Heartflow, Inc.
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
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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.
Sep 30, 2025 · Filed Nov 12, 2025
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-09-19.
0001464521-25-000012
Item 1A. Risk FactorsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001464521-25-000019
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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2159 unchanged; 179 reworded; 43 added; 23 removed; 2 previous and 3 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (43)
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all seven local Medicare Administrative Contractors (MACs) regions and select commercial payors.
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However, the coverage criteria, timing, commercial payor reimbursement rates and availability of
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coverage are still evolving and may vary by payor and jurisdiction, and other payors may not adopt similar
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coverage policies. As a result, even with these developments, we may not be able to achieve customer
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inflationary trends, interest rate volatility, and uncertainty with respect to the federal debt ceiling and
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budget and potential government shutdowns related thereto, cyberattack (including a ransomware attack),
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services companies. Although our cloud offering has not been affected by these outages, a similar outage
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could render our cloud offering inaccessible to customers, and such outages may be prolonged.
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Further, the ability of the FDA to review and approve new products, to provide feedback on clinical trials
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and development programs, to meet with manufacturers, and other related processes can be affected by
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a variety of factors, including government budget and funding levels, reductions in workforce, ability to
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hire and retain key personnel, and statutory, regulatory and policy changes. Government shutdowns, if
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prolonged, can significantly impact the ability of government agencies upon which we rely, such as the
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FDA, to timely review and process our regulatory submissions, which could have a material adverse
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or other third parties. For example, in October 2025, we and certain of our employees received civil
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investigative demands (the “CID”) from the U.S. Department of Justice, Civil Division, in connection with
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an investigation under the federal Anti-Kickback Statute and Civil False Claims Act (the “Investigation”).
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The CID requests information, documents, and testimony focused on our financial and contractual
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arrangements with providers and our sales and marketing activities. We are cooperating with the
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Investigation. We are unable to express a view at this time regarding the likely duration, or ultimate
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outcome, of the Investigation. Depending on the outcome of the Investigation, there may be a material
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impact on our business, results of operations, financial condition, or cash flows.
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federal Civil Money Penalty Statute also creates potential civil liability, with a lower threshold for violation,
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of the same types of activities that would violate the criminal Anti-Kickback Statute.
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Nonpublication requests may allow a United States patent application to go unpublished until issuance.
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and economic instability, including domestic and global inflationary trends, interest rate volatility, and
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uncertainty with respect to the federal debt ceiling and budget and potential government shutdowns
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as well as asset and liability balances. During the nine months ended September 30, 2025, we were
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investment to decline and could result in substantial losses for investors.
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performance or the operating performance of our competitors, including inflation, interest rate
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volatility, and uncertainty with respect to the federal debt ceiling and budget and potential government
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time. These sales, or the perception in the market that the holders of a large number of shares of our
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common stock intend to sell shares, could reduce the market price of our common stock. If our existing
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Removed paragraphs (23)
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time and significant resources to develop, and we may not be able to achieve customer acceptance or
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Although our customers were not affected by that outage, a similar outage could render our cloud offering
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balances. During the six months ended June 30, 2025, we were exposed to foreign currency risks in
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In addition, in the past, stockholders have instituted securities class action litigation following periods of
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market volatility. If we were to become involved in securities, it could subject us to substantial costs, divert
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resources and the attention of management from our business and harm our business, results of
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operations, financial condition and reputation. These factors may materially and adversely affect the
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services, or technologies. See the section titled “Use of proceeds” for additional information.
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If securities or industry analysts do not publish research or reports about our business, or if they
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research coverage by securities and industry analysts. If no or few securities or industry analysts
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commence coverage of us, the market price for our stock would be negatively impacted. In the event we
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obtain securities or industry analyst coverage, if any of the analysts who cover us downgrade their
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substantial losses in the foreseeable future. For the three and six months ended June 30, 2025, we
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substantial losses in the foreseeable future. For the three and nine months ended September 30, 2025,
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incurred net losses of $9.2 million and $41.5 million, respectively. As of June 30, 2025, we had an
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we incurred net losses of $50.9 million and $92.4 million, respectively. As of September 30, 2025, we had
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accumulated deficit of approximately $1.0 billion. Since inception, we have spent significant amounts of
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an accumulated deficit of approximately $1.1 billion. Since inception, we have spent significant amounts
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cash to develop the Heartflow Platform, to fund research and development, including our preclinical
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of cash to develop the Heartflow Platform, to fund research and development, including our preclinical
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Asof June 30, 2025, our Heartflow FFRCT Analysis represented 98%of our total revenue. In the second
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Asof September 30, 2025, our Heartflow FFRCT Analysis represented 98%of our total revenue. In the
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half of 2023, we began limited market education efforts of our second product, Heartflow Plaque Analysis.
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second half of 2023, we began limited market education efforts of our second product, Heartflow Plaque
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Over the next several years, we expect to continue to devote a substantial amount of resources to
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Analysis. Over the next several years, we expect to continue to devote a substantial amount of resources
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increase sales of our Heartflow FFRCT Analysis and also expand our commercialization efforts and drive
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to increase sales of our Heartflow FFRCT Analysis and also expand our commercialization efforts and
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increased adoption of our Heartflow Plaque Analysis. However, we may not succeed in increasing sales
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drive increased adoption of our Heartflow Plaque Analysis. However, we may not succeed in increasing
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of our Heartflow FFRCT Analysis or in increasing adoption of our Heartflow Plaque Analysis. We expect to
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sales of our Heartflow FFRCT Analysis or in increasing adoption of our Heartflow Plaque Analysis. We
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continue to derive almost all of our revenue from sales of Heartflow FFRCT Analysis for the foreseeable
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expect to continue to derive almost all of our revenue from sales of Heartflow FFRCT Analysis for the
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future, so we are highly dependent on its success.
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foreseeable future, so we are highly dependent on its success.
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accounts, no single customer accounted for 10% or more of our revenue during the three and six months
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accounts, no single customer accounted for 10% or more of our revenue during the three and nine
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ended June 30, 2025 and 2024. However, the decision-making function for some of these accounts is
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months ended September 30, 2025 and 2024. However, the decision-making function for some of these
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concentrated in a relatively small number of customers, such that the loss of one customer could result in
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accounts is concentrated in a relatively small number of customers, such that the loss of one customer
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a disproportionate loss across our accounts. For example, for the year ended December 31, 2024, our top
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could result in a disproportionate loss across our accounts. For example, for the year ended December
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two largest customers, both large health systems with multiple accounts, collectively represented
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31, 2024, our top two largest customers, both large health systems with multiple accounts, collectively
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and we have generated very minimal revenue from this product. Heartflow Plaque Analysis has taken
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and we have generated very minimal revenue from this product. HeartFlow Plaque Analysis is covered by
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broad commercial reimbursement coverage, which could limit its adoption.
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acceptance or broad commercial reimbursement coverage, which could limit its adoption.
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making that may require risks and to provide notice and rights to opt-out and access to information
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making that may require assessing risks and to provide notice and rights to opt-out and access to
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underlying the logic and outputs. Colorado passed the Colorado AI Act, which will go into effect in
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information underlying the logic and outputs. Colorado passed the Colorado AI Act, which will go into
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February 2026. This law creates duties for developers and deployers to use reasonable care to protect
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effect in February 2026. This law creates duties for developers and deployers to use reasonable care to
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consumers from any known or reasonably foreseeable risks of “algorithmic discrimination” arising from
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protect consumers from any known or reasonably foreseeable risks of “algorithmic discrimination” arising
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the intended and contracted uses of “high-risk AI systems,” including those that impact healthcare
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from the intended and contracted uses of “high-risk AI systems,” including those that impact healthcare
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unrest, geopolitical instability, severe or prolonged economic downturn, cyberattack (including a
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unrest, geopolitical instability, severe or prolonged economic downturn, including domestic and global
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ransomware attack), war or terrorist attack, could result in lengthy interruptions in our ability to serve our
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war or terrorist attack, could result in lengthy interruptions in our ability to serve our customers. In
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customers. In addition, acts of terrorism could cause disruptions to the internet or the economy as a
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addition, acts of terrorism could cause disruptions to the internet or the economy as a whole and could
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whole and could disproportionately affect us given our reliance on the internet and cloud-based services.
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disproportionately affect us given our reliance on the internet and cloud-based services. Specifically, our
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Specifically, our corporate headquarters are located in Mountain View, California and our production-
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corporate headquarters are located in Mountain View, California and our production-related computers
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related computers are currently located in our Mountain View office and in Austin, Texas. California is
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are currently located in our Mountain View office and in Austin, Texas. California is considered to be an
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considered to be an active earthquake zone, is prone to catastrophic fires, severe weather events and the
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active earthquake zone, is prone to catastrophic fires, severe weather events and the follow-on effects
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follow-on effects thereof, including tsunamis, mudslides, flooding, power outages and other events that
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thereof, including tsunamis, mudslides, flooding, power outages and other events that could disrupt our
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could disrupt our business. Texas is also subject to severe weather events, power outages and other
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business. Texas is also subject to severe weather events, power outages and other events that could
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events that could disrupt our business. Any event that prevents our access to such facilities, physically or
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disrupt our business. Any event that prevents our access to such facilities, physically or virtually, would
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virtually, would prevent us from operating our business and have an adverse effect on our business,
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prevent us from operating our business and have an adverse effect on our business, financial condition,
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resources that are needed in other parts of our business; adverse effects to our existing business
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resources that are needed in other parts of our business; adverse effects on our existing business
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accounted for approximately 8% and 9%, respectively, and accounted for approximately 8% and 9% of
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accounted for approximately 7% and 8%, respectively, and accounted for approximately 8% and 9% of
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our revenue in the six months ended June 30, 2025 and 2024, respectively. One element of our growth
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our revenue in the nine months ended September 30, 2025 and 2024, respectively. One element of our
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strategy is to further expand our international operations and worldwide customer base. Operating in
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growth strategy is to further expand our international operations and worldwide customer base. Operating
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reputation, business, financial condition, results of operations and prospects.
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expected benefits from our NOLs, and our business, financial condition, results of operations and
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Sales of a substantial number of shares of our common stock in the public market could occur at any
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market price of our common stock.
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•the last day of the fiscal year following the fifth anniversary of our IPO;