WillItSurvive
Medical technology and health companies · United States

HeartFlow

heartflow.com ↗

Makes AI software that turns CT scans into 3D heart models for doctors to plan care.

Protection under test
Assessed 22 July 2026 · Evidence as of 22 July 2026
Something worth protecting exists and is being tested right now.
On the recordSince 22 July 2026 · Checkable from July 8, 2026 and mid-August 2026 · Every call on the record Checkpoint: Cleerly's answer in the patent lawsuit is due, and Q2 2026 earnings report losses and case growth
The call

HeartFlow sits inside a regulatory and reimbursement barrier that keeps AI labs and hospital-equipment giants out for now, but it is racing Cleerly for the same paid cases while still losing money.

HeartFlow sells artificial intelligence software that helps doctors see inside arteries without surgery by analyzing heart scans. The company is hard to copy because the government has approved its product and insurance companies will pay for it, which takes years and lots of money to repeat. However, smaller rivals like Cleerly and Elucid have the same protections, the company is losing over 100 million dollars per year, and a legal fight with Cleerly over patents could disrupt things in the next six months. The biggest wild card is whether giant scanner makers like GE or Siemens decide to build their own competing product and use their existing relationships with hospitals to muscle in on the market.

Why
01
AI pressure: Cleerly. Cleerly runs a rival FDA-cleared AI plaque analysis product and is suing over patents, fighting for the same reimbursed cases. Could AI do the core job? Unlikely.
02
Bigger players: GE, Siemens, or Philips. A scanner maker could bundle its own FDA-cleared, reimbursed heart AI directly into the CT machine, cutting HeartFlow out. Could a giant copy it? No, they are blocked.
03
What protects it. FDA clearance plus a Category I CPT code and 75% payer coverage make it slow and costly to launch a rival that gets paid the same way.
What would change this call
Cleerly's answer to its patent suit against HeartFlow, due July 8, 2026, and any ruling within 6 months. Shows whether Cleerly can legally erode HeartFlow's product differentiation.
GE, Siemens, or Philips shipping an FDA-cleared, CPT-reimbursed FFR CT plaque product. Would show a scanner OEM entering HeartFlow's regulated niche directly.
HeartFlow's Q2/Q3 2026 earnings net loss and cash burn trend versus FY2025's 21% YoY widening. Shows whether losses are narrowing toward a profitability path.
Key numbers
  • Q1 2026 revenue $52.6M, up 41% YoY (2026-03-31)
  • FY2025 net loss ~$116.8M, widening 21% YoY (2025-12-31)
  • 1,465 US hospital accounts installed (2025-12-31)
Named risks
  • Net losses widening: FY2025 loss ~$116.8M, up 21% YoY, no clear profitability path yet. Severity: high
  • Active patent litigation with Cleerly could reshape competitive dynamics by mid-2026. Severity: medium
  • Negative and declining employee sentiment reported through 2025. Severity: medium
  • Insider selling and stock volatility, including a 14.36% single-day drop in June 2026. Severity: low
  • Reimbursement and regulatory moat is shared with named peers, limiting differentiation. Severity: medium
Rivals, as read in July 2026
RivalDirectionEvidence
CleerlycontestingHeartFlow filed 6-patent infringement suit April 13, 2026; Cleerly's answer due July 8, 2026
ElucidcontestingShares same Category I CPT reimbursement code with HeartFlow effective January 2026
GE, Siemens, Philips (CT OEMs)contestingNo FDA-cleared, CPT-reimbursed competing product shipped by these OEMs as of July 2026
Questions people ask
Is HeartFlow profitable in 2026?
No. HeartFlow's FY2025 net loss widened to about $116.8M (-21% YoY), and Q1 2026 GAAP net loss was $27.4M including a $7.5M non-cash HQ relocation charge. Revenue is growing 40%+ but the company has not reached profitability as of mid 2026.
Who owns HeartFlow?
Bain Capital was HeartFlow's lead private investor before its Nasdaq IPO closed August 8, 2025 at $19/share, raising about $364.2M. Other pre-IPO backers included Capricorn Investment Group, U.S. Venture Partners, and Sandbox Industries; it now trades publicly as HTFL.
Who is HeartFlow's biggest competitor?
Cleerly, founded around 2016-2017 by Dr. James K. Min, a former HeartFlow consultant, is HeartFlow's closest rival in AI-driven CCTA plaque analysis. HeartFlow sued Cleerly for patent infringement on April 13, 2026, in E.D. Texas; Cleerly's answer is due July 8, 2026.
Could generic AI replace HeartFlow's diagnostics?
Unlikely soon. HeartFlow's product holds FDA 510(k) clearance and a Category I CPT reimbursement code effective January 2026, backed by over 200 million annotated CCTA images and 650,000+ managed patients, creating regulatory and data moats a new AI entrant cannot quickly replicate.
Is HeartFlow stock a buy in 2026?
Analysts are cautious but not bearish. JPMorgan cut its target to $35 (from $40) in March 2026 and Canaccord to $37 (from $43) in May 2026, both above the $24-27 trading range in July 2026, amid insider selling and cash burn concerns.
How fast is HeartFlow growing revenue?
FY2025 revenue reached $176.03M, up 39.9% YoY; Q1 2026 revenue hit $52.6M, up 41% YoY on 67% global case growth, with FY2026 guidance raised to $228-232M as of May 14, 2026.
Timeline
  • 2026-07-22Market cap about $2.19-2.26B, shares trading $24-27
  • 2026-06-30Stock fell 14.36% in a session amid insider selling concerns
  • 2026-05-14Q1 2026 results: revenue $52.6M, guidance raised to $228-232M
  • 2026-04-13HeartFlow sues Cleerly for patent infringement in E.D. Texas
  • 2026-03-18FY2025 results: revenue $176.03M, net loss ~$116.8M
  • 2026-01-01New Category I CPT code for AI plaque analysis takes effect
  • 2025-09-22FDA 510(k) clearance and launch of Next-Gen Plaque Analysis
  • 2025-08-08IPO closes on Nasdaq (HTFL), raising about $364.2M
Revision history
22 July 2026
First assessed. Protection under test. The text above is fixed as of this date and is not edited afterwards.
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