{"url_path":"/sec/elut/10-q/2026/cover-page","section_key":"cover-page","section_title":"Cover Page","topic":"sec","document":{"doc_type":"10-Q","doc_date":"2026-05-15","source_url":"https://www.sec.gov/Archives/edgar/data/1708527/0001104659-26-062634-index.html","accession_number":"0001104659-26-062634","cik":"0001708527","ticker":"ELUT","issuer_name":"ELUTIA INC.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1708527/0001104659-26-062634-index.html","primary_entity_key":"0001708527","primary_entity_name":"ELUTIA INC."},"word_count":2270,"has_tables":true,"body_markdown":"Elutia Inc._March 31, 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of Contents](#TOC)\n\n​\n\n​\n\n​\n\n**UNITED STATES**\n\n**SECURITIES AND EXCHANGE COMMISSION**\n\n**WASHINGTON, D.C. 20549**\n\n**FORM ****10-Q**\n\n(Mark One)\n\n☒\n\n**QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**\n\n**For the quarterly period ended****March 31, 2026**\n\n**or**\n\n☐\n\n**TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**\n\n**For the transition period from to**\n\n​\n\n**Commission file number:****001-39577**\n\n**Elutia Inc.**\n\n(Exact name of registrant as specified in its charter)\n\n​\n\n​\n\n​\n\n​\n\n**Delaware**\n\n​\n\n**47-4790334**\n\n(State or other jurisdiction of incorporation or\norganization)\n\n​\n\n(I.R.S. Employer Identification No.)\n\n​\n\n​\n\n​\n\n**20 Firstfield Road**\n\n**Gaithersburg****,****MD**\n\n​\n\n**20878**\n\n(Address of principal executive offices)\n\n​\n\n(Zip Code)\n\n​\n\n(Registrant’s telephone number, including area code): **(****240****)****247-1170**\n\n​\n\n**Not applicable**\n\n(Former name, former address and former fiscal year, if changed since last report)\n\n​\n\nSecurities registered pursuant to Section 12(b) of the Act:\n\n​\n\n​\n\n​\n\n**Title of each class**\n\n**  ​ ​ ​**\n\n**Trading Symbol(s)**\n\n**  ​ ​ ​**\n\n**Name of each exchange on which registered**\n\nClass A Common Stock, par value $0.001 per share\n\n​\n\nELUT\n\n​\n\nThe Nasdaq Capital Market\n\n​\n\nIndicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes  ☒ No  ☐\n\nIndicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes  ☒  No  ☐\n\nIndicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.\n\n​\n\nLarge accelerated filer       ☐\n\n  ​ ​ ​\n\nAccelerated filer                           ☐\n\nNon-accelerated filer         ☒\n\n​\n\nSmaller reporting company            ☒\n\n​\n\nEmerging growth company          ☐\n\n​\n\nIf an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐\n\n​\n\nIndicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes  ☐  No  ☒\n\nAs of May 12, 2026, there were 44,208,236 shares of the registrant’s Class A common stock and no shares of the registrant’s Class B common stock outstanding.\n\n​\n\n​\n\n​\n\n​\n\n[Table of Contents](#TOC)\n\nFORWARD-LOOKING STATEMENTS\n\nThis Quarterly Report on Form 10-Q (the “Quarterly Report”) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Quarterly Report, including, without limitation, statements regarding our results of operations, financial position, and business strategy; expectations regarding our products and their targeted effects; plans for our sales and marketing growth; expectations regarding the potential payment of post-closing escrow amounts from the sale of our former Device Protection segment, which consisted of our cardiac implantable electronic device business (the “CIED Business”), to Boston Scientific Corporation and Cardiac Pacemakers Inc.; expectations regarding the potential payment of post-closing earnout payments from the sale of our former Orthobiologics segment (the “Orthobiologics Business”) to Berkeley Biologics, LLC; our anticipated expansion of our product development and research activities, including the expected development timelines of NXT-41 and NXT-41x, which are our next-generation biologic scaffolds combined with local antibiotic delivery; any statements and information concerning our future interactions with the U.S. Food and Drug Administration (“FDA”) regarding NXT-41 and NXT-41x; expectations for FDA clearance of NXT-41 and NXT-41x, including the timing and anticipated success thereof; the sufficiency of our current capital resources to develop and commercialize NXT-41 and NXT-41x; the size of the breast reconstruction market and the potential of the Company’s next-generation drug-eluting biomatrix products to compete in that market;  increases in expenses and seasonality; expectations regarding our competitive advantages, and overall clinical and commercial success; expectations regarding the pending lawsuits and claims related to our recall of a single lot of Fiber Viable Bone Matrix (“FiberCel”) and a separate single lot of viable bone matrix (“VBM”) and expectations regarding the litigation matters with Medtronic Sofamor Danek USA, Inc. (“Medtronic”), Tiger Aesthetics Medical, LLC (“Tiger”) and a former lab and safety equipment supplier, amounts recoverable under insurance, indemnity and contribution agreements and the impact of such lawsuits and claims on our future financial position are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.\n\nWithout limiting the foregoing, the words “aim,” “believe,” “may,” “will,” “should,” “expect,” “exploring,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “seeks,” or “continue” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these words. These forward-looking statements are not a guarantee of future results, performance, or achievements, and one should avoid placing undue reliance on such statements.\n\nThese forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following:\n\n●our ability to enhance our products, expand our product indications and successfully develop, acquire and commercialize additional product offerings, including NXT-41 and NXT-41x;\n\n●our ability to obtain regulatory approval or other marketing authorizations by the U.S. Food and Drug Administration and comparable foreign authorities for our products and product candidates;\n\n●our ability to raise funds in the future in the amounts and at the times needed;\n\n●our ability to achieve or sustain profitability;\n\n●the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance;\n\n1\n\n[Table of Contents](#TOC)\n\n●our ability to defend against the various lawsuits related to FiberCel and VBM, and any other ongoing or future litigation, and avoid a material adverse financial consequence;\n\n●the continued and future acceptance of our products by the medical community;\n\n●our dependence on independent sales agents to generate a substantial portion of our net sales;\n\n●our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases, are exclusive suppliers for products essential to our business;\n\n●our ability to successfully realize the anticipated benefits of the sale of our CIED and Orthobiologics Businesses;\n\n●physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products;\n\n●our ability to maintain compliance with the continued listing requirements of, and maintain a listing of our Class A common stock on, the Nasdaq Capital Market;\n\n●our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do;\n\n●pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; and\n\n●our ability to obtain, maintain and adequately protect our intellectual property rights.\n\n​\n\nThese and other important factors discussed in Part I, Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and Part II, Item 1A. “Risk Factors” in this Quarterly Report, and in Part I, Item 1A. “Risk Factors” and Part II, Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (the “2025 Annual Report”) and in our other filings with the Securities and Exchange Commission (the “SEC”), each of which filings are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of our website at https://investors.Elutia.com/financials/sec-filings, could cause actual results to differ materially from those indicated by the forward-looking statements made in this Quarterly Report.\n\nMoreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.\n\nYou should read this Quarterly Report and the documents that we reference in this Quarterly Report completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.\n\nAs used in this Quarterly Report, unless otherwise specified or the context otherwise requires, references to “we,” “us,” “our,” the “Company” and “Elutia” refer to the operations of Elutia Inc. and its consolidated subsidiaries.\n\nWEBSITE DISCLOSURE\n\nWe may use our website as a distribution channel of material information about the Company. Financial and other important information regarding the Company is routinely posted on and accessible through the Investor Relations sections of its website at *www.Elutia.com*. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address by visiting the “Email Alerts” option under the IR Resources menu of the\n\n2\n\n[Table of Contents](#TOC)\n\nInvestor Relations of our website at *www.Elutia.com*. The reference to our website address does not constitute incorporation by reference of the information contained on or available through our website, and you should not consider such information to be a part of this Quarterly Report.\n\n​\n\nTRADEMARKS, TRADE NAMES AND SERVICE MARKS\n\nThis Quarterly Report includes our trademarks, trade names and service marks, including, without limitation, “Elutia®,” “ProxiCor®,” “Tyke®,” “VasCure®,” “SimpliDerm®,” “SimpliDerm Ellipse®” and our logo, which are our property and are protected under applicable intellectual property laws. This Quarterly Report also contains trademarks, trade names and service marks of other companies, which are the property of their respective owners. Solely for convenience, trademarks, trade names and service marks may appear in this Quarterly Report without the ®, TM and SM symbols, but such references are not intended to indicate, in any way, that we or the applicable owner forgo or will not assert, to the fullest extent permitted under applicable law, our rights or the rights of any applicable licensors to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us, by these other parties.\n\n​\n\nINDUSTRY AND OTHER DATA\n\nUnless otherwise indicated, information contained in this Quarterly Report concerning our industry and the markets in which we operate, including our general expectations, market position and market opportunity, is based on our management’s estimates and research, as well as industry and general publications and research, surveys and studies conducted by third parties. We believe the information from these third-party publications, research, surveys and studies included in this Quarterly Report is reliable. Management’s estimates are derived from publicly available information, their knowledge of our industry and their assumptions based on such information and knowledge, which we believe to be reasonable. This data involves a number of assumptions and limitations which are subject to a high degree of uncertainty and risk due to a variety of factors, including those described in this Quarterly Report under “Forward-Looking Statements” and Part I, Item 1A. “Risk Factors” in our 2025 Annual Report which can be found at https://investors.Elutia.com/financials/sec-filings. These and other factors could cause our future performance to differ materially from our assumptions and estimates.\n\n​\n\n3\n\n[Table of Contents](#TOC)\n\nTABLE OF CONTENTS\n\nPage\n\n[FORWARD-LOOKING STATEMENTS](#FORWARDLOOKINGSTATEMENTS_207286)\n\n1\n\n[WEBSITE DISCLOSURE](#WEBSITEDISCLOSURE_212612)\n\n2\n\n[TRADEMARKS, TRADE NAMES AND SERVICE MARKS](#TRADEMARKS_NAMES_SERVICEMARKS_9239)\n\n3\n\n[INDUSTRY AND OTHER DATA](#INDUSTRYANDOTHERDATA_184363)\n\n3\n\n[PART I – FINANCIAL INFORMATION](#PARTIFINANCIALINFORMATION_244549)\n\n[Item 1.](#Item1FinancialStatements_101569)\n\n[Financial Statements (Unaudited)](#Item1FinancialStatements_101569)\n\n​\n\n​\n\n[Condensed Consolidated Balance Sheets](#CONDENSEDCONSOLIDATEDBALANCESHEETS_10466)\n\n5\n\n​\n\n[Condensed Consolidated Statements of Operations](#CONDENSEDCONSOLIDATEDSTATEMENTSOFOPERATI)\n\n6\n\n​\n\n[Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit)](#CONDENSEDCONSOLIDATEDSTATEMENTSOFCHANGES)\n\n7\n\n​\n\n[Condensed Consolidated Statements of Cash Flows](#CONDENSEDCONSOLIDATEDSTATEMENTSOFCASHFLO)\n\n8\n\n​\n\n[Notes to Condensed Consolidated Financial Statements](#NOTESTOCONDENSEDCONSOLIDATEDFINANCIALSTA)\n\n9\n\n[Item 2.](#Item2ManagementsDiscussionandAnalysisofF)\n\n[Management’s Discussion and Analysis of Financial Condition and Results of Operations](#Item2ManagementsDiscussionandAnalysisofF)\n\n28\n\n[Item 3.](#Item3QuantitativeandQualitativeDisclosur)\n\n[Quantitative and Qualitative Disclosures About Market Risk](#Item3QuantitativeandQualitativeDisclosur)\n\n38\n\n[Item 4.](#Item4ControlsandProcedures_472757)\n\n[Controls and Procedures](#Item4ControlsandProcedures_472757)\n\n39\n\n[PART II – OTHER INFORMATION](#PARTIIOTHERINFORMATION_343778)\n\n[Item 1.](#Item1LegalProceedings_778412)\n\n[Legal Proceedings](#Item1LegalProceedings_778412)\n\n40\n\n[Item 1A.](#Item1ARiskFactors_985070)\n\n[Risk Factors](#Item1ARiskFactors_985070)\n\n40\n\n[Item 2.](#Item2UnregisteredSalesofEquitySecurities)\n\n[Unregistered Sales of Equity Securities and Use of Proceeds](#Item2UnregisteredSalesofEquitySecurities)\n\n40\n\n[Item 3.](#Item3DefaultsUponSeniorSecurities_323509)\n\n[Defaults Upon Senior Securities](#Item3DefaultsUponSeniorSecurities_323509)\n\n40\n\n[Item 4.](#Item4MineSafetyDisclosures_851610)\n\n[Mine Safety Disclosures](#Item4MineSafetyDisclosures_851610)\n\n40\n\n[Item 5.](#Item5OtherInformation_139851)\n\n[Other Information](#Item5OtherInformation_139851)\n\n40\n\n[Item 6.](#Item6Exhibits_211620)\n\n[Exhibits](#Item6Exhibits_211620)\n\n40\n\n[Signatures](#SIGNATURES_900854)\n\n43\n\n​\n\n​\n\n​\n\n4\n\n[Table of Contents](#TOC)\n\n**PART I – FINANCIAL INFORMATION**"}