Heartflow, Inc.
For the period ended Mar 31, 2026. Filed May 14, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 14, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001464521-25-000019
Item 1A. Risk FactorsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-14.
0001464521-26-000071
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
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A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
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Item 2. Unregistered Sales of Equity Securities and Use of Proceed
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Investing in our common stock involves a high degree of risk. You should carefully consider the risks
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described below, as well as the other information in this Quarterly Report on Form 10-Q, including our
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condensed consolidated financial statements and the related notes and “Management’s Discussion and
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Analysis of Financial Condition and Results of Operations.” The risks described below are not the only
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are not material may also impair our business, financial condition, results of operations and prospects.
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Please also see the sections titled “Special Note Regarding Forward-looking Statements.”
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The following risks and uncertainties included in this subsection are among the most significant we face
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and are qualified in their entirety by reference to all of the risk factors as further described in this Item 1A.
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•We have incurred significant net losses since our inception, we expect to incur additional substantial
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losses in the foreseeable future and we may not be able to achieve or sustain profitability.
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•Our revenue is currently generated almost entirely from the sales of only one product, Heartflow
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FFRCT Analysis, and we are therefore highly dependent on the success of this product, which makes
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it difficult to evaluate our current business, predict our future prospects and forecast our financial
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•If healthcare providers are unwilling to change their standard practice regarding the evaluation of
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CAD, our business, financial condition, results of operations and prospects will be adversely affected.
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•If third-party payors, including government payors, do not cover and provide adequate reimbursement
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for the Heartflow Platform, or if existing payment amounts are reduced or coding policies change,
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adoption of the Heartflow Platform by healthcare providers may be negatively impacted, and our
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business, financial condition, results of operations and prospects will be adversely affected.
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•We face risks associated with a concentrated customer base.
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•We face significant competition in an environment of rapid technological change, and there is a
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possibility that our competitors may develop products that are more effective, accurate, reliable, cost-
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effective or more advanced than ours, which may harm our financial condition. If we are unable to
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compete successfully or our potential market share is reduced, we may be unable to increase or
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•The commercialization of Heartflow Plaque Analysis is nascent, and we may not be able to achieve or
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maintain sufficient market acceptance or the levels of utilization we expect from Heartflow Plaque
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•We face risks associated with our use and development of AI models, which may result in operational
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challenges, legal liability, reputational concerns and competitive risks.
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•If we fail to properly manage our future growth, our business could suffer.
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•Our business could be disrupted by catastrophic events.
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•We depend on our information technology systems, and any failure of these systems could harm our
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business and adversely affect our business and operating results.
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•Our networks and those of our third-party service providers may become the target of bad actors or
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security breaches that we cannot anticipate or successfully defend, which could have an adverse
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•We face extensive regulatory requirements to bring our products to market, and our failure to receive
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ones facing us. Additional risks and uncertainties not presently known to us or that we currently believe
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We have described under the heading “Risk Factors” included in our Annual Report on Form 10-K filed with the SEC on March 18, 2026 a number of risks and uncertainties that could cause our actual results of operations and financial condition to vary materially from past, or from anticipated future, results of operations and financial condition. There have been no material changes from these risk factors previously described in our Annual Report on Form 10-K filed with the SEC on March 18, 2026. These risks and uncertainties are not the only risks facing us. Additional risks and uncertainties not presently known to us or that we currently deem not material may also adversely affect our business, financial condition, results of operations or the market price of our common stock.