it. Line thickness shows the strength of each tie (supply-chain dependency, customer earnings contribution). Hover to isolate a tie.
GE HealthCare / Siemens Healthineers / Canon Medical / Philips CT scanner installed base — the upstream input. Every Cleerly analysis requires a coronary CTA acquired on OEM hardware Cleerly does not own, which makes these four simultaneously the supply of scans and the most credible bundlers of a competing feature.
GPU compute for per-study inference across large CT volumes. Falling compute cost is retained margin because CMS fixes the sell-side price.
PHI-compliant image transfer, storage and hosting; consumed as opex. Azure = MSFT, GCP = GOOGL.
Human quality step on cardiologist-facing output. The COGS line that does not fall with GPU prices, and the main reason AI-QCT gross margin should be modelled below classic SaaS.
Bill 75577 at $950.50 in APC 1511 (canon REG-CPT-003). The setting the board's HeartFlow short leg is dated to.
Freestanding imaging centres and cardiology physician offices $1,021 national average for the same code in this setting (canon PB-039) — a DIFFERENT setting that must never be compared with the APC figure as if it were one number. Mix shift here is accretive per study.
Preventive-cardiology and executive-health programmes Cash-pay and employer-sponsored demand less exposed to CMS ratesetting; the natural home for the Allelica polygenic-risk-score product.
Quantified plaque as a surrogate endpoint for cardiometabolic drug programmes — a non-reimbursement revenue channel that leverages the same engine.
The listed instance of exactly this business model and the board's short leg — $25.23 / $2.18B on the 31 Jul 2026 close, 52-week range $20.13–$41.22, Q1 2026 revenue $52.6M (+41.3%) at 80.2% GAAP gross margin, FY2026 guided $228–232M, TTM net loss $111.83M. Bills 75577 at the same $950.50 as Cleerly, and its own FFR-CT code 75580 has been cut from $1,017.39 (CY2025) to $877.34 (CY2026) with $850.50 proposed for CY2027. Also Cleerly's litigation adversary since 13 Apr 2026.
Private. Direct AI plaque-characterisation rival that also bills the shared 75577, and the holder of the only code in the cohort whose rate is RISING — 0712T at $88.05 (CY2025) → $220.60 (CY2026) → $250.50 proposed (CY2027) (canon REG-CPT-009). FDA-cleared in 2024. The cleanest evidence that Cleerly's rate stasis is not a sector-wide CMS posture.
ASX-listed Australian AI-QCT vendor; FDA clearance for CCTA coronary plaque assessment (2025), positioned on vulnerable-plaque detection. Smaller clinical and payer footprint, but a listed, funded entrant able to bill the same category code once US coverage is in place.
Private. Cardiac-imaging post-processing incumbent with a broad installed base across cardiac MR and CT, FDA-cleared for CCTA AI (2025). Its advantage is the reading workstation it already occupies — plaque analytics as a feature of an existing workflow rather than a send-out.
Private (UK). FDA-cleared 2025 on a differentiated axis — perivascular/pericoronary fat inflammation rather than plaque volume — so it competes for the same CCTA read while arguing a different biomarker. Distinct code path, overlapping budget.
Private. Holds a second FDA clearance under CPT 75580's own product code (DEEPVESSEL FFR, K213657, cleared 1 April 2022, product code PJA — canon). The living proof that these payment pathways are non-exclusive at the device level, not just the code level. US commercial presence is limited; no US listing exists and none is assumed.
95 FDA AI authorisations on the canon corporate-family roll-up basis (90 Siemens-named + Varian 5; list vintage 2026-06-16). Controls the acquisition point via its CT installed base and can seat coronary analytics at the console, where the marginal price to the customer is near zero.
130 FDA AI authorisations — the leaderboard top on the same single canon basis. Same bundling logic as Siemens plus a cardiology-specific software franchise; also one of the board's named candidates to acquire a private imaging-AI moat outright.
43 FDA AI authorisations (canon basis). Strong cardiac CT hardware position, particularly in high-end coronary imaging; console-level analytics compress the willingness to pay for a third-party per-study read.
45 FDA AI authorisations (canon basis; the trade-press tally of 58 does not reproduce against the FDA file and is retired). Cardiovascular informatics and enterprise-imaging footprint make it a bundler and a plausible acquirer rather than a head-to-head AI-QCT rival today.