What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2026-03-13 compared with 2025-03-11 · 416 added, 338 removed, 759 unchanged (50% of the section changed)

11 unchanged sentences

Attestation Report of the Registered Public Accounting Firm

Our independent registered accounting firm will not be required to opine on the effectiveness of our internal control over financial reporting pursuant to Section 404 of Sarbanes-Oxley Act of 2002 until we are no longer an “emerging growth company” as defined in the JOBS Act.

As a “smaller reporting company”, our independent registered accounting firm is not required to issue an attestation report on our internal control over financial reporting.

Changes in Internal Control over Financial Reporting

6 unchanged sentences

The information required by this Item 10 is incorporated herein by reference to the information that will be contained in our proxy statement related to our annual meeting of stockholders to be held in 2026 (the “2026 Annual Meeting of Stockholders”), which we intend to file with the SEC within 120 days of the year ended December 31, 2025.

A copy of our Insider Trading Compliance Policy is filed as Exhibit 19 to this Annual Report on Form 10-K.

Executive Compensation.

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Certain Relationships and Related Transactions, and Director Independence.

The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the 2025 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2024.

The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement relating to the 2026 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2025.

Principal Accountant Fees and Services.

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(solely with respect to Section 11.18)

Exhibit Number

Filed/Furnished Herewith

Restated Certificate of Incorporation of Elutia Inc.

6 unchanged sentences

Form of Common Warrant

Exhibit Number

Filed/Furnished Herewith

2023 Form of Prefunded Warrant

2 unchanged sentences

2024 Form of Prefunded Warrant

Exhibit Number

Filed/Furnished Herewith

2025 Form of Prefunded Warrant

Description of Securities

5 unchanged sentences

2015 Stock Option/Stock Issuance Plan (as amended)

2020 Incentive Award Plan and form of stock option agreements thereunder

2020 Incentive Award Plan

Exhibit Number

Filed/Furnished Herewith

and form of stock option agreements thereunder

Form of Restricted Stock Unit Award Agreement (approved August 2022)

1 unchanged sentence

Non-Employee Director Compensation Program

Exhibit Number

Filed/Furnished Herewith

2020 Employee Stock Purchase Plan

Amended and Restated Employment Agreement, by and between the Registrant and Ronald Lloyd, dated as of September 30, 2021

Amended and Restated Employment Agreement, by and between the Registrant and Ronald Lloyd, dated as of December 31, 2021

Separation and Release of Claims Agreement, dated June 21, 2022, by and between Ronald Lloyd and Elutia Inc.

4 unchanged sentences

and Thomas Englese

Exhibit Number

Filed/Furnished Herewith

Letter Agreement, dated as of March 22, 2023, by and between Elutia Inc.

4 unchanged sentences

Credit Agreement, dated as of August 10, 2022, between Elutia Inc.

and SWK Funding LLC, as

Exhibit Number

Filed/Furnished Herewith

Agent and the Lenders from time to time party thereto

and SWK Funding LLC, as Agent and the Lenders from time to time party thereto

Amendment Letter, dated as of October 9, 2022 to Credit Agreement, dated as of August 10, 2022, between Elutia Inc.

2 unchanged sentences

and SWK Funding LLC, as Agent and the Lenders from time to time party thereto (as amended by the Amendment Letter dated as of October 9, 2022)

Amendment Letter, dated as of November 21, 2022, to the Credit Agreement, dated as of August 10, 2022, among Elutia Inc., SWK Funding LLC, as Agent, and the Lenders from time to time party thereto (as amended).

Amendment Letter, dated as of November 30, 2022, to the Credit Agreement, dated as of August 10, 2022, among Elutia Inc., SWK Funding LLC, as Agent, and the Lenders from time to time party thereto (as amended).

Exhibit Number

Filed/Furnished Herewith

First Amendment, dated as of May 12, 2023, to the Credit Agreement, dated August 10, 2022, by and among Aziyo Biologics, Inc., SWK Funding LLC, as Agent and the Lenders from time to time party thereto

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Amendment No.

1 to Royalty Agreement with Ligand Pharmaceuticals Incorporated

1 to Royalty Agreement with

Exhibit Number

Filed/Furnished Herewith

Ligand Pharmaceuticals Incorporated

Form of Amendment to Stock Option Agreements, dated January 31, 2024, between the Company and C.

2 unchanged sentences

Randal Mills, Ph.D.

Exhibit Number

Filed/Furnished Herewith

Form of Stock Option Agreement under the Elutia Inc.

6 unchanged sentences

Form of Securities Purchase Agreement

2025 Form of Placement Agency Agreement

Exhibit Number

Filed/Furnished Herewith

dated February 3, 2025 between Lake Street Capital Markets, LLC and Elutia In.

2025 Form of Securities Purchase Agreement dated February 3, 2025 between Elutia Inc.

and the purchasers named therein

Subscription Agreement and Amendment No.

2 to Royalty Agreement dated May 8, 2025 between Elutia Inc., Elutia Med LLC and Ligand Pharmaceuticals Incorporation

Fourth Amendment to Credit Agreement dated May 7, 2025 by and among Elutia Inc., SWK Funding LLC as Agent and the lenders from time to time party thereto

Fifth Amendment to Credit Agreement, dated as of August 14, 2025, by and among Elutia Inc., SWK Funding LLC, as Agent, and the Lenders from time to time party thereto.

Asset Purchase Agreement, dated September 8, 2025, by and among Boston Scientific Corporation and Cardiac Pacemakers Inc.

and Elutia Inc.

and Elutia Med LLC

Consent, Release and Amendment No.

3 dated as of October 1, 2025 to Royalty Agreement by and between Elutia Med

Exhibit Number

Filed/Furnished Herewith

LLC and Ligand Pharmaceuticals Incorporated.

Consulting Agreement, dated December 1, 2023, between Elutia Inc.

and Guido Neels

Insider Trading Compliance Policy

2 unchanged sentences

Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

Exhibit Number

Filed/Furnished Herewith

Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

1 unchanged sentence

Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

Certification of Principal Financial Officer Pursuant to 18 U.S.C.

Certification of Principal Financial Officer Pursuant to 18

Exhibit Number

Filed/Furnished Herewith

Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

3 unchanged sentences

Inline XBRL Taxonomy Extension Calculation Linkbase Document

Exhibit Number

Filed/Furnished Herewith

Inline XBRL Taxonomy Extension Definition Linkbase Document

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† Denotes a management contract or compensation plan or arrangement.

+ Certain confidential information contained in this exhibit, marked in brackets, has been omitted, because it is both not material and of the type of information that the registrant treats as private or confidential.

# Annexes, schedules and exhibits have been omitted pursuant to Item 601(a)(5)(b)(2) of Regulation S-K.

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March 13, 2026

March 11, 2025

/s/Maybelle Jordan

/s/Guido Neels

March 13, 2026

Maybelle Jordan

/s/David Colpman

13 unchanged sentences

We have audited the accompanying consolidated balance sheets of Elutia Inc.

and its subsidiaries (the “Company”) as of December 31, 2024 and 2023, and the related consolidated statements of operations, of changes in stockholders’ equity (deficit) and of cash flows for the years then ended, including the related notes (collectively referred to as the “consolidated financial statements”).

and its subsidiary (the "Company") as of December 31, 2025 and 2024, and the related consolidated statements of operations, of changes in stockholders' equity (deficit) and of cash flows for the years then ended, including the related notes (collectively referred to as the "consolidated financial statements").

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.

Substantial Doubt about the Company’s Ability to Continue as a Going Concern

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.

As discussed in Note 2 to the consolidated financial statements, the Company has generated recurring losses from operations and is expected to incur cash outflows from operating activities that raise substantial doubt about its ability to continue as a going concern.

Management's plans in regard to these matters are also described in Note 2.

The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

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We believe that our audits provide a reasonable basis for our opinion.

Emphasis of Matter

As discussed in Note 2 to the consolidated financial statements, the Company has negative cash flows from operations and an accumulated deficit as of December 31, 2025.

Management’s evaluation of the events and conditions related to this matter are also described in Note 2.

Critical Audit Matters

The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments.

The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

Litigation Contingencies - FiberCel and Viable Bone Matrix Products

As described in Note 17 to the consolidated financial statements, the Company’s contingent liability for legal proceedings related to FiberCel and viable bone matrix (VBM) products was $11.2 million as of December 31, 2025.

Management records accruals for contingencies when it is probable that a liability has been incurred and the amount can be reasonably estimated.

Where the available information is only sufficient to establish a range of probable liability, and no point within

the range is more likely than any other, the lower end of the range has been used.

When a material loss contingency is reasonably possible, but not probable, the Company does not record a liability, but instead discloses the nature of the matter and an estimate of the loss or range of loss, to the extent such estimate can be made.

Accruals recorded are adjusted periodically as assessments change or additional information becomes available, and management's judgments may be materially different than the actual outcomes.

In June 2021, the Company announced a voluntary recall of a single lot of FiberCel fiber viable bone matrix.

In July 2023, the Company announced a voluntary recall of a single lot of a certain VBM product and the market withdrawal of all of its VBM products produced after a specified date.

The principal considerations for our determination that performing procedures relating to the litigation contingencies for FiberCel and VBM products is a critical audit matter are (i) the significant judgment by management when assessing whether a loss is reasonably possible or probable and if probable, whether the amount of the loss or range of loss can be reasonably estimated and (ii) a high degree of auditor judgment, subjectivity, and effort in performing procedures and evaluating audit evidence related to management’s assessment of the litigation contingencies.

Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements.

These procedures included, among others (i) confirming with external legal counsel the possibility or probability of an unfavorable outcome and the extent to which the loss or range of loss is reasonably estimable;

(ii) obtaining and evaluating certain settlement agreements;

(iii) testing a sample of legal settlements paid;

(iv) evaluating the reasonableness of management’s assessment regarding whether an unfavorable outcome is reasonably possible or probable and reasonably estimable;

and (v) evaluating the sufficiency of the Company’s litigation contingency disclosures related to the FiberCel and VBM matters.

/s/ PricewaterhouseCoopers LLP

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Prepaid expenses and other current assets

Divestiture proceeds receivable

Current assets of discontinued operations

Total current assets

2 unchanged sentences

Operating lease right-of-use assets and other

Noncurrent assets of discontinued operations

Liabilities and Stockholders’ Equity (Deficit)

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Current operating lease liabilities

Current liabilities of discontinued operations

Total current liabilities

3 unchanged sentences

Long-term operating lease liabilities

Other long-term liabilities

Noncurrent liabilities of discontinued operations

Total liabilities

2 unchanged sentences

Class A Common stock, $ 0.001 par value, 200,000,000 shares authorized as of December 31, 2025 and December 31, 2024, and 42,784,848 and 30,897,232 shares issued and outstanding , as of December 31, 2025 and December 31, 2024, respectively

Class B Common stock, $ 0.001 par value, 20,000,000 shares authorized, as of December 31, 2024 and December 31, 2023 and 4,313,406 issued and outstanding as of December 31, 2024 and December 31, 2023

Class B Common stock, $ 0.001 par value, 20,000,000 shares authorized as of December 31, 2025 and December 31, 2024, and 0 and 4,313,406 shares issued and outstanding , as of December 31, 2025 and December 31, 2024, respectively

Additional paid-in capital

Accumulated deficit

Total stockholders’ deficit

Total liabilities and stockholders' deficit

Total stockholders’ equity (deficit)

Total liabilities and stockholders' equity (deficit)

The accompanying notes are an integral part of these consolidated financial statements.

8 unchanged sentences

Loss from continuing operations

Interest expense, net

Loss on revaluation of warrant liability

Other (income) expense, net

Loss before provision for income taxes

Interest (income) expense, net

(Gain) loss on revaluation of warrant liability

Other expense (income), net

Loss from continuing operations before provision for income taxes

Income tax expense

Net loss from continuing operations

Income from discontinued operations

Net loss per share from continuing operations attributable to common stockholders - basic and diluted

Income per share from discontinued operations attributable to common stockholders - basic and diluted

Net loss per share - basic and diluted

Weighted average common shares outstanding - basic and diluted

Income (loss) from discontinued operations

Net income (loss)

dilutive gain on revaluation of warrant liability

Net income (loss) for dilutive earnings per share

Net loss from continuing operations per share - basic

Net loss from continuing operations per share - diluted

Net income (loss) from discontinued operations per share - basic

Net income (loss) from discontinued operations per share - diluted

Net income (loss) per share - basic

Net income (loss) per share - diluted

Weighted average common shares outstanding - basic

Weighted average common shares outstanding - diluted

The accompanying notes are an integral part of these consolidated financial statements.

4 unchanged sentences

Balance, December 31, 2023

Issuance of common stock in connection with private placement, net of issuance costs of $ 0.4 million

Issuance of common stock in connection with registered direct offering, net of issuance costs of $ 1.1 million

Exercise of stock options

Exercise of Common Warrants and Prefunded Warrants

Issuance of common stock under Employee Stock Purchase Plan

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Issuance of common stock in connection with registered direct offering, net of issuance costs of $ 1.1 million

Exercise of stock options

Exercise of Common Warrants and Prefunded Warrants

Issuance of common stock under Employee Stock Purchase Plan

Issuance of stock for interest payment

Vesting of restricted stock units, net of shares withheld and taxes paid

Stock-based compensation

Conversion of Class B Common Stock to Class A Common Stock

( 4,313,406 )

Balance, December 31, 2025

2 unchanged sentences

(In Thousands)

Adjustments to reconcile net loss to net cash used in operating activities:

Net income (loss)

Adjustments to reconcile net income (loss) to net cash used in operating activities:

Depreciation and amortization

Gain on sale of Orthobiologics Business, excluding divestiture costs

Loss on revaluation of warrant liability

Gain on sale of CIED Business, excluding divestiture costs

Loss on early repayment of debt

(Gain) loss on revaluation of warrant liability

Gain on revaluation of revenue interest obligation

Amortization of deferred financing costs and debt discount

Interest expense recorded as additional revenue interest obligation and long-term debt

1 unchanged sentence

Bad debt expense

Losses associated with viable bone matrix recall and market withdrawal

Payments on revenue interest obligation

Changes in operating assets and liabilities, net:

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Proceeds from sale of Orthobiologics Business

Expenditures for property, plant and equipment

Net cash (used in) provided by investing activities

Proceeds from sale of CIED Business

Expenditures for property and equipment, net

Net cash provided by (used in) investing activities

FINANCING ACTIVITIES:

Proceeds from public offering or private placement with warrants, net of offering costs

Proceeds (repayments) of long-term debt

Proceeds from public offering with warrants, net of offering costs

Repayments of long-term debt

Proceeds from exercises of Common Warrants and Prefunded Warrants

4 unchanged sentences

Proceeds from stock option exercises and issuance of common stock under ESPP

Net cash provided by financing activities

Net (decrease) increase in cash

Net cash (used in) provided by financing activities

Net increase (decrease) in cash and cash equivalents

Cash and cash equivalents, beginning of year

Cash and cash equivalents, end of year

Supplemental Cash Flow and Non-Cash Financing Activities Disclosures:

Supplemental Cash Flow and Non-Cash Investing and Financing Activities Disclosures:

Cash paid for interest

Fair value of warrants issued

Operating lease right-of-use asset extensions executed, net of early terminations

Deferred proceeds from sale of CIED Business recognized as receivable

Issuance of common stock as payment under revenue interest obligation and long-term debt

Additions to operating lease right-of-use assets in exchange for lease liabilities, net of early terminations

Conversion of Common Warrants and Prefunded Warrants to common stock

2 unchanged sentences

Organization and Description of Business

(together with its consolidated subsidiaries, "Elutia” or the “Company”) is a commercial-stage company leveraging its unique understanding of biologics combined with local drug delivery to improve the interaction between implanted medical devices and patients by reducing complications associated with these surgeries.

The Company has developed a portfolio of products using both human and porcine tissue that are designed to be as close to natural biological material as possible.

Elutia’s portfolio of products spans the Device Protection, Women’s Health and Cardiovascular markets.

These products are primarily sold to healthcare providers or commercial partners.

(together with its consolidated subsidiary, "Elutia” or the “Company”) is a commercial-stage company developing proprietary drug-eluting biomatrix products for use in surgical reconstruction and related applications.

These products are designed to improve the interaction between implanted medical devices and patients.

The Company’s focus is on addressing unmet medical needs and reducing complications associated with surgery, including infection, migration, erosion, implant rejection, and fibrosis.

Elutia’s portfolio of products spans the Women’s Health and Cardiovascular markets.

These products are sold to healthcare providers.

Summary of Significant Accounting Policies

3 unchanged sentences

Intercompany accounts and transactions have been eliminated in consolidation.

On September 8, 2025, Elutia executed an Asset Purchase Agreement (the “APA”) with Boston Scientific Corporation (“BSC”), a Delaware corporation, and Cardiac Pacemakers Inc.

(“CPI”), a Minnesota corporation (collectively with BSC, the “ CIED Buyers”).

On October 1, 2025, at the closing of the transactions contemplated by the APA, the CIED Buyers purchased from the Company substantially all of the assets that are related to the Company’s business of researching, developing, administering, operating, commercializing, manufacturing, selling and marketing its cardiac implantable electronic device (“CIED”) products, including its CanGaroo®, CanGaroo® RM, EluPro™ and CIED envelope products, including next generation CIED envelope products (collectively the “CIED Business”).

The assets of the CIED Business constitute substantially all of the assets previously held in Elutia’s Device Protection segment.

The CIED Buyers only assumed certain liabilities related to performance of the contracts transferred in the APA.

The APA provides for an aggregate purchase price, subject to certain adjustments pursuant to the terms of the APA, of up to $ 88.0 million in cash, with $ 80.4 million (which includes an inventory adjustment of $ 0.4 million) that was paid in cash to Elutia at the closing of the transactions or shortly thereafter, and $ 8.0 million that was deposited at the closing of the transactions in escrow with a bank for twelve months , which is subject to potential reduction in the event of certain post-closing breaches of representations and warranties within the APA by the Company.

The Company recognized a gain , net of tax effect and divestiture costs, of $ 76.1 million on the sale of the CIED Business during the year ended December 31, 2025.

Such gain includes the recognition of the $ 8.0 million in escrow as a divestiture proceeds receivable on the accompanying balance sheet as of December 31, 2025.

The sale of the CIED Business represents a strategic shift that has a major effect on the Company’s operations and financial results.

Consequently, the Company met the held-for-sale criteria of Accounting Standards Codification (“ASC”) 205-20, Discontinued Operations .

Accordingly, this transaction is accounted for as Discontinued Operations for all periods presented in accordance with ASC 205-20, Discontinued Operations .

Unless indicated otherwise, the information in the notes to the consolidated financial statements relates to continuing operations.

See Note 4 for further discussion of the divestiture of the CIED Business.

On November 8, 2023, the Company completed the sale of substantially all of the assets relating to its Orthobiologics segment (the “Orthobiologics Business”) to Berkeley Biologics, LLC (“Berkeley”).

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The assets sold represent the entirety of the Company’s Orthobiologics segment.

In the sale, the Company received $ 14.6 million, and the Company may earn up to an additional $ 20 million, in the aggregate, in the form of earn-out payments.

In the sale, the Company received approximately

$ 14.6 million, and the Company may earn up to an additional $ 20 .0 million, in the aggregate, in the form of earn-out payments.

The earn-out payments are equal to 10 % of the actual revenue earned by Berkeley in each of the five years after the closing of the sale from sales of specified Orthobiologics products under the purchase agreement (including improvements, modifications, derivatives and enhancements related to those products).

There have been no earn-out payments made to date.

Additionally, the purchase agreement provides for a customary indemnity holdback in the amount of $ 1.5 million to be retained by Berkeley for 24 months after close.

There were no earn-out payments earned or paid in the years ended December 31, 2025 or 2024.

In the purchase agreement, the Company has retained the liabilities arising out of the VBM and FiberCel matters, as described in Note 17, both of which products were part of the Orthobiologics Business.

The Company recognized a gain of $ 6.0 million on the sale of the Orthobiologics Business during the year ended December 31, 2023 and an additional gain of $ 0.2 million during the year ended December 31, 2024 from an adjustment payment related to the final working capital received by Berkeley at the sale date.

The indemnity holdback is available as a source of recovery for Berkeley for claims of indemnification under the purchase agreement, and some or all of the holdback may be retained by Berkeley if Berkeley is successful in asserting a claim or claims for indemnification against the Company.

The Company is aware of certain indemnity-related claims raised, including a claim from a former supplier alleging breach of contract.

Based on the Company’s ongoing assessment of these claims, along with the remaining indemnity holdback of $ 1.5 million, the Company does not consider a loss to be probable or estimable as of December 31, 2024.

Should the Company receive incremental proceeds in the future through an earn-out payment or payment of the holdback amount, an additional gain will be recorded upon the receipt of such amounts.

See Note 4 for further discussion of the sale of the Orthobiologics Business and the presentation of such business as discontinued operations for the year ended December 31, 2023.

Unless indicated otherwise, the information in the notes to consolidated financial statements for the year ended December 31, 2023 relates to continuing operations.

The Company recognized a gain of $ 6.0 million on the sale of the Orthobiologics Business in the fourth quarter of 2023 and an additional gain of $ 0.2 million in the second quarter of 2024 from an adjustment payment related to the final working capital received by Berkeley at the sale date.

Additionally, the purchase agreement provided for a customary indemnity holdback in the amount of $ 1.5 million to be retained by Berkeley for 24 months after closing of the transaction.

The indemnity holdback was available as a source of recovery for Berkeley for claims of indemnification under the purchase agreement, and some or all of the holdback could be retained by Berkeley if Berkeley was successful in asserting a claim or claims for indemnification against the Company.

In March 2026, the indemnity holdback was resolved with Berkeley remitting $ 0.4 million to Elutia.

Such amount will be recognized as additional gain in the first quarter of 2026.

Should the Company receive incremental proceeds in the future through an earn-out payment, an additional gain will be recorded upon the receipt of such amounts.

Since inception, the Company has financed its operations primarily through amounts borrowed under its credit facilities, proceeds from its initial public offering (“IPO”), sales of its products and more recently, the sale of its Orthobiologics and CIED Businesses and proceeds from follow-on offerings and private placements of its common stock and warrants to purchase its common stock.

The Company’s historical cash outflows have primarily been associated with manufacturing and administrative costs, sales and marketing, research and development, clinical activity, purchase of property and equipment used in its production activities, litigation defense and settlement costs and investing in its commercial infrastructure.

For the year ended December 31, 2025, the Company incurred a loss from continuing operations of $ 15.9 million, and as of December 31, 2025, the Company had an accumulated deficit of $ 176.2 million.

In addition, during the year ended December 31, 2025, the Company used $ 44.8 million of cash in operating activities.

The Company expects to incur operating losses and negative cash flows from operations for the foreseeable future, as the Company advances its development and commercialization of NXT-41 and NXT-41x.

Because of the numerous risks and uncertainties associated with the Company’s development and commercialization efforts, the Company is unable to predict when it will become profitable, and it may never become profitable.

The future viability of the Company is dependent on its ability to generate cash flows from current or future product sales and/or raise additional capital to finance its operations.

The Company may seek to raise capital through the issuance of common stock or debt such as the offerings described in Note 14 or pursue asset sales or other transactions, such as the sale of the CIED and Orthobiologics Businesses described above.

However, such transactions may not be successful, and we may not be able to raise additional equity, refinance our debt instruments, sell assets or obtain waivers or amendments to our obligations on acceptable terms, or at all.

In accordance with Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are issued.

For the year ended

December 31, 2024, the Company incurred a net loss of $ 53.9 million, and as of December 31, 2024, the Company had an accumulated deficit of $ 229.6 million.

In addition, during the year ended December 31, 2024, the Company used $ 22.7 million of cash in operating activities and expects to continue to incur cash outflows in 2025.

Because of the numerous risks and uncertainties associated with the Company’s commercialization and development efforts, the Company is unable to predict when it will become profitable, and it may never become profitable.

The Company’s inability to achieve and then maintain profitability would negatively affect its business, financial condition, results of operations and cash flows.

Furthermore, even if the Company does achieve profitability, it may not be able to sustain or increase profitability on an ongoing basis, or, in general, be able to satisfy its obligations, including those related to the FiberCel Litigation and VBM Litigation described in Note 17, when they become due.

In order to mitigate the current and potential future liquidity issues caused by the matters noted above, we may seek to raise capital through the issuance of common stock or pursue asset sales or other transactions, such as the sale of the Orthobiologics Business described above.

However, such transactions may not be successful, and we may not be able to raise additional equity, refinance our debt instruments, or sell assets on acceptable terms, or at all.

As such, based on our current operating plans, we believe there is uncertainty as to whether our future cash flows along with our existing cash, issuances of additional equity and cash generated from expected future sales will be sufficient to meet our anticipated operating needs through twelve months from the consolidated financial statement issuance date.

Due to these factors, there is substantial doubt about our ability to continue as a going concern within one year after the issuance of the consolidated financial statements.

The accompanying consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

That is, the accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates continuity of operations, realization of assets, and satisfaction of liabilities in the ordinary course of business.

The Company believes that its existing cash and cash equivalents as of December 31, 2025, which include the proceeds from the sale of the CIED Business, will be sufficient to fund its operating expenses and capital expenditure requirements through at least one year after the issuance date of the consolidated financial statements.

If the Company is unable to obtain sufficient funding when needed and/or on acceptable terms, the Company may be required to significantly curtail, delay or discontinue its research and development programs, the manufacture of clinical and commercial supplies, product portfolio expansion, commercialization efforts and/or commercial operations, which could adversely affect its business prospects, or the Company may be unable to continue operations.

Reclassifications

A reclassification has been made to prior year amounts to conform to current year financial statement presentation and had no impact on previously reported results.

The reclassification relates to the separate presentation of the prior year loss on revaluation of warrant liability.

Such loss was formerly shown as a component of other (income) expense, net in the accompanying consolidated statements of operations.

T he Company has determined that its operating and reportable segments are consistent with its major product groupings which in prior periods included Device Protection, Women’s Health and Cardiovascular.

Segment results for the year ended December 31, 2024, have been recast to conform to the new segment presentation, which now excludes Device Protection due to its divestiture noted above.

Refer to the Segment Information in Note 18.

Use of Estimates

3 unchanged sentences

Actual results could differ from those estimates.

Net Loss per Share Attributable to Common Stockholders

Net Income (Loss) per Share

Our common stock has a dual class structure, consisting of Class A common stock, $ 0.001 par value per share (the “Class A common stock”) and Class B common stock, $ 0.001 par value per share (the “Class B common stock”).

1 unchanged sentence

The Company is also authorized to issue up to 10,000,000 shares of preferred stock with a par value of $ .001 .

No shares have been issued or are outstanding as of December 31, 2024 and December 31, 2023.

Basic net income per share is computed by dividing net income available to each class of shares by the weighted-average number of shares of common stock and participating securities outstanding during the period.

No shares have been issued or are outstanding as of December 31, 2025 and 2024.

During the year ended December 31, 2025, all outstanding shares of Class B common stock were converted to Class A common stock.

Consequently, as of December 31, 2025, there are no shares of Class B common stock outstanding.

Basic net income (loss) per share is computed by dividing net loss available to each class of shares by the weighted-average number of shares of common stock and participating securities outstanding during the period.

Participating securities include common and prefunded warrants.

Net loss is not allocated to participating securities as they do not have

an obligation to fund losses.

For purposes of the diluted net income per share attributable to common stockholders calculation, stock options, restricted stock units (“RSUs”) and warrants are considered to be common stock equivalents.

See Note 16 for further discussion of net loss per share attributable to common stockholders.

For purposes of the diluted net income (loss) per share calculation, stock options, restricted stock units (“RSUs”) and warrants are considered to be common stock equivalents.

In applying the two-class method, the Company has elected an accounting policy to determine whether undistributed earnings are allocated to participating securities by analogy to the ‘control number’ concept in ASC 260.

Accordingly, the Company evaluates income (loss) from continuing operations to determine whether participating securities are allocated earnings.

Participating securities are not allocated losses as they are not contractually obligated to share in losses.

This policy is applied consistently from period to period.

See Note 16 for further discussion of net income (loss) per share attributable to common stockholders.

Fair Value of Financial Instruments

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The Company's allowance for doubtful accounts was approximately $ 0.5 million and $ 0.6 million as of December 31, 2025 and 2024, respectively.

Inventory, consisting of purchased materials, direct labor and manufacturing overhead, is stated at the lower of cost or net realizable value, with cost determined generally using the average cost method.

Inventory, consisting of primarily purchased materials, is stated at the lower of cost or net realizable value, with cost determined generally using the average cost method.

At each balance sheet date, the Company also evaluates inventory for excess quantities, obsolescence or shelf-life expiration.

This evaluation includes an analysis of the Company’s current and future strategic plans, historical sales levels by product, projections of future demand, the risk of technological or competitive obsolescence for products, general market conditions and a review of the

shelf-life expiration dates for products.

To the extent that management determines there is excess or obsolete inventory or quantities with a shelf life that is too near its expiration for the Company to reasonably expect that it can sell those products prior to their expiration, the Company adjusts the carrying value to the estimated net realizable value.

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The Company determines if an arrangement contains a lease at inception.

Right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from that lease.

For leases with a term greater than 12 months, ROU assets and liabilities are recognized at the lease commencement date based on the estimated present value of lease payments over the lease term.

For leases with a term of greater than 12 months, ROU assets and liabilities are recognized at the lease commencement date based on the estimated present value of lease payments over the lease term.

The lease term includes the option to extend the lease when it is reasonably certain the Company will exercise that option.

When available, the Company uses the rate implicit in the lease to discount lease payments to present value.

In the case the implicit rate is not available, the Company uses its incremental borrowing rate based on information available at the lease commencement date, including publicly available data for instruments with similar characteristics, to determine the present value of lease payments.

In the case that the implicit rate is not available, the Company uses its incremental borrowing rate based on information available at the lease commencement date, including publicly available data for instruments with similar characteristics, to determine the present value of lease payments.

The Company combines lease and non-lease elements for office leases.

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Changes in assumptions or market conditions could result in a change in estimated future cash flows and could result in a lower fair value and therefore an impairment, which could impact reported results.

There were no impairment losses for the years ended December 31, 2024 and 2023.

There were no impairment losses in the years ended December 31, 2025 and 2024.

Warrant Liability

The Company accounts for its warrants in accordance with ASC 815, Derivatives and Hedging – Contracts in Entity's Own Equity , as either liabilities or as equity instruments depending on the specific terms of the warrant agreement.

The warrants issued in connection with the September 2023 private placement and June 2024 registered direct offering (see Note 14) are classified as liabilities and are recorded at fair value.

The warrants are subject to re-measurement at each

settlement date and at each balance sheet date and any change in fair value is recognized in other (income) expense, net in the consolidated statements of operations.

The Company estimates the fair value of the warrant liability using a Black-Scholes pricing model.

We are required to make assumptions and estimates in determining an appropriate term, risk-free interest rate, volatility factor, dividend yield, and the fair value of common stock.

Any significant adjustments to the unobservable inputs would have a direct impact on the fair value of the warrant liability.

The warrants issued in connection with the September 2023 private placement and June 2024 registered direct offering and February 2025 registered direct offering (see Note 14) are classified as liabilities and are recorded at fair value.

The warrants are subject to re-measurement at each settlement date and at each balance sheet date and any change in fair value is recognized in (Gain) loss on revaluation of warrant liability in the accompanying consolidated statements of operations.

Revenue Recognition

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(1) identify the contracts with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when (or as) the entity satisfies a performance obligation.

As noted above, the Company enters into contracts to primarily sell and distribute products to healthcare providers or commercial partners.

As noted above, the Company enters into contracts to primarily sell and distribute products to healthcare providers.

Revenue is recognized when the Company has met its performance obligations pursuant to its contracts with its customers in an amount that the Company expects to be entitled to in exchange for the transfer of control of the products to the Company’s customers.

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The Company elected to account for shipping and handling activities as a fulfillment cost rather than a separate performance obligation.

Amounts billed to customers for shipping and handling are included as part of the transaction price and recognized as revenue when control of the underlying products is transferred to the customer.

Amounts billed to customers for shipping and handling are included as part of the transaction

price and recognized as revenue when control of the underlying products is transferred to the customer.

The related shipping and freight charges incurred by the Company are included in sales and marketing costs.

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The Company’s cash balances with the individual institutions may at times exceed the federally insured limits.

During the year ended December 31, 2024, there was one customer that represented 15 % of the Company’s net sales in such year, and during the year ended December 31, 2023, there was one customer that represented 10 % of the Company’s sales in such year.

During the year ended December 31, 2025, there was one customer that represented 18 % of the Company’s net sales in such year, and during the year ended December 31, 2024, there were two customers that represented 13 % and 10 %, respectively of the Company’s sales in such year.

There was one customer that represented 13 % of the Company’s accounts receivable as of December 31, 2025, and there was one customer that represented 14 % of the Company’s accounts receivable as of December 31, 2024.

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Comprehensive income (loss) comprises net income (loss) and other changes in equity that are excluded from net income (loss).

For the years ended December 31, 2024 and 2023, the Company’s net loss equaled its comprehensive loss and accordingly, no additional disclosure is presented.

For the years ended December 31, 2025 and 2024, the Company’s net income or loss equaled its comprehensive income or loss and accordingly, no additional disclosure is presented.

The Company uses the asset and liability method of accounting for income taxes.

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The Company is subject to income taxes in the federal and state jurisdictions.

Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment to apply.

Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment to

In accordance with the authoritative guidance on accounting for uncertainty in income taxes, the Company recognizes tax liabilities for uncertain tax positions when it is more likely than not that a tax position will not be sustained upon examination and settlement with various taxing authorities.

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Recently Issued Accounting Standards

In November 2023, the FASB issued ASU No.

2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures.

This update improves reportable segment disclosure requirements, primarily through enhanced disclosures of significant segment expenses.

The amendments in this update should be applied retrospectively to all prior periods presented in the consolidated financial statements and are effective for fiscal years beginning after December 31, 2023 and interim periods within fiscal years beginning after December 31, 2024.

The adoption of this standard did not have a material impact on the Company’s consolidated financial statements;

however, the Company has expanded its disclosures in Note 18, Segment Information.

In December 2023, the FASB issued ASU No.

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The amendments in this update should be applied prospectively with the option to apply retrospectively and are effective for fiscal years beginning after December 15, 2024.

Early adoption is permitted.

The Company does not expect the adoption of this guidance to have any material effects on its financial condition, results of

operations or cash flows.

The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2023-09.

The prospective adoption of this guidance by the Company in the year ended December 31, 2025 did not have a material effect on its financial condition, results of operations or cash flows.

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Topic 220-40).

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The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2024-03.

Sale of Orthobiologics Business

As described in Note 2, on November 8, 2023, the Company completed the sale of its Orthobiologics Business.

Accordingly, the Orthobiologics Business is reported as discontinued operations in accordance with ASC 205-20 - Discontinued Operations and the amounts for the years ended December 31, 2023 have been recast to conform to this discontinued operations presentation.

Divestiture of CIED Business

As described in Note 2, on October 1, 2025, the Company completed the sale of its CIED Business and the CIED Business met the criteria for reporting as discontinued operations in accordance with ASC 205-20 - Discontinued Operations .

The related assets and liabilities of the CIED Business are classified as assets and liabilities of discontinued operations as of December 31, 2024 in the consolidated balance sheets and the results of operations from the CIED Business are reported as discontinued operations in the consolidated statements of operations for the years ended December 31, 2025 and 2024.

Applicable amounts in the prior year have been recast to conform to this discontinued operations presentation.

The following tables shows the assets and liabilities of the discontinued operations as of December 31, 2024:

Carrying amounts of the major classes of assets included in discontinued operations:

Total current assets

Property and equipment, net

Intangible assets, net

Operating lease right-of-use assets and other

Total non-current assets

Total assets of discontinued operations

Carrying amounts of the major classes of liabilities included in discontinued operations:

Current operating lease liabilities

Total current liabilities

Long-term operating lease liabilities

Total liabilities of discontinued operations

In accordance with ASC 205-20, only expenses specifically identifiable and related to a business to be disposed may be presented in discontinued operations.

The following table shows the financial results of the discontinued operations from January 1, 2023 through the transaction closing date of November 8, 2023.

Additionally, a gain of $ 0.2 million was recognized during the year ended December 31, 2024 related to the final working capital adjustment received from Berkeley.

The following table shows the financial results of the discontinued operations for the years ended December 31, 2025 and 2024, with the year ended December 31, 2025 including the financial results from January 1, 2025 through the transaction closing date of October 1, 2025.

Cost of goods sold

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Interest expense

Net income (loss)

Total operating and investing cash flows of discontinued operations from January 1, 2023 through the transaction closing date of November 8, 2023 are comprised of the following:

Gain on sale of CIED Business

Tax impact of gain on sale of CIED Business

Income (loss) from discontinued operations

Total operating and investing cash flows of discontinued operations for the years ended December 31, 2025 and 2024 are comprised of the following, with the year ended December 31, 2025 including the cash flows from January 1, 2025 through the transaction closing date of October 1, 2025:

Significant operating non-cash reconciliation items:

Depreciation and amortization

Stock-based compensation

Changes in operating assets and liabilities:

Accounts receivable

Prepaid expenses and other

Accounts payable and accrued expenses and other current liabilities

Obligations to tissue suppliers

Operating lease right-of-use

Operating lease liabilities

Significant investing items:

Expenditures for property, plant and equipment

Expenditures for property and equipment

Stock-Based Compensation

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As of December 31, 2025, the Company had 1,597,158 shares of Class A common stock available for issuance under the 2020 Plan, and on January 1, 2026, the shares available for issuance were increased by 1,711,394 pursuant to the automatic increase provisions of the plan.

In March 2026, the Company established the Elutia Inc.

2026 Inducement Award Plan (the “Inducement Plan”) to attract, retain and motivate persons who are expected to make important contributions to the Company.

Shares of Class A common stock totaling 2,000,000 are reserved for issuance pursuant to the Inducement Plan.

Stock Options

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The weighted average grant date fair value of options granted during the years ended December 31, 2025 and 2024 were $ 1.13 and $ 2.38 , respectively.

The total intrinsic value of options exercised was not material for both the years ended December 31, 2024 and 2023.

The total intrinsic value of options exercised during the year ended December 31, 2024 was not material.

The Company uses the Black-Scholes model to value its stock option grants that vest based on the passage of time or the achievement of certain performance criteria and expenses the related compensation cost using the straight-line method over the vesting period.

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In January 2024, the Company granted 390,625 options that vested on a defined date following the U.S.

Food and Drug Administration’s (“FDA”) clearance of the Company’s EluPro product (referred to as CanGarooRM during development) product.

With the FDA’s approval of EluPro in June 2024, such vesting occurred in August 2024.

Food and Drug Administration’s (“FDA”) clearance of EluPro.

With the FDA’s clearance of EluPro in June 2024, such vesting occurred in August 2024.

Consistent with the above, these performance vesting options were valued using the Black-Scholes model.

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Restricted stock units (“RSUs”) represent rights to receive common shares at a future date.

There is no exercise price and no monetary payment is required for receipt of restricted stock units or the shares issued in settlement of the award.

There is no exercise price and no monetary payment is required for receipt of RSUs or the shares issued in settlement of the award.

A summary of the RSU activity under the Company’s 2020 Plan for the year ended December 31, 2025 is as follows:

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Unvested, December 31, 2024

( 1,129,748 )

Unvested, December 31, 2025

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As of December 31, 2025, $ 1.6 million of unrecognized compensation costs related to RSUs is expected to be recognized over a weighted average period of 1.1 years.

During the year ended December 31, 2024, the Company granted 554,375 RSUs that vested on a defined date following the FDA’s clearance of the Company’s EluPro product.

With the FDA’s approval of EluPro in June 2024, such vesting occurred in August 2024.

During the year ended December 31, 2024, the Company granted 554,375 RSUs that vested on a defined date following the FDA’s clearance of EluPro.

With the FDA’s clearance of EluPro in June 2024, such vesting occurred in August 2024.

These performance vesting RSUs were valued using the fair value of the Company’s Class A common stock on the date of grant.

The Company has also granted 162,500 RSUs that vest in equal installments upon the achievement of certain share price thresholds for twenty consecutive days of trading at each respective threshold.

For these RSUs, the Company accounted for the awards as market condition awards and used a Monte Carlo model to

determine the fair value of these RSUs as well as the expense recognition term of approximately three years using the graded vesting method.

For these RSUs, the Company accounted for the awards as market condition awards and used a Monte Carlo model to determine the fair value of these RSUs as well as the expense recognition term of approximately three years using the graded vesting method.

As of December 31, 2025, there were 252,394 RSUs outstanding that were market condition RSU awards.

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The number of shares reserved under the ESPP will automatically increase on the first day of each fiscal year through January 1, 2030, in an amount as set forth in the ESPP.

As of December 31, 2024, the total shares of Class A common stock authorized for issuance under the ESPP was 774,341 , of which 471,126 remained available for future issuance.

As of December 31, 2025, the total shares of Class A common stock authorized for

issuance under the ESPP was 1,126,448 , of which 763,965 remained available for future issuance.

During the year ended December 31, 2025, 59,268 shares of Class A common stock were issued under the ESPP.

Stock-Based Compensation Expense

Stock-based compensation expense recognized during the years ended December 31, 2024 and 2023 comprised of the following (in thousands):

Stock-based compensation expense recognized during the years ended December 31, 2025 and 2024 was comprised of the following (in thousands):

Sales and marketing

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Raw materials

Work in process

Finished goods

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Computer hardware and software

Assets under construction

accumulated depreciation and amortization

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Amounts included within cost of goods sold are not material.

As of December 31, 2024, the Company leases one production facility, one administrative and research facility and one administrative facility under non-cancelable operating lease arrangements that expire through October 2026.

As of December 31, 2025, the Company leases one administrative facility under a non-cancelable operating lease arrangement that expires in June 2028 and one administrative, research and production facility under a non-cancelable operating lease arrangement that expires in January 2036 with early termination options in May 2029 and May 2033.

The following is a summary of the Company’s ROU assets and operating lease liabilities as of December 31, 2025 and 2024 (in thousands):

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For the years ended December 31, 2025 and 2024, the Company recognized operating lease costs of approximately $ 0.5 million and $ 0.2 million, respectively.

Cash paid for amounts included in the measurement of operating lease liabilities are included in operating cash flows and were approximately $ 0.6 million for both the years ended December 31, 2024 and 2023.

Cash paid for amounts included in the measurement of operating lease liabilities are included in operating cash flows and were approximately $ 0.1 million and $ 0.2 million for the years ended December 31, 2025 and 2024, respectively.

The table below reconciles the Company’s future cash obligations to the operating lease liabilities recorded on the balance sheet as of December 31, 2025 (in thousands):

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Long-term operating lease liabilities

In March 2025, the Company signed a new lease for 26,598 square feet.

This new facility will be utilized for office, manufacturing and laboratory space.

The lease expires in January 2036 with early termination dates in 2029 and 2033.

Monthly lease payments (including allocation portions of property taxes, insurance and other landlord operating expenses) total approximately $ 75,000 with annual rent escalations of 3 %.

Rent is abated for the first 12 months of occupancy and is discounted at 50 % for months 18 through 24.

Intangible Assets

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A substantial portion of the assets acquired consisted of intangible assets related to the acquired products and customer relationships.

determined that the estimated acquisition-date fair values of the intangible assets related to acquired products and customer relationships were $ 29.3 million and $ 4.7 million, respectively.

The components of identified intangible assets as of December 31, 2025 and 2024 are as follows (in thousands):

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Amortization expense totaled approximately $ 1.1 million for each of the years ended December 31, 2025 and 2024, which is included in Cost of goods sold in the accompanying consolidated statements of operations.

Annual amortization expense is expected to be approximately $ 3.4 million during the years ended December 31, 2024 through 2026 and approximately $ 1.5 million during the year ended December 31, 2027.

Annual amortization expense is expected to be approximately $ 1.1 million during the year ending December 31, 2026 and approximately $ 0.4 million during the year ending December 31, 2027.

Long-Term Debt

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An initial draw of $ 21 million was made in August 2022, and an additional $ 4 million was made on December 14, 2022.

The SWK Loan Facility also allows for the establishment of a separate, new asset-based revolving loan facility of up to $ 8 million, which has not been entered into to date.

The SWK Loan Facility matures on August 10, 2027 and accrues interest, payable quarterly in arrears.

Principal amortization of the SWK Loan Facility, as amended in September 2024, starts in November 2025.

Principal payments during the amortization period will be limited based on revenue-based caps, although as of December 31, 2024, no such caps are applicable and quarterly principal payments will be in an amount equal to 5 % of the aggregate principal amount funded with the balance paid at maturity.

T he SWK Loan Facility also includes both revenue and liquidity covenants, restrictions as to payment of dividends, and is secured by all assets of the Company, subject to certain customary exceptions.

As of December 31, 2024, Elutia was in compliance with its financial covenants under the agreement governing the SWK Loan Facility (“SWK Loan Facility Agreement”).

All of the SWK Loan Facility borrowings take the form of Secured Overnight Financing Rate (“SOFR”) loans and bear interest at a rate per annum equal to the sum of an applicable margin of (i) 7.75 % and the “Term SOFR Rate” (based upon an interest period of 3 months), or (ii) if the Company has elected the PIK Interest option (as defined below), 3.75 % and the “Term SOFR Rate.” The Company may elect a portion of the interest due, to be paid in-kind at a rate per annum of 4.5 % (“PIK Interest”), and such election may be made until November 15, 2025.

The “Term SOFR Rate” is subject to a floor of 2.75 %.

The agreement governing the SWK Loan Facility also includes an exit fee equal to 6.5 % of the aggregate principal amount funded prior to termination plus $ 112,500 .

The SWK Loan Facility also allowed for the establishment of a separate, new asset-based revolving loan facility of up to $ 8 million, which was not entered into before termination of the SWK Loan Facility, as described below.

T he SWK Loan Facility also included both minimum revenue and liquidity covenants, restrictions as to payment of dividends, and was secured by all assets of the Company, subject to certain customary exceptions.

See below for discussion of an amendment to the minimum liquidity covenant in May 2025.

All of the SWK Loan Facility borrowings took the form of Secured Overnight Financing Rate (“ SOFR ”) loans and bore interest at a rate per annum equal to the sum of an applicable margin of (i) 7.75 % and the “Term SOFR Rate” (based upon an interest period of 3 months), or (ii) if the Company elected the PIK Interest option (as defined below), 3.75 % and the “Term SOFR Rate.” The Company could elect a portion of the interest due, to be paid in-kind at a rate per annum of 4.5 % (“PIK Interest”), and such election could be made until November 15, 2025.

The “Term SOFR Rate” was subject to a floor of 2.75 %.

The agreement governing the SWK Loan Facility also included an exit fee equal to 6.5 % of the aggregate principal amount funded prior to termination plus $ 112,500 .

The weighted average interest rate on the SWK Loan Facility was 12.5 % and 13.4 % for the years ended December 31, 2025 and 2024, respectively.

The Company elected the PIK interest option for all four quarters of both 2024 and 2023.

On August 10, 2022, the Company issued to SWK Funding LLC a warrant (“Class A Warrant”) to purchase, in the aggregate, up to 187,969 shares of Class A common stock of the Company, $ 0.001 par value per share at an exercise price of $ 6.65 per share.

The Class A Warrant is immediately exercisable for up to 187,969 shares of Class A common stock from time to time on or after the Closing Date.

The exercise price and number of shares of Class A common stock issuable upon exercise of the Class A Warrant are subject to adjustment in the event of stock dividends, stock splits and certain other events affecting the Class A common stock.

Unless earlier exercised or terminated in accordance with its terms, the Class A Warrant will expire on the seventh anniversary of the Closing Date.

Upon issuance, the Company valued the Class A Warrant at approximately $ 0.6 million using the Black-Scholes model.

The recognition of the Class A Warrant as well as deferred financing costs of approximately $ 0.5 million incurred in securing the SWK Loan Facility

served to reduce the recorded value of the associated debt.

The debt discount and deferred financing costs will be recognized as interest expense through the maturity of the loan.

The SWK Loan Facility Agreement requires certain mandatory prepayments, subject to certain exceptions, with:

On August 10, 2022 (the “Closing Date”), the Company issued to SWK Funding LLC a warrant (“SWK Warrant”) to purchase, in the aggregate, up to 187,969 shares of Class A common stock of the Company, $ 0.001 par value per share at an exercise price of $ 6.65 per share.

The SWK Warrant is immediately exercisable for up to 187,969 shares of Class A common stock from time to time on or after the Closing Date.

The exercise price and number of shares of Class A common stock issuable upon exercise of the SWK Warrant are subject to adjustment in the event of stock dividends, stock splits and certain other events affecting the SWK common stock.

Unless earlier exercised or terminated in accordance with its terms, the SWK Warrant will expire on the seventh anniversary of the Closing Date.

Upon issuance, the Company valued the SWK Warrant at approximately $ 0.6 million using the Black-Scholes model.

The recognition of the SWK Warrant as well as deferred financing costs of approximately $ 0.5 million incurred in securing the SWK Loan Facility served to reduce the recorded value of the associated debt.

The debt discount and deferred financing costs are recognized as interest expense through the maturity of the loan.

In May 2025, Elutia entered into a fourth amendment (the “Fourth Amendment”) to the SWK Loan Facility.

The Fourth Amendment, among other things:

(i) allowed for 100 % of the interest payment due in May 2025 to be paid as PIK Interest, (ii) removed mandatory repayment obligations related to non-ordinary course asset sales, (iii) allowed the Company to request that SWK advance a new term loan in the amount of up to $ 5.0 million, which advance will be in the sole and absolute discretion of SWK and (iv) fixed the amount of the minimum liquidity covenant to be $ 8.0 million.

In consideration for the Fourth Amendment, the Company agreed to issue SWK 50,000 shares of its Class A Common Stock in a private placement.

In August 2025, the Company entered into a fifth amendment (the “Fifth Amendment”) to the SWK Loan Facility, which, among other things, provided that the following amounts were capitalized into the unpaid principal balance of the SWK Loan Facility:

(i) all accrued and unpaid interest due and owing to the lenders on the payment date in August 2025, (ii) a $ 50,000 amendment fee agreed to by the Company on June 30, 2025, and (iii) a $ 10,000 amendment fee to be paid pursuant to the Fifth Amendment.

Prior to the May 2025 amendment described above, the SWK Loan Facility Agreement required certain mandatory prepayments, subject to certain exceptions, with:

(1) 100 % of any net casualty proceeds in excess of $ 250,000 and (2) for non-ordinary course asset sales, an amount equal to the difference between (x) the proportion of divested gross profit (as defined in the SWK Loan Facility Agreement) to the Company’s total gross profit (as defined in the SWK Loan Facility Agreement) multiplied by the outstanding loans under the SWK Loan Facility and (y) the difference between $ 1,000,000 and the aggregate sale proceeds of any assets previously sold during the fiscal year.

The closing of the divestiture of the Orthobiologics Business in November 2023 triggered the mandatory prepayment of $ 4.0 million.

The closing of the divestiture of the Orthobiologics Business in November 2023 triggered a mandatory prepayment of $ 4.0 million.

Of such amount, $ 2.0 million wa s paid shortly after closing of the divestiture in 2023 and the remainder was paid in February 2024 based on mutual agreement between the parties.

As noted above, the Company executed an amendment to the SWK Loan Facility in September 2024 which, among other items, served to defer the commencement of principal repayment from November 2024 to November 2025.

As of December 31, 2024, the contractual maturities of the long-term debt are as follows (in thousands):

Years ending December 31,

Debt Discount

Deferred Financing Costs

Exit Fee Liability

Current Portion

Long-term Debt

In addition to the above, the Company finances the annual premiums of certain insurance policies through short-term financing arrangements and includes the liabilities associated with such arrangements within accrued liabilities in accompanying consolidated balance sheets.

On October 1, 2025, in connection with and through the proceeds of the sale of the Company’s CIED Business described in Note 2, Elutia fully repaid the SWK Loan Facility as required by the terms of the loan agreement.

The outstanding principal, including the accrued exit fee, and accrued interest recognized as of this date totaled approximately $ 26.9 million.

The total payment by the Company to SWK in full satisfaction of the debt was $ 27.8 million, yielding a loss on early repayment of debt of $ 1.3 million (including the write-off of the unamortized debt discount and deferred financing costs of $ 0.4 million) which is recorded within Other expense (income), net in the accompanying statement of operations.

As of December 31, 2024, the Company’s long-term debt was comprised of SWK Loan Facility balance, net of unamortized discount and deferred financing fees of $ 23.9 million less the current portion of $ 1.3 million resulting from an amendment to the SWK Loan Facility in September 2024 which, among other items, served to defer the commencement of principal repayment from November 2024 to November 2025.

In addition to the above, in 2024, the Company financed the annual premiums of certain insurance policies through short-term financing arrangements and included the liabilities associated with such arrangements within accrued liabilities in accompanying consolidated balance sheet.

The fair value of all debt instruments, which is based on inputs considered to be Level 2 under the fair value hierarchy, approximates the respective carrying values as of December 31, 2025 and 2024.

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As part of the CorMatrix asset acquisition described in Note 9, the Company assumed a restructured, long-term obligation (the “Initial Revenue Interest Obligation”) to Ligand Pharmaceuticals (“Ligand”) with an estimated present value on the acquisition date of $ 27.7 million.

Subject to annual minimum payments of $ 2.75 million per year, the terms of the Initial Revenue Interest Obligation require Elutia to pay Ligand, 5 % of future sales of the products Elutia acquired from CorMatrix, including CanGaroo, ProxiCor, Tyke and VasCure, as well as products substantially similar to those products, such as EluPro.

Subject to annual minimum payments of $ 2.75 million per year, the terms of the Initial Revenue Interest Obligation required Elutia to pay Ligand 5 % of future sales of the products Elutia acquired from CorMatrix, including CanGaroo, ProxiCor, Tyke and VasCure, as well as products substantially similar to those products, such as EluPro.

Furthermore, a $ 5.0 million payment would be due to Ligand if cumulative sales of these products exceed $ 100 million and a second $ 5.0 million will be due if cumulative sales exceed $ 300 million or the assets related to CanGaroo and any substantially similar products undergo a change of control during the ten-year term of the agreement which expires on May 31, 2027.

On January 10, 2024, the Company entered into an amendment to the Revenue Interest Obligation (the “Amended Revenue Interest Obligation”).

In January 2024, the Company entered into an amendment to the Revenue Interest Obligation (the “Amended Revenue Interest Obligation”).

Pursuant to the Amended Revenue Interest Obligation, the parties modified and restructured the Revenue Interest Obligation by revising the annual minimum payments for 2024 and each subsequent fiscal year during the term of the agreement from $ 2.75 million to $ 4.4 million.

Such minimums are payable quarterly within 30 days after each quarter-end date.

Additionally, the Company made payments totaling $ 3.0 million ( 50 % paid in January 2024 and 50 % paid in April 2024) in satisfaction of all royalty obligations for the first three fiscal quarters of 2023 and made a payment in February 2024 of $ 1.1 million in satisfaction of the royalty obligations for the fourth quarter

Furthermore, as part of the Amended Revenue Interest Obligation, Ligand waived the Company’s obligation to make the $ 5.0 million milestone payment that became due to Ligand in the second quarter of 2023.

The Company has estimated the value of the Initial Revenue Interest Obligation as of December 31, 2024 and 2023, including contingent milestone payments and estimated sales-based payments, based on assumptions related to future sales of the acquired products.

Total payments to Ligand during the year ended December 31, 2024 were $ 7.4 million.

In May 2025, Elutia entered into a subscription agreement and further amendment to the Amended Revenue Interest Obligation with Ligand.

Through such amendment, $ 2.2 million in outstanding royalty obligations (royalty

obligations for the quarters ended December 31, 2024 and March 31, 2025) owed by Elutia to Ligand under the Amended Revenue Interest Obligation was satisfied by the issuance of 1,105,528 shares of Elutia’s Class A common stock to Ligand in a transaction registered with the Securities and Exchange Commission.

An additional cash payment to Ligand of $ 2.2 million was made in October 2025 in satisfaction of the royalty obligation for the quarters ended June 30, 2025 and September 30, 2025.

Moreover, also in October 2025, a further amendment to the Amended Revenue Interest Obligation was executed which eliminated the provision that a $ 5.0 million milestone payment would be due if cumulative sales exceed $ 300 million or the assets related to CanGaroo and any substantially similar products undergo a change of control.

The Company records the present value of the estimated total future payments under both the Revenue Interest Obligation and Amended Revenue Interest Obligation as a long-term obligation, with the short-term portion being recorded as described below.

At each reporting period, the value of the Revenue Interest Obligation is re-measured based on current estimates of future payments, with changes to be recorded in the consolidated statements of operations using the catch-up method.

The Amended Revenue Interest Obligation changed the timing and extent of future payments by the Company to Ligand and such change to the estimated future payments yielded a reduction to the total obligation of approximately $ 1.4 million during the year ended December 31, 2024.

The resulting gain was recognized as other income in the accompanying consolidated statement of operations.

There was no change to estimated future payments during the year ended December 31, 2023, and thus, no re-measurement gain or loss was recognized.

As of December 31, 2024, the short-term portion of the Amended Revenue Interest Obligation is comprised of the newly established annual minimum payments of $ 4.4 million.

As of December 31, 2023, the short-term portion of the Initial Revenue Interest Obligation is comprised of (i) the 2023 and 2024 minimum payments, (ii) the first $ 5.0 million sales milestone payment noted above and (iii) the unpaid portion of the 2022 minimum payments.

The resulting gain was recognized as Other expense (income), net in the accompanying consolidated statement of operations.

During the second quarter of 2025, the Company identified and corrected an accounting error related to the January 2024 amendment of the Revenue Interest Obligation.

The Company inappropriately accounted for it under the catch-up method and recognized a gain instead of accounting for it as a modification.

As a result, the Company recorded a gain of $ 1.4 million recognized in the first quarter of 2024 and overstated interest expense in the subsequent periods.

The Company has determined that the error was not material to the current or any of the prior periods.

However, as of the second quarter of 2025, the revenue interest obligation was understated by $ 0.8 million.

As such, the Company corrected this as an out of period adjustment in June 2025 through a $ 1.4 million increase in Other expense (income), net to reverse the original gain and a reduction of $ 0.6 million in Interest (income) expense, net to reverse the overstatement of interest expense.

The out of period correction is not material to the consolidated financial statements.

As of December 31, 2025 and 2024, the short-term portion of the Amended Revenue Interest Obligation is comprised of the annual minimum payments of $ 4.4 million.

Fair Value Measurements

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Money market fund

Revenue Interest Obligation*

Warrant liability

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Money market fund

Revenue Interest Obligation*

Warrant liability

*Net Present Value;

see discussion of value below

The warrant liability in the table above consisted of the fair value of Common Warrants, 2023 Prefunded Warrants and 2024 Prefunded Warrants (as defined in Note 14 below) to purchase the Company’s Class A Common Stock and, with respect to the Common Warrants, was based on significant inputs not observable on the market, which represents a Level 3 measurement within the fair value hierarchy.

The warrant liability in the tables above consists of the fair value of 2025 Prefunded Warrants, 2024 Prefunded Warrants and 2023 Prefunded Warrants (as defined in Note 14 below) to purchase the Company’s Class A Common Stock.

The prior year warrant liability was updated to be presented as a level 2 measurement as there was an observable input in determining its fair value.

See Note 14 for discussion of the Company’s valuation methods and related impacts on the consolidated statement of operations relative to the warrant liability.

See Note 11 for discussion of the fair valuation of the Company’s Revenue Interest Obligation.

The following table provides a rollforward of the aggregate fair value of the Revenue Interest Obligation categorized with a Level 3 input for the years ended December 31, 2024 and 2023 (in thousands):

The following table provides a rollforward of the Revenue Interest Obligation categorized with Level 3 inputs for the years ended December 31, 2025 and 2024 (in thousands):

Revenue Interest Obligation

Balance, January 1, 2024

Payments on Revenue Interest Obligation

Interest accrued to Revenue Interest Obligation

Gain on revaluation of Revenue Interest Obligation

Balance, December 31, 2024

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Interest accrued to Revenue Interest Obligation

Gain on revaluation of revenue interest obligation

Loss on revaluation of Revenue Interest Obligation

Balance, December 31, 2025

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Deferred income tax assets and liabilities are calculated based on the difference between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases using the enacted income tax rates expected to be in effect during the years in which the temporary differences are expected to reverse.

The Company has elected to prospectively adopt the guidance in ASU No.

2023-09 (see Note 3).

The reconciliation of the U.S.

federal statutory rate to the consolidated effective tax rate is as follows:

Years Ended December 31,

federal statutory rate to the consolidated effective tax rate for continuing operations as of December 31, 2025 is as follows:

Tax benefit at U.S.

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Nondeductible expenses:

Revaluation of warrant liability

Excess tax deficiency from stock-based compensation

Change in valuation allowance

Effective tax rate

*For the year ended December 31, 2025, the states of Alabama and Tennessee comprised greater than 50% of the state income tax benefit in this category.

The reconciliation of the U.S.

federal statutory rate to the consolidated effective tax rate as of December 31, 2024 is as follows:

Tax benefit at U.S.

statutory rate

State income tax benefit, net of federal benefit

Nondeductible expenses

State law changes

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Effective tax rate

Deferred income taxes reflect the net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes as well as net operating loss

carryforwards.

As of December 31, 2024 and 2023, significant components of the Company’s net deferred income taxes are as follows (in thousands):

The significant components of the Company’s net deferred income taxes are as follows (in thousands):

Deferred tax assets:

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Net deferred tax asset, net of valuation allowance

The Company did not recognize any deferred benefit for income taxes for the years ended December 31, 2024 and 2023, as the increases to the respective net deferred tax assets of $ 8.4 million and $ 7.1 million, respectively, were offset by corresponding increases to the Company’s deferred tax asset valuation allowance due to the uncertainty of realizing the deferred tax assets.

During the year ended December 31, 2025, the Company realized the value of deferred tax assets totaling $ 9.6 million and the corresponding valuation allowance was reversed in connection with its taxable income generated from the gain on sale of its CIED Business.

The Company did not recognize any deferred benefit for income taxes for the years ended December 31, 2024 as the increases to the net deferred tax asset of $ 8.4 million was offset by corresponding increases to the Company’s deferred tax asset valuation allowance due to the uncertainty of realizing the deferred tax assets.

The Company evaluates the need for deferred tax asset valuation allowances based on a more likely than not standard.

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The income tax expense for the years ended December 31, 2025 and 2024 relates to current amounts due on certain state tax obligations.

As of December 31, 2024, the Company had net operating loss carryforwards for federal income tax purposes of approximately $ 129.3 million, comprised of $ 17.7 million that will expire beginning in 2036 and $ 111.6 million that have no expiration date.

Furthermore, state taxes totaling $ 0.2 million related to the gain on sale of the CIED Business is recorded within Income (loss) from Discontinued Operations in the accompanying consolidated statements of operations.

During the year ended December 31, 2025, the Company’s income taxes paid (net of refunds received) was not material.

As of December 31, 2025, the Company had remaining net operating loss carryforwards for federal income tax purposes of approximately $ 118.6 million, comprised of $ 6.6 million that will expire beginning in 2038 and 112.0 million that have no expiration date.

The Company also had state net operating loss carryforwards of approximately $ 42.4 million that will expire beginning in 2031.

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These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income.

The Company has not conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control since inception due to the significant

complexity and cost associated with such a study.

If the Company has experienced a change of control, as defined by Section 382, at any time since inception, utilization of the net operating loss carryforwards would be subject to an annual limitation under Section 382.

If the Company has experiences a change of control, as defined by Section 382, utilization of the net operating loss carryforwards would be subject to an annual limitation under Section 382.

Any limitation may result in the expiration of a portion of the net operating loss carryforwards before utilization.

In July 2025, the One Big Beautiful Bill Act (OBBBA) was enacted into law.

The OBBBA amends U.S.

tax laws, including provisions related to bonus depreciation and deductions for research and development expenses.

The OBBBA accelerated the deductibility of the Company’s previously capitalized research and development expenses..

As of December 31, 2025 and 2024, the Company had no unrecognized tax benefits.

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Registered Direct Offerings of Common Stock and Warrants

On June 16, 2024, the Company sold, in a registered direct offering (“2024 Registered Offering”) an aggregate of (i) 3,175,000 shares of the Company’s Class A common stock and (ii) prefunded warrants (“2024 Prefunded Warrants”) to purchase up to an aggregate of 725,000 shares of Class A Common Stock.

On February 4, 2025, the Company sold, in a registered direct offering (“2025 Registered Offering”), an aggregate of (i) 5,520,000 shares of our Class A common stock and (ii) prefunded warrants (“2025 Prefunded Warrants”) to purchase up to an aggregate of 480,000 shares of Class A Common Stock.

The public offering price for each share of Class A Common Stock was $ 2.50 , and the public offering price for each 2025 Prefunded Warrant was $ 2.499 , for aggregate gross proceeds of approximately $ 15.0 million, before deducting offering expenses.

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The Company incurred transaction fees, including commissions and legal fees, of approximately $ 1.3 million in connection with the 2025 Registered Offering, of which $ 1.2 million were allocated to the issuance of the common stock.

Subsequent to December 31, 2024, on February 4, 2025, the Company sold, in a registered direct offering (“2025 Registered Offering”) an aggregate of (i) 5,520,000 shares of our Class A common stock and (ii) prefunded warrants (“2025 Prefunded Warrants”) to purchase up to an aggregate of 480,000 shares of Class A Common Stock.

The public offering price for each share of Class A Common Stock was $ 3.40 , and the public offering price for each 2024 Prefunded Warrant was $ 3.399 , for aggregate gross proceeds of approximately $ 13.3 million, before deducting offering expenses.

The 2024 Prefunded Warrants have an exercise price of $ 0.001 per share of Class A Common Stock, are exercisable immediately and will expire when exercised in full.

The Company incurred transaction fees, including commissions and legal fees, of approximately $ 1.4 million in connection with the 2024 Registered Offering, of which $ 1.1 million were allocated to the issuance of the common stock.

Private Placement of Common Stock and Warrants

On September 21, 2023, the Company sold, in a private offering (“Private Offering”) an aggregate of (i) 6,852,811 units (“Common Units”) each comprised of (a) one share of the Company’s Class A common stock and (b) a warrant (“Common Warrant”) to purchase one and one half shares of Class A Common Stock, and (ii) 503,058 units (the “Prefunded Units”), each comprised of (a) a prefunded warrant (“2023 Prefunded Warrant”) to purchase one share of Class A Common Stock, and (b) a Common Warrant.

(“Common Warrant”) to purchase one and one half shares of Class A Common Stock, and (ii) 503,058 units (the “Prefunded Units”), each comprised of (a) a prefunded warrant (“2023 Prefunded Warrant”) to purchase one share of Class A Common Stock, and (b) a Common Warrant.

The Common Units were sold at a purchase price of $ 1.4275 per unit, and the Prefunded Units were sold at a purchase price of $ 1.4265 per unit, for aggregate gross proceeds of approximately $ 10.5 million, before deducting offering expenses.

Each Common Warrant was exercisable until July 31, 2024, the date which was 30 trading days after the clearance by the FDA of the Company’s EluPro product, at an exercise price per share of $ 1.4275 .

Each Common Warrant was exercisable until July 31, 2024, the date which was 30 trading days after the clearance by the FDA of EluPro, at an exercise price per share of $ 1.4275 .

As discussed below, all Common Warrants were exercised before they expired.

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The Company incurred transaction fees, including commissions and legal fees, of approximately $ 1.1 million in connection with the Private Offering, of which $ 0.4 million were allocated to the issuance of the common stock.

See below for discussion of the accounting for the warrants and the allocation of the remainder of the transaction fees from both the 2024 Registered Offering and Private Offering.

See below for discussion of the accounting for the warrants and the allocation of the remainder of the transaction fees from the 2025 Registered Offering, 2024 Registered Offering and Private Offering.

Warrant Liabilities

The Company has concluded that the 2024 Prefunded Warrants from the Registered Offering and the Common Warrants and the 2023 Prefunded Warrants from the Private Offering do not meet the equity contract scope exception under ASC 815-40 as in the event of a (i) fundamental transaction such as a merger and (ii) failure to timely deliver warrant

shares upon exercise, certain provisions of which may require the Company to adjust the settlement value in a manner that is not consistent with a fixed-for-fixed option pricing model.

As a result, with respect to the 2024 Prefunded Warrants, the Company allocated $ 2.5 million of the gross proceeds from the Registered Offering to such warrants based on their fair value.

Similarly, with respect to the Common Warrants and 2023 Prefunded Warrants, the Company allocated $ 8.6 million of the gross proceeds from the Private Offering to such warrants based on their fair value.

Additionally, the Company allocated a portion of the transaction fees from both the Registered Offering and the Private Offering to the respective warrants and recognized the expense within other (income) expense, net.

Such expenses totaled $ 0.3 million during the year ended December 31, 2024, and $ 0.8 million during the year ended December 31, 2023.

The Company has concluded that the 2025 Prefunded Warrants from the 2025 Registered Offering, the 2024 Prefunded Warrants from the 2024 Registered Offering and the Common Warrants and the 2023 Prefunded Warrants from the Private Offering do not meet the equity contract scope exception under ASC 815-40 as in the event of a (i) fundamental transaction such as a merger and (ii) failure to timely deliver warrant shares upon exercise, certain provisions of which may require the Company to adjust the settlement value in a manner that is not consistent with a fixed-for-fixed option pricing model.

As a result, the Company allocated a portion of the gross proceeds from the respective offerings to the related warrants based on their fair values and have recorded such amounts as a Warrant liability in the accompanying consolidated balance sheets as of December 31, 2025 and December 31, 2024.

Additionally, the Company allocated a portion of the transaction fees from the 2024 Registered Offering, 2025 Registered Offering and the Private Offering to the respective warrants and recognized the expense within Other expense (income), net.

Such expenses totaled $ 0.1 million and $ 0.3 million for the years ended December 31, 2025 and 2024, respectively.

As noted above, the last exercise date for the Common Warrants was July 31, 2024.

1 unchanged sentence

Certain of these exercises ultimately resulted in their conversion to 2023 Prefunded Warrants.

The liability associated with the 2024 Prefunded Warrants, Common Warrants and 2023 Prefunded Warrants is recorded as warrant liability in the accompanying consolidated balance sheet as of December 31, 2024 and December 31, 2023.

The liability associated with the 2025 Prefunded Warrants, 2024 Prefunded Warrants and 2023 Prefunded Warrants is recorded as Warrant liability in the accompanying consolidated balance sheet as of December 31, 2025 and December 31, 2024.

A summary of the warrant activity for the years ended December 31, 2025 and 2024, respectively is as follows:

2 unchanged sentences

2024 Prefunded Warrants

2025 Prefunded Warrants

Outstanding, January 1, 2024

Outstanding, December 31, 2023

Conversions of Common Warrants to 2023 Prefunded Warrants

2 unchanged sentences

Outstanding, December 31, 2024

The valuation of the warrants is adjusted to fair value (Level 3) at each subsequent balance sheet date until the warrants are settled.

Outstanding, December 31, 2025

The valuation of the warrants is adjusted to fair value at each subsequent balance sheet date until the warrants are settled.

The following table provides a rollforward of the aggregate fair value of the warrant liability for the years ended December 31, 2025 and 2024, respectively (in thousands):

2 unchanged sentences

2024 Prefunded Warrants

2025 Prefunded Warrants

Total Offering Warrants

2 unchanged sentences

Loss on revaluation of warrant liability

Conversions of Common Warrants to 2023 Prefunded Warrants

Warrant Liability, December 31, 2024

Fair value upon issuance

Loss on revaluation of warrant liability

Conversions of Common Warrants to 2023 Prefunded Warrants

Gain on revaluation of warrant liability

Warrant Liability, December 31, 2025

The fair value adjustments were driven mainly by changes in the Company’s stock price and have been recorded as loss on revaluation of warrant liability in the accompanying consolidated statements of operations for the years ended December 31, 2024 and 2023.

The Company calculated the fair value of the Common Warrants using the Black-Scholes option pricing model with the following inputs as of June 30, 2024 (the last reporting date prior to all remaining Common Warrant exercises in July 2024) and December 31, 2023:

June 30, 2024

December 31, 2023

The Company has used the price of its Class A Common Stock to estimate the fair value of the 2025 Prefunded Warrants, 2024 Prefunded Warrants and 2023 Prefunded Warrants at each measurement date.

The price of the Company’s Class A Common Stock approximates fair value of the 2025 Prefunded Warrants, 2024 Prefunded Warrants and 2023 Prefunded Warrants due to the exercise price per share of $ 0.001 .

As such warrants utilize quoted prices for the Company’s Class A common stock (similar assets in the active market), their fair valuation is deemed to be “Level 2” within the fair value hierarchy.

The fair value adjustments have been recorded as (Gain) loss on revaluation of warrant liability in the accompanying consolidated statements of operations.

The Company had previously calculated the fair value of the Common Warrants immediately before exercise using the Black-Scholes option pricing model with the following inputs as of September 30, 2024:

Common stock price

3 unchanged sentences

Dividend yield

The Company has used the price of its Class A Common Stock to estimate the fair value of the 2024 Prefunded Warrants and 2023 Prefunded Warrants at each measurement date.

The price of the Company’s Class A Common Stock approximates the fair value of the 2024 Prefunded Warrants and 2023 Prefunded Warrants due to the exercise price per share of $ 0.001 .

Retirement Plan

2 unchanged sentences

The Company matches employee contributions made to the plan according to a specified formula.

The Company’s matching contributions totaled approximately $ 0.1 million and $ 0.3 million for the years ended December 31, 2024 and 2023, respectively.

Net Loss Per Share

The Company’s matching contributions totaled approximately $ 0.1 million for both the years ended December 31, 2025 and 2024, respectively.

Matching contributions are a component of employee compensation.

Accrued employee compensation as of December 31, 2025 and 2024 totaled $ 2.4 million and $ 2.2 million, respectively and is included in Accrued Expenses in the accompanying consolidated balance sheets.

Net Income (Loss) Per Share

Net income (loss) per share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding during the period.

Diluted net income (loss) per share is computed by dividing net income (loss), adjusted for gains on the revaluation of warrant liability (see Note 14), by the weighted average number of shares of common stock outstanding during the period, adjusted for the potential dilutive effect of the Company’s prefunded warrants (see Note 14), outstanding stock options, outstanding RSUs, and shares issuable under the ESPP.

The treasury stock method was used to calculate the potential dilutive effect of these common stock equivalents.

(in thousands, except share and per share data)

Net loss from continuing operations

Net income from discontinued operations

Weighted average number of common shares - basic and diluted

Net loss per share from continuing operations attributable to common stockholders - basic and diluted

Net income per share from discontinued operations attributable to common stockholders - basic and diluted

Net loss per share - basic and diluted

The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be anti-dilutive.

Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same.

The Company excluded

the following potential common shares, presented based on amounts outstanding at period end, from the computation of diluted net loss per share attributable to common stockholders:

Income (loss) from discontinued operations

Net income (loss)

dilutive gain on revaluation of warrant liability

Net income (loss) for dilutive earnings per share

Weighted average number of common shares - basic

Effect of dilutive prefunded warrants

Weighted average number of common shares - diluted

Net loss from continuing operations per share - basic

Net loss from continuing operations per share - diluted

Net income (loss) from discontinued operations per share - basic

Net income (loss) from discontinued operations per share - diluted

Net income (loss) per share - basic

Net income (loss) per share - diluted

Certain of the Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be anti-dilutive.

The Company excluded the following potential common shares, presented based on amounts outstanding at period end, from the computation of diluted net loss per share attributable to common stockholders:

Options to purchase common stock

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Class A common stock warrants

Common Warrants

2023 Prefunded Warrants

2024 Prefunded Warrants

2025 Prefunded Warrants

Commitment and Contingencies

Cook Biotech License and Supply Agreements

Elutia has entered into a license agreement, as amended, with Cook Biotech (“Cook”), now owned by Evergen, for an exclusive, worldwide license to the porcine tissue for use in the Company’s Cardiac Patch and CanGaroo products, subject to certain co-exclusive rights retained by Cook (the “Cook License Agreement”).

The term of such license is through the date of the last to expire of the licensed Cook patents, which is anticipated to be July 2031.

In 2017, Elutia entered into a license agreement, as amended, with Cook Biotech (“Cook”), now owned by Evergen, for an exclusive, worldwide license to the porcine tissue for use in the Company’s Cardiovascular, CanGaroo and EluPro products, subject to certain co-exclusive rights retained by Cook.

Along with this license agreement, Elutia entered into a supply agreement whereby Cook would be the exclusive supplier to Elutia of licensed porcine tissue.

On October 1, 2025, in connection with the sale of the CIED Business described in Note 2, the Company entered into amendments to both the license (the “Amended License Agreement”) and supply agreements such that the Amended License Agreement removed all products divested with the sale of the CIED Business and includes only the Company’s remaining Cardiovascular products.

Both agreements expire on December 31, 2028.

Under certain limited circumstances, Elutia has the right to manufacture the licensed product and pay Cook a royalty of 3 % of sales of the Elutia-manufactured tissue.

The supply agreement expires on the same date as the related license agreement.

No royalties were paid or due to be paid to Cook during the years ended December 31, 2024 or 2023.

The Cook License Agreement also provides for a worldwide exclusive license to the porcine tissue for use with neuromodulation devices in addition to cardiovascular devices and includes license fee payments of $ 0.1 million per year in each of the years 2021 through 2026.

Such license payments would accelerate if a change in control, as defined in the Cook License Agreement, occurs within Elutia.

The Company, in its sole discretion, can terminate the Cook License Agreement at any time.

No royalties were due or paid to Cook during the year ended December 31, 2025 or 2024.

The Amended License

Agreement includes a final license fee payment of $ 0.1 million to be paid by the Company in October 2026.

The Company, in its sole discretion, can terminate the Amended License Agreement at any time.

Legal Proceedings

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Since September 2021, 110 product liability lawsuits or claims have been filed or asserted against the Company involving FiberCel.

As of December 31, 2024, there were 66 active lawsuits or claims against the Company, including 23 lawsuits or claims where settlements have been reached but not yet been paid as of December 31, 2024.

The lawsuits, which have been filed against Elutia, certain Medtronic entities, and others, allege that the plaintiffs were exposed to and/or contracted tuberculosis and/or suffered substantial symptoms and complications following the implantation of FiberCel during orthopedic fusion operations.

Such lawsuits were filed in the Superior Court of Marion County, Indiana (collectively, the “Indiana State Complaints”);

the Superior Court of the State of Delaware (collectively, the “Delaware State Complaints”);

the Circuit Court of Maryland (collectively, the “Maryland State Complaints”);

the Court of Common Pleas of

Montgomery County, Ohio and the U.S.

District Court of the Southern District of Ohio (the “Ohio Complaints”);

District Court for the Western District and Eastern District of North Carolina (collectively, the “North Carolina Federal Complaints”);

the Circuit Court of Okaloosa County, Florida, and the U.S.

District Court for the Northern District and the Southern District of Florida (collectively, the “Florida Complaints”);

District Courts for the Eastern District of Michigan (collectively “Michigan Federal Complaints.”);

District Court for the District of Colorado (“Colorado Federal Complaint”);

District Court for the District of Oregon (“Oregon Federal Complaint”);

the Circuit Court of Fayette County, Kentucky and the U.S.

District Court for the Eastern District of Kentucky (collectively, “Kentucky Complaints.”);

District Court for the Western District of Louisiana (“Louisiana Federal Complaint”);the Circuit Court of Cook County, Illinois and the U.S.

District Court for the Northern District of Illinois (collectively, the “Illinois Complaints”);

District Court for the Eastern District of Pennsylvania (“Pennsylvania Federal Complaint);

District Court for the Eastern District of Virginia (“Virginia Federal Complaint”);

District Court for the Central District of California (“California Federal Complaint”);

District Court of Arizona (“Arizona Federal Complaint");

District Court for the Northern District of Georgia (“Georgia Federal Complaint”).

Plaintiffs in the Indiana State Complaints allege a cause of action under Indiana’s Product Liability Act, citing manufacturing defects, defective design and failure to properly warn and instruct, and several of the complaints allege loss of consortium.

As of December 31, 2025, five lawsuits or claims are active, 104 have been settled and one case where the statute of limitations to file a lawsuit has expired.

Of the 104 cases that have settled, 35 have not yet been fully paid due to one or more scheduled payments being made after December 31, 2025.

The unsettled lawsuits allege that the plaintiffs were exposed to and/or contracted tuberculosis and/or suffered substantial symptoms and complications following the implantation of FiberCel during orthopedic fusion operations.

Such remaining lawsuits were filed in the Superior Court of Marion County, Indiana (collectively, the “Indiana Complaints”) and the Court of Common Pleas, Philadelphia County (“Pennsylvania Complaint).

Plaintiffs in the Indiana Complaints allege a cause of action under Indiana’s Product Liability Act, citing manufacturing defects, defective design and failure to properly warn and instruct, and several of the complaints allege loss of consortium.

Plaintiffs in these actions assert that the defendants are strictly liable or have breached the duty of care owed to plaintiffs by failing to exercise reasonable care in designing, manufacturing, marketing and labeling FiberCel and seek various types of damages, including economic damages, non-economic damages and loss of consortium.

Plaintiffs in one of the Indiana State Complaints allege causes of action for product liability, negligence, breach of express and implied warranties, and punitive damages.

Each of the plaintiffs in the Delaware State Complaints alleges negligence, breach of implied warranty, breach of express warranty, medical monitoring, and punitive damages, and two also allege loss of consortium.

Plaintiffs in the Delaware State Complaints seek economic, consequential, and punitive damages.

The Maryland State Complaints assert claims of negligence, breach of implied warranty, breach of express warranty, medical monitoring, and loss of consortium.

The Florida Complaints contain three strict liability claims for defective design, defective manufacture, and failure to warn.

A claim for punitive damages is also pled.

The Ohio State Complaint alleges causes of action for product liability and negligence and seeks compensatory damages.

The Colorado Federal Complaint asserts causes of action for strict product liability, misrepresentation, negligence, breach of express warranty, and breach of implied warranty of merchantability.

The Michigan Federal Complaints assert causes of action for negligence, gross negligence breach of implied warranty, breach of express warranty, intentional infliction of emotional distress, and liability under the res ipsa loquitur doctrine.

The Michigan Federal Complaints seek compensatory damages and punitive damages.

The North Carolina Federal Complaints allege causes of action for negligence, defective design, breach of implied warranty, breach of express warranty, and loss of consortium, and seek both compensatory and punitive damages.

The Oregon Federal Complaint asserts strict liability claims for defective design, defective manufacture, and failure to warn, and seeks compensatory damages.

The Ohio Federal Complaint asserts strict liability claims for defective manufacturing, inadequate warning, nonconformance with representations, and also alleges loss of consortium and seeks compensatory damages.

The Kentucky Complaints assert strict liability claims based on manufacturing defect, design defect, failure to warn, negligence, breach of implied warranty, breach of express warranty, and seek recovery for medical monitoring, loss of consortium, compensatory damages, and punitive damages.

The Louisiana Federal Complaint asserts claims of violation of the Louisiana Products Liability Act, negligence and gross negligence, breach of implied warranty, and breach of express warranty and seeks recovery for medical monitoring.

The Illinois Complaints contain claims of strict liability, defective design and manufacturing, breach of express warranty, breach of implied warranty and negligence and seek compensatory damages.

The Pennsylvania Federal Complaint asserts claims for strict liability, negligence, breach of implied warranty, and breach of express warranty, as well as claims under the Wrongful Death Act and the Survival Act, and seeks compensatory and punitive damages.

The Virginia Federal Complaint asserts causes of action for negligent failure to warn, negligence, breach of implied warranty, and breach of express warranty and seeks recovery for medical monitoring, compensatory damages and punitive damages.

The California Federal Complaint advances claims of strict liability (defective design and manufacture), negligence and breach of implied warranty and seeks compensatory damages and recovery for medical monitoring.

The Arizona Federal Complaint asserts strict product liability claims for defective design, manufacture and failure to warn, negligence, breach of implied warranty and breach of express warranty and seeks recovery for medical monitoring, loss of consortium, compensatory damages, and punitive damages.

The Georgia Federal Complaint asserts causes of action for negligence, including negligent design, negligent failure to warn, negligent manufacturing, and negligent misrepresentation;

strict liability claims based on manufacturing defect, design defect, and

failure to warn;

breach of implied warranty of merchantability;

breach of implied warranty of fitness for a particular purpose;

breach of express warranty;

and loss of consortium and it seeks compensatory damages and punitive damages.

The Pennsylvania Complaint asserts claims for strict liability, negligence, breach of implied warranty, and breach of express warranty, as well as claims under the Wrongful Death Act and the Survival Act, and seeks compensatory and punitive damages.

The Company refers to the aforementioned litigation and claim notices collectively as the “FiberCel Litigation.”

5 unchanged sentences

Since August 2023, 28 product liability lawsuits or claims have been filed or asserted against the Company involving VBM.

As of December 31, 2024, there were 15 active lawsuits or claims against the Company, including three lawsuits or claims where settlements had been reached but not yet paid.

Furthermore, there is one claim where the statute of limitation to file a lawsuit has expired.

The lawsuits, which have been filed against Elutia and others, allege that the plaintiffs were exposed to and/or contracted tuberculosis and/or suffered substantial symptoms and complications following the implantation of VBM during orthopedic fusion operations.

To date, these lawsuits have been filed in California Superior Court (collectively, the “California State Complaints”), the United States District Court for the Southern District of California (the “California Federal Complaint”), the United States District Court for the Eastern District of Louisiana (collectively, the “Louisiana Federal Complaints”), and the United States District Court for the Western District of Texas (the “Texas Federal Complaint”).

Plaintiffs in the California State Complaints and California Federal Complaint assert that the defendants are strictly liable or have breached the duty of care owed to plaintiffs by failing to exercise reasonable care in designing, manufacturing, marketing, and labeling VBM and seek various types of damages, including economic damages, non-economic damages, and loss of consortium damages.

As of December 31, 2025, 11 lawsuits or claims are active, 16 have been settled and one case has been dismissed.

Of the settled cases, thirteen have been fully paid and three have not yet been paid as of December 31, 2025.

Furthermore, there are four potential claims where the statute of limitation to file a lawsuit has expired.

The unsettled lawsuits, which have been filed against Elutia and others, allege that the plaintiffs were exposed to and/or contracted tuberculosis and/or suffered substantial symptoms and complications following the implantation of VBM during orthopedic fusion operations.

To date, these lawsuits have been filed in California Superior Court

(collectively, the “California State Complaints”), the United States District Court for the Southern District of California (collectively, the “California Federal Complaints”), the United States District Court for the Eastern District of Louisiana (collectively, the “Louisiana Federal Complaint”), the United States District Court for the Western District of Texas (the “Texas Federal Complaint”), the United States District Court for the Western District of Michigan (the “Michigan Federal Complaint”), the Circuit Court of the State of Oregon (the “Oregon State Complaint”) and the United States District Court for the Southern District of New York (the “New York Complaint”).

Plaintiffs in the California State Complaints and California Federal Complaints assert that the defendants are strictly liable or have breached the duty of care owed to plaintiffs by failing to exercise reasonable care in designing, manufacturing, marketing, and labeling VBM and seek various types of damages, including economic damages, non-economic damages, and loss of consortium damages.

The Plaintiffs in one of the California State Complaints also assert claims for fraudulent inducement, misrepresentation, and intentional infliction of emotional distress.

Plaintiffs in the Louisiana Federal Complaints generally assert causes of action under the Louisiana Product Liability Act, citing design defects, manufacturing defects, and failure to properly warn, and several plaintiffs allege loss of consortium.

Plaintiffs in these actions also assert that defendants are strictly liable or have breached the duty of care owed to plaintiffs by failing to exercise reasonable care in designing, manufacturing, marketing and labeling VBM and seek economic damages, non-economic damages and loss of consortium.

Some plaintiffs in the Louisiana Federal Complaints also allege claims for breach of implied warranty and breach of express warranty, medical monitoring, and punitive damages.

Plaintiff in the Louisiana Federal Complaint asserts causes of action under the Louisiana Product Liability Act citing unreasonably dangerous construction or composition, unreasonably dangerous design, and inadequate warning.

Plaintiff in this action also alleges claims for breach of implied warranty, breach of express warranty, and negligence.

Plaintiffs in the Texas Federal Complaint assert violations of the Texas Business and Commerce Code, citing alleged breaches of the warranties of merchantability and fitness for a particular purpose.

Plaintiffs further assert that the defendants breached the duty of care owed to plaintiffs by failing to exercise reasonable care in designing, manufacturing, marketing, and labeling VBM and seek various types of damages, including economic damages, non-economic damages, exemplary damages, and loss of consortium damages.

Plaintiffs in the Oregon State Complaint assert causes of action for negligence, lack of informed consent, medical battery, and loss of consortium.

Plaintiffs in the Michigan Federal Complaint assert causes of action for negligence and gross negligence.

Plaintiffs in the New York Complaint assert causes of action for negligence, strict liability and breach of implied warranty.

The Company refers to the aforementioned litigation and claim notices collectively as the “VBM Litigation.”

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(“Medtronic”) in the Superior Court of the State of Delaware.

The Company’s complaint alleges breach of the 2019 Tissue Product Supply Agreement (the “Supply Agreement”) between the Company and Medtronic.

In particular, the complaint alleges that Medtronic did not honor its contractual obligations to obtain insurance coverage and to defend and indemnify the Company for over 100 lawsuits against the Company alleging claims arising from the use of FiberCel products distributed by Medtronic.

The Company’s operative complaint alleges breach of the 2019 Tissue Product Supply Agreement (the “Supply Agreement”) between the Company and Medtronic.

In particular, the complaint alleges that Medtronic did not honor its contractual obligations to defend and indemnify the Company for over 100 lawsuits against the Company alleging claims arising from the use of FiberCel products distributed by Medtronic and that Medtronic concealed and misrepresented an insurance policy potentially applicable to those FiberCel-related lawsuits.

The complaint does not specify the amount of damages owed by Medtronic for these breaches.

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The counterclaim does not specify the amount of any alleged damages.

On October 15, 2024,

Medtronic filed a motion to dismiss Elutia’s claims.

The court held a hearing on January 9, 2025, and has not yet issued a ruling on the motion to dismiss.

Given the early stages of this matter and the Company’s intention to vigorously defend this counterclaim, we do not consider a loss to be probable or estimable at this time.

On September 19, 2025, Medtronic filed a partial motion to dismiss some of the claims in Elutia’s current complaint.

Elutia filed an opposition to that motion, and Medtronic filed a reply brief.

The court set a hearing for the motion for February 20, 2026, and its decision on the partial motion to dismiss is expected after the hearing.

Discovery is ongoing in the case.

Given the early stages of this matter and the Company’s intention to vigorously defend Medtronic’s counterclaim, we do not consider a loss to be probable or estimable at this time.

Tiger Litigation

On October 21, 2025, Tiger Aesthetics Medical, LLC (“Tiger”) filed an action against Elutia in the Superior Court of the State of Delaware.

The Complaint alleges breach of contract and related claims related to the 2023 distribution agreement (the “Tiger Distribution Agreement”) between the Company and Tiger as well as the August 2025 letter of intent (the “Tiger LOI”) for the possible sale by the Company to Tiger of certain assets and rights.

The complaint does not specify the amount of any alleged damages.

On November 13, 2025, Elutia filed a motion to dismiss.

Tiger filed an opposition to that motion, and Elutia filed a reply brief.

A hearing on the Company’s motion to dismiss is scheduled for March 23, 2025.

Given the early stages of this matter and the Company’s intention to vigorously defend against Tiger’s

claims, Elutia does not consider a loss to be probable or estimable at this time.

Elutia terminated the Tiger Distribution Agreement effective October 25, 2025.

Additionally, the Tiger LOI expired on October 25, 2025.

Supplier Litigation

In October 2024, a former lab and safety equipment supplier filed a lawsuit in California Superior Court (Contra Costa County) against the Company and two co-defendants.

The complaint alleges breach of contract and related equitable claims based on a 2014 agreement that the supplier claims automatically renewed in 2023 for an 84-month term.

The lawsuit seeks specified damages.

On April 1, 2025, the Company filed an answer denying the allegations in the complaint and asserting affirmative defenses.

The court has set a trial for January 2027.

Given the early stages of this matter and the Company’s intention to vigorously defend the case, we do not consider a loss to be probable or estimable at this time.

Contingent Liability for Legal Proceedings

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Since August 2022, the Company has engaged in a process to negotiate and attempt to resolve many of the cases in the FiberCel Litigation.

In total, Elutia’s liability in 44 of the cases was settled for a total cash outlay of approximately $ 14.4 million.

For the remaining 66 cases, the Company estimated a probable loss related to each case and has recorded a liability at a total estimated amount of $ 15.9 million at December 31, 2024, which is recorded as Contingent Liability for Legal Proceedings in the accompanying consolidated balance sheets.

Such liability includes $ 8.2 million for which the settlements have been reached but have not yet been paid.

In total, through December 31, 2025, settlement agreements have been reached in 104 of the cases and full or partial settlement payments of $ 28.8 million have been made by Elutia, with $ 9.6 million of such total settlement outlays having been paid through insurance proceeds.

As of December 31, 2025, the Company has a total liability for FiberCel Litigation of $ 6.8 million which is recorded within Contingent Liability for Legal Proceedings in the accompanying consolidated balance sheets.

Such liability includes $ 5.8 million for 35 cases in which the settlements have been reached but had not yet been fully paid and $ 1.0 million for the five cases which have not yet been settled or adjudicated and for which the Company has estimated a probable loss for those cases as of December 31,2025.

In order to reasonably estimate the liability for the unsettled FiberCel Litigation cases, the Company, along with outside legal counsel, has assessed a variety of factors, including (i) the extent of the injuries incurred, (ii) recent experience on the settled claims, (iii) settlement offers made to the other parties to the litigation and (iv) any other factors that may have a material effect on the FiberCel Litigation.

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Since June 2023, the Company has also engaged in a process to negotiate and attempt to resolve many of the cases in the VBM Litigation.

In total, Elutia’s liability in nine of the cases has been settled for a total cash outlay of approximately $ 1.0 million.

For the remaining 26 cases, which includes unasserted claims that the Company believes are probable of assertion, the Company estimated a probable loss at an estimated amount of $ 4.5 million at December 31, 2024, which is recorded as Contingent Liability for Legal Proceedings in the accompanying consolidated balance sheets.

Such liability includes $ 0.5 million for which the settlements have been reached but have not yet been paid.

In total, through December 31, 2025, settlement agreements have been reached in 16 of the cases and settlement payments of $ 1.5 million have been made by Elutia, all of which has been paid through insurance proceeds.

As of December 31, 2025, the Company has a total liability for VBM Litigation of $ 4.4 million which is recorded within Contingent Liability for Legal Proceedings in the accompanying consolidated balance sheets.

Such liability includes $ 1.0 million for three cases in which settlements have been reached but had not yet been paid and the remaining 15 cases, including unasserted claims that the Company believes are probable of assertion, and for which an estimation of probable loss is required as of year-end.

The expense related to this estimate was recorded within Litigation costs, net in the accompanying consolidated statement of operations, with the entirety of such expense offset by insurance recoveries received or receivable as further described below.

In order to reasonably estimate the liability for the unsettled VBM Litigation cases and unasserted claims, the Company, along with outside legal counsel, has assessed a variety of factors, including (i) the extent of the injuries incurred, (ii) recent experience on the settled claims, (iii) settlement offers made to the other parties to the litigation and (iv) any other factors that may have a material effect on the VBM Litigation.

(iv) any other factors that may have a material effect on the VBM Litigation.

While the Company believes its estimated liability to be reasonable, the actual loss amounts are highly variable and are dependent upon the relevant facts and case-by-case resolutions.

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When settlements are reached and/or amounts are recorded in the related Contingent Liability for FiberCel Litigation, the Company calculates amounts due to be reimbursed pursuant to the terms of the coverage and related agreements, and pursuant to other indemnity or contribution claims, in respect of product liability losses and related defense costs.

The amounts probable of reimbursement or recovery from this calculation are recorded as receivables.

The probable amounts of reimbursement or recovery from this calculation are recorded as receivables.

The determination that the recorded receivables are probable of collection is based on the terms of agreements reached in respect of indemnity and contribution claims as well as the advice of the Company’s outside legal counsel.

These receivables as of December 31, 2024 and 2023 totaled $ 4.8 million and $ 2.7 million, respectively and are recorded as Insurance Receivables of Litigation Costs in the accompanying consolidated balance sheets.

All such receivables as of December 31, 2024 related to the VBM Litigation, and nearly all of such receivables at December 31, 2023 related to the FiberCel Litigation.

The Company had been pursuing additional recovery amounts in respect of indemnity and contribution claims with certain insurance providers.

During the year ended December 31, 2024, the Company resolved these matters through a settlement totaling $ 1.6 million, with such recovery being recorded within Litigation costs, net in the accompanying consolidated statement of operations for the year ended December 31, 2024.

As of both December 31, 2024 and 2023, the Company was not a party to, or aware of, any legal matters or claims with material financial exposure, except for the FiberCel Litigation, VBM Litigation and Medtronic matter.

These receivables as of both December 31, 2025 and 2024 totaled $ 4.8 million and are recorded as Insurance Receivables of Litigation Costs in the accompanying consolidated balance sheets.

As of December 31, 2025, all amounts recorded as Insurance Receivables of Litigation Costs relate to the VBM Litigation, and additional insurance remains available to cover the future cost of the VBM Litigation and related defense costs.

Conversely, the Company has no more insurance to cover the cost of the FiberCel Litigation and the related defense costs.

As of both December 31, 2025 and 2024, the Company was not a party to, or aware of, any legal matters or claims with material financial exposure, except for the FiberCel Litigation, VBM Litigation, and the matters involving Medtronic, Tiger and a former supplier.

Segment Information

With the divestiture of the Orthobiologics Business, the Company now operates in three segments.

The Company determined its operating and reportable segments to be consistent with its major product groupings – Device Protection, Women’s Health and Cardiovascular.

With the divestiture of the CIED Business, the Company now operates in two segments.

The Company determined its operating and reportable segments to be consistent with its major product groupings – Women’s Health and Cardiovascular.

The accounting policies of the segments are the same as those described in the summary of significant accounting policies.

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For the year ended December 31, 2025, the Company’s segment gross profit was comprised of the following (in thousands):

Device Protection

Women's Health

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The net sales for the year ended December 31, 2025 include the revenues derived from one customer which represents 18 % of total net sales.

Such customer is included within the Cardiovascular segment.

Such customer is included within the Women’s Health segment.

For the year ended December 31, 2024, the Company’s segment gross profit was comprised of the following (in thousands):

Device Protection

Women's Health

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The net sales for the year ended December 31, 2024 include the revenues derived from one customer which represents 13 % of total net sales.

Such customer is included within the Women’s Health segment.

The net sales for the year ended December 31, 2024 also include the revenues derived from one customer, which represents 10 % of total net sales.

Such customer is included within the Cardiovascular segment.

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Other (income) expense, net

Loss before provision for income taxes

Loss from continuing operations before provision for income taxes

During the years ended December 31, 2025 and 2024, the Company did not have any material international product sales, and the Company did not own any long-lived assets outside the United States.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures