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| PART I. FINANCIAL INFORMATION |
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| Item 1. | Financial Statements | 1 |
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| Unaudited Condensed Consolidated Balance Sheets as of June 30, 2026 and December 31, 2025 | 1 |
| Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2026 and 2025 | 2 |
| Unaudited Condensed Consolidated Statements of Changes in Temporary Equity and Stockholders’ Equity (Deficit) for the three and six months ended June 30, 2026 and 2025 | 3 |
| Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2026 and 2025 | 4 |
| Notes to Financial Statements (Unaudited) | 5 |
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 23 |
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| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 29 |
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| Item 4. | Controls and Procedures | 29 |
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| PART II. OTHER INFORMATION |
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| Item 1. | Legal Proceedings | 30 |
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| Item 1A. | Risk Factors | 30 |
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| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds from Registered Securities | 30 |
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| Item 3. | Defaults Upon Senior Securities | 30 |
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| Item 4. | Mine Safety Disclosures | 30 |
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| Item 5. | Other Information | 30 |
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| Item 6. | Exhibits | 31 |
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (the “Form 10-Q”) includes statements that are, or may be deemed to be, “forward-looking statements” within the meaning of the U.S. federal securities laws, are statements of future expectations and other forward-looking statements. Forward-looking statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “guidance,” “intend,” “may,” “opportunity,” “plan,” “potential,” “predict,” “projected,” “should,” “strategy,” “suggests,” “targets,” “will,” “will be” or “would” or similar expressions or the negatives thereof, or other variations thereof, or comparable terminology, or by discussions of strategy, plans or intentions. These forward-looking statements include all matters that are not historical facts. They appear in a number of places throughout this Form 10-Q and include statements regarding the intentions, beliefs or current expectations of our management teams concerning, among other things, their respective results of operations, financial condition, liquidity, prospects, growth, strategies, and the industry in which they operate.
You are cautioned that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from those made in or suggested by the forward-looking statements contained in this Form 10-Q. In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in this Form 10-Q, those results or developments may not be indicative of results or developments in subsequent periods.
By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors because they relate to events and depend on circumstances that may or may not occur in the future. Forward-looking statements are not guarantees of future performance and our actual financial condition, results of operations and cash flows. The development of the industry in which we operate may differ materially from (and be more negative than) those made in, or suggested by, the forward-looking statements contained in this Form 10-Q.
These statements are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance, or events to differ materially from those anticipated by such statements. You should not place undue reliance on these forward-looking statements in deciding whether to invest in our securities. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Factors that could cause such differences in actual results include:
| ● | Loss of, reduced purchases by, or delayed payments from any of our customers, which are concentrated among a limited number of heart transplant centers, hospitals, surgeons, and their distributors; |
| ● | Our concentration risk due to reliance on a limited number of products, and the material impact that any disruption in production, quality, regulator status, safety, or market acceptance of these products could have on our business; |
| ● | Manufacturing of our products is complex, highly manual, and concentrated, which exposes us to risks related to workforce constraints, training timelines, equipment failures, natural disasters, or noncompliance with U.S. Food and Drug Administration ("FDA") regulation; |
| ● | Our reliance on single- or limited-source suppliers for many critical components, including valves and drive parts, and lack of secondary sources, which could cause shortages and/or require new regulatory clearances or approvals; |
| ● | Changes in regulatory policy, including new requirements, could lead to delays or denials for new research, expansions, or product upgrades; |
| ● | Delays or failure to obtain certification under EU Medical Devices Regulation would limit or prevent our growth in European markets; |
| ● | Clinical studies necessary for approvals, expansions, and updates are costly, lengthy, and uncertain; difficulties with site qualification, enrollment, protocol adherence, adverse events or inconclusive results may prevent or delay approvals; |
| ● | Device malfunctions or quality issues could lead to field actions, corrections, recalls, investigations, enforcement, reputational harm, and substantial costs, which we may be unable to remediate promptly or effectively; |
| ● | We could face significant penalties, sanctions, litigation exposure, and reputational damage if our products are misused; |
| ● | Physician adoption requires education, clinical evidence, and perceived advantages over alternatives; reluctance to adopt total artificial heart therapy may limit demand and financial support; |
| ● | Competitive products that are more effective, convenient, or less costly from larger companies with greater resources and relationships could reduce demand for our products; |
| ● | Profit margin improvement depends on successful product enhancements, and delays or setbacks could constrain profitability even if revenues grow; |
| ● | Insurance coverage and reimbursements are uncertain and vary by payer and country; insufficient coverage would adversely affect utilization and revenues; |
| ● | Our industry is heavily regulated and subjects us to evolving and complex healthcare, privacy, and other laws, in addition to the compliance and obligations of being a public company, and can result in civil, criminal, and administrative penalties or business restrictions; |
| ● | International expansion exposes us to risks including political and economic instability, sanctions, tariffs, export controls, currency fluctuations, local regulatory requirements, limited recourse to protect intellectual property, and challenges overseeing distributors; |
| ● | Significant product-liability risk is inherent in life-sustaining implantable medical devices, and our insurance coverage may be insufficient or unavailable on acceptable terms, and adverse claims could materially impact our financial condition; |
| ● | Our reliance on information technology systems and third-party service exposes us to cybersecurity risks, which could disrupt operations, compromise sensitive data, trigger regulatory scrutiny, and lead to significant costs; |
| ● | Many aspects of our technology are no longer protected by patents and rely on trade secrets and contractual protections, which may be breached or independently developed by others; |
| ● | Intellectual property disputes could be costly, divert management attention, require licenses or redesigns, or restrict our ability to market products; |
| ● | Acquisitions, if pursued, involve integration, operational, and financial risks and may not achieve anticipated benefits, which could dilute stockholders, increase leverage, or require significant management attention and resources; |
| ● | Exposure to credit risk from hospital and distributor receivables, particularly in certain international markets, can increase bad-debt expense and reduce cash collections; |
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| ● | Tax laws could limit our net operating loss carryforwards and increase our cash tax liabilities in future profitable periods; |
| ● | Significant volatility in our financial results as a result of the Company's election to account for its Senior Secured Note (as defined below) at fair value, as well as the classification of associated warrants as liabilities; |
| ● | As a newly public company, emerging growth company, and smaller reporting company, we face increased costs to establish effective internal controls and comply with evolving disclosure and governance requirements, which may result in our inability to maintain the Company's NYSE American listing. Furthermore, compliance failures could harm our reputation and stock price; |
| ● | There can be no assurance that we will be able to comply with the continued listing standards of the NYSE; |
| ● | The market price of our common stock may be volatile, an active trading market may not develop or be sustained, and/or future equity or debt financings, conversions, or other securities issuances could cause substantial dilution and further volatility; |
| ● | Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements; |
| ● | We have been, and may in the future be, subject to securities class action or derivative litigation; and |
| ● | Any other risk set forth in Part I, Item 1A. Risk Factors of our Form 10-K, filed with the SEC on March 30, 2026. |
We undertake no obligations to update publicly or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this Form 10-Q or to reflect the occurrence of unanticipated events, other than as required by law.
The forward-looking statements are based on plans, estimates and projections as they are currently available to our management, and neither undertakes any obligation, and neither expects, to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. All subsequent written and oral forward-looking statements attributable to us or to persons acting on our behalf are expressly qualified in their entirety by the cautionary statements referred to above and contained elsewhere in this Form 10-Q.
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