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NOT FOR DISTRIBUTION TO U.S. NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES A&R PROSPECTUS AND FINAL PROSPECTUS ACCESSIBLE ON SEDAR+ TORONTO, April 15, 2025 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI; OTC: CNVIF) (“Conavi” or the “Company”), a commercial stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures, is pleased to announce the pricing and terms of its previously announced public offering. The offering is of common shares of the Company (“Common Shares”) or pre-funded common share purchase warrants of the Company in lieu of Common Shares (“Pre-Funded Warrants” and, together with the Common Shares, the “Securities”) (the “Offering”). The Offering is being conducted on a commercially reasonable efforts agency basis for the issuance of a minimum of 37,500,000 Securities and a maximum of 50,000,000 Securities at a price of $0.40 per Common Share or $0.39999 per Pre-Funded Warrant, for gross proceeds of between $15,000,000 and $20,000,000. Each Pre-Funded Warrant issued in lieu of a Common Share at the election of any purchaser entitles the holder thereof to acquire one Common Share at an exercise price of $0.00001 per Common Share. The Pre-Funded Warrants will not expire. The Company intends to use the net proceeds from the Offering to advance and complete the development and pre-clinical testing of its Novasight 3.0 technology, with the goal of submitting a 510(k) clearance application to the U.S. Food and Drug Administration in Q3 of 2025. The Company also intends to use the net proceeds for working capital and other general corporate purposes. The Offering is expected to be completed pursuant to the terms and conditions of an agency agreement entered into between the Company and Bloom Burton Securities Inc. (the “Agent”). The Company will file today a final short form prospectus (the “Final Prospectus”) with the securities regulatory authorities in the provinces of Alberta, British Columbia and Ontario. There will not be any sale of Securities until a receipt for the Final Prospectus has been issued. The Offering is expected to close on or about April 22, 2025, or such other date as may be mutually agreed to by the Company and the Agent (the “Closing Date”). The Offering is subject to the satisfaction of customary closing conditions, including the receipt of all necessary regulatory and stock exchange approvals, including approval of the TSX Venture Exchange (“TSXV”). The Company will pay to the Agent a cash fee equal to 7.0% of the gross proceeds raised under the Offering, and grant the Agent compensation options equal to 7.0% of the aggregate number of Securities issued under the Offering (the “Compensation Options”), provided however the Agent will receive a reduced cash commission of 3.5% and no Compensation Options in respect of Securities sold to certain purchasers on a president’s list to be agreed to between the Company and the Agent. Each Compensation Option shall entitle the Agent to buy one Common Share at the same price per Common Share as under the Offering. The Compensation Options shall be exercisable until that date which is 24 months following the Closing Date. In addition, the Securities are anticipated to be offered by way of private placement in certain jurisdictions outside of Canada pursuant to and in compliance with applicable securities laws. This press release is not an offer to sell or the solicitation of an offer to buy the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), and such securities may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons absent registration or an applicable exemption from U.S. registration requirements. “United States” and “U.S. persons” have the meanings ascribed to them in Regulation S under the U.S. Securities Act. Access to the amended and restated preliminary prospectus dated March 20, 2025 (the “A&R Prospectus”), the Final Prospectus and any amendments to such documents will be provided in accordance with securities legislation relating to procedures for providing access to a short form prospectus and any amendment thereto. The A&R Prospectus is, and the Final Prospectus will be accessible on SEDAR+ at www.sedarplus.ca. Alternatively, an electronic or paper copy of the A&R Prospectus and the Final Prospectus (when filed), and any amendment to such documents may be obtained without charge, from the Agent by email at ECM@bloomburton.com, by telephone at 416-640-7585 or by providing the contact with an email address or address, as applicable. The A&R Prospectus and the Final Prospectus (when filed) contain important, detailed information about the Company and the Offering. Prospective investors should read the A&R Prospectus and the Final Prospectus (when filed) before making an investment decision. About Conavi Medical Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ System is the first system to combine both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to enable simultaneous and co-registered imaging of coronary arteries. The Novasight Hybrid System has 510(k) clearance from the U.S. Food and Drug Administration; and regulatory approval for clinical use from Health Canada, China’s National Medical Products Administration, and Japan’s Ministry of Health, Labor and Welfare. For more information, visit http://www.conavi.com/. Notice on forward-looking statements: This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding Conavi and its business, which may include, but are not limited to, statements with respect to the anticipated terms and jurisdictions of the Offering; securities offered thereunder; the timing of the Offering, including the anticipated Closing Date and timing for the Final Prospectus; use of proceeds from the Offering; fees anticipated to be paid to the Agent and terms thereof; and regulatory and exchange approvals, including the listing of the Common Shares offered pursuant to the Offering on the TSXV. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking information or statements”. Often but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate” “anticipate” or any variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, those listed in the “Risk Factors” section of the A&R Prospectus dated March 20, 2025 and the joint information circular of the Company dated August 30, 2024 (both of which are on the Company’s profile at www.sedarplus.ca). Although Conavi has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Conavi does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release. CONTACT: CONTACT:
Stefano Picone
Chief Financial Officer
(416) 483-0100
MENLO PARK, Calif., April 15, 2025 /PRNewswire/ — Subtle Medical, a leading provider of AI-powered solutions for faster and higher-quality medical imaging, has announced a new partnership with Strategic Radiology, a national coalition of 43 private radiology practices representing more…
KIRKLAND, Wash., April 14, 2025 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS) (“Kestra”), a wearable medical device and digital healthcare company, today reported financial results for the third quarter fiscal 2025, which ended January 31, 2025. Recent Highlights Q3 FY25 revenue and gross margin were in line with the preliminary estimated financial results previously disclosed in the company’s IPO prospectus. Generated revenue of $15.1 million in Q3 FY25, an increase of 82% compared to the prior year period.Achieved gross margin of 43.4% in Q3 FY25 compared to 10.6% in the prior year period. Completed initial public offering in March 2025, raising approximately $205.2 million of net proceeds.Signed in-network contracts with additional insurers, with covered lives for the ASSURE® system now totaling more than 285 million health plan members in the United States.Appointed Mr. Al Ford as Chief Commercial Officer. “Our quarterly results reflect sustained commercial momentum as Kestra grows and penetrates the wearable defibrillator market,” said Brian Webster, President and CEO. “We continue to make progress on our key operational objectives, including expansion of our commercial organization and advancement of our revenue cycle management capabilities. Following our initial public offering in March, we remain focused on delivering strong growth and executing on our commitments to patients and their prescribers.” Q3 FY25 Financial Results Total revenue was $15.1 million, an increase of 82% compared to the prior year period. 3,459 prescriptions were written for the ASSURE® system, an increase of 51% compared to the prior year period.Revenue growth was driven by higher share of wallet at existing customers and activation of new accounts. Revenue also benefited from a higher mix of in-network patients and improvements in revenue cycle management capabilities. Gross profit was $6.5 million compared to $0.9 million in the prior year period. Gross margin improved to 43.4% compared to 10.6% in the prior year period, driven by volume leverage and a higher mix of in-network patients. Operating expenses were $27.1 million compared to $20.8 million in the prior year period. The increase was attributable to growth in commercial and revenue cycle headcount and a $1.9 million increase in professional services expenses related to the IPO. GAAP net loss and comprehensive loss was $21.8 million compared to GAAP net loss and comprehensive loss of $21.6 million in the prior year period. Adjusted EBITDA loss was $16.3 million compared to an adjusted EBITDA loss of $16.2 million in the prior year period. Cash and cash equivalents totaled $54.4 million as of January 31, 2025. Net proceeds from the initial public offering completed in March 2025 totaled $205.2 million, after deducting underwriting discounts, commissions and offering expenses. Fiscal Year 2025 Revenue Outlook Kestra expects revenue for fiscal year ending April 30, 2025 to be in the range of $58.0 million to $58.5 million, representing growth of approximately 109% to 110% compared to fiscal year 2024. Webcast and Conference CallKestra will host a conference call today, April 14, 2025, at 4:30 p.m. ET to discuss third quarter fiscal 2025 financial results. A live and archived webcast of the event will be available in the “Events” section of the investor relations website. Explanatory NoteOn March 7, 2025, Kestra completed its initial public offering of its Common Shares, par value $1.00 per share (the “Common Shares”). Kestra was formed solely for the purpose of completing the IPO and prior to the consummation of the IPO, did not engage in any business or activities other than those incidental to its formation, the organizational transactions consummated in connection with the IPO and the preparation of the prospectus and registration statement in connection with the IPO. Prior to the consummation of the IPO, the Company’s business was conducted through West Affum Intermediate Holdings Corp. In connection with the IPO, certain organizational transactions were completed, pursuant to which West Affum Intermediate Holdings Corp. became a wholly owned subsidiary of Kestra. West Affum Intermediate Holdings Corp is the predecessor to Kestra for financial reporting purposes. As such, the financial statements and the discussion of the Company’s financial results for the third quarter fiscal 2025 included in this press release represent the financial results of West Affum Intermediate Holdings Corp. and the financial statements of Kestra Medical Technologies, Ltd. are not included in this press release. Unless otherwise indicated or the context requires, “Kestra,” the “Company,” “we,” “our,” “us” and other similar terms refer collectively to West Affum Intermediate Holdings Corp. and its consolidated subsidiaries for periods prior to the consummation of the initial public offering, and to Kestra Medical Technologies, Ltd. and its consolidated subsidiaries for periods following the consummation of the initial IPO. Use of Non-GAAP Financial MeasuresThis press release contains certain financial information that is not presented in conformity with U.S. generally accepted accounting principles (“GAAP”), including adjusted EBITDA. The non-GAAP financial measures are provided as supplemental information to Kestra’s financial measures presented in this press release that are calculated and presented in accordance with GAAP. Adjusted EBITDA, which is calculated as net income (loss), as adjusted to exclude other income/expense (including interest), income tax expense (benefit), depreciation and amortization expense, stock-based compensation expense, and expenses related to Kestra’s initial public offering, is presented because management believes it allows investors to view the Company’s performance in a manner similar to the method used by management to evaluate the Company’s performance for both strategic and annual operating planning. Management believes that in order to properly understand short-term and long-term financial trends, it is helpful for investors to understand the impact of the items excluded from the calculation of Adjusted EBITDA, in addition to considering the Company’s GAAP financial measures. The excluded items vary in frequency and/or impact on our results of operations and management believes that the excluded items are not reflective of our ongoing core business operations and financial condition. Excluding such items allows investors and analysts to compare our operating performance to other companies in our industry and to compare our period-over-period results. The non-GAAP financial measures used by Kestra may not be the same or calculated in the same manner as those used and calculated by other companies. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for Kestra’s financial results prepared and reported in accordance with GAAP. We urge investors to review the reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures included in this press release, and not to rely on any single financial measure to evaluate our business. A reconciliation of adjusted EBITDA reported in this press release to the most comparable GAAP measure for the respective periods appears in the table captioned “Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA” later in this release. Within the accompanying financial tables presented, certain columns and rows may not add due to the use of rounded numbers. Forward-Looking StatementsExcept where otherwise noted, the information contained in this press release is as of April 14, 2025. Statements in this press release and on the related teleconference that express a belief, expectation or intention, as well as those that are not historical fact, are forward-looking statements. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about, among other topics, our anticipated operating and financial performance, including financial guidance and projections; business plans, strategy, goals and prospects; and expectations for our products. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions, and we cannot ensure that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning. Kestra’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following: risks related to our limited operating history and history of net losses; our ability to successfully achieve substantial market adoption of our products; competitive pressures; our ability to adapt our manufacturing and production capacities to evolving patterns of demand, governmental actions and customer trends; product defects or complaints and related liability; our ability to obtain and maintain adequate coverage and reimbursement levels for our products; our ability to comply with changing laws and regulatory requirements and resulting costs; our dependence on a limited number of suppliers; and other risks and uncertainties, including those described under the heading “Risk Factors” in our Registration Statement on Form S-1 and other filings filed or to be filed with the U.S. Securities and Exchange Commission (“SEC”). These filings, when made, are available on the Investor Relations section of our website at https://investors.kestramedical.com/ and on the SEC’s website at https://sec.gov/. About KestraKestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, visit www.kestramedical.com. WEST AFFUM INTERMEDIATE HOLDINGS CORP. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share amounts)(unaudited) January 31,2025 April 30,2024 Assets Current assets Cash and cash equivalents$54,352 $8,249 Accounts receivable, net 7,929 1,998 Disposable medical equipment supplies 5,999 3,290 Prepaid expenses and other current assets 1,636 1,370 Total current assets 69,916 14,907 Right-of-use assets 1,956 2,286 Deposits 2,058 1,710 Restricted cash 334 334 Property and equipment, net 31,387 26,105 Other long-term assets 2,344 607 Total assets$107,995 $45,949 Liabilities, Redeemable Preferred Stock and Stockholder’s Deficit Current liabilities Accounts payable$25,657 $23,892 Accrued liabilities 13,036 9,079 Total current liabilities 38,693 32,971 Operating lease liabilities, net of current portion 2,862 2,633 Other long-term liabilities 76 76 Long-term debt, net 43,749 42,536 Total liabilities 85,380 78,216 Commitments and contingencies Redeemable preferred stock, $0.01 par value; 5,000,000 shares authorized; 280,510 and 177,110 shares issued and outstanding as of January 31, 2025 and April 30, 2024, respectively 280,510 177,110 Stockholder’s deficit Common stock, $0.01 par value; 5,000,000 shares authorized; 105,808 shares issued and outstanding 1 1 Additional paid-in capital 194,142 197,057 Accumulated deficit (468,196) (406,435)Total West Affum Intermediate Holdings Corp. stockholder’s deficit (274,053) (209,377)Non-controlling interest 16,158 — Total stockholder’s deficit (257,895) (209,377)Total liabilities and stockholder’s deficit$107,995 $45,949 WEST AFFUM INTERMEDIATE HOLDINGS CORP. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share amounts)(unaudited) Three Months Ended January 31, Nine Months Ended January 31, 2025 2024 2025 2024 Revenue$15,090 $8,277 $42,582 $17,760 Costs of revenue 8,543 7,397 26,005 18,795 Gross margin 6,547 880 16,577 (1,035)Operating expenses: Research and development costs 3,353 3,735 10,266 11,669 Selling, general and administrative 23,795 17,091 64,477 52,010 Total operating expenses 27,148 20,826 74,743 63,679 Loss from operations (20,601) (19,946) (58,166) (64,714)Other expense (income): Interest expense 1,783 1,651 5,974 4,295 Interest income (628) — (1,543) — Other expense (income) (15) 8 73 2,776 Net loss before provision for income taxes (21,741) (21,605) (62,670) (71,785)Provision for income taxes 18 14 33 51 Net loss and comprehensive loss (21,759) (21,619) (62,703) (71,836)Net loss attributable to non-controlling interest (250) — (942) — Net loss and comprehensive loss attributable to West Affum Intermediate Holdings Corp. (21,509) (21,619) (61,761) (71,836)Less: Undeclared preferred stock dividends 3,324 1,812 9,030 4,727 Net loss attributable to common stockholder, basic and diluted$(24,833) $(23,431) $(70,791) $(76,563) Net loss per share attributable to common stockholder, basic and diluted$(1.25) $(1.18) $(3.56) $(3.85)Weighted-average shares of common stock outstanding, basic and diluted 19,885,382 19,885,382 19,885,382 19,885,382 RECONCILIATION OF GAAP NET LOSS AND COMPREHENSIVE LOSS TO ADJUSTED EBITDA(in thousands)(unaudited) Three Months Ended January 31, Nine Months Ended January 31, 2025 2024 2025 2024 GAAP Net loss and comprehensive loss$(21,759) $(21,619) $(62,703) $(71,836)Non-GAAP Adjustments: Interest expense 1,783 1,651 5,974 4,295 Interest income (628) — (1,543) — Other expense (income) (15) 8 73 2,776 Provision for income taxes 18 14 33 51 Depreciation expense 1,888 3,363 6,132 8,058 Stock-based compensation expense 459 372 1,958 1,099 IPO expense 1,927 — 1,927 — Adjusted EBITDA$(16,327) $(16,211) $(48,149) $(55,557) CONTACT: Investor contact
Neil Bhalodkar
neil.bhalodkar@kestramedical.com
IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences Corporation (NYSE: EW) today announced the company’s SAPIEN M3 mitral valve replacement system received CE Mark for the transcatheter treatment of patients with symptomatic (moderate-to-severe or severe) mitral regurgitation (MR) who are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy. Leveraging the company’s SAPIEN technology, […]
Recruitment of the second cohort expected to begin in H2 2025 PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure (the “Company” or “CARMAT”), today announces that it […]
WHITE PLAINS, N.Y.–(BUSINESS WIRE)–Spectrum Vascular (“Spectrum” or the “Company”), a provider of vascular access and medication management products designed to reduce health care-acquired infections, is pleased to announce the appointment of Ken Miller as Chief Executive Officer and Doug Shook as Chief Commercial Officer. These strategic leadership additions mark a […]
Fort Mill, S.C., April 14, 2025 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (VTAK – NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market announced that it has received a notice of allowance from the US Patent Office of its first patent in the US for its LockeT product, filed in December 2022, for its design of a surgical closure device for orthoscopic entry wounds.
SILVER SPRING, Md., April 14, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, today confirmed that the ongoing global tariff environment has had no material impact on its commercial or operational performance. Elutia sources, manufactures, and distributes 100% of its products within the United States, primarily from its Roswell, Georgia production facility and U.S.-based suppliers. These products include EluPro™, CanGaroo®, SimpliDerm®, and its full Cardiovascular portfolio. Furthermore, all Elutia product sales occur within the United States. “We are proud to be a U.S.-based company with all operations and sales occurring domestically,” said Dr. Randy Mills, CEO of Elutia. “Thanks to our vertically integrated manufacturing and U.S.-focused commercial strategy, we remain insulated from the uncertainties surrounding the current tariff landscape and continue to reliably produce and deliver our advanced medical products so patients can thrive without compromise.” Elutia’s Roswell facility is FDA-registered as a medical device manufacturing establishment and has not experienced any delays, cost increases, or supplier issues related to the tariffs. The Company believes it is well-positioned to continue serving the U.S. market without impacts to its pricing or margins. About Elutia Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. Forward-looking statements contained in this press release include, without limitation, any statements we make regarding any future impacts on Elutia’s performance of current or new and/or increased global tariffs, and any resulting future difficulties, delays or cost increases in securing necessary suppliers or materials for Elutia’s products. These 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: the risk that clinical research data may not match preclinical study data; our ability to successfully commercialize, market and sell our EluPro product; our ability to continue as a going concern; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; 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; our ability to successfully realize the anticipated benefits of the sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; 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; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors:Matt SteinbergFINN Partnersmatt.steinberg@finnpartners.com This press release was published by a CLEAR® Verified individual.
