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ARTIVION, INC.

For the period ended Sep 30, 2026. Filed Nov 6, 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.

Sep 30, 2026 · Filed Nov 6, 2026

AORT$20.64+2.1%Stored close · as of Nov 9, 2026

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Notes to Condensed Consolidated Financial Statements

  1. Basis of Presentation and Summary of Significant Accounting Policies

The accompanying Condensed Consolidated Financial Statements include the accounts of Artivion, Inc. and its subsidiaries (“Artivion,” the “Company,” “we,” or “us”). All significant intercompany accounts and transactions have been eliminated in consolidation. The accompanying Consolidated Balance Sheet as of December 31, 2025 has been derived from audited financial statements. The accompanying unaudited Condensed Consolidated Financial Statements as of, and for the three and nine months ended September 30, 2026 and 2025 have been prepared in accordance with (i) accounting principles generally accepted in the United States of America (“US GAAP”) for interim financial information and (ii) the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the US Securities and Exchange Commission (the “SEC”). Accordingly, such statements do not include all the information and disclosures that are required by US GAAP for a complete presentation of financial statements. In the opinion of management, all adjustments (including those of a normal, recurring nature) considered necessary for a fair presentation have been included. Operating results for the three and nine months ended September 30, 2026 are not necessarily indicative of the results that may be expected for the year ending December 31, 2026. These Condensed Consolidated Financial Statements should be read in conjunction with the Consolidated Financial Statements and Notes included in Artivion’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on February 18, 2026.

Foreign Currency Translation and Transactions

Assets and liabilities of international subsidiaries whose functional currency is the local currency are translated at the rate of exchange in effect on the balance sheet date; income and expenses are translated at the average exchange rates throughout the year. Foreign currency exchange rate realized and unrealized gains and losses resulting from transactions are included in Other expense (income), net in our Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income and resulted in net losses of$0.6 million and$2.2 million for the three and nine months ended September 30, 2026, respectively, as compared to a net loss of$0.1 million and a net gain of $7.3 million for the three and nine months ended September 30, 2025, respectively. Currency translation adjustments resulting from intra-entity loans that are of a long-term investment nature, net of tax, are included in Accumulated other comprehensive loss and resulted in a net gain of$1.3 million and a net loss of$6.5 million for the three and nine months ended September 30, 2026, respectively, as compared tonet gains of$0.4 million and$14.0 millionfor the three and nine months ended September 30, 2025, respectively.

Significant Accounting Policies

A summary of our significant accounting policies is included in Note 1 of the “Notes to Consolidated Financial Statements” contained in our Form 10-K for the year ended December 31, 2025. Management believes that the consistent application of these policies enables us to provide users of the financial statements with useful and reliable information about our operating results and financial condition. The Condensed Consolidated Financial Statements are prepared in accordance with US GAAP, which require us to make estimates and assumptions. Except for the adoption of a new accounting policy as described below, we did not experience any significant changes during the three and nine months ended September 30, 2026 in any of our Significant Accounting Policies from those contained in our Form 10-K for the year ended December 31, 2025.

Business Combinations

We account for business combinations using the acquisition method. The identifiable assets acquired and liabilities assumed are recognized at their respective acquisition-date fair values. The excess of the consideration transferred over the estimated fair value of the identifiable net assets acquired is recorded as goodwill. Acquisition-related costs are expensed as incurred and recognized within general, administrative, and marketing in the Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income.

New Accounting Pronouncements

Recently Adopted

In July 2025 the FASB issued ASU No. 2025-05 – Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets, which provides a practical expedient for estimating expected credit losses on current accounts receivable and current contract assets arising from transactions accounted for under Topic 606 – Revenue from Contracts with Customers. Under this practical expedient, entities may assume that current conditions as of the balance sheet date do not change for the remaining life of the asset. The updated standard is effective for financial statements issued for fiscal years beginning after December 15, 2025. We adopted ASU 2025-05 on a prospective basis effective January 1, 2026. The adoption of ASU 2025-05 did not have a material impact on our financial condition or results of operations.

In September 2025 the FASB issued ASU No. 2025-06, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software, which modernizes the accounting for internal-use software costs under Subtopic 350-40. The amendments remove references to prescriptive and sequential software development stages and clarify when entities begin capitalizing internal-use software costs. The updated standard is effective for financial statements issued for fiscal years beginning after December 15, 2027. We early adopted ASU 2025-06 on a prospective basis effective January 1, 2026. See further discussion below regarding our accounting for internal-use software.

Internal-Use Software, net

Following the adoption of ASU 2025-06, we capitalize eligible costs incurred to develop or obtain internal-use software when management has authorized and committed to funding the software project and it is probable that the project will be completed and the software will be used to perform its intended function. Costs incurred before these criteria are met, as well as training, maintenance, data conversion and other costs that do not qualify for capitalization, are expensed as incurred.

Capitalized internal-use software includes software used in manufacturing operations, which is included in Property and equipment, net, and software used in non-manufacturing activities, which is included in Other intangibles, net, in the Condensed Consolidated Balance Sheets. We apply the disclosure requirements of ASC 360-10 to all capitalized internal-use software, regardless of balance sheet presentation.

Capitalized internal-use software is stated at cost less accumulated amortization. Capitalized internal-use software is amortized on a straight-line basis over the estimated useful lives of the related assets, generally five years, beginning when the software is substantially complete and ready for its intended use.

Internal-use software, net consists of the following (in thousands):

September 30, 2026December 31, 2025
Internal-use software$31,590$21,738
Less: Accumulated amortization(7,637)(8,936)
Internal-use software, net$23,953$12,802

As of September 30, 2026, of the $24.0 million net carrying amount of internal-use software, $7.4 million was included in Property and equipment, net and $16.6 million was included in Other intangible assets, net in the Condensed Consolidated Balance Sheets.

As of December 31, 2025, of the $12.8 million net carrying amount of internal-use software, $1.5 million was included in Property and equipment, net and $11.3 million was included in Other intangible assets, net in the Condensed Consolidated Balance Sheets.

Amortization expense was as follows (in thousands):

Three Months EndedSeptember 30,Nine Months EndedSeptember 30,
2026202520262025
Amortization expense$872$429$2,560$1,376

Not Yet Effective

In November 2024 the FASB issued ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses to improve the disclosures about a public business entity’s expenses for more detailed information about the types of expenses in commonly presented expense captions such as cost of sales; selling, general, and administrative expenses; and research and development. The updated accounting guidance, among other things, requires quantitative disclosures for employee compensation, selling expenses, and purchases of inventory. The updated guidance is effective for financial statements issued for fiscal years beginning after December 15, 2026. We are currently evaluating the impacts of the new standard.

  1. Sale of PerClot

On July 28, 2021 we entered into an asset purchase agreement, Transitional Manufacturing and Supply Agreement (“TMSA”), and other ancillary agreements related to the sale of PerClot®, a polysaccharide hemostatic agent used in surgery (“PerClot”), to a subsidiary of Baxter International, Inc. (“Baxter”) and an agreement to terminate all of our material agreements with Starch Medical, Inc. (“SMI”) related to PerClot (collectively the “Baxter Transaction”). Under the terms of the Baxter Transaction, Baxter will pay an aggregate of up to $54.5 million in consideration (we will receive up to $41.0 million and SMI will receive up to $13.5 million), consisting of (i) $25.0 million at closing, of which $6.0 million was paid to SMI; (ii) $18.8 million upon our receipt of Premarket Approval (“PMA”) from the US Food and Drug Administration (the “FDA”) for PerClot and our transfer of the PMA to Baxter, of which $4.5 million was paid to SMI; and (iii) up to $10.0 million upon Baxter’s achievement of certain cumulative worldwide net sales of PerClot prior to December 31, 2026 and December 31, 2027, of which up to $3.0 million is payable to SMI. In connection with Baxter’s achievement of a cumulative worldwide net sales milestone, we received $5.0 million from Baxter in 2025 and paid $1.5 million to SMI in January 2026. In addition, at the conclusion of our manufacturing and supply services for Baxter, Baxter will pay $0.8 million upon transfer of our PerClot manufacturing equipment. Under the terms of the Baxter Transaction, we will continue to provide to Baxter certain transition services relating to the sale of SMI PerClot outside of the US. Within the terms of the TMSA, we will manufacture and supply PerClot for Baxter post PMA for a contractual period. The TMSA has been extended for an additional 24-month term and will expire in February 2027. We expect to conclude our PerClot manufacturing activities by the end of 2026.

PerClot PMA

Upon receipt of the PMA in May 2023, under the terms of the TMSA, we began manufacturing and supplying PerClot for Baxter and recorded $2.5 million and $4.9 million of PerClot revenues on the Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income during the three and nine months ended September 30, 2026, respectively, as compared to $0.6 million and $2.4 million during the three and nine months ended September 30, 2025, respectively.

PerClot Sales Milestone

During the second half of 2025, upon Baxter’s achievement of certain cumulative worldwide net sales of PerClot, we recorded a pre-tax gain of $7.0 million, of which $3.5 million was recognized during the three and nine months ended September 30, 2025, and included as Gain from sale of non-financial assets within the Consolidated Statements of Operations and Comprehensive Income (Loss). The $7.0 million gain was comprised of a cash payment of $5.0 million from Baxter, a receivable of $5.0 million due from Baxter, and a payable of $3.0 million due to SMI. The receivable and payable are reflected in Other receivables and Other current liabilities, respectively, in the Consolidated Balance Sheets as of December 31, 2025. Pursuant to the terms of the Baxter Transaction, we made a payment of $1.5 million to SMI in January 2026 in connection with Baxter’s achievement of the PerClot sales milestone. As of September 30, 2026, $1.5 million remained payable to SMI and $5.0 million was receivable from Baxter, which were reflected in Other current liabilities and Other receivables, respectively, in the Condensed Consolidated Balance Sheets. The Company expects to receive the $5.0 million from Baxter during the fourth quarter of 2026.

  1. Acquisition of Ascyrus

On September 2, 2020 we entered into a Securities Purchase Agreement (the “Ascyrus Agreement”) to acquire 100% of the outstanding equity interests of Ascyrus Medical LLC (“Ascyrus”). Ascyrus developed the AMDS, the world’s first aortic arch remodeling device for use in the treatment of acute Type A aortic dissections.

Under the terms of the Ascyrus Agreement, we will pay an aggregate of up to $200.0 million in consideration, consisting of: (i) a cash payment of approximately $60.0 million and the issuance of $20.0 million in shares of Artivion common stock, in each case, that were delivered at the closing of the acquisition, (ii) a cash payment of $10.0 million and the issuance of $10.0 million in shares of Artivion common stock upon FDA approval of the Investigational Device Exemption (“IDE”) application for the AMDS in 2021, (iii) if the FDA approves PMA application submitted for the AMDS, a cash payment of $25.0 million, (iv) if regulatory approval of the AMDS is obtained in Japan on or before June 30, 2027, a cash payment of $10.0 million, (v) if regulatory approval of the AMDS is obtained in China on or before June 30, 2027, a cash payment of $10.0 million and (vi) a potential additional consideration cash payment capped at $55.0 million (or up to $65.0 million to $75.0 million if the Japanese or Chinese approvals are not secured on or before June 30, 2027 and those approval milestone payments are added to the potential additional consideration cash payment cap) calculated as two times the incremental worldwide sales of the AMDS (or any other acquired technology or derivatives of such acquired technology) outside of the European Union during thethree-year period following the date the FDA approves a PMA application submitted for the AMDS.

Accounting for the Transaction

In June 2026 the FDA approved the PMA application for the AMDS Hybrid Prosthesis for use in patients with acute DeBakey Type I aortic dissections with clinical or radiographic malperfusion, satisfying the related regulatory milestone and triggering the associated$25.0 million contingent payment, which was paid in July 2026. Of the $25.0 million contingent payment, $13.3 million was classified as an operating cash outflow and $11.7 million was classified as a financing cash outflow in the Condensed Consolidated Statement of Cash Flows.

Following the $25.0 million PMA milestone payment made in July 2026, we may be required to pay additional consideration up to$75.0 million to the former shareholders of Ascyrus upon the achievement of certain milestones and the sales-based additional earnout described above.

The contingent consideration represents the estimated fair value of potential future payments. The fair value of the contingent consideration liability was estimated by discounting expected contingent payments to present value based on a probability-weighted scenario approach. We applied a discount rate based on our unsecured credit spread and the term commensurate risk-free rate to the additional consideration to be paid, and considered the probability of achieving the applicable contingent payment milestones and sales-based earnout to calculate the fair value of the contingent consideration. As of September 30, 2026, management expects the maximum sales-based earnout of $75.0 million to be achieved and estimated the fair value of the remaining contingent consideration by discounting the expected payment to present value. This fair value measurement was based on unobservable inputs, including management estimates and assumptions about future revenues and the timing of expected payments, and is, therefore, classified as Level 3 within the fair value hierarchy. We used a discount rate of approximately 17% to calculate the fair value of contingent consideration as of September 30, 2026. We remeasure this liability at each reporting date and record changes in the fair value of the contingent consideration in General, administrative, and marketing expenses in the Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income. Increases or decreases in the fair value of the contingent consideration liability can result from changes in the passage of time, discount rates, the timing and amount of our revenue estimates, and the timing and expectation of regulatory approvals.

We perform quarterly assessments of the fair value of our contingent consideration liabilities. We recorded net fair value losses related to Ascyrus of $1.1 million and $10.8 million for the three and nine months ended September 30, 2026, respectively, as compared to net fair value losses of $2.6 million and $2.4 million for the three and nine months ended September 30, 2025, respectively. These amounts were recognized in General, administrative, and marketing expenses in the Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income. The $10.8 million net fair value loss recognized during the nine months ended September 30, 2026 was primarily attributable to the increase in the probability of achieving the PMA approval milestone to 100% upon receipt of FDA approval in June 2026 and the passage of time.

As of September 30, 2026 the contingent consideration liabilities related to AMDS totaled $46.4 million, all of which were classified as non-current contingent consideration. During July 2026, we paid $25.0 million related to the PMA approval milestone achieved in June 2026, which reduced the contingent consideration liabilities. As of December 31, 2025 the contingent consideration liabilities totaled $60.6 million.

  1. Acquisition of Endospan

On May 18, 2026 (the “Acquisition Date”), we acquired 100% of the outstanding securities of Endospan Ltd. (“Endospan”) from its securityholders (the “Endospan Acquisition”). The Endospan Acquisition was completed through the exercise of our purchase option pursuant to the Securities Purchase Option Agreement, dated September 11, 2019, as amended on July 1, 2024, January 9, 2026, and May 17, 2026 (the “Agreement”). Endospan designs, develops, manufactures, and commercializes the NEXUS™ family of aortic arch stent graft systems. The Endospan Acquisition expands our aortic arch product portfolio and provides us with ownership of the NEXUS platform and related product-development pipeline.

We accounted for the Endospan Acquisition as a business combination using the acquisition method of accounting in accordance with ASC 805, Business Combinations. The Agreement provided for a base purchase price of $175.0 million, payable in cash and subject to adjustments for working capital, indebtedness, cash, transaction expenses, and other specified items. The acquisition-date fair value of total consideration transferred was $174.0 million, as summarized below. At closing, we paid approximately $131.3 million in cash in connection with the Endospan Acquisition. This amount included $10.2 million of transaction bonuses, as further discussed below. The remaining $121.0 million consisted of $106.8 million of cash consideration and $14.2 million paid to settle Endospan debt obligations. Following a $0.2 million measurement period adjustment, which remained unpaid as of September 30, 2026, total cash consideration increased to $107.0 million.

Endospan’s former securityholders are also entitled to receive contingent consideration of up to $200.0 million based on 2.5 times the increase in worldwide revenue from sales of NEXUS™ products during the 12-month period ending approximatelytwo years after the Acquisition Date compared with the 12-month period leading up to the Acquisition Date. Any amount payable will be determined following the second anniversary of the Acquisition Date and paid in accordance with the Agreement. The contingent consideration had an initial acquisition-date fair value of $21.8 million, including a $4.4 million measurement period adjustment as described below, and increased to $24.7 million as of September 30, 2026. The liability was included in Non-current contingent consideration in the Condensed Consolidated Balance Sheets. See Note 5– “Financial Instruments” for additional information regarding the valuation of the contingent consideration.

We incurred acquisition transaction, diligence, and integration costs of $2.0 million and $14.5 million during the three and nine months ended September 30, 2026, respectively, including $10.2 million of transaction bonuses recognized during the nine months ended September 30, 2026 in connection with the Endospan Acquisition. These costs were accounted for separately from the business combination, expensed as incurred, and included in General, administrative, and marketing expenses and Research and development expenses in the Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income.

We recorded preliminary goodwill of $94.7 million, of which none is expected to be deductible for income tax purposes. Goodwill represents the excess of the consideration transferred over the fair value of the identifiable net assets acquired and primarily reflects expected synergies from the Endospan Acquisition and the value of the assembled workforce. The entire balance of acquired goodwill was assigned to our Medical Devices segment. During the three months ended September 30, 2026, measurement-period adjustments decreased preliminary goodwill by approximately $4.5 million, primarily reflecting revisions to the acquisition-date fair values of contingent consideration and identifiable intangible assets and adjustments to the consideration transferred and other net assets acquired. In addition, the acquisition-date fair values of contingent consideration and identifiable intangible assets remain preliminary as we complete our valuation analyses and related review procedures. The preliminary purchase price allocation is based on information available as of September 30, 2026 and remains subject to adjustment, primarily related to other closing adjustments and income tax matters. The measurement period will not exceed one year from the Acquisition Date, as additional information about facts and circumstances existing at the Acquisition Date becomes available. Measurement-period adjustments will be recognized as if the accounting had been completed at the Acquisition Date, including the related effect on depreciation, amortization, and other income-statement amounts.

The preliminary purchase consideration allocated as of the Acquisition Date consisted of the following (in thousands):

Consideration
Cash consideration$107,042
Debt obligations settled in cash by Artivion14,206
Noncash settlement of preexisting relationships and Endospan Option (1)31,000
Contingent consideration21,782
Fair value of total consideration transferred$174,030
Purchase Price Allocation
Cash and cash equivalents$4,363
Intangible assets, net72,400
Net other assets/liabilities acquired2,601
Goodwill94,666
Net assets acquired$174,030

(1) Represents amounts included in consideration transferred in connection with the settlement or exercise of preexisting contractual relationships between Artivion and Endospan, consisting of the acquisition-date fair value of the effective settlement of the Endospan Loans ($24.9 million) and the Buyer Deposits ($3.0 million), and the carrying amount of the Endospan Option ($3.1 million) upon exercise. See “Settlement of Preexisting Relationships and Endospan Option” below.

Identifiable Intangible Assets

The following table presents details of the identifiable intangible assets recognized in connection with the Endospan Acquisition (in thousands, except estimated useful life):

Identifiable Intangible AssetsFair ValueEstimated Useful Life (Years)
Developed technology$31,80010.0
Trade name1,70015.0
In-process research and development (“IPR&D”)38,900Indefinite
Total identifiable intangible assets$72,400

The weighted-average amortization period for the acquired amortizable intangible assets was approximately 10.3 years. The IPR&D asset is considered indefinite-lived and is not amortized until the underlying project is completed or abandoned.

Fair Value Measurements

The acquisition-date fair values of the identifiable intangible assets were estimated using income-based valuation techniques. Significant assumptions included forecasted revenues and operating results, expected commercialization and regulatory timelines, estimated useful lives, and discount rates. The acquisition-date fair value of the contingent consideration was estimated using a Monte Carlo simulation based primarily on forecasted NEXUS™ revenues, revenue volatility, discount rates, credit risk, and the expected timing of payment.

These fair value measurements were based on significant unobservable inputs and were classified as Level 3 measurements. See Note 5 – “Financial Instruments” for additional information regarding the subsequent measurement of contingent consideration.

Settlement of Preexisting Relationships and Endospan Option

Artivion and Endospan entered into a loan agreement (the “Endospan Loan”), dated September 11, 2019, by which Artivion funded Endospan a secured loan of $15.0 million and also an amendment to the Endospan Loan, dated July 1, 2024, by which we funded Endospan additional secured loans of $25.0 million (the “Additional Endospan Loan” and, together with the Endospan Loan, the “Endospan Loans”). We elected the fair value option for recording the Endospan Loans. Immediately before the effective settlement of the Endospan Loans, we recognized a settlement gain of $4.5 million in Other expense (income), net in the Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income to adjust the Endospan Loans to their acquisition-date fair value and included the $24.9 million fair value of the Endospan Loans as part of the fair value of the total consideration transferred.

Before the Endospan Acquisition, we had prepaid $3.0 million in advance deposits relating to certain purchase orders with Endospan. In connection with the settlement of this preexisting contractual relationship, the fair value of the settled relationship, which approximated its carrying amount, was included as part of the fair value of the total consideration transferred, and no settlement gain or loss was recognized.

In connection with the Agreement, we had recognized the value of the option right (“Endospan Option”) of $3.1 million, which was reflected in Other current assets in the Condensed Consolidated Balance Sheets. In connection with the exercise of the option to effect the Endospan Acquisition, the carrying amount of the Endospan Option was included as part of the fair value of the total consideration transferred, and no gain or loss was recognized.

Accordingly, the amounts associated with the Endospan Loans, advance deposits, and Endospan Option were included in the calculation of consideration transferred but were not recognized as acquired assets because they represented the settlement or exercise of preexisting contractual relationships accounted for separately from the business combination.

  1. Financial Instruments

A summary of financial instruments measured at fair value was as follows (in thousands):

September 30, 2026Level 1Level 2Level 3Total
Cash equivalents
Money market funds$10,668$—$—$10,668
Certificates of deposit1,132——1,132
Total assets$11,800$—$—$11,800
Liabilities
Current portion of contingent consideration$—$—$—$—
Non-current contingent consideration——71,10071,100
Total liabilities$—$—$71,100$71,100
December 31, 2025Level 1Level 2Level 3Total
Cash equivalents
Money market funds$20,725$—$—$20,725
Certificates of deposit1,080——1,080
Endospan Loans——19,87219,872
Total assets$21,805$—$19,872$41,677
Liabilities
Current portion of contingent consideration$—$—$20,690$20,690
Non-current contingent consideration——39,89039,890
Total liabilities$—$—$60,580$60,580

We used prices quoted from our investment advisors to determine the Level 1 valuation of our investments in money market funds and certificates of deposit. The estimated market value of all cash equivalents is equal to the cost basis as there wereno gross realized gains or losses on cash equivalents for the three and nine months ended September 30, 2026 and 2025.

The fair values of contingent consideration associated with the Ascyrus and Endospan acquisitions were determined using Level 3 inputs. Changes in fair value of Level 3 assets and liabilities are listed in the tables below (in thousands):

AMDS Contingent Consideration
Balance as of December 31, 2025$60,580
PMA approval payment(25,000)
Change in valuation10,840
Balance as of September 30, 2026$46,420
Endospan Contingent Consideration
Balance as of December 31, 2025$—
Initial value21,782
Change in valuation2,898
Balance as of September 30, 2026$24,680

In connection with the Endospan acquisition, we initially recognized contingent consideration related to the future performance of NEXUS™ products at an acquisition-date fair value of $26.2 million. During the measurement period, we recorded a purchase accounting adjustment of $4.4 million, reducing the acquisition-date fair value to $21.8 million. Following this adjustment, the fair value of the contingent consideration increased by $2.9 million to $24.7 million as of September 30, 2026. See Note 4– “Acquisition of Endospan” for additional information.

The determination of fair value and the assessment of a measurement’s placement within the hierarchy requires judgment. Level 3 valuations often involve a higher degree of judgment and complexity. Although we believe that the recorded fair values of our financial instruments are appropriate, these fair values may not be reflective of future fair values.

  1. Inventories and Deferred Preservation Costs

Inventories consist of the following (in thousands):

September 30,2026December 31,2025
Raw materials and supplies$40,427$36,355
Work-in-process24,29917,133
Finished goods42,32738,939
Inventories$107,053$92,427

To facilitate product usage, we maintain consignment inventory of On-X heart valves at domestic hospital locations and On-X heart valves, aortic stent grafts, and AMDS products at international hospital locations. We retain title and control over this consignment inventory until we receive a notification of implantation, at which time we invoice the hospital and recognize revenue. As of September 30, 2026 we had $17.7 million in consignment inventory, with approximately 34% in domestic locations and 66% in international locations. As of December 31, 2025 we had $14.9 million in consignment inventory, with approximately 33% in domestic locations and 67% in foreign locations.

Total deferred preservation costs were $53.7 million and $54.5 million as of September 30, 2026 and December 31, 2025, respectively.

  1. Goodwill and Other Intangible Assets

Goodwill and certain definite-lived and indefinite-lived intangible assets increased during the nine months ended September 30, 2026 primarily as a result of the Endospan acquisition, which was completed on May 18, 2026, and the related preliminary purchase price allocation. See Note 4– “Acquisition of Endospan” for additional information regarding the acquisition and the preliminary amounts recognized for goodwill and identifiable intangible assets.

Indefinite Lived Intangible Assets

The carrying values of our indefinite lived intangible assets were as follows (in thousands):

September 30,2026December 31,2025
Goodwill$344,961$254,091
In-process R&D41,1142,291
Procurement contracts and agreements2,0132,013

We monitor the phases of development of our acquired in-process research and development projects, including the risks associated with further development and the amount and timing of benefits expected to be derived from the completed projects. Incremental costs associated with development are charged to expense as incurred. Capitalized costs are amortized over the estimated useful life of the developed asset once completed. Our in-process research and development projects are reviewed for impairment annually, or more frequently, if events or changes in circumstances indicate that the asset might be impaired. We evaluate our goodwill and indefinite lived intangible assets for impairment on an annual basis during the fourth quarter of the year, and, if necessary, during interim periods if factors indicate that an impairment review is warranted. We didnot record any impairment of indefinite lived intangible assets, including goodwill, during the three and nine months ended September 30, 2026. In-process research and development and procurement contracts and agreements are included in Other intangibles, net in the Condensed Consolidated Balance Sheets as of September 30, 2026 and December 31, 2025.

Based on our experience with similar agreements, we believe that our acquired procurement contracts and agreements have indefinite useful lives, as we expect to continue to renew these contracts for the foreseeable future.

Changes in the carrying value of our goodwill, all of which was related to our Medical Devices segment, were as follows (in thousands):

September 30,2026
Balance as of December 31, 2025$254,091
Endospan acquisition94,666
Foreign currency translation(3,796)
Balance as of September 30, 2026$344,961

Definite Lived Intangible Assets

The definite lived intangible assets balance includes balances related to acquired technology, customer relationships, distribution and manufacturing rights and know-how, patents, and other definite lived intangible assets. The major intangible asset classes consist of the following (in thousands, except weighted average useful life):

September 30, 2026Gross CarryingValueAccumulatedAmortizationNet Carrying ValueWeighted AverageUseful Life(Years)
Acquired technology$238,282$92,381$145,90116.4
Other intangibles:
Customer lists and relationships$28,783$14,025$14,75821.6
Patents1,4062711,13517.0
Other22,9165,92816,9885.0
Other intangibles, net$53,105$20,224$32,8818.8
December 31, 2025Gross CarryingValueAccumulatedAmortizationNet Carrying ValueWeighted AverageUseful Life(Years)
Acquired technology$208,235$84,571$123,66418.1
Other intangibles:
Customer lists and relationships$28,853$13,057$15,79621.5
Patents4,6583,5231,13517.0
Other18,5526,95611,5965.0
Other intangibles, net$52,063$23,536$28,5279.8

Amortization Expense

Amortization expense recorded in General, administrative, and marketing expenses in our Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income was as follows (in thousands):

Three Months EndedSeptember 30,Nine Months EndedSeptember 30,
2026202520262025
Amortization expense$4,771$3,476$12,908$10,291
  1. Income Taxes

Income Tax Expense

Our effective income tax rate was (34)% and (16)% for the three and nine months ended September 30, 2026, respectively, as compared to 8% and 11% for the three and nine months ended September 30, 2025, respectively. Our income tax rate was primarily impacted by state income taxes, non-deductible executive compensation, and the impact of tax rate changes to our deferred tax liabilities, offset by changes in our valuation allowance against our net deferred tax assets, excess tax deductions on stock based compensation, and foreign provision to return adjustments.

On July 4, 2025 the One Big Beautiful Bill Act (“OBBBA”) was enacted in the US. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework, and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. We have reflected the impact of the enactment in our results for the three and nine months ended September 30, 2026.

In connection with the ongoing examination of the Company’s 2022 German income tax return, the Company received correspondence during the quarter ended September 30, 2026 from the German Federal Central Tax Office regarding the Company’s tax treatment of certain transactions related to its intercompany financing arrangements. The examination remains in its preliminary stages, and no assessment has been issued.

The Company has evaluated the information received from the tax authority, including the positions asserted in the correspondence, and continues to believe that its tax treatment is supportable and meets the more-likely-than-not recognition threshold under ASC 740, Income Taxes. Accordingly, no adjustment has been recorded in the accompanying consolidated financial statements. While the ultimate outcome of the matter is uncertain and cannot be predicted with certainty at this time, if the tax authority were to prevail in full, the additional tax exposure associated with the matter would be approximately €7 million, excluding any related interest and penalties.

  1. Debt

Debt consists of the following (in thousands):

September 30,2026December 31,2025
Term Loan Facility$190,000$190,000
Revolving Credit Facility30,00030,000
New Delayed Draw Term Loan Facility150,000—
Total principal debt370,000220,000
Less: Unamortized debt issuance costs(a)(6,213)(4,886)
Total debt363,787215,114
Less: Current portion of long-term debt——
Long-term debt, net$363,787$215,114

(a) Additional unamortized debt issuance costs totaling $1.3 million and $1.5 million related to the Revolving Credit Facility are included in “Other long-term assets” in the Condensed Consolidated Balance Sheets as of September 30, 2026 and December 31, 2025, respectively. Additional unamortized debt issuance costs totaling $1.1 million related to the New Delayed Draw Term Loan Facility are included in “Other long-term assets” in the Consolidated Balance Sheets as of December 31, 2025 as a result of the Amendment discussed below.

Our liquidity needs arise from the funding of our cost of operations and capital expenditures and from debt service on our indebtedness. We believe that cash generated from operations, together with amounts available under our Revolving Credit Facility, as defined below, will be adequate to permit us to meet our obligations over the next twelve months from the date of this report.

Credit Facilities

On January 18, 2024 we entered into a credit and guaranty agreement with Ares Management Credit funds for $350.0 million of senior secured, interest-only, credit facilities, consisting of a $190.0 million secured term loan facility (the “Term Loan Facility”), a $100.0 million secured delayed draw term loan facility (the “Delayed Draw Term Loan Facility” and, together with the Term Loan Facility, the “Term Loan Facilities”) and a $60.0 million “senior-priority” secured revolving credit facility which has a priority claim ahead of the other secured facilities (the “Revolving Credit Facility” and, together with the Term Loan Facilities, the “Credit Facilities”). Upon closing, we borrowed $190.0 million under the Term Loan Facility and $30.0 million under the Revolving Credit Facility. The proceeds of the borrowings were used along with cash on hand to pay off our previously existing credit agreement and pay related fees and expenses.

The remaining $30.0 million of undrawn availability under the Revolving Credit Facility as of September 30, 2026 may be drawn for working capital, capital expenditures, and other general corporate purposes. The Delayed Draw Term Loan Facility remained undrawn and was terminated on July 2, 2025 as we entered into separate, privately negotiated exchange agreements with the Holders of the Convertible Senior Notes as discussed below.

On September 12, 2025 (the “Second Amendment Effective Date”) we entered into a Second Amendment to the credit and guaranty agreement (the “Amendment”), with Ares Management Credit funds, which amends the credit and guaranty agreement dated as of January 18, 2024. The Amendment provides for (i) an extension of the maturity date of the existing term loans (the “Existing Term Loan Facility”) and the existing revolving credit facility (the “Existing Revolving Credit Facility”) under the Credit Agreement byone year to January 18, 2031, (ii) a reduction in the interest rate margin applicable to the Existing Term Loan Facility and the Existing Revolving Credit Facility and (iii) a new $150.0 million secured delayed draw term loan facility (the “New Delayed Draw Term Loan Facility” and, together with the Existing Term Loan Facility, the “Term Loan Facilities”).

Prior to the May 2026 borrowing described below, and subject to the satisfaction of a specified maximum total net leverage ratio and other customary conditions, we were permitted to borrow under the New Delayed Draw Term Loan Facility at any time and from time to time on or prior to September 12, 2027. Borrowings under the New Delayed Draw Term Loan Facility were permitted to be used to fund permitted acquisitions (including any earnouts and other similar payments in connection therewith), other investments permitted by the Credit Agreement and capital expenditures, among other things. Loans borrowed under the New Delayed Draw Term Loan Facility have the same terms and interest rate margins as the loans under the Existing Term Loan Facility.

In May 2026, in connection with our acquisition of Endospan, we borrowed $150.0 million under the New Delayed Draw Term Loan Facility, as further described below. The proceeds of borrowings were used in part to fund the upfront purchase price for the acquisition of Endospan. See Part I, Item 1, Note 4– “Acquisition of Endospan” for further discussion of the Endospan Acquisition.

Ranking; Guarantees

The Credit Facilities are secured by a security interest in substantially all existing and after-acquired real and personal property (subject to certain exceptions and exclusions) of us and the Guarantors.

Maturity and Prepayment

The final scheduled maturity date of the amended Credit Facilities is January 18, 2031. There are no scheduled repayments of principal required to be made prior to the final maturity date. We have the right to prepay loans under the Credit Agreement in whole or in part at any time, provided that any prepayment of loans under the Term Loan Facilities (or loans under the Revolving Credit Facility to the extent of reducing the balance of outstanding loans below $30.0 million) will be subject to a prepayment premium of 1.00% if the prepayment occurs prior to July 18, 2027. Amounts repaid in respect of loans under the Term Loan Facilities may not be reborrowed.

Covenants

The Credit Facilities contain certain customary affirmative and negative covenants, including covenants that limit our ability and the ability of our subsidiaries to, among other things, grant liens, incur debt, dispose of assets, make loans and investments, make acquisitions, make certain restricted payments (including cash dividends), merge or consolidate, change business or accounting or reporting practices, in each case subject to customary exceptions for a credit facility of this size and type. The covenants include a financial maintenance covenant that requires the company’s total net leverage ratio, as defined in the agreement, to be not greater than 6.25 x for the test periods from the second quarter of fiscal year 2024 through the fourth quarter of fiscal year 2024 and not greater than 5.75 x from the first quarter of fiscal year 2025 and thereafter. As of September 30, 2026 we are in compliance with our debt covenants.

Interest

On and after the Second Amendment Effective Date, borrowings under the Revolving Credit Facility bear interest, at our option, at a floating annual rate equal to either the base rate plus a margin of 2.50%, or the Secured Overnight Financing Rate (“SOFR”) plus a margin of 3.50%. In addition, we are required to pay fees of 0.50% per annum on the daily unused amount of the Revolving Credit Facility and, prior to the borrowing described below, a fee of 1.00% per annum on the daily unused amount of the New Delayed Draw Term Loan Facility.

In May 2026, we borrowed $150.0 million under the New Delayed Draw Term Loan Facility, after which the 1.00% unused commitment fee ceased to apply. The borrowings under the Term Loan Facilities bear interest, at our option, at a floating annual rate equal to either the base rate plus a margin of 3.75%, or SOFR plus a margin of 4.75%. As of September 30, 2026 the stated interest rates on the Term Loan Facility, Revolving Credit Facility, and New Delayed Draw Term Loan Facility were 8.48%,7.23%, and 8.51%, respectively. As of September 30, 2026 the effective interest rates on the Term Loan Facility and New Delayed Draw Term Loan Facility were 9.10% and 8.90%, respectively.

Debt Discount and Debt Issuance Costs

In connection with the Amendment, we capitalized $0.5 million in debt issuance costs under the Existing Term Loan Facility, $0.2 million in other long-term assets under the Existing Revolving Credit Facility, and $1.1 million in other long-term assets under the New Delayed Draw Term Loan Facility.

In May 2026, upon borrowing $150.0 million under the New Delayed Draw Term Loan Facility, the lender withheld a draw fee of $1.1 million, which was accounted for as deferred financing costs, resulting in net cash proceeds of $148.9 million. Upon the borrowing, we reclassified $1.1 million of previously capitalized debt issuance costs from other long-term assets as a deduction from the carrying amount of the New Delayed Draw Term Loan Facility. In connection with the borrowing, the debt discount and debt issuance costs associated with the New Delayed Draw Term Loan Facility totaled $2.3 million and are being amortized to interest expense over the term of the facility.

Non-cash amortization of debt issuance costs and debt discounts for our Credit Facilities totaled $0.4 million and $1.2 million for the three and nine months ended September 30, 2026, respectively, as compared to $0.4 million and $1.4 million for the three and nine months ended September 30, 2025, respectively.

Convertible Senior Notes

On June 18, 2020 we issued $100.0 million aggregate principal amount of 4.25% Convertible Senior Notes with a maturity date of July 1, 2025 (the “Convertible Senior Notes”). The net proceeds from this offering, after deducting initial purchasers’ discounts and costs directly related to this offering, were approximately $96.5 million. On January 1, 2021 we adopted ASU 2020-06 and adjusted the carrying balance of the Convertible Senior Notes to notional.

In May 2025 we entered into separate, privately negotiated exchange agreements (“Exchange Agreements”) with the Holders ofthe Convertible Senior Notes. The transactions contemplated by the Exchange Agreements closed on May 28, 2025. Under the terms of the Exchange Agreements, the Holders exchanged an aggregate principal amount of approximately $99.5 million of the Convertible Senior Notes held by the Holders in exchange for an aggregate of 4,334,347 shares of our common stock. In addition, pursuant to the Exchange Agreements, we made a cash payment of approximately $1.7 million to the Holders in respect of accrued and unpaid interest on the exchanged Convertible Senior Notes. The remaining$0.5 million in aggregate principal amount of the Convertible Senior Notes was settled on July 1, 2025 resulting in the issuance of 19,605 shares of our common stock. The Delayed Draw Term Loan Facility was terminated on July 2, 2025 after all of the Convertible Senior Notes were settled.

The Convertible Senior Notes could have been settled in cash, stock, or a combination thereof, solely at our discretion. The initial conversion rate of the Convertible Senior Notes was 42.6203 shares per $1,000 principal amount, which is equivalent to a conversion price of approximately $23.46 per share, subject to adjustments. We used the if-converted method for assumed conversion of the Convertible Senior Notes for the diluted earnings per share calculation in periods prior to inducement.

Due to the settlement of the Convertible Senior Notes in July 2025, as discussed above, we didnot incur interest expense on the Convertible Senior Notes for the three and nine months ended September 30, 2026 or for the three months ended September 30, 2025. We incurred approximately $2.1 million of interest expense on the Convertible Senior Notes for the nine months ended September 30, 2025. Interest on the Convertible Senior Notes began accruing upon issuance and was payable semi-annually.

  1. Commitments and Contingencies

Liability Claims

In the normal course of business, we are made aware of adverse events involving our products and tissues. Future adverse events could ultimately give rise to a lawsuit against us, and liability claims may be asserted against us in the future based on past events that we are not aware of at the present time. We maintain claims-made insurance policies to mitigate our financial exposure to product and tissue processing liability claims. Claims-made insurance policies generally cover only those asserted claims and incidents that are reported to the insurance carrier while the policy is in effect. The amounts recorded in these Condensed Consolidated Financial Statements as of September 30, 2026 and December 31, 2025 represent our estimate of the probable losses and anticipated recoveries for incurred but not reported claims related to products sold and services performed prior to the balance sheet date.

  1. Revenue Recognition

Disaggregation of Revenue

Revenues are disaggregated by the following geographic regions:

North America: consists of the US and Canada. We market our approved medical device products and preservation services (predominantly in the US), primarily to physicians through our direct sales representatives who are managed by regional managers.

Europe, the Middle East, and Africa (“EMEA”): in certain countries, we market approved medical device products to physicians, hospitals, and distributors through our direct sales force. In countries where we have no direct sales forces, regional sales managers market to distributors who buy medical device products directly from us and sell to hospitals in their respective countries.

Asia Pacific (“APAC”): we market medical device products that are approved in each country to distributors in the region.

Latin America (“LATAM”): we market medical device products that are approved in each country to distributors in the region except for Brazil where we sell directly to end customers and distributors.

Net revenues by geographic location based on the location of the customer were as follows (in thousands):

Three Months EndedSeptember 30,Nine Months EndedSeptember 30,
2026202520262025
North America$63,222$58,315$184,250$163,677
EMEA40,08736,224128,621111,982
APAC13,26712,23734,12631,582
LATAM7,2146,61218,88718,097
Total revenues$123,790$113,388$365,884$325,338

Also see segment disaggregation information in Note 14 below.

  1. Stock Compensation

We have stock option and stock incentive plans for employees and non-employee directors that provide for grants of restricted stock awards (“RSAs”), restricted stock units (“RSUs”), performance stock units (“PSUs”), and options to purchase shares of our common stock at exercise prices generally equal to the fair value of such stock at the dates of grant. We also maintain a stockholder-approved Employee Stock Purchase Plan (“ESPP”) for the benefit of our employees. The ESPP allows eligible employees to purchase common stock on a regular basis at the lower of 85% of the market price at the beginning or end of each offering period.

Equity Grants

During the nine months ended September 30, 2026 the Compensation Committee of our Board of Directors (the “Committee”) authorized awards from approved stock incentive plans of RSAs to non-employee directors and RSUs and PSUs to certain employees and company officers, which, assuming that performance under the PSUs will be achieved at target levels, together totaled 856,000 shares and had an aggregate grant date fair value of $29.3 million.

During the nine months ended September 30, 2025 the Committee authorized awards from approved stock incentive plans of RSAs to non-employee directors and RSUs and PSUs to certain employees and company officers, which, assuming that performance under the PSUs were to be achieved at target levels, together totaled 914,000 shares and had an aggregate grant date fair value of $24.0 million.

The Committee didnot authorize any grants of stock options during the nine months ended September 30, 2026 and 2025.

Employees purchased common stock totaling 115,000 and 97,000 shares in the nine months ended September 30, 2026 and 2025, respectively, through the ESPP.

13.(Loss) Income Per Common Share

The following table sets forth the computation of basic and diluted (loss) income per common share (in thousands, except per share data):

Three Months EndedSeptember 30,Nine Months EndedSeptember 30,
Basic (loss) income per common share2026202520262025
Net (loss) income$(7,926)$6,502$(20,019)$7,342
Net loss (income) allocated to participating securities10(7)23(9)
Net (loss) income allocated to common stockholders$(7,916)$6,495$(19,996)$7,333
Basic weighted-average common shares outstanding48,71847,23348,44744,605
Basic (loss) income per common share$(0.16)$0.14$(0.41)$0.16
Three Months EndedSeptember 30,Nine Months EndedSeptember 30,
Diluted (loss) income per common share2026202520262025
Net (loss) income$(7,926)$6,502$(20,019)$7,342
Net loss (income) allocated to participating securities10(7)23(8)
Net (loss) income allocated to common stockholders$(7,916)$6,495$(19,996)$7,334
Basic weighted-average common shares outstanding48,71847,23348,44744,605
Effect of dilutive stock options and awards—1,542—1,388
Diluted weighted-average common shares outstanding48,71848,77548,44745,993
Diluted (loss) income per common share$(0.16)$0.13$(0.41)$0.16

We excluded stock options and awards from the calculation of diluted weighted-average common shares outstanding if the per share value, including the sum of (i) the exercise price of the options and (ii) the amount of the compensation cost attributed to future services and not yet recognized, was greater than the average market price of the shares because the inclusion of these stock options would be antidilutive to loss per common share. For thethree and nine months ended September 30, 2026 all stock options and awards were excluded from the calculation of diluted weighted-average common shares outstanding as these would be antidilutive to the net loss. For the three and nine months ended September 30, 20259,000 and 3,000 potential common shares, respectively, related to stock options and awards were antidilutive and excluded from the calculation of diluted weighted-average common shares outstanding.

  1. Segment Information

We havetwo reportable segments organized according to our products and services: Medical Devices and Preservation Services. The Medical Devices segment includes external revenues from product sales of aortic stent grafts, On-X®, surgical sealants, and other product revenues. Aortic stent grafts include aortic arch stent grafts, abdominal stent grafts, and synthetic vascular grafts. Aortic arch stent grafts include our E-vita® Open NEO, E-vita Open Plus, Arcevo LSA, AMDSTM, the NEXUS ONETM, NEXUS DUOTM, and NEXUS TRETM aortic arch stent graft systems (the “NEXUS family of products”), and E-vita Thoracic 3G. Abdominal stent grafts include our E-xtra Design Engineering, E-nside TM, Artivex TM, E-tegra TM, E-ventus TM BX, Tuva TMBX, and E-liac TM products. Surgical sealants include BioGlue® Surgical Adhesive products. The Preservation Services segment includes external services revenues from the preservation of cardiac and vascular tissues. There areno intersegment revenues.

Our Chief Operating Decision Maker (“CODM”) is the Company’s Chairman, President, and CEO. The CODM reviews financial information to assess segment performance and determine how to allocate resources across segments.

The primary measure of segment performance, as assessed by our management, is segment gross margin or net external revenues less cost of products and preservation services. The CODM regularly reviews these costs, recognizing them as significant segment expenses. We do not segregate assets by segment; therefore, asset information is excluded from the segment disclosures below.

The following table summarizes revenues, cost of products and preservation services, and gross margins for our reportable segments (in thousands):

Three Months EndedSeptember 30,Nine Months EndedSeptember 30,
2026202520262025
Revenues:
Medical devices$98,160$87,665$289,507$253,907
Preservation services25,63025,72376,37771,431
Total revenues123,790113,388365,884325,338
Cost of products and preservation services:
Medical devices35,70127,81199,38981,389
Preservation services12,11211,18234,55332,865
Total cost of products and preservation services47,81338,993133,942114,254
Gross margin:
Medical devices62,45959,854190,118172,518
Preservation services13,51814,54141,82438,566
Total gross margin$75,977$74,395$231,942$211,084

Net revenues by product were as follows (in thousands):

Three Months EndedSeptember 30,Nine Months EndedSeptember 30,
2026202520262025
Products:
Aortic stent grafts$44,278$39,585$135,089$116,028
On-X30,31726,79786,77473,943
Surgical sealants18,94618,89357,03856,287
Other4,6192,39010,6067,649
Total products98,16087,665289,507253,907
Preservation services25,63025,72376,37771,431
Total revenues$123,790$113,388$365,884$325,338

Forward-Looking Statements

This Form 10-Q includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). Forward-looking statements give our expectations or forecasts of future events as of the date of this Form 10-Q. In some cases, words such as “could,” “may,” “might,” “will,” “would,” “shall,” “should,” “pro forma,” “potential,” “pending,” “intend,” “believe,” “expect,” “anticipate,” “estimate,” “plan,” “future,” “assume,” and variations of these types of words or other similar expressions identify forward-looking statements. These forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements, which are made as of the date of this Form 10-Q.

All statements included herein, other than statements of historical facts, that address activities, events, or developments that we expect or anticipate will or may occur in the future, or that reflect our beliefs about the future and/or expectations, are forward-looking statements, including statements about the following:

The potential impact that public health crises and geopolitical conflicts may have on demand for and sales of our products and services, business operations, manufacturing operations, supply chain, cash flow, workforce, clinical and regulatory timelines, and our research and development projects;

The potential impact that general global, regional, or national economic downturns and macroeconomic trends, including heightened inflation, interest rates, currency fluctuations, and proposed and enacted tariffs, as well as general or localized economic slowdowns or recessions, may have on demand for and sales of our products and services, including ordering trends for international distributors based on currency fluctuations against the US dollar, and our business operations, manufacturing operations, supply chain, and workforce;

Our beliefs about the robustness of our global supply chain in light of current global and macroeconomic conditions and about the potential impact of supply chain disruptions, particularly disruptions to single and sole source suppliers and third-party manufacturing partners;

Our beliefs about our R&D and product pipeline, including our beliefs about the timing and results of our clinical trials, approvals, and product commercialization and launches;

Our expectations related to anticipated expansion of our business and the sufficiency of our leased and recently acquired properties for such expansion;

Our beliefs and anticipation regarding the favorable attributes, benefits, and clinical advantages of our products and services, the basis on which our products and services compete, the benefits of our physician education activities, and the advantages of our relationships with organ and tissue procurement organizations and tissue banks;

Our beliefs about the future regulatory status of our medical devices and processed tissues, our compliance with applicable laws and regulations, and our ability to make timely transitions to our Notified Bodies and obtain renewals for our Conformité Européenne Mark (“CE Mark”) product certification impacted by the transition to the Medical Device Regulation in Europe, and the impact these transitions, renewals, and related processes may have on our business, including any impact on our customers’ ordering patterns and our ability to supply products;

Our beliefs regarding our global expansion efforts;

Our beliefs about the potential impact on our business of changes to regulations, regulators, Notified Bodies, and related matters;

Our beliefs about the advantages of our intellectual property and its significance to our segments and our business as a whole, and our beliefs about the present value and potential impairment of our intangible assets and leases;

Our beliefs about our workforce, including our ability to attract and retain talent at all levels, and about our relationship with our workforce, including our works council in Germany and union in Brazil;

Our beliefs about potential information security vulnerabilities, and the associated potential adverse effects on our business;

Our beliefs about the business impact of, and expenses associated with, the 2024 cybersecurity incident, and our beliefs about the cybersecurity threat environment;

The dependencies affecting our ability to realize the anticipated business opportunities, growth prospects, synergies, and other benefits of the agreement with Baxter, our acquisition and integration of Endospan, and our acquisition of Ascyrus, and our beliefs about the costs and timelines for certain regulatory approvals and clinical trial milestones;

Our beliefs regarding the fair value of our acquisitions, divestitures, and other business development activities and the estimates and assumptions about the future achievements of milestones and future revenues and cash flows related to those business development activities, including our ability to achieve the milestones in the Endospan, Ascyrus, and Baxter transactions;

Our belief regarding potential future contingent consideration payable pursuant to the Endospan and Ascyrus transactions;

Our belief that revenues for preservation services, particularly revenues for certain high-demand cardiac tissues, can vary from quarter-to-quarter and year-to-year due to a variety of factors including: quantity and type of incoming tissues, yields of tissue through the preservation process, timing of receipt of donor information, staffing levels, timing of the release of tissues to an implantable status, demand for certain tissue types due to the number and type of procedures being performed, and pressures from competing products or services;

Our beliefs regarding the seasonal nature of the demand for some of our products and services and the reasons for such seasonality, if any, and regarding the impact of consignment inventory on product sales, if any;

Our belief that our cash from operations and existing cash and cash equivalents will enable us to meet our current operational liquidity needs for at least the next twelve months, our expectations regarding future cash requirements and expenditures, and the impact that our cash requirements might have on our cash flows for the next twelve months;

Our expectation regarding the impact on cash flows of undertaking significant business development activities and the potential need to obtain additional debt financing or equity financing;

Our belief that we will incur expenses for research and development projects, including for clinical research projects to gain regulatory approvals for products or indications, including existing products, and for new products and technologies that will likely require additional investment, research, and new clinical studies or data;

Our beliefs about market opportunity and our ability to capture market share;

Our beliefs about pending and potential legal or other governmental or regulatory proceedings;

Our expectations regarding the timing and impact of clinical research work and regulatory approvals for certain products or indications, including On-X products, aortic stent grafts, and surgical sealants, and the CryoValve SG pulmonary heart valve if the US Food and Drug Administration (“FDA”) reclassifies allograft heart valves as Class III medical devices;

Our beliefs and expectations regarding the utilization of net operating loss carryforwards from our acquisitions of JOTEC GmbH, On-X Life Technologies, Inc., Hemosphere, Inc., and Cardiogenesis Corporation;

Our belief regarding the impact of the One Big Beautiful Bill Act on our tax obligations for the 2025 tax year and beyond;

Our beliefs about our operating results which may fluctuate significantly on a periodic basis as a result of internal and external factors, including reduced demand for our products, the potential impact of new therapies, healthcare workforce trends and labor disputes, regulatory challenges, the availability of products, materials, and supplies, strategic actions we take such as acquisitions or divestitures, unanticipated costs and expenses, market reception of our new or improved product offerings, and interest rate and currency fluctuations; and

Other statements regarding projections of future financial and business performance; anticipated growth and trends in our business and the markets relevant to our business, including how our growth relates to our competitors; the robustness and reliability of our workforce and supply chain; future production capacity and product supply; the availability and benefits of our products in the future; and the expected timing and impact of our strategic initiatives.

These and other forward-looking statements reflect the views of management at the time and such statements are originally made based on certain assumptions and analyses made by us in light of our experience and our perception of historical trends, current conditions, and expected future developments as well as other factors we believe are appropriate in the circumstances and are subject to a number of risks, uncertainties, estimates, and assumptions. Whether actual results and developments will conform with our expectations and predictions is subject to a number of risks and uncertainties which could cause actual results to differ materially and adversely from our expectations, including, without limitation, in addition to those specified in the text surrounding such statements, the risks described in Part II, Item 1A, “Risk Factors” in this Form 10-Q and elsewhere throughout this report, the risks described in our other filings with the Securities and Exchange Commission including the risks described in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 and elsewhere throughout that report, and other risks which we may not be able to identify in advance, many of which are beyond our control. Consequently, all of the forward-looking statements made in this Form 10-Q are qualified by these cautionary statements, and there can be no assurance that the actual results or developments anticipated by us will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, us or our business or operations. We assume no obligation, and expressly disclaim any duty, to update publicly any such forward-looking statements, whether as a result of new information, future events, or otherwise.

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