S-1: Heartflow Files S-1 for IPO, Highlights AI-Powered CAD Growth

Sentiment:

Initial Public Offering Registration Statement 17 July 2025 9:09 PM

Heartflow, a pioneer in AI-powered coronary artery disease diagnostics, has filed its S-1 registration statement for an initial public offering, showcasing significant revenue growth and an expanding product pipeline despite ongoing net losses.

Delay expectedThe initial public offering itself is a 'proposed sale to the public' and will commence 'as soon as practicable after the effective date of this Registration Statement,' indicating it is not yet finalized.Expanding the Heartflow Platform for asymptomatic patients is noted as a 'high-risk nature of the effort' with potential for delays in achieving regulatory approval, payor coverage, and commercialization.

Capital raiseThis S-1 filing is for an Initial Public Offering (IPO) of common stock, which is a capital raise.Issued $98.3 million in aggregate principal amount of 2025 Convertible Notes in January and March 2025.Obligated to use certain net proceeds from this offering to repay $50.0 million (or $55.0 million if underwriters exercise option) of indebtedness outstanding under the 2024 Credit Agreement.

Worse than expectedNet losses increased from $20.9 million in Q1 2024 to $32.3 million in Q1 2025.The Centers for Medicare and Medicaid Services (CMS) issued a proposed 2026 OPPS rule that could result in a reduction of up to 15% in the Medicare reimbursement rate for Heartflow FFRCT Analysis.

Summary

Heartflow has pioneered the use of software and AI for non-invasive diagnosis and management of coronary artery disease (CAD), assessing over 400,000 patients by March 31, 2025, including 132,000 in 2024 alone.
The Heartflow Platform leverages AI and computational fluid dynamics to create personalized 3D heart models from CCTA scans, providing insights on blood flow, stenosis, plaque volume, and composition.
The company's product portfolio includes Heartflow RoadMap Analysis (workflow efficiency), Heartflow FFRCT Analysis (blood flow quantification, 99% of current revenue), Heartflow Plaque Analysis (plaque assessment, limited market education since H2 2023), and the upcoming Heartflow PCI Planner (2026 launch for revascularization strategies).
Heartflow reported revenue of $125.8 million for 2024, a 44% year-over-year increase from $87.2 million in 2023. Q1 2025 revenue was $37.2 million, up 39% from $26.8 million in Q1 2024.
Gross margins improved to 75% in 2024 (up 8 percentage points from 2023) and remained 75% in Q1 2025 (up 3 percentage points from Q1 2024), driven by AI automation and increased revenue cases.
Despite revenue growth, net losses were $96.4 million in 2024 and $32.3 million in Q1 2025, contributing to an accumulated deficit of $1.0 billion as of March 31, 2025.
The estimated U.S. market opportunity for Heartflow FFRCT Analysis and Heartflow Plaque Analysis is approximately $5 billion, targeting 3.1 million patients for FFRCT ($3.3 billion) and 5.5 million patients for Plaque Analysis ($1.7 billion).
The CCTA + Heartflow FFRCT Analysis pathway is supported by AHA and ACC Class 1, Level A guidelines for CCTA and Class 2a, Level B for FFRCT Analysis.
Heartflow FFRCT Analysis is reimbursed under a dedicated Category I CPT code (effective Jan 1, 2024) with coverage for ~99% of covered lives in the U.S. Heartflow Plaque Analysis received a Category I CPT code effective Jan 1, 2026, and is covered by all seven Medicare administrative contractors (MACs).

Sentiment

Score: 6

Explanation: Heartflow demonstrates strong revenue growth, expanding gross margins, and a robust product pipeline with significant market opportunity and clinical validation. However, the company continues to incur substantial net losses, faces intense competition, and is exposed to regulatory and reimbursement risks, including a proposed Medicare rate reduction, which temper the overall positive outlook.

Positives

Achieved significant revenue growth: 44% year-over-year in 2024 ($125.8 million) and 39% in Q1 2025 ($37.2 million).
Gross margins expanded to 75% in 2024 and Q1 2025, driven by AI automation and efficiency improvements in the production process, reducing average per analyst case processing time by approximately 50% in 2024.
The Heartflow Platform is supported by extensive clinical evidence, with over 100 clinical studies and more than 130,000 patients, demonstrating superior accuracy and clinical utility compared to traditional non-invasive tests.
Favorable reimbursement landscape with Heartflow FFRCT Analysis having a dedicated Category I CPT code and ~99% coverage in the U.S., and Heartflow Plaque Analysis receiving a Category I CPT code effective January 1, 2026, with coverage by all seven MACs.
Strong clinical guideline support from AHA and ACC, elevating CCTA to Class 1, Level A and Heartflow FFRCT Analysis to Class 2a, Level B for CAD diagnosis.
Identified a large addressable market opportunity in the U.S. of approximately $5 billion for current products, with potential for expansion into the global asymptomatic CAD market (200 million people).
Proprietary, secure bi-directional data communication with customers feeds a growing database of approximately 110 million annotated CCTA images, enhancing AI algorithm refinement and future product development.
Heartflow RoadMap Analysis improves CCTA interpretation times by ~25% and reduces inter-reader variability by ~40%, enhancing workflow efficiency for physicians.

Negatives

Incurred significant net losses since inception, with $96.4 million in 2024 and $32.3 million in Q1 2025, leading to an accumulated deficit of $1.0 billion as of March 31, 2025.
Revenue is highly concentrated, with Heartflow FFRCT Analysis representing 99% of total revenue as of March 31, 2025, making the company highly dependent on its success.
Commercialization of Heartflow Plaque Analysis is nascent, with minimal revenue generated to date, and market acceptance and broad commercial reimbursement coverage are still uncertain.
The company faces significant competition from established traditional non-invasive tests and emerging AI-based platforms, which could impact market share and profitability.
Proposed 2026 OPPS rule by CMS could result in a reduction of up to 15% in the Medicare reimbursement rate for Heartflow FFRCT Analysis, potentially impacting adoption and revenue.
Reliance on third-party CCTA images and CT scanner manufacturers poses a risk if manufacturers change to proprietary formats or develop competing integrated products.
The company's credit agreement contains restrictive covenants that may limit business operations, and a portion of the 2024 Term Loan will remain outstanding after the IPO.

Risks

Inability to achieve or sustain profitability due to significant net losses and anticipated increases in operating expenses.
High dependence on the success of Heartflow FFRCT Analysis, which currently generates almost all revenue.
Healthcare providers may be unwilling to change standard practice regarding CAD evaluation, hindering adoption of the Heartflow Platform.
Third-party payors, including government payors, may not provide adequate reimbursement for the Heartflow Platform, or existing payment amounts may be reduced (e.g., proposed 15% Medicare cut for FFRCT).
Risks associated with a concentrated customer base, where the loss of a few large health systems could disproportionately impact revenue.
Significant competition from traditional non-invasive tests and other AI-based platforms, potentially leading to reduced market share or price pressure.
Commercialization of Heartflow Plaque Analysis may not achieve sufficient market acceptance or expected utilization levels.
Risks associated with the use and development of AI models, including operational challenges, legal liability, reputational concerns, and competitive risks from rapidly evolving AI technology.
Potential for bugs, defects, or errors in the Heartflow Platform, including human quality control errors, which could adversely affect reputation and operating results.
Dependence on information technology systems and third-party cloud providers (AWS), with potential for failures, security breaches, or service interruptions.
Inability to hire, integrate, develop, motivate, and retain highly qualified technical personnel, especially in AI and cardiology.
Challenges in managing future growth, which could strain personnel, IT systems, and other resources.
Business disruptions from catastrophic events such as natural disasters, power loss, or cyberattacks.
Consolidation among healthcare providers could lead to pressure for price concessions or reduced purchases of the Heartflow Platform.
Risks inherent in international sales, including regulatory requirements, economic and political risks, and limited operating experience in foreign markets.
Failure to obtain and maintain international regulatory registrations, clearances, or approvals for products outside the U.S.
Delays in the commencement or completion of future or ongoing clinical testing could increase costs and delay market entry for additional indications.
Interim, top-line, and preliminary clinical trial data may change, potentially harming business prospects.
Exposure to product liability claims, which could result in costly litigation and significant liabilities.
Products may be subject to recalls, which could be costly and harm reputation and business (e.g., past MAUDE reports for false negatives).
Off-label or other unlawful promotion of products could result in costly investigations and sanctions.
Subject to numerous federal, state, and foreign healthcare fraud and abuse, compliance, transparency, and privacy laws and regulations, with potential for significant penalties for non-compliance.
Risks associated with currency fluctuations impacting results of operations.
Limitations on the ability to use net operating losses (NOLs) and tax credits to offset future taxable income and taxes.
Potential for successful assertion by taxing authorities that sales and use, value-added, or similar taxes should have been collected.
The market price of common stock may be volatile, and there may not be an active trading market after the IPO.
Increased costs and additional regulations as a public company, potentially lowering profits.
If estimates or judgments relating to critical accounting policies are incorrect, operating results could fall below expectations.
Principal stockholders and management will own a significant percentage of stock, exerting control over stockholder approval matters.
Sales of a substantial number of shares in the public market after lock-up periods could cause stock price to decline.
Provisions in charter documents and Delaware law could discourage takeovers and entrench management.

Future Outlook

Heartflow expects to continue significant investments in research and development to introduce new products, features, and improvements, including the launch of Heartflow PCI Planner in 2026. The company anticipates broadening market education for Heartflow Plaque Analysis as payor coverage increases and investing in additional clinical evidence to support expanded indications, particularly for asymptomatic patients. Management believes gross margins will increase over the long term due to AI automation, despite short-term increases in production team hiring and training costs. The company expects to expand its geographic footprint and clinical applications beyond symptomatic CAD.

Management Comments

We believe that we are the most widely adopted AI-powered test for CAD.
We believe the differentiated accuracy and clinical utility of our Heartflow Platform, along with its ability to enhance workflows, will continue to support our growth and advance the CCTA + Heartflow pathway as the definitive standard for the non-invasive diagnosis and management of CAD.
We believe our Heartflow Platform delivers superior clinical utility and economic value to our customers and the broader healthcare system.
We believe the CCTA + Heartflow pathway will become the standard of care for the non-invasive diagnosis of CAD over time.
We believe the Heartflow Platform is the most extensively studied AI-enabled test for CAD.
We believe our favorable reimbursement and society support provides a strong foundation and tailwind for our continued growth.
We expect to launch our next product, Heartflow PCI Planner, in 2026 as an integrated feature to enhance procedural efficiency, not as a stand-alone product.
We expect our gross margin will increase over the longer term as we leverage the AI-based nature of our software platform to automate an increasing number of the manual components of our production teams process.
We believe that all accounts with an active CCTA program would benefit from adopting the Heartflow Platform into their workflow in order to improve efficiency and patient care.

Industry Context

Heartflow operates in the cardiovascular disease diagnostics market, specifically targeting coronary artery disease (CAD), which is the leading cause of death worldwide. The industry is shifting towards more precise, personalized approaches, driven by AI advancements and imaging technologies. Traditional non-invasive tests (NITs) like SPECT and PET are often unreliable, leading to false negatives and positives. CCTA has emerged as a preferred first-line test, and Heartflow's AI-powered platform enhances CCTA's utility by providing quantitative insights into blood flow, plaque, and stenosis, addressing the limitations of CCTA alone. The company is positioned to capitalize on the growing adoption of CCTA and the increasing demand for more accurate, non-invasive diagnostic tools, potentially expanding into the large asymptomatic CAD market.

Comparison to Industry Standards

Heartflow FFRCT Analysis demonstrated superior diagnostic accuracy compared to CCTA alone, SPECT, and PET in the PACIFIC trial, with an AUC of 0.94 versus PET (0.87), CTA (0.83), and SPECT (0.70) (p < 0.001).
The PRECISE randomized controlled trial showed Heartflow FFRCT Analysis was 78% more likely to identify patients needing revascularization and resulted in a 69% reduction in unnecessary invasive tests compared to a usual care pathway, leading to a 2x yield of invasive coronary angiography (ICA) for revascularization.
Heartflow Plaque Analysis showed 95% agreement with invasive intravascular ultrasound (IVUS) in quantifying total coronary plaque volume in the REVEALPLAQUE study, validating its accuracy against the reference standard.
The DECIDE registry's current findings indicate Heartflow Plaque Analysis led to medical management changes in over half of patients beyond CCTA alone, demonstrating incremental clinical utility over traditional methods.
Heartflow RoadMap Analysis reduced CCTA interpretation times by approximately 25% and increased inter-reader agreement by approximately 40% in the SMART-CT study, indicating superior workflow efficiency compared to manual interpretation.
The PLATFORM trial showed the CCTA + Heartflow FFRCT Analysis pathway reduced unnecessary ICA by 83% and resulted in a 23% reduction in costs at 90 days and a 32% reduction at one year, demonstrating economic efficiency over traditional invasive pathways.
Heartflow's approach of leveraging a single CCTA for multiple products (FFRCT, Plaque Analysis, PCI Planner) offers lower radiation exposure and a streamlined patient journey compared to nuclear imaging tests like SPECT and PET, which take multiple hours and require radioactive tracers.

Management Changes

Role	Previous Person	New Person	Effective Date	Reason
Director	Nicholas Downing, M.D.	N/A	Upon commencement of trading on Nasdaq Global Select Market	Resignation from the board of directors.
Director	Lonnie M. Smith	N/A	Upon commencement of trading on Nasdaq Global Select Market	Resignation from the board of directors.

Corporate Governance

Change Type	Description	Effective Date	Impact Assessment
Bylaws and Certificate of Incorporation	Adoption of new amended and restated bylaws and certificate of incorporation, effective upon completion of the IPO. These include provisions for a classified board of directors with staggered three-year terms, removal of directors only for cause, and restrictions on stockholder action by written consent or calling special meetings.	July 17, 2025	These changes are designed to delay or prevent changes in control or management without board consent, potentially entrenching current management and discouraging hostile takeovers.
Director Compensation Policy	Adoption of a new director compensation policy for non-employee directors, including annual retainer fees and long-term equity awards (nonstatutory stock options).	July 17, 2025	Aims to attract and retain qualified non-employee directors by providing competitive compensation, aligning their interests with stockholders through equity awards.
Senior Leadership Severance Policy	Adoption of a senior leadership severance policy covering executive officers, providing benefits upon qualifying terminations of employment, including accelerated vesting of equity awards upon a qualifying change in control termination.	July 17, 2025	Provides financial protection to key executives in the event of certain terminations, potentially aiding in retention and ensuring smooth transitions during corporate events.
Equity Incentive Plan	Adoption of the 2025 Performance Incentive Plan, which will become effective upon Nasdaq listing, to facilitate granting cash and equity incentives to employees, directors, and consultants. No more grants will be made under the 2009 Plan.	Upon commencement of trading on Nasdaq Global Select Market	Establishes a new framework for equity compensation, crucial for attracting and retaining talent in a public company setting, aligning incentives with long-term company success.
Employee Stock Purchase Plan	Adoption of the 2025 Employee Stock Purchase Plan (ESPP), effective upon Nasdaq listing, to allow eligible employees to purchase common stock at a favorable price.	Upon commencement of trading on Nasdaq Global Select Market	Encourages employee stock ownership, fostering alignment with company performance and potentially aiding in employee retention.
Exclusive Forum Provisions	Amended and restated certificate of incorporation designates the Delaware Court of Chancery (or federal district court for Delaware) as the exclusive forum for certain corporate disputes and federal district courts for Securities Act claims.	Upon completion of this offering	Aims to provide consistency in legal interpretations and reduce multi-forum litigation burdens, but may limit stockholders' choice of forum for disputes.

Legal Proceedings

No pending legal proceedings that are believed to have a material adverse effect on financial condition, results of operations, or cash flows.
Subject to legal proceedings and claims arising in the ordinary course of business, including intellectual property, product liability, breach of contract, commercial, employment, and other general claims.

Related Party Transactions

In January and March 2025, issued $98.3 million in 2025 Convertible Notes to various investors and certain employees, including related parties such as Hayfin HeartFlow UK Limited, BCLS Fund III Investments, LP, Capricorn Entities, Timothy C. Barabe, Lonnie M. Smith, HCPCIV 1, LLC, U.S. Venture Partners Funds, Casey M. Tansey, and Vikram Verghese.
On January 24, 2025, Hayfin converted $23.0 million of outstanding indebtedness under the 2024 Term Loan to 2025 Convertible Notes, making Hayfin a holder of 5% or more of capital stock.
In March 2023, completed Series F and Series F-1 redeemable convertible preferred stock financing, with significant participation from related parties including BCLS Fund III Investments, LP, The Lonnie and Cheryl Smith Family Trust, Hayfin HeartFlow UK Limited, HCPCIV 1, LLC, Wellington Entities, U.S. Venture Partners Funds, Capricorn Entities, The Schiehallion Fund Limited, and William C. Weldon.
In connection with the Series F financing, anti-dilution adjustments to warrants resulted in the issuance of additional warrants to Hayfin Tourmaline Luxco S.a.r.l. to purchase 4,269,801 shares of common stock at $0.01 per share.
From September to December 2022, issued $40.0 million in 2022 Convertible Notes to investors, including related parties such as The Lonnie and Cheryl Smith Family Trust, Hayfin HeartFlow UK Limited, HCPCIV 1, LLC, and William C. Weldon, which converted to Series F-1 preferred stock in March 2023.
Party to an amended and restated investors rights agreement with purchasers of redeemable convertible preferred stock, including various directors and 5%+ stockholders, granting certain registration rights.
Party to an amended and restated voting agreement with certain stockholders, including directors and 5%+ stockholders, which will terminate upon IPO completion.
Party to an amended and restated right of first refusal and co-sale agreement with certain stockholders, which will terminate upon IPO completion.
Entered into management rights letters with certain preferred stock purchasers, including 5%+ stockholders, granting certain management rights, which will terminate upon IPO completion.
Entered into a letter agreement with BCLS Fund III Investments, LP, granting a board observer right, which will terminate upon IPO completion.
Entered into a letter agreement with Capricorn Entities, granting a board observer right, which will terminate upon IPO completion.
On March 29, 2023, repurchased 300,000 shares of common stock from the Taylor Family Revocable Trust (Charles A. Taylor, Jr., Ph.D., a director) for $855,150.00.
Michael Smith, a relative of director Lonnie M. Smith, has been a non-executive employee since 2014.

Stakeholder Impact

Shareholders: Potential for dilution from the IPO and future equity issuances, but also opportunity for liquidity and value appreciation if the company achieves profitability and market acceptance. Existing stockholders will experience immediate and substantial dilution.
Employees: Benefits from new equity incentive plans (2025 Performance Incentive Plan, 2025 Employee Stock Purchase Plan) designed to attract, retain, and motivate talent. Senior leadership severance policy provides protection for executives.
Customers (Healthcare Providers): Enhanced diagnostic tools (FFRCT, Plaque Analysis, PCI Planner) aim to improve patient care, workflow efficiency, and economic efficiency in cardiac catheterization labs. However, potential changes in reimbursement policies could impact their adoption decisions.
Patients: Access to more accurate, non-invasive CAD diagnostic solutions, potentially reducing unnecessary invasive procedures, lowering radiation exposure, and streamlining the diagnostic journey, leading to better personalized care and reduced anxiety.
Creditors (Lenders): The 2024 Credit Agreement and 2025 Convertible Notes outline repayment obligations and security interests. IPO proceeds will be used to repay a portion of the 2024 Term Loan, reducing debt burden, but significant debt remains.
Regulatory Bodies: The company is subject to extensive and evolving regulatory requirements (FDA, CPT codes, AI regulations, privacy laws), with ongoing compliance efforts and potential for investigations or sanctions impacting operations.

Next Steps

Complete the Initial Public Offering (IPO) of common stock.
Broaden market education efforts for Heartflow Plaque Analysis as payor coverage increases.
Launch Heartflow PCI Planner in 2026 as an integrated feature.
Invest in additional clinical evidence to support adoption and expand indications, including for asymptomatic risk prediction.
Extend technology leadership through continued investment in the AI-powered platform.
Pursue adjacent and international markets for platform expansion.
Comply with the FDA Quality Management System Regulation Final Rule (QMSR) effective February 2, 2026.
Monitor and respond to potential changes in Medicare reimbursement rates, including the proposed 15% reduction for FFRCT in the 2026 OPPS rule.
Prepare for potential resurvey of FFRCT CPT codes by the American Medical Association as early as 2027 and Plaque Analysis CPT codes as early as 2029.

Key Dates

Date	Description
2007	Company incorporated as Cardiovascular Simulation, Inc.
June 18, 2009	Software Exclusive License Agreement with Stanford.
April 20, 2010	Software Exclusive License Agreement with Stanford.
July 22, 2010	Exclusive Agreement with Stanford.
July 26, 2011	CE Certificate of Conformity for Heartflow Platform v1.0 issued.
December 2011	Jeffrey C. Lightcap joined the board of directors.
March 2012	Campbell D.K. Rogers, M.D. became Chief Medical Officer.
September 2014	William C. Weldon joined the board of directors.
November 26, 2014	FDA de novo clearance for Heartflow FFRCT Analysis v1.4.
2015	Began commercializing the Heartflow Platform.
January 2015	FDA 510(k) clearance for Heartflow FFRCT Analysis v2.x.
August 2015	Received initial Canadian Medical Device License.
March 9, 2016	Stock option grant to Campbell D.K. Rogers, M.D.
August 2016	FDA 510(k) clearance for modification to FFRCT intended use language.
November 2016	Received marketing authorization in Japan.
March 2017	CE Certificate of Conformity for Heartflow Platform v2.x confirmed.
December 2018	FDA 510(k) clearance for strategic architecture scope change (Heartflow Platform).
June 17, 2019	Amendment No. 2 to Stanford Software Exclusive License.
August 2019	FDA 510(k) clearance for Planner capabilities.
November 20, 2019	Heartflow Platform version 3.x CE marked under the MDD.
November 2020	Julie A. Cullivan joined the board of directors.
January 8, 2021	FDA clearance for Heartflow Platform version 3.0.
January 19, 2021	Entered into a Credit Agreement with Hayfin Services, LLP.
March 1, 2021	Completed an internal reorganization, establishing HeartFlow Holding, Inc. as the parent company.
April 12, 2021	Stock option grant to Campbell D.K. Rogers, M.D.
August 9, 2021	Entered into a facility lease agreement for office space in Mountain View, California.
August 24, 2021	Stock option grant to John C.M. Farquhar.
January 2022	Timothy C. Barabe joined the board of directors.
March 2022	John C.M. Farquhar became Chief Executive Officer.
March 17, 2022	Entered into Amendment No. 1 to the Credit Agreement with Hayfin for an additional $50.0 million term loan.
September 2022	Entered into Amendment No. 2 to the Credit Agreement with Hayfin.
September 30, 2022	Issued convertible promissory notes (2022 Convertible Notes) to certain investors.
October 14, 2022	FDA clearance for Heartflow Platform version 3.18, adding Roadmap and Plaque functions.
December 2022	Entered into Amendment No. 3 to the Credit Agreement with Hayfin.
December 16, 2022	Issued convertible promissory notes (2022 Convertible Notes) to certain investors.
January 2023	Amended facility lease agreement in Austin, Texas.
March 2023	Completed Series F and Series F-1 redeemable convertible preferred stock financing.
March 2, 2023	All 2022 Convertible Notes converted into Series F-1 redeemable convertible preferred stock.
March 2, 2023	Entered into Amendment No. 4 and Waiver to Credit Agreement with Hayfin.
March 3, 2023	Warrants issued in connection with the prior credit agreement with Hayfin were adjusted due to anti-dilution provisions.
March 16, 2023	Entered into Amendment No. 5 to the Credit Agreement with Hayfin.
March 29, 2023	Entered into Amendment No. 6 to the Credit Agreement with Hayfin.
March 29, 2023	Repurchased 300,000 shares of common stock from the Taylor Family Revocable Trust.
June 2023	Vikram Verghese became Chief Financial Officer.
July 10, 2023	Stock option grant to John C.M. Farquhar and Campbell D.K. Rogers, M.D.
Second half of 2023	Initiated limited market education efforts for Heartflow Plaque Analysis.
December 24, 2023	Stock option grant to Vikram Verghese.
January 1, 2024	Dedicated Category I CPT code for Heartflow FFRCT Analysis became effective.
March 2024	Initiated the DECIDE registry, a 20,000-patient study for Heartflow Plaque Analysis.
June 14, 2024	Entered into a new Credit Agreement and Guaranty (2024 Credit Agreement) with Hayfin Services, LLP to refinance outstanding obligations.
October 2024	Entered into an agreement to sublease office space in Santa Rosa, California.
December 26, 2024	Stock option grants to John C.M. Farquhar and Vikram Verghese.
January 2025	Issued convertible promissory notes (2025 Convertible Notes) to various investors and employees.
January 7, 2025	FDA issued draft guidance on Artificial Intelligence-Enabled Device Software Functions.
January 24, 2025	Entered into Amendment No. 1 to the 2024 Credit Agreement, converting $23.0 million of outstanding indebtedness to 2025 Convertible Notes.
January 31, 2025	Issued additional 2025 Convertible Notes.
March 2025	Issued an additional $50.0 million in aggregate principal of 2025 Convertible Notes.
March 12, 2025	Amended the lease for the Austin, Texas facility to extend the term.
July 2, 2025	Entered into a facility lease agreement for office space in San Francisco, California.
July 4, 2025	The One Big Beautiful Bill Act (OBBBA) was signed into law, impacting Medicaid spending and ACA marketplace enrollment.
July 17, 2025	Consolidation of HeartFlow Holding, Inc. into HeartFlow, Inc., name change to Heartflow, Inc., adoption of new amended and restated bylaws and certificate of incorporation, senior leadership severance policy, director compensation policy, 2025 Performance Incentive Plan, and 2025 Employee Stock Purchase Plan.
October 1, 2025	Heartflow Plaque Analysis is anticipated to be included in updated cardiac imaging guidelines by radiology benefit manager EviCore by Evernorth.
Fourth quarter of 2025	CMS is expected to publish final OPPS and MPFS rules, with a proposed 15% reduction in Medicare reimbursement for Heartflow FFRCT Analysis.
2026	Heartflow PCI Planner is expected to launch.
January 1, 2026	Dedicated Category I CPT code for Heartflow Plaque Analysis will go into effect.
February 2, 2026	FDA Quality Management System Regulation Final Rule (QMSR) becomes effective.
February 2026	Colorado AI Act will go into effect.
2027	American Medical Association may resurvey CPT codes describing Heartflow FFRCT Analysis.
December 31, 2027	Transitional provisions for MDD/AIMD CE Certificates of Conformity for Class III and Class IIb implantable medical devices expire.
June 14, 2028	2024 Term Loan matures.
November 30, 2028	San Francisco facility lease expires.
December 31, 2028	Transitional provisions for MDD/AIMD CE Certificates of Conformity for other Class IIb, Class IIa, and Class I devices expire.
2029	American Medical Association may resurvey CPT codes describing Heartflow Plaque Analysis.
August 2030	Mountain View, California facility lease expires.
June 30, 2030	UKCA Mark transitional provision for medical devices ends.
2030	Federal net operating loss carryforwards begin to expire.
March 21, 2031	Amended and Restated 2009 Equity Incentive Plan terminates.
2045	Last to expire pending patent application is expected to expire.

Keywords

Coronary Artery Disease, CAD, AI Diagnostics, Medical Technology, SEC Filing, IPO, Heartflow Platform, FFRCT Analysis, Plaque Analysis, PCI Planner, CCTA, Non-invasive Testing, Cardiology, Radiology, Healthcare, FDA Clearance, CPT Code, Reimbursement, Clinical Trials, Deep Learning, Computational Fluid Dynamics, Risk Stratification, Cardiovascular Health

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