Heart Failure Society of America’s (HFSA) Annual Scientific Meeting (ASM) 2026 will convene the entire heart failure care team to explore late-breaking science, emerging technologies, device innovation, and practical strategies that can improve care for millions of patients living with…
Author: Ken Dropiewski
Atrium Therapeutics Reports Second Quarter 2026 Financial Results
— IND clearance for ATR 1072 and launch of Corventis Phase 1/2 trial in PRKAG2 syndrome — — Achieved second milestone payment under global cardiovascular collaboration with Bristol Myers Squibb — SAN DIEGO, Aug. 13, 2026 /PRNewswire/ — Atrium Therapeutics, Inc. (Nasdaq: RNA)…
Elutia Secures Up to $26 Million to Fund NXT-41x Through Commercial Launch; Reports Second Quarter 2026 Results
Independent Blinded Survey of 50 Plastic Surgeons Validates Demand; NXT-41 and NXT-41x Remain On-TrackFunded through launch: secured up to $26 million of capital without an equity offeringThe unmet need is real: 86% of surgeons surveyed say the matrices they use today increase infection riskThe demand is strong: 96% of surgeons surveyed are interested in adopting NXT-41x; 92% responded they would champion it at their hospital value analysis committeeOn track: NXT-41 FDA clearance decision expected in 4Q 2026; NXT-41x FDA clearance decision expected in 1H 2027 GAITHERSBURG, Md., Aug. 13, 2026 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today provided a business update and announced financial results for the second quarter ended June 30, 2026. “We have intentionally focused Elutia where our strengths create the greatest value for patients and shareholders,” said Dr. Randy Mills, Chief Executive Officer of Elutia. “We believe we are now funded through the anticipated clearance and full commercial launch of NXT-41x, our antibiotic-eluting biomatrix for use in plastic and reconstructive surgical procedures. And we did it without an equity offering.“As we approach anticipated FDA clearance decisions and launch, surgeon interest in NXT-41x has exceeded our expectations. In an independent study of 50 board-certified plastic and reconstructive surgeons, 86% said matrices used today increase infection risk, 96% believed our antibiotic combination would be effective at preventing infection, and 92% said they would help get NXT-41x approved at their hospital’s value analysis committee.“Having successfully created value with this technology in the pacemaker market, we are now applying it to a larger market with a substantially greater unmet need. And we believe we have the team and capital to execute.” Capital Secured to Support NXT-41x Through Clearance and Commercial LaunchElutia has secured up to $26 million of additional capital to support the Company through the anticipated clearance of NXT-41x and its first full year of commercial launch in 2028, without an equity offering: $15 million credit facility, including $10 million funded at closing and an additional $5 million available following NXT-41x FDA clearanceUp to $11 million from the SimpliDerm divestiture, including $8 million in cash at closing and up to $3 million in contingent technology transfer and commercial milestone payments In addition, the Company anticipates receiving the full $8 million held in escrow from the 2025 divestiture of the BioEnvelope business, with release expected in the fourth quarter of this year. Independent Blinded Survey Validates Surgeon Demand for NXT-41xAn independent market research firm conducted a blinded survey of 50 board-certified plastic and reconstructive surgeons across 28 states. The surgeons average 11.6 years in practice and perform about 140 complex reconstructive procedures annually. Surgeons Say the Problem Is Real Surgeons estimate a 17% surgical-site infection rate in the published literature for these procedures.86% (95% confidence interval (CI): 74–93%) report that matrices used today increase infection risk. Surgeons View NXT-41x as Differentiated and Mechanistically Sound 98% (CI: 90–99.6%) rated NXT-41x new and different from products available today.96% (CI: 87–99%) rated the combination of rifampin and minocycline effective, with 64% (CI: 50–76%) describing it as extremely effective at reducing surgical site infections. No respondents rated the combination ineffective. Surgeon Intent to Adopt NXT-41x Is Strong 100% (CI: 93–100%) indicated they would use NXT-41x in diabetic patients and in patients with high BMI, who together represent approximately one third of all reconstruction patients.96% (CI: 87–99%) expressed interest in incorporating NXT-41x into their general practice.92% (CI: 81–97%) indicated willingness to approach their hospital value analysis committee in support of NXT-41x. Interest measures are based on ratings of 4 or 5 on a five-point scale. All results are reported with 95% Wilson confidence intervals; where responses were unanimous, the lower bound of the interval is 93%. Regulatory Review and Manufacturing Progressing on ScheduleRegulatory and development activities for both NXT-41 (biologic surgical matrix without drug) and NXT-41x continue to advance according to plan. Elutia recently held a productive meeting with the FDA regarding the NXT-41 submission, which remains on track. The Company continues to expect FDA clearance for NXT-41 in the fourth quarter of 2026 and for NXT-41x in the first half of 2027. Elutia also completed the installation and operational qualification of its automated drug-coating system for commercial manufacturing. The system is designed to support target gross margins in excess of 80% at scale. Product Divestitures Further Sharpen the Company’s FocusOn July 16, 2026, Elutia signed a definitive agreement to sell its SimpliDerm business for up to $11 million in total consideration, including up to $3 million in contingent technology transfer and commercial milestone payments over the 18 months following closing, with closing expected in the third quarter of 2026. The Company’s previously announced strategic process for its Cardiovascular business also continues to advance. Together with the 2025 divestiture of the BioEnvelope business, these transactions extend Elutia’s runway and focus the organization on the launch of NXT-41x in the second half of 2027. Funded Catalysts Ahead MilestoneExpected TimingSimpliDerm business divestiture closing3Q 2026Potential cardiovascular business transaction2H 2026$8 million BioEnvelope escrow release4Q 2026NXT-41 FDA clearance decision4Q 2026NXT-41x FDA clearance decision1H 2027NXT-41x commercial soft launch2H 2027NXT-41x full commercial launch2028 Second Quarter 2026 Financial ResultsNet sales and operating results discussed below reflect continuing operations. For the three-month period ended June 30, 2026, as compared to the same period of 2025: Overall net sales were $2.4 million, compared to $2.7 million. The decrease was the result of $0.7 million reduction in SimpliDerm revenue due to a production disruption with the product’s contract manufacturer, offset by a $0.4 million increase in Cardiovascular revenue due to the transition back to direct sales.Gross margin on a GAAP basis was 59.6%, compared to 52.9%.Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was 70.7%, compared to 62.7%. A reconciliation of GAAP gross margin to adjusted gross margin is included in the accompanying financial tables.Total operating expenses were $9.4 million, compared to $9.8 million. The decrease was driven by a $1.9 million reduction in net litigation costs, partially offset by a $1.5 million increase in research and development expense supporting the NXT-41 and NXT-41x programs.Loss from operations was $8.0 million, compared to $8.4 million.Net loss from continuing operations was $7.6 million, compared to $7.1 million.There was no loss from discontinued operations in the second quarter of 2026, compared to a loss of $2.5 million in the second quarter of 2025.Net loss was $7.6 million, compared to $9.6 million.Adjusted EBITDA (a non-GAAP measure that excludes from net loss certain non-operating, non-cash and non-recurring items) was a loss of $4.6 million, compared to a loss of $3.0 million. A reconciliation of net loss to adjusted EBITDA is included in the accompanying financial tables.Cash and cash equivalents at June 30, 2026 were $19.9 million. This cash position is expected to be augmented by up to an additional $34 million from signed transactions, including $10 million already received from Avenue Capital Group pursuant to a new loan agreement, $8 million held in escrow in connection with the 2025 divestiture of the BioEnvelope business, up to $11 million from the sale of the SimpliDerm business and an additional $5 million available from the Avenue Capital loan facility following FDA clearance of NXT-41x. Conference CallElutia will host a conference call on August 13, 2026 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its second quarter 2026 financial results and business performance. The conference call can be accessed using the following information: Webcast: Click hereDial-In: Click here To receive the dial-in number, as well as your personalized PIN, you must register at the above link. Once registered, you will also have the option to have the system dial out to you once the conference call begins. If you forget your PIN prior to the conference call, you can simply re-register. Please log in approximately 10 minutes prior to the scheduled start time. A live and archived webcast of the event will be available on the “Investors” section of the Elutia website at http://investors.elutia.com/. About ElutiaElutia 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. Non-GAAP DisclosureIn addition to the Company’s financial results determined in accordance with U.S. GAAP, the Company provides non-GAAP measures that it determines to be useful in evaluating its operating performance and liquidity. The Company presents in this press release the following non-GAAP financial measures: earnings before interest, taxes, depreciation and amortization (“EBITDA”), adjusted earnings before interest, taxes, depreciation and amortization (“adjusted EBITDA”), adjusted gross margin and adjusted gross profit. The Company defines EBITDA as GAAP net loss excluding interest expense, income tax expense, depreciation and amortization, and the Company defines adjusted EBITDA as EBITDA excluding income or loss from discontinued operations, stock-based compensation, FiberCel and VBM litigation costs, loss or gain on revaluation of warrant liability, warrant issuance expenses and loss or gain on revaluation of revenue interest obligation. The Company defines adjusted gross profit and adjusted gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. Management believes that presentation of non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. The Company uses this non-GAAP financial information to establish budgets, manage the Company’s business, and set incentive and compensation arrangements. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For a reconciliation of these non-GAAP measures to GAAP, see below “Non-GAAP Reconciliations of EBITDA and Adjusted EBITDA” and “Non-GAAP Reconciliations of Adjusted Gross Profit and Adjusted Gross Margin.” Forward-Looking StatementsThis 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, including 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; preparations for the commercial launch of NXT-41x, including the timing, scale and anticipated success thereof; the sufficiency of our capital resources to fund the Company through anticipated FDA clearance and the first full year of commercial launch of NXT-41x without an equity offering; the availability of the additional $5 million tranche under our Avenue Capital financing; the expected closing of the sale of our SimpliDerm business and our receipt of the associated contingent technology transfer and commercial milestone payments; the outcome and timing of the previously announced strategic process for our Cardiovascular business; the anticipated release of the $8 million held in escrow in connection with the divestiture of the BioEnvelope business; the results, interpretation and predictive value of the independent blinded surgeon survey described in this press release, including surgeons’ stated intent to adopt NXT-41x and to support it before hospital value analysis committees; the size of the plastic and reconstructive surgery market and the potential of the Company’s next-generation drug-eluting biomatrix pipeline to compete in that market; expectations regarding manufacturing capacity, scale and target gross margins; and any statements regarding future liability with respect to the FiberCel and VBM litigation. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. 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: our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings, including NXT-41 and NXT-41x; 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, including NXT-41 and NXT-41x; our ability to comply with the covenants under, and to draw the remaining availability under, our credit facility; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to achieve or sustain profitability; our ability to regain compliance with Nasdaq’s minimum bid price requirement and otherwise maintain compliance with any other listing requirement of Nasdaq Capital Market, and our ability to maintain a listing of our Class A common stock on the Nasdaq Capital Market; our ability to raise funds in the future in the amounts and at the times needed; our ability to service our indebtedness; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; risks relating to the pending sale of the SimpliDerm business, including the occurrence of any event, change or circumstance that could delay the sale of the SimpliDerm business or give rise to termination of the related asset purchase agreement, the risk that the technology transfer and commercial milestone payments from the sale of the SimpliDerm business are reduced, delayed, or not earned or received, the outcome of any legal proceedings instituted against us following announcement of the sale of the SimpliDerm business, the inability to consummate the sale of the SimpliDerm business due to failure to satisfy closing conditions; the risk that the sale of the SimpliDerm business disrupts our current plans and operations, including distraction of management and employees, and costs related to the sale of the SimpliDerm business; our ability to complete any strategic transaction involving our Cardiovascular business, on the anticipated timeline and terms, or at all, and to realize the anticipated benefits of that transaction; our ability to defend against the various lawsuits and claims related to our former FiberCel and other bone viable matrix (“VBM”) products and avoid a material adverse financial consequence; the continued and future acceptance of our products by the medical community; our dependence on 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 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, 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, 2025, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, 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:Elutia Investor Relationsir@elutia.com ELUTIA INC. CONSOLIDATED BALANCE SHEET DATA(Unaudited, in thousands) AssetsJune 30, 2026 December 31, 2025Current assets: Cash and cash equivalents$19,896 $36,350 Accounts receivable, net 1,438 1,734 Inventory 2,649 2,617 Insurance receivables of litigation costs 3,854 4,846 Prepaid expense and other current assets 9,378 10,271 Total current assets 37,215 55,818 Property and equipment, net 2,922 2,511 Intangible assets, net 990 1,529 Operating lease right-of-use assets, and other 2,522 2,492 Total assets$ 43,649 $ 62,350 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable and accrued expenses$8,329 $9,143 Current portion of revenue interest obligation 6,412 4,400 Contingent liability for legal proceedings 5,619 11,241 Current operating lease liabilities 685 355 Total current liabilities 21,045 25,139 Long-term revenue interest obligation — 2,828 Warrant liability 3,163 3,124 Long-term operating lease liabilities 3,695 3,587 Total liabilities 27,903 34,678 Stockholders’ equity: Common stock 44 43 Additional paid-in capital 207,030 203,842 Accumulated deficit (191,328) (176,213)Total stockholders’ equity 15,746 27,672 Total liabilities and stockholders’ equity$ 43,649 $ 62,350 ELUTIA INC. CONSOLIDATED STATEMENT OF OPERATIONS(Unaudited, in thousands, except share and per share data) Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 Net sales$2,427 $2,747 $5,541 $5,698 Cost of goods sold 980 1,294 2,292 2,863 Gross profit 1,447 1,453 3,249 2,835 Operating expenses: Sales and marketing 1,366 1,273 2,846 2,268 General and administrative 3,454 3,552 7,545 7,273 Research and development 2,527 989 4,500 1,860 Litigation costs, net 2,057 4,004 2,663 6,576 Total operating expenses 9,404 9,818 17,554 17,977 Loss from operations (7,957) (8,365) (14,305) (15,142)Interest income, net (35) (491) (143) (307)Other (income) expense, net (284) (791) 1,300 (5,873)Loss before provision for income taxes (7,638) (7,083) (15,462) (8,962)Provision for income taxes 8 8 78 16 Net loss from continuing operations (7,646) (7,091) (15,540) (8,978)Loss income from discontinued operations — (2,519) 425 (4,565)Net loss$ (7,646) $ (9,610) $ (15,115) $ (13,543) Net loss per share — basic$(0.17) $(0.23) $(0.35) $(0.34)Net loss per share — diluted$(0.17) $(0.26) $(0.35) $(0.47) Weighted average common shares outstanding — basic 44,223,722 41,782,556 43,622,360 40,239,372 Weighted average common shares outstanding — diluted 44,223,722 46,308,642 43,622,360 44,765,897 ELUTIA INC.NON-GAAP GROSS PROFIT AND NON-GAAP GROSS MARGIN RECONCILIATIONS(Unaudited, in thousands) Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 Net sales$2,427 $2,747 $5,541 $5,698 Gross profit 1,447 1,453 3,249 2,835 Intangible asset amortization expense 270 270 540 542 Adjusted gross profit (Non-GAAP)$ 1,717 $ 1,723 $ 3,789 $ 3,377 Gross margin 59.6% 52.9% 58.6% 49.8%Adjusted gross margin percentage (Non-GAAP) 70.7% 62.7% 68.4% 59.3% ELUTIA INC.EBITDA AND ADJUSTED EBITDA RECONCILIATIONS(Unaudited, in thousands) Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 Net loss$(7,646) $(9,610) $(15,115) $(13,543)Interest income expense, net(1) (35) (491) (143) (307)Provision for income taxes 8 8 78 16 Depreciation and amortization 348 312 679 598 Earnings before interest, taxes, depreciation and amortization (“EBITDA”) (Non-GAAP) (7,325) (9,781) (14,501) (13,236)Loss (income) from discontinued operations(2) — 2,519 (425) 4,565 Stock-based compensation 905 1,028 1,836 2,116 Litigation costs, net(3) 2,057 4,004 2,663 6,576 (Gain) loss on revaluation of warrant liability(4) (226) (2,233) 1,429 (7,420)Warrant issuance expenses — — — 105 Loss on revaluation of revenue interest obligation(5) — 1,442 — 1,442 Adjusted EBITDA (Non-GAAP)$ (4,589) $ (3,021) $ (8,998) $ (5,852) (1) Represents interest expense recorded on all outstanding long-term debt as well as the revenue interest obligation. (2) Represents the financial results of the BioEnvelope business sold to Boston Scientific Corporation on October 1, 2025. (3) Represents litigation costs consisting primarily of legal fees and the estimated and actual costs to resolve the outstanding FiberCel and VBM litigation cases offset by the amounts recovered and recoverable under insurance, indemnity and contribution agreements for such costs. (4) Represents the non-cash revaluation of Common Warrants and Prefunded Warrants issued in connection with a private offering in September 2023 and registered direct offerings in June 2024 and February 2025. (5) Represents the non-cash revaluation of the revenue interest obligation. 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.
Heartflow Reports Second Quarter 2026 Financial Results and Raises Full Year 2026 Guidance
SAN FRANCISCO, Aug. 13, 2026 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for diagnosing coronary artery disease (CAD), today reported financial results for the second quarter ended June 30, 2026. Second Quarter 2026 Highlights Total revenue of $64.1 million, a 48% increase year-over-yearGross margin of 83.0%, non-GAAP gross margin of 83.3%Net operating loss of $17.9 million; non-GAAP net operating loss of $7.9 million 2026 Annual Guidance Total revenue of $246 million to $250 million (approximately 40% to 42% growth year-over-year), compared to previous guidance of $228 million to $232 million (approximately 29% to 32% growth year-over-year)Non-GAAP gross margin of approximately 82%, compared to previous guidance of approximately 81% “The second quarter reflects the growing strength of Heartflow’s category leadership and unique AI technology platform for identifying, diagnosing, managing and treating coronary artery disease,” said John Farquhar, President and CEO of Heartflow. “The CCTA market for detecting CAD continues to grow rapidly and remains significantly under-penetrated, providing a strong backdrop for continued growth. Our FFRCT business remains strong and durable, while Plaque is rapidly emerging as a meaningful second growth engine — helping us win new accounts, deepen physician utilization and expand the value of the Heartflow platform for our customers. At the same time, record gross margin and improving operating leverage demonstrate the increasing scalability of our model, giving us greater confidence in long-term, profitable growth.” Second Quarter 2026 Financial ResultsTotal revenue was $64.1 million, a 48% increase year-over-year. U.S. revenue was $59.6 million, a 51% increase year-over-year. International and other revenue was $4.5 million, a 12% increase year-over-year. The year-over-year increase in total global revenue was primarily attributable to an increase in total U.S. FFRCT revenue case volume and an increase in total U.S. Plaque revenue case volume. Gross profit was $53.2 million, compared to $32.8 million in the prior year period. Non-GAAP gross profit was $53.4 million, compared to $32.8 million in the prior year period. Gross margin was 83.0%, compared to 75.5% in the prior year period. Non-GAAP gross margin was 83.3%, compared to 75.6% in the prior year period. The year-over-year gross margin expansion was primarily attributable to an increase in total revenue case volume, an increase in total U.S. Plaque revenue case volume, and improved production team productivity driven by AI efficiency initiatives, partially offset by the hiring and training of production team personnel. Total operating expenses were $71.1 million, or 111% of total revenue, compared to $46.5 million, or 107% of total revenue, in the prior year period. Non-GAAP total operating expenses were $61.3 million, or 96% of total revenue, compared to $44.3 million, or 102% of total revenue, in the prior year period. The year-over-year operating expense increase was primarily attributable to increased investment in sales personnel and related expenses, as well as increased investments in technology and clinical research. Net operating loss was $17.9 million, compared to $13.7 million in the prior year period. Non-GAAP net operating loss was $7.9 million, compared to $11.5 million in the prior year period. Net loss was $15.7 million, or ($0.18) net loss per share, compared to $9.2 million, or ($1.46) net loss per share, in the prior year period. Non-GAAP net loss was $5.8 million, or ($0.07) non-GAAP net loss per share, compared to $17.6 million, or ($2.79) non-GAAP net loss per share, in the prior year period. Adjusted EBITDA was ($6.7) million, compared to ($10.1) million in the prior year period. Cash, cash equivalents and investments totaled $246.8 million as of June 30, 2026. For additional information regarding non-GAAP financial measures, see “Use of Non-GAAP Measures,” “Heartflow GAAP to Non-GAAP Reconciliations” and “Reconciliation of GAAP Net Loss to Adjusted EBITDA” below. Webcast and Conference Call DetailsHeartflow will host a conference call today, August 13, 2026, at 1:30 p.m. PT / 4:30 p.m. ET to discuss its second quarter 2026 financial results. Those interested in listening to the conference call should register online using this link. Once registered, participants will receive dial-in numbers and a unique PIN to join the call. Participants are encouraged to register more than 15 minutes prior to the start of the call. A live and archived webcast of the event will also be available on the “Investor Relations” section of the Heartflow website at https://ir.heartflow.com. The archived version will be available for 12 months following completion of the live call. About Heartflow’s Technology and ResearchHeartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,800 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by American College of Cardiology and American Heart Association (ACC/AHA) guidelines and supported by more than 625 peer-reviewed publications, Heartflow has redefined how clinicians manage care for more than 750,000 patients worldwide.1 Key benefits include: Unmatched Proprietary data pipeline: Built from the world’s largest database of more than 200 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations.Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 200 studies assessing over 365,000 patients. Heartflow is the only AI platform prospectively validated against invasive gold standards and demonstrated through real-world evidence to improve patient outcomes.2,3,4,5 Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001. About Heartflow, Inc.Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com. Use of Non-GAAP MeasuresTo supplement its consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company discloses non-GAAP gross profit and non-GAAP gross margin, non-GAAP total operating expenses, non-GAAP research and development expense, non-GAAP selling, general and administrative expense, non-GAAP net operating loss, non-GAAP net loss, non-GAAP net loss per share, basic and diluted, and Adjusted EBITDA (collectively, the “Non-GAAP Measures”) in this press release. As used by the Company, these measures are adjusted to exclude stock-based compensation expense from the comparable GAAP financial measure. Non-GAAP net loss and non-GAAP net loss per share, basic and diluted, are also adjusted for change in fair value of common stock warrant liability, change in fair value of derivative liability, certain litigation expenses and asset impairment charge. In addition, Adjusted EBITDA is calculated by adding back to net loss or excluding, as appropriate, interest income and expense, provision for income taxes, certain litigation expenses, and charges for depreciation and amortization and is further adjusted by adding back in or excluding, stock-based compensation and, as appropriate, other income and expense items that are not reflective of the Company’s underlying continuing operating performance. Reconciliations of the Non-GAAP Measures to their most directly comparable GAAP financial measures are provided in the financial statement tables included at the end of this press release, and investors are encouraged to review the reconciliations. The Company believes the presentation of the Non-GAAP Measures, when shown in conjunction with the corresponding GAAP measures, provides useful information to investors as it provides visibility to the Company’s underlying continuing operating performance from period to period by excluding the impact of stock-based compensation and certain other items that are not reflective of the Company’s ongoing operations. Because of the variety of equity awards used by companies, the varying methodologies for determining stock-based compensation expense, the subjective assumptions used in those determinations, and the volatility in valuations that can be driven by market conditions outside the Company’s control, we believe excluding stock-based compensation expense enhances the ability of management and investors to understand and assess the underlying performance of our business over time and compare it against our peers, a majority of whom also exclude stock-based compensation expense from their non-GAAP results. With respect to the presentation of Adjusted EBITDA, the Company believes it is a useful measure to evaluate the Company’s operating performance and it is used by the Company to evaluate ongoing operations and for planning and forecasting purposes. Adjusted EBITDA is also a measure frequently used by analysts, investors and other interested parties to evaluate companies in our same industry. The Company’s definition of the Non-GAAP Measures may differ from similarly titled measures used by others. The Non-GAAP Measures should be considered only as a supplement to, and not as a substitute for, or superior to, their most directly comparable GAAP financial measures. Because the Non-GAAP Measures exclude the effect of items that increase or decrease the Company’s reported results of operations, management strongly encourages investors to review the reconciliations to the most comparable GAAP financial measures at the end of this press release and, when they become available, the Company’s consolidated financial statements and publicly filed Securities and Exchange Commission (“SEC”) reports in their entirety. The Company is not able to provide a reconciliation without unreasonable efforts of its forward-looking guidance related to non-GAAP gross margin to the most directly comparable GAAP financial measure due to the unknown effect of stock-based compensation that is material to the comparable GAAP financial measure. Forward-Looking StatementsThis press release contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release, including statements regarding our strategy, market conditions, expected market growth and financial guidance, are forward-looking statements. These forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements, including, but not limited to: we may not be able to achieve or sustain profitability; our dependence on the success of our two products, Heartflow FFRCT Analysis and Heartflow Plaque Analysis, healthcare providers may be unwilling to change their standard practice regarding the evaluation of coronary artery disease; adoption of the Heartflow Platform by healthcare providers may be negatively impacted if third-party payors, including government payors, do not cover or provide adequate reimbursement; the concentration of our customer base; the significant competition we face in an environment of rapid technological change; the commercialization of Heartflow Plaque Analysis is nascent; risks associated with our use and development of AI models; risks related to failing to properly manage our future growth; disruption by catastrophic events; risks associated with our dependence on our information technology systems; security breaches that we cannot anticipate or successfully defend; extensive regulatory requirements we face to bring our products to market; and third parties could develop and commercialize technology and products similar or identical to ours. For a more extensive description of these and other risks and uncertainties that could materially affect our results, you should read our filings with the SEC, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as such filings may be amended, supplemented or superseded from time to time by other reports Heartflow files with the SEC. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and we undertake no obligation to update the forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law. Investor ContactNick Laudiconlaudico@heartflow.com Media ContactElliot Levyelevy@heartflow.com ____________________1Gulati, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation & Diagnosis of Chest Pain. J Am Coll Cardiol2 Narula, et al. EHJ CVI 20243 Danad, et al. JAMA Cardiol 20174 Fairbairn et al. Coronary CT Angiography Plaque as a Predictor of Death, Cardiovascular Death and Myocardial Infarction. Presented at AHA 2025. (Real-world study with n=7,899 patients, higher TPV results in increased cardiovascular death and MI)5 Madsen KT, et al. ADVANCE-DK 7-year. Presented at TCT Scientific Sessions 2024 (n=900 patients determined a 2.5x increase in cardiovascular events or deaths at 7 years) HEARTFLOW, INC.Consolidated Statements of Operations Data(unaudited, in thousands, except share and per share data) Three Months Ended Six Months Ended June 30, June 30, 2026 2025 2026 2025 Revenue$64,082 $43,424 $116,669 $80,629 Cost of revenue 10,892 10,646 21,315 19,910 Gross profit 53,190 32,778 95,354 60,719 Operating Expenses: Research and development 26,261 15,032 47,881 28,956 Selling, general and administrative 44,829 31,461 87,395 62,980 Asset impairment charge – – 7,482 – Total operating expenses 71,090 46,493 142,758 91,936 Loss from operations (17,900) (13,715) (47,404) (31,217)Interest income 2,305 635 4,769 1,178 Interest expense – (6,621) (3) (11,714)Change in fair value of common stock warrant liability – (863) – (2,469)Change in fair value of derivative liability – 11,538 – 2,493 Other income (expense), net (126) (111) (440) 247 Loss before provision for income taxes (15,721) (9,137) (43,078) (41,482)Provision for income taxes (22) (59) (45) (59)Net loss$(15,743) $(9,196) $(43,123) $(41,541)Comprehensive loss: Net loss$(15,743) $(9,196) $(43,123) $(41,541)Other comprehensive loss: Foreign currency translation gain (loss) (9) 291 253 55 Unrealized loss on investments, net (204) – (726) – Total other comprehensive loss (213) 291 (473) 55 Total comprehensive loss$(15,956) $(8,905) $(43,596) $(41,486) Net loss per share, basic and diluted$(0.18) $(1.46) $(0.50) $(6.66)Weighted-average shares used to compute net loss per share, basic and diluted 86,398,778 6,316,315 86,021,323 6,240,885 HEARTFLOW, INC.Consolidated Balance Sheets Data(unaudited, in thousands, except par value) June 30, December 31, 2026 2025Assets Current assets Cash and cash equivalents$34,362 $44,776 Short-term investments 128,189 132,010 Accounts receivable, net 42,761 29,343 Prepaid expenses and other current assets 18,657 14,075 Total current assets 223,969 220,204 Long-term investments 84,289 103,365 Property and equipment, net 9,646 8,587 Operating lease right-of-use assets 15,236 17,488 Restricted cash, non-current 4,702 4,709 Other non-current assets 6,621 5,099 Total assets$344,463 $359,452 Liabilities and stockholders’ equity Current liabilities Accounts payable$4,937 $3,169 Accrued expenses and other current liabilities 32,367 33,279 Operating lease liabilities, current portion 6,784 5,922 Total current liabilities 44,088 42,370 Operating lease liabilities, non-current portion 20,343 16,132 Other non-current liabilities 305 303 Total liabilities 64,736 58,805 Stockholders’ equity Preferred stock, $0.001 par value – – Common stock, $0.001 par value 87 85 Additional paid-in capital 1,411,411 1,388,737 Accumulated other comprehensive loss (898) (425)Accumulated deficit (1,130,873) (1,087,750)Total stockholders’ equity 279,727 300,647 Total liabilities and stockholders’ equity$344,463 $359,452 HEARTFLOW, INC. GAAP to Non-GAAP Reconciliations (unaudited, in thousands except for per share amounts and percentage data) Three Months Ended June 30, 2026 Three Months Ended June 30, 2025 GAAP Adjustments Non-GAAP GAAP Adjustments Non-GAAP Gross profit $53,190 $173 (a)$53,363 $32,778 $45 (a)$32,823 Gross margin 83.0% 0.3% 83.3% 75.5% 0.1% 75.6% Operating Expenses: Research and development $26,261 $(2,732)(a)$23,529 $15,032 $(381)(a)$14,651 Selling, general and administrative $44,829 $(7,071)(b)$37,758 $31,461 $(1,827)(a)$29,634 Total operating expenses $71,090 $(9,803) $61,287 $46,493 $(2,208) $44,285 Loss from operations $(17,900) $9,976 $(7,924) $(13,715) $2,253 $(11,462) Net loss $(15,743) $9,976 (c)$(5,767) $(9,196) $(8,422)(d)$(17,618) Net loss per share, basic and diluted $(0.18) $0.11 $(0.07) $(1.46) $(1.33) $(2.79) (a) Represents adjustments related to stock-based compensation expense (b) Represents adjustments for: (i) stock-based compensation expense of $5.0 million; and (ii) certain litigation expenses of $2.1 million (c) Represents adjustments for: (i) stock-based compensation expense of $7.9 million; and (ii) certain litigation expenses of $2.1 million (d) Represents adjustments for: (i) stock-based compensation expense of $2.3 million; (ii) change in fair value of common stock warrant liability of $0.9 million; and (iii) change in fair value of derivative liability of $11.5 million Six Months Ended June 30, 2026 Six Months Ended June 30, 2025 GAAP Adjustments Non-GAAP GAAP Adjustments Non-GAAP Gross profit $95,354 $340 (a)$95,694 $60,719 $102 (a)$60,821 Gross margin 81.7% 0.3% 82.0% 75.3% 0.1% 75.4% Operating Expenses: Research and development $47,881 $(4,871)(a)$43,010 $28,956 $(928)(a)$28,028 Selling, general and administrative $87,395 $(11,736)(b)$75,659 $62,980 $(3,715)(a)$59,265 Asset impairment charge $7,482 $(7,482) $- $- $- $- Total operating expenses $142,758 $(24,089) $118,669 $91,936 $(4,643) $87,293 Loss from operations $(47,404) $24,429 $(22,975) $(31,217) $4,745 $(26,472) Net loss $(43,123) $24,429 (c)$(18,694) $(41,541) $4,721 (d)$(36,820) Net loss per share, basic and diluted $(0.50) $0.28 $(0.22) $(6.66) $0.76 $(5.90) (a) Represents adjustments related to stock-based compensation expense (b) Represents adjustments for: (i) stock-based compensation expense of $9.3 million; (ii) certain litigation expenses of $2.5 million; and (iii) asset impairment charge of $7.5 million (c) Represents adjustments for: (i) stock-based compensation expense of $14.5 million; (ii) certain litigation expenses of $2.5 million; and (iii) asset impairment charge of $7.5 million (c) Represents adjustments for: (i) stock-based compensation expense of $4.7 million; (ii) change in fair value of common stock warrant liability of $2.5 million; and (iii) change in fair value of derivative liability of $2.5 million HEARTFLOW, INC.Reconciliation of GAAP Net Loss to Adjusted EBITDA(unaudited, in thousands) Three Months Ended Six Months Ended June 30, June 30, 2026 2025 2026 2025 GAAP net loss$(15,743) $(9,196) $(43,123) $(41,541)Non-GAAP adjustments: Interest (income) expense, net (2,305) 5,986 (4,766) 10,536 Asset impairment charge – – 7,482 – Change in fair value of common stock warrant liability – 863 – 2,469 Change in fair value of derivative liability – (11,538) – (2,493)Other (income) expense, net 126 111 440 (247)Provision for income taxes 22 59 45 59 Certain litigation expenses 2,064 – 2,481 – Depreciation and amortization 1,220 1,395 2,643 2,767 Stock-based compensation expense 7,912 2,253 14,466 4,745 Adjusted EBITDA$(6,704) $(10,067) $(20,332) $(23,705)
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WallabyPhenox Announces First Patient Enrolled in PROMISE Study Evaluating Treatment of Medium Vessel Occlusion Stroke
IRVINE, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) — WallabyPhenox today announced that the first patient has been enrolled in PROMISE (PROspective study on Management of Ischemic Stroke secondary to mEvo), an investigator initiated prospective study examining how medium vessel occlusion (MeVO) acute ischemic strokes are managed within the first 24 hours. The first subject was enrolled at Indiana University, Methodist Hospital. Dr. Devi Patra and Dr. Ann Jones are co-leads at Indiana University. Medium vessel occlusions account for a meaningful share of acute ischemic strokes, yet the field has not reached consensus on how best to treat them — mechanical thrombectomy versus medical management. PROMISE is designed to capture real-world practice across participating U.S. sites and to help characterize the current “equipoise” among treating physicians, enrolling patients managed with mechanical thrombectomy as well as those treated medically and following their outcomes over six months. “Management for MeVO related stroke is one of the next frontiers in advancing care for stroke patients. We planned this study to better understand the practice and challenges involved in management of these patients in a prospective, unbiased way. To achieve a higher level of nuanced understanding we planned the imaging to be core lab adjudicated. I thank WallabyPhenox for their support to this investigator-initiated project.” — Kaustubh Limaye, MD, Global Principal Investigator, Associate Professor at Indiana University Medical Center “This important study is expected to help answer a critical clinical question: whether revascularization attempt benefits patients with medium-vessel occlusion (MeVO). Current evidence remains largely equivocal, underscoring the need for clearer data to guide treatment decisions,” said Dr. Devi Patra, MD, a neuroendovascular surgeon at Indiana University Medical Center. Dr. Froehler, Director of Cerebrovascular Program at Vanderbilt University Medical Center said, “This study is important because it includes all MVO patients; not just those treated endovascularly. The results will help us to understand real-world MVO outcomes.” WallabyPhenox is supporting PROMISE as part of its commitment to advancing the evidence base behind stroke care. “Reaching first enrollment in PROMISE reflects WallabyPhenox’s commitment to advancing the science behind stroke care, not just the tools that support it. We’re proud to stand behind Dr. Limaye and the investigators as they generate the evidence the neurovascular community needs to make the best possible decisions for MeVO patients.” — Ruilin Zhao, Chief Executive Officer, WallabyPhenox The registry plans to enroll patients across 30 participating U.S. sites. The study is registered with Clinical Trials.gov https://clinicaltrials.gov/study/NCT07746947 CONTACT: CONTACT Ruilin Zhao
Chief Executive Officer
COMPANY WallabyPhenox
PHONE 1-844-674-3669
EMAIL cs@phenox.com
WEB https://www.phenox.com/
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SeaStar Medical Reports Second Quarter 2026 Financial Results and Provides Business Updates
Added 3 top-rated children’s hospitals to QUELIMMUNE® pediatric acute kidney injury (AKI) customer base, increasing net revenue 82% versus second quarter 2025 Advanced enrollment in the NEUTRALIZE-AKI pivotal clinical trial in adult patients with AKI Obtained ICD-10-PCS codes to enable standardized inpatient hospital billing for its selective cytopheretic device (SCD) therapy, including QUELIMMUNE Webcast today at 4:30 pm Eastern Time DENVER, Aug. 12, 2026 (GLOBE NEWSWIRE) — SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life, announced today financial results for the three months ended June 30, 2026, and provided business updates on key initiatives. “The enthusiasm for the use of our QUELIMMUNE therapy is resonating broadly throughout the pediatric critical care community,” said Eric Schlorff, CEO of SeaStar Medical. “We believe our continued QUELIMMUNE revenue growth bodes well for our future potential opportunity in the adult AKI market that is 50 times larger than the current pediatric market in the U.S.” Mr. Schlorff continued, “We are keenly focused on achieving our enrollment target of 339 adult AKI patients in the NEUTRALIZE-AKI trial, and we are working with the FDA on our modular Premarket Approval (PMA) application for our SCD therapy as an organ-sparing and life-saving treatment for the adult patient population. With strong gross margins for QUELIMMUNE and universal ICD-10-PCS codes already established for our SCD therapies, we believe this first-in-class therapy for the treatment of adult patients with AKI has clear potential to both save lives and create significant shareholder value, should we obtain FDA approval.” Key Business Highlights SeaStar Medical’s achievements since the beginning of the second quarter of 2026 include the following: Expanded the use of QUELIMMUNE (SCD-PED) therapy for ultra-rare pediatric AKI, adding 3 new customers from top-rated children’s hospitals, bringing the total customer base to 20 and building increased depth in customer orders. This led to second quarter 2026 net revenue of $0.6 million for QUELIMMUNE product sales, an increase of 82% versus the second quarter of 2025.Advanced enrollment in the NEUTRALIZE-AKI pivotal clinical trial evaluating the SCD therapy as a potential treatment of adult patients with AKI in the ICU receiving continuous renal replacement therapy. The trial has enrolled 223 of 339 patients to date. Completion of enrollment is anticipated around year end or into the first quarter of 2027, which would enable a PMA application to the FDA near the end of 2027, pending a positive outcome of the trial.Received from the Centers for Medicare & Medicaid Services (CMS) dedicated International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) codes. These codes enable administrative, billing, and statistical reporting for the use of SeaStar Medical’s SCD therapy in patients with AKI requiring renal replacement therapy in the inpatient hospital setting. The new ICD-10-PCS codes are expected to take effect on October 1, 2026.Sponsored and participated in the KidneyBee Summit 2026. The Summit, which occurs annually, is a highly specialized, interdisciplinary conference that brings together nurses, advanced practice providers, and physicians from across the country. Its core importance stems from tackling the exact systemic failures that leave pediatric kidney failure under-recognized.Assembled leading experts in the treatment of pediatric AKI to speak at the SeaStar Medical educational webinar, “Rethinking Pediatric Sepsis-Associated AKI,” that brought together practicing pediatric nephrologists, critical care physicians, advanced practice providers, nurses, and critical care teams to learn more about pediatric sepsis-associated AKI and the use of the QUELIMMUNE therapy. Financial Results for the Second Quarter 2026 Net revenue for the three months ended June 30, 2026, was approximately $0.6 million reflecting increased demand for the QUELIMMUNE therapy. This compared to net revenue of approximately $0.3 million for the three months ended June 30, 2025. Cost of goods sold for the three months ended June 30, 2026, and 2025, was $54 thousand and $27 thousand reflecting gross margins of 91% and 92% for the three months ended June 30, 2026, and 2025, respectively. Research and development expenses for the three months ended June 30, 2026, and 2025, were $2.5 million and $1.0 million, respectively. The increase in research and development expenses was primarily driven by increased clinical trial expenses and personnel costs. General and administrative expenses for the three months ended June 30, 2026, and 2025, were approximately $1.8 million and $1.0 million, respectively. The increase in general and administrative expenses was the result of an increase in compensation costs, legal and professional fees, and certain Securities and Exchange Commission (SEC) related expenses. Other income (net) was $0.1 million for the three months ended June 30, 2026, compared to other expense (net) of $0.2 million for the three months ended June 30, 2025. The change was primarily related to a reduction in financing fees and increased interest income. Net loss for the three months ended June 30, 2026, was approximately $3.7 million, or $0.91 per share on approximately 4.1 million weighted-average shares outstanding. This compares with a net loss of approximately $2.0 million, or $1.77 per share, on approximately 1.1 million weighted-average shares outstanding for the three months ended June 30, 2025. Cash at June 30, 2026, was $7.0 million, compared to $12.0 million at December 31, 2025. SeaStar Medical Second Quarter Financial Results Conference CallDate/Time:Wednesday, August 12, 2026, at 4:30 p.m. ET / 2:30 p.m. MTWebcast:The live webcast and replay can be found here.Register for the call:Preregistration is required to attend the live call and can be accessed here. A pin code and dial in number will be provided with registration. A replay of the call will be available after 7:30 p.m. ET and can be accessed here. About QUELIMMUNE The QUELIMMUNE® (SCD-PED) therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with RRT. It was approved in February 2024 under a Humanitarian Device Exemption application. Data from two clinical trials of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors, and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge. In February 2026, data published in the prestigious, peer-reviewed journal, Pediatric Nephrology, highlighted the early experience from the QUELIMMUNE SAVE Registry, a post-approval surveillance registry, evaluating the role of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI) and sepsis requiring renal replacement therapy. Observations from the first 21 pediatric patients with AKI and sepsis requiring renal replacement therapy showed no device-related adverse events or infections and no reports of immunosuppressive effects by the device. In addition, preliminary outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90. These new data are on track to validate a 50% reduction in patient mortality at 60 days compared to historical data, similar to what was observed in the registration study reported in Kidney Medicine. The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy and has broad applications for treating the destructive hyperinflammation that shuts down organ function and causes loss of life. About the SeaStar Medical Selective Cytopheretic Device (SCD) Therapy The SCD therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy is designed for broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous RRT hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future continuous RRT, including dialysis, and prevent loss of life. About NEUTRALIZE-AKI Pivotal Trial The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU receiving continuous RRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to continuous RRT as the standard of care, compared with the control group receiving only continuous RRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. About Acute Kidney Injury (AKI) and Hyperinflammation AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as severe infections or other septic conditions, severe trauma, surgery, and organ failures. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation. About SeaStar Medical SeaStar Medical is a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life. SeaStar Medical’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening Acute Kidney Injury (AKI) due to sepsis or a septic condition requiring renal replacement therapy (RRT) in critically ill pediatric patients. SeaStar Medical’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting the NEUTRALIZE-AKI pivotal clinical trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually. For more information visit www.seastarmedical.com or visit us on LinkedIn or X. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements include, without limitation, SeaStar Medical’s expectations with respect our future potential opportunity in the adult AKI market; the size of the adult AKI market compared to the pediatric market; commercial acceptance of QUELIMMUNE; the ability of SCD to treat patients with AKI and other diseases; ; the anticipated timing of regulatory submissions; the ability to meet our enrollment targets; the ability to create shareholder value; the expected regulatory approval process and timeline for commercialization; and the ability of SeaStar Medical to meet the expected timeline. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to secure additional financing on acceptable terms; (vi) the risk that third-party suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Contact: IR@SEASTARMED.COM SeaStar Medical Holding CorporationCondensed Consolidated Balance Sheets(in thousands, except for share and per-share amounts) June 30,2026 December 31, 2025 (unaudited) ASSETS Current assets Cash $6,959 $11,980 Accounts receivable, net of allowance for credit losses of $2 and $3, respectively 208 237 Inventory 77 66 Prepaid expenses 984 1,297 Total current assets 8,228 13,580 Other assets 421 578 Total assets $8,649 $14,158 LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIT) Current liabilities Accounts payable $750 948 Accrued expenses 3,468 2,268 Notes payable, net of deferred financing costs 134 525 Liability classified warrants 1 1 Total current liabilities 4,353 3,742 Total liabilities 4,353 3,742 Commitments and contingencies (Note 10) Stockholders’ equity Preferred stock – $0.0001 par value, 10,000,000 shares authorized at June 30, 2026 and December 31, 2025; no shares issued and outstanding at June 30, 2026 and December 31, 2025 — — Common stock – $0.0001 par value per share; 425,000,000 and 450,000,000 shares authorized at June 30, 2026 and December 31, 2025, respectively; 4,259,842 and 3,844,613 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively 4 4 Additional paid-in capital 163,257 162,126 Accumulated deficit (158,965) (151,714)Total stockholders’ equity 4,296 10,416 Total liabilities and stockholders’ equity $8,649 $14,158 SeaStar Medical Holding CorporationCondensed Consolidated Statements of Operations(unaudited)(in thousands, except for share and per-share amounts) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Net revenue $615 $338 $1,110 $631 Cost of goods sold 54 27 100 27 Gross profit 561 311 1,010 604 Operating expenses Research and development 2,520 1,037 4,864 3,468 General and administrative 1,832 1,030 3,540 2,716 Total operating expenses 4,352 2,067 8,404 6,184 Loss from operations (3,791) (1,756) (7,394) (5,580)Other income (expense) Interest income 69 45 160 93 Interest expense (8) (9) (14) (18)Other financing costs — (298) — (298)Change in fair value of warrants liability — 16 — 32 Total other income (expense), net 61 (246) 146 (191)Loss before provision for income taxes (3,730) (2,002) (7,248) (5,771)Provision for income taxes — — 3 3 Net loss $(3,730) $(2,002) $(7,251) $(5,774)Net loss per share of common stock, basic and diluted $(0.91) $(1.77) $(1.81) $(5.78)Weighted-average shares outstanding, basic and diluted 4,084,283 1,132,952 4,001,770 998,122 SeaStar Medical Holding CorporationCondensed Consolidated Statements of Cash Flows(unaudited)(in thousands) Six Months Ended June 30, 2026 2025 Cash flows from operating activities Net loss $(7,251) $(5,774)Adjustments to reconcile net loss to net cash used in operating activities Amortization of deferred financing costs 14 18 Change in fair value of liability classified warrants — (32)Shares issued for the standby equity purchase agreement commitment fee — 298 Stock-based compensation (8) 264 Change in operating assets and liabilities Accounts receivables 29 (105)Inventory (11) (77)Prepaid expenses 313 784 Other assets 157 156 Accounts payable (198) 112 Accrued expenses 1,200 (1,305)Net cash used in operating activities (5,755) (5,661) Cash flows from financing activities Proceeds from issuance of shares, net of offering costs 1,139 5,154 Proceeds from exercise warrants — 2 Proceeds of pre-funded warrants — 5,580 Payment of notes payable (405) (592)Net cash provided by financing activities 734 10,144 Net increase (decrease) in cash (5,021) 4,483 Cash, beginning of period 11,980 1,819 Cash, end of period $6,959 $6,302 QUELIMMUNE is a registered trademark of SeaStar Medical Holding Corporation.



