PALO ALTO, Calif.–(BUSINESS WIRE)– #BioPharma–Greenstone Biosciences, a biotechnology company advancing New Approach Methodologies (NAMs) for drug discovery, today announced that it has received a Catalyze R61 award from the National Heart, Lung, and Blood Institute (NHLBI), a component of the National Institutes of Health (NIH). The award funds a research program to discover novel drug candidates for myocardial fibrosis and dilated cardiomyopathy in Duchenne muscular dystrophy (DMD). DMD is a rare genet
Financial
Profound Medical Reports Second Quarter 2026 Financial Results
– Operating expenses decline 16%, helping drive a 39% improvement in net loss – – Approximately $3.1 million of TULSA revenue recognition shifts into early Q3 due to shipment timing – – Strong clinical, commercial and reimbursement momentum continues – – Company reiterates full-year 2026 revenue guidance – – Announces first employer owned health plans to list the TULSA Procedure™ as a covered service – TORONTO, Aug. 06, 2026 (GLOBE NEWSWIRE) — Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets innovative interventional MRI (“iMRI”) procedures, today announced financial results for the second quarter ended June 30, 2026. Unless specified otherwise, all amounts in this press release are expressed in U.S. dollars and are presented in accordance with U.S. generally accepted accounting principles (U.S. GAAP). “Commercial momentum continued to accelerate during the second quarter,” said Arun Menawat, Profound’s CEO and Chairman. “We received over $7.0 million in new purchase orders, a new quarterly record. Approximately $2.5 million of those orders were recognized as revenue during the quarter, while approximately $3.1 million was shipped in July and will be recognized in the third quarter. The shipment timing reflected a temporary logistics issue—not customer demand—and, absent the timing difference, second quarter revenue would have increased approximately 153% year-over-year. The logistics issue has since been resolved. Beyond top-line growth, our business model continued to demonstrate meaningful operating leverage. Gross margin remained above our long-term target of 70%, operating expenses declined 16%, and net loss improved by 39% year-over-year. Momentum has continued into the third quarter, including another monthly record for new order activity in July and exceptional physician engagement at SRS2026 that generated more than 160 qualified commercial opportunities over just four days. Based on continued payer coverage expansion, growing clinical validation, and a strengthening sales pipeline, we believe we are now in the strongest commercial position in the Company’s history. Based on this momentum and our improved visibility into the second half of the year, we are reiterating the $25.0 million bar we previously set for 2026 total revenue.” Business Highlights Clinical Momentum The post-market CAPTAIN Level 1 randomized clinical data continued to demonstrate statistically significant advantages of the TULSA Procedure™ over robotic radical prostatectomy, with new penile length preservation data presented in July 2026.Physician awareness of, and engagement with, the TULSA Procedure continued to expand through presentations at the 2026 meetings of the Society of Interventional Radiology (SIR), the American Urological Association (AUA), and the Society of Robotic Surgery (SRS). Reimbursement Expansion Payer coverage expanded by approximately 18.3 million covered lives during the second quarter, substantially broadening patient access to the TULSA Procedure. Most of the newly covered lives came through state Medicaid and managed Medicaid (Ambetter) programs.Today, Profound is pleased to announce that the Johns Hopkins Employee Health Plan and the Prime Healthcare Employee Health Plan, covering more than 50,000 and 55,000 employees, medical staff and family members, respectively, have become the first employer owned health plans to list the TULSA Procedure as a covered service. Commercial Execution & Adoption Profound’s TULSA-PRO® installed base increased to 84 at the end of Q2-2026.Profound estimates that the current aggregate total dollar value of its qualified sales pipeline (defined as within one of the “Verify, Negotiate and Contracting” stages) for TULSA-PRO and Sonalleve® is approximately $70.0 million.* Continuing Innovation Profound also launched an initiative to explore the potential of integrating PSMA PET molecular imaging technologies with the TULSA Procedure to support intention-to-treat decisions and patient monitoring. * There can be no assurance given with respect to the extent and/or timing of the Company’s qualified sales pipeline resulting in recognized revenue. Q2-2026 Clinical Utilization Trends Physicians continued to utilize the TULSA Procedure’s customizable prostate tissue ablation capabilities in the second quarter of 2026: Prostate Condition Ablation of malignant prostate tissueAblation of malignant and benign enlarged prostate tissueAblation of recurrent malignant prostate tissueAblation of benign enlarged prostate tissue71%(12% GG1, 58% GG2, 21% GG3, 9% GG4&5)14%11%4% Regional Ablation Whole-glandSub-total but more than half the glandHemi-ablationFocal therapy43%24%21%12% Prostate Size 100 cc8%39%31%17%5% TULSA INDEX20 Introduced by the Company in the first quarter of 2026, the following supplemental ‘same-store’ TULSA Procedure volume analysis is designed to track a fixed cohort (i.e. without any changes or substitutions) of 20 active commercial TULSA-PRO sites over time. The TULSA INDEX20 includes a representative variety of providers, including teaching hospitals and private-pay practices, all of which have been performing TULSA Procedures for at least 12 months. Geographically, 80% of the index sites are in the U.S. and 20% are international. TULSA INDEX20Q2-2025Q3-2025Q4-2025Q1-2026Q2-2026# TULSA Sites2020202020Average Procedures/Quarter8.28.610.311.310.0Average Procedures Annualized32.834.441.245.240.0Quarter-Over-Quarter Sequential Growth15%5%20%10%(12%)H1-2026 Over H1-2025 Growth 39%Quarterly Year-Over-Year Growth 22% Summary Second Quarter 2026 Results For the quarter ended June 30, 2026, Profound recorded total revenue of approximately $2.5 million, up 12% year-over-year, including $1.6 million of recurring non-capital revenue from single-use devices and services associated with extended warranties, and $871,000 from capital equipment sales. Approximately $3.1 million of TULSA product shipments originally anticipated in the final week of June were completed in July. The timing affected only the period of revenue recognition and did not reflect any change in customer demand or order activity. Excluding this shipment timing, second quarter revenue would have been approximately $5.6 million, representing 153% year-over-year growth. Gross margin expanded to 78% in Q2-2026 from 73% in the prior-year period, reflecting a favorable product mix, including multiple capital system sales that were previously under operating leases to customers. Operating expenses declined 16% year over year to approximately $13.0 million, primarily reflecting lower personnel, commercial, travel, insurance and CAPTAIN clinical trial costs following completion of enrollment. These reductions were partially offset by higher R&D investments focused on product cost reduction, quality improvements and manufacturing efficiencies. Second quarter 2026 net loss was approximately $9.5 million, or $0.26 per common share, a 39% improvement from a net loss of approximately $15.7 million, or $0.52 per common share, in the three months ended June 30, 2025. Liquidity and Outstanding Share Capital As at June 30, 2026, Profound had cash of approximately $38.3 million. As at August 6, 2026, Profound had 36,532,594 common shares issued and outstanding. For complete financial results, please see Profound’s filings, which will be made available under Profound’s profile at www.sedarplus.com, www.sec.gov and on Profound’s website under “SEC & SEDAR+ Filings.” Full Year 2026 Financial Outlook Based on record order activity, continued expansion of its commercial pipeline and improved visibility into second-half shipments, Profound continues to project total revenue for full-year 2026 to be approximately $25.0 million, which represents 56% growth compared to its prior year revenue. The Company also continues to expect full year 2026 gross margin to be 70% or higher. Conference Call Details Profound is pleased to invite all interested parties to participate in a conference call today at 4:30 pm ET during which time the results will be discussed. To participate in the conference call by telephone, please pre-register via this link to receive the dial-in number and your unique PIN. The call will also be broadcast live and archived on Profound’s website in the Investors section here. About Profound Medical Corp. Profound is a commercial-stage medical device company and an innovator in interventional MRI (iMRI) procedures. The company’s flagship platform, TULSA-PRO®, enables MRI-guided, incision-free prostate ablation. Physicians use the TULSA Procedure™ to see, ablate, and confirm therapy in real time, supporting personalized treatment strategies across the continuum of prostate care—from whole-gland to subtotal, hemi, multifocal, and focal treatment. This approach enables individualized care using prostate tissue ablation, while minimizing the potential of the side effects that are typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction. Profound also commercializes Sonalleve®, an MRI-guided therapy that provides a non-surgical treatment option for pain palliation of bone metastases, desmoid tumors, and osteoid osteoma, as well as for common gynecologic conditions including uterine fibroids and adenomyosis. Sonalleve delivers targeted therapy with no incisions, no blood loss during the procedure, no overnight hospital stay, and faster recovery — and, in gynecologic applications, enables uterine-sparing treatment that may help preserve fertility. Profound is also exploring additional clinical applications for Sonalleve, including non-invasive ablation of abdominal cancers and hyperthermia-based cancer therapies. Profound Medical’s technologies are approved across major global markets. TULSA-PRO is cleared by the FDA in the United States for transurethral ultrasound ablation (TULSA) of prostate tissue. In addition, TULSA-PRO is cleared for use in various jurisdictions including Europe, Canada, Saudi Arabia, India, Australia/New Zealand, and the UAE. Sonalleve is approved by the FDA as HDE in the United States for the treatment of osteoid osteomas in the extremities. Sonalleve is also cleared or approved in the Europe, Canada, China, and Saudi Arabia. Through real-time MRI guidance and data-driven innovation, Profound is advancing the future of MRI-guided therapy — expanding access to precise, personalized, and incision-free treatment options worldwide. Forward-Looking Statements This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technologies for disease conditions requiring MR-Guided ablation procedures for prostate, uterine fibroids, adenomyosis, palliative pain treatment, desmoid tumors, and osteoid osteoma; the extent and timing of Profound’s completion of TULSA-PRO® and Sonalleve® system sales from its qualified sales pipeline; Profound’s expectations for future revenues/financial results; and the success of Profound’s commercialization strategy and activities for TULSA-PRO and Sonalleve. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound 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. No forward-looking statement can be guaranteed. Other factors and risks that may cause actual results to differ materially from those set out in the forward-looking statements are described in Profound’s Annual Report on Form 10-K and other filings made with U.S. and Canadian securities regulators, available at www.sedarplus.com and www.sec.gov. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law. Financial Outlook This press release contains a financial outlook within the meaning of applicable securities laws. The financial outlook has been prepared by management of the Company to provide an outlook for the Company’s forecasted revenue for the 12 months to be ended December 31, 2026, and may not be appropriate for any other purpose. The financial outlook has been prepared based on a number of assumptions, including the assumptions discussed under the heading “Forward-Looking Statements” herein. The actual results of the Company’s operations for any period may vary from the amounts set forth in these projections, and such variations may be material. The Company and its management believe that the financial outlook has been prepared on a reasonable basis. However, because this information is highly subjective and subject to numerous risks, including the risks discussed under the heading “Forward-Looking Statements” herein, it should not be relied on as necessarily indicative of future results. For further information, please contact: Stephen KilmerInvestor Relationsskilmer@profoundmedical.com T: 647.872.4849 Profound Medical Corp.CONDENSED CONSOLIDATED BALANCE SHEETS (USD in thousands, except per share data) (unaudited) June 30, 2026$ December 31, 2025$ Assets Current assets: Cash38,271 59,723 Trade and other receivables, net9,614 7,200 Inventory10,456 8,238 Prepaid expenses and deposits523 928 Total current assets58,864 76,089 Trade and other receivables, net- 300 Property and equipment, net556 698 Intangible assets, net121 138 Right-of-use assets, net2,763 184 Deferred tax assets, net81 66 Total assets62,385 77,475 Liabilities Current liabilities: Accounts payable955 1,563 Accrued expenses and other current liabilities3,127 3,815 Deferred revenue342 445 Long-term debt4,507 – Lease liabilities119 213 Income tax payable63 39 Total current liabilities9,113 6,075 Deferred revenue618 388 Long-term debt- 4,499 Lease liabilities2,754 – Other non-current liabilities92 79 Total liabilities12,577 11,041 Shareholders’ equity Common shares, no par value, unlimited shares authorized, 36,532,594 and 36,293,640 issued and outstanding at June 30, 2026 and December 31, 2025, respectively325,383 323,839 Additional paid-in capital25,688 25,310 Accumulated other comprehensive income3,070 5,025 Accumulated deficit(304,333)(287,740)Total shareholders’ equity49,808 66,434 Total liabilities and shareholders’ equity62,385 77,475 Profound Medical Corp.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME(USD in thousands, except per share data) (unaudited) Three Months EndedJune 30, Six Months EndedJune 30, 2026$ 2025$ 2026$ 2025$ Revenue Recurring – non-capital1,612 1,561 4,086 3,362 Capital equipment871 650 3,734 1,470 2,483 2,211 7,820 4,832 Cost of sales536 593 2,041 1,361 Gross profit1,947 1,618 5,779 3,471 Operating expenses Research and development5,654 6,098 10,916 10,906 Selling, general and administrative7,359 9,326 13,950 17,537 Total operating expenses13,013 15,424 24,866 28,443 Operating loss11,066 13,806 19,087 24,972 Other (income) expenses Net finance income(336)(343)(713)(788)Net foreign exchange (gain) loss(1,245)2,168 (1,861)2,130 Total other (income) expenses(1,581)1,825 (2,574)1,342 Net loss before income taxes9,485 15,631 16,513 26,314 Income tax expense68 78 95 119 Deferred tax recovery(13)(14)(15)(14)Total income tax expense55 64 80 105 Net loss attributed to shareholders for the period9,540 15,695 16,593 26,419 Other comprehensive (income) loss Item that may be reclassified to (income) loss Foreign currency translation adjustment950 (2,713)1,955 (2,816) Net loss and other comprehensive loss for the period10,490 12,982 18,548 23,603 Loss per share Basic and diluted net loss per common share0.26 0.52 0.46 0.88 Basic and diluted weighted average common shares outstanding36,350,665 30,053,142 36,324,393 30,055,047 Profound Medical Corp.CONDENSED CONSOLIDATED STATEMENTS OF CASHFLOWS(USD in thousands, except per share data) (unaudited) Six Months Ended June 30, 2026$ 2025$ Cash flows from operating activities Net loss for the period(16,593)(26,419)Adjustments to reconcile net loss to net cash provided by operating activities: Depreciation of property and equipment219 218 Amortization of intangible assets16 86 Non-cash lease expense adjustment99 (19)Share-based compensation1,922 2,440 Interest and accretion expense9 51 Changes in operating assets and liabilities: Trade and other receivables(2,473)2,449 Inventory(2,686)(2,723)Prepaid expenses and deposits384 1,042 Accounts payable, accrued expenses and other liabilities(991)545 Deferred revenue164 317 Income taxes payable27 – Deferred tax assets(18)(14)Net cash used in operating activities(19,921)(22,027) Cash flows from financing activities Repayments of long-term debt- (290)Net cash provided by (used in) financing activities- (290) Net increase (decrease) in cash(19,921)(22,317)Effect of exchange rate changes on cash(1,531)2,600 Cash, beginning of period59,723 54,912 Cash, end of period38,271 35,195
CVRx Reports Second Quarter 2026 Financial and Operating Results
MINNEAPOLIS, Aug. 06, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced its financial and operating results for the second quarter of 2026. Recent Highlights Total revenue for the second quarter of 2026 was $15.7 million, an increase of approximately 16% over the prior year quarterU.S. revenue for the second quarter of 2026 was $14.8 million, an increase of 21% over the prior year quarterActive implanting centers in the U.S. grew to 258 as of June 30, 2026, as compared to 240 as of June 30, 2025Humana issued a Medicare Advantage coverage policy, effective May 1, 2026 for Barostim therapy, which is the first coverage policy of its kind for Barostim “We are pleased with the strong revenue growth and margin performance in the second quarter along with the reimbursement progress we made, including the new Medicare Advantage coverage policy from Humana. However, we are not satisfied with our updated outlook for the balance of the year, driven by fewer sales territories than anticipated, lower sales force productivity and a prolonged challenge with one of our largest payers,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “We are taking direct action to address these headwinds, and our confidence in the long-term fundamentals of this business remains high, supported by strong growth observed in our most stable regions and encouraging early progress on the BENEFIT-HF trial and our broader clinical and reimbursement strategies.” Second Quarter 2026 Financial and Operating Results Revenue was $15.7 million for the three months ended June 30, 2026, an increase of $2.1 million, or 16%, over the three months ended June 30, 2025. Revenue generated in the U.S. was $14.8 million for the three months ended June 30, 2026, an increase of $2.5 million, or 21%, over the three months ended June 30, 2025. Revenue units in the U.S. totaled 466 and 391 for the three months ended June 30, 2026 and 2025, respectively. The increases were primarily driven by continued growth in the U.S. HF business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of Barostim. As of June 30, 2026, the Company had a total of 258 active implanting centers in the U.S., as compared to 240 as of June 30, 2025. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. As of June 30, 2026, the number of sales territories in the U.S. is 56 as compared to 47 sales territories as of June 30, 2025. Revenue generated in Europe was $0.9 million for the three months ended June 30, 2026, a decrease of $0.4 million, or 31%, compared to the three months ended June 30, 2025. Total revenue units in Europe decreased to 40 for the three months ended June 30, 2026, from 61 in the prior year period. The number of sales territories in Europe remained consistent at five as of June 30, 2026. Gross profit was $13.7 million for the three months ended June 30, 2026, an increase of $2.3 million, or 20%, over the three months ended June 30, 2025. Gross margin was 87% and 84% for the three months ended June 30, 2026 and June 30, 2025, respectively. R&D expenses increased $0.7 million, or 27%, to $3.1 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. This change was driven by a $0.6 million increase in headcount expenses and a $0.1 million increase in clinical trial expenses. SG&A expenses increased $0.3 million, or 1%, to $23.6 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. This change was primarily driven by a $0.7 million increase in non-cash stock-based compensation expenses and a $0.5 million increase in legal expenses, partially offset by a $0.6 million decrease in advertising expenses and a $0.3 million decrease in travel expenses. Interest expense increased $0.1 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, driven by interest expense on the increased borrowings under the term loan agreement with Innovatus Capital Partners. Other income, net was $0.6 million and $1.1 million for the three months ended June 30, 2026 and 2025, respectively. These balances consisted of interest income on our interest-bearing accounts. The decrease was primarily driven by the lower cash balance. Net loss was $14.0 million, or $0.53 per share, for the three months ended June 30, 2026, compared to a net loss of $14.7 million, or $0.57 per share, for the three months ended June 30, 2025. Net loss per share was based on 26.5 million weighted average shares outstanding for three months ended June 30, 2026 and 26.1 million weighted average shares outstanding for the three months ended June 30, 2025. As of June 30, 2026, cash and cash equivalents were $64.6 million. Net cash used in operating and investing activities was $8.9 million for the three months ended June 30, 2026, compared to $8.0 million for the three months ended June 30, 2025. Humana Medicare Advantage Coverage Policy In May 2026, Humana issued a Medicare Advantage coverage policy for Barostim therapy, effective May 1, 2026. Humana, a national health insurance company with the second largest Medicare Advantage program in the U.S., provides coverage to approximately 5.2 million Medicare Advantage members across 46 states. The policy covers Barostim for patients meeting its current FDA-approved indication as well as patients enrolled in the BENEFIT-HF trial. This is now the third significant reimbursement development for Barostim this year, following the transition to Category I CPT codes and CMS approval of Category B IDE coverage for BENEFIT-HF patients, each of which took effect in the first quarter of 2026. Business Outlook For the full year of 2026, the Company now expects: Total revenue between $58.0 million and $60.0 million;Gross margin between 86% and 87%;Operating expenses between $99.0 million and $101.0 million. For the third quarter of 2026, the Company expects to report total revenue between $13.5 million and $14.5 million. Webcast and Conference Call Information The Company will host a conference call to review its results at 4:30 p.m. Eastern Time today. A live webcast of the investor conference call will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-877-704-4453 for U.S. callers, or 1-201-389-0920 for international callers, approximately ten minutes prior to the start time. About CVRx, Inc. CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding our future financial performance (including our financial guidance regarding full year and third quarter 2026 results), our anticipated growth strategies (including statements regarding the expected timing, enrollment, scope and outcomes of the BENEFIT-HF clinical trial, potential expansion of the Barostim indication, and anticipated benefits of Barostim therapy), anticipated trends in our industry, our business prospects and our opportunities. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “outlook,” “guidance,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our expectations regarding enrollment in BENEFIT-HF and the resulting impact on our addressable market; our history of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to continue demonstrating to physicians and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product, including those resulting from the BENEFIT-HF trial; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily Meyers CVRx, Inc. 763-416-2853emeyers@cvrx.com CVRx, INC.Condensed Consolidated Balance Sheets(In thousands, except share and per share data)(Unaudited) June 30,2026 December 31,2025Assets Current assets: Cash and cash equivalents$64,586 $75,708 Accounts receivable, net of allowances of $869 and $871, respectively 9,401 10,665 Inventory 13,028 12,205 Prepaid expenses and other current assets 2,473 3,069 Total current assets 89,488 101,647 Property and equipment, net 2,061 2,243 Operating lease right-of-use asset 708 878 Other non-current assets 26 26 Total assets$92,283 $104,794 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable$3,874 $3,833 Accrued expenses 7,250 9,484 Total current liabilities 11,124 13,317 Long-term debt 58,571 49,514 Operating lease liability, non-current portion 448 638 Other long-term liabilities 2,187 2,001 Total liabilities 72,330 65,470 Commitments and contingencies Stockholders’ equity: Common stock, $0.01 par value, 200,000,000 authorized as of June 30, 2026 and December 31, 2025; 26,641,597 and 26,311,607 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively 266 263 Additional paid-in capital 637,707 629,916 Accumulated deficit (617,816) (590,652)Accumulated other comprehensive loss (204) (203)Total stockholders’ equity 19,953 39,324 Total liabilities and stockholders’ equity$92,283 $104,794 CVRx, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share data)(Unaudited) Three months endedJune 30, Six months endedJune 30, 2026 2025 2026 2025 Revenue$15,705 $13,589 $30,474 $25,937 Cost of goods sold 1,981 2,139 3,869 4,175 Gross profit 13,724 11,450 26,605 21,762 Operating expenses: Research and development 3,130 2,469 6,214 4,986 Selling, general and administrative 23,617 23,357 45,575 44,589 Total operating expenses 26,747 25,826 51,789 49,575 Loss from operations (13,023) (14,376) (25,184) (27,813)Interest expense (1,578) (1,473) (3,129) (2,930)Other income, net 560 1,110 1,153 2,233 Loss before income taxes (14,041) (14,739) (27,160) (28,510)Benefit (provision) for income taxes (3) 3 (4) 8 Net loss (14,044) (14,736) (27,164) (28,502)Cumulative translation adjustment — 3 — 3 Comprehensive loss$(14,044) $(14,733) $(27,164) $(28,499)Net loss per share, basic and diluted$(0.53) $(0.57) $(1.03) $(1.10)Weighted-average common shares used to compute net loss per share, basic and diluted 26,515,442 26,071,316 26,435,958 25,974,229
Tectonic Therapeutic Announces Second Quarter 2026 Financial Results and Recent Business Highlights
Enrollment completed in TX45 APEX Phase 2 clinical trial in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (“PH-HFpEF”) with topline results anticipated in early Q1 2027TX45 APEX Phase 2 clinical trial Independent Data Monitoring Committee (“IDMC”) met in July 2026 and recommended continuation of the study without modificationTX2100, a potential treatment for Hereditary Hemorrhagic Telangiectasia (“HHT”), completed dosing of the six single dose healthy volunteer cohorts in the Phase 1a clinical trial, with topline results anticipated by end of Q3 2026Cash and cash equivalents were $227.1 million as of June 30, 2026, including approximately $11.7 million in net proceeds raised from an at-the-market offering for the three months ended June 30, 2026, is expected to provide cash runway into Q1 2029 WATERTOWN, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) — Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic” or the “Company”), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (GPCRs), today announced financial results for the second quarter ended June 30, 2026, and provided an overview of recent business highlights. “In the second quarter, we completed enrollment in our global APEX Phase 2 trial in PH-HFpEF, a critical milestone for TX45, and we look forward to topline results in early Q1 2027,” said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic Therapeutic. “We also completed dosing of the single dose cohorts in the TX2100 Phase 1a clinical trial in healthy volunteers. Subject to favorable safety, tolerability and pharmacokinetic results, we plan to advance TX2100 into a Phase 1b trial in patients with hematologic-support dependent HHT and a Phase 2 trial in moderate to severe HHT patients, bringing us one step closer to a first-in-class therapy for a disease with no approved treatments.” Recent Business Highlights Completed Enrollment of TX45 APEX Phase 2 Clinical Trial in PH-HFpEF Patients: In June 2026, the Company completed enrollment for the APEX trial, a global, randomized, placebo-controlled 24-week Phase 2 clinical trial evaluating the safety and efficacy of TX45 in patients with PH-HFpEF. In July 2026, the Independent Data Monitoring Committee (“IDMC”) met to review unblinded safety and efficacy data from the TX45 APEX Phase 2 clinical trial, including approximately 80% of the expected patient exposure. The IDMC recommended the continuation of the trial without modification. The trial was designed to include an enriched population of a more severe disease subtype of combined pre- and post-capillary pulmonary hypertension (“CpcPH”) patients with a pulmonary vascular resistance (“PVR”) >3 Wood Units (“WU”) at baseline. The APEX Phase 2 clinical trial enrolled a total of 191 patients across 14 countries of which 137 patients were enrolled with CpcPH and PVR >3 WU at baseline, consistent with the goal for this patient population to represent approximately 70% of the overall patients enrolled in APEX. The mean baseline PVR in the overall patient population and the subset of patients with CpcPH and PVR >3 WU was 4.2 WU¹ and 5.2 WU¹, respectively. Completed Dosing of Single Dose Cohorts in Phase 1a Clinical Trial of TX2100 in Healthy Volunteers: In July 2026, the Company completed dosing of the six single dose cohorts in the Phase 1a clinical trial of TX2100 in healthy volunteers. The randomized, placebo-controlled, double-blind, single ascending-dose trial is intended to characterize safety and tolerability, with pharmacokinetics assessed as a secondary endpoint. TX2100 is a VHH-Fc antagonist of the APJ (apelin) receptor, a GPCR involved in pro-angiogenic signaling, and is being developed as a potential treatment for Hereditary Hemorrhagic Telangiectasia (HHT). Upcoming Milestones TX2100 Phase 1a Topline Results Expected by End of Q3 2026 with Phase 2 Planned in Early 2027: The Company expects to report topline results for the TX2100 Phase 1a clinical trial in healthy volunteers by the end of Q3 2026, with detailed data planned to be subsequently presented at a scientific meeting. Subject to favorable safety, tolerability and pharmacokinetic results, Tectonic plans to advance TX2100 into an open-label Phase 1b clinical trial in patients with hematologic-support dependent HHT and a placebo-controlled, Phase 2 clinical trial in moderate-to-severe HHT patients, with endpoints expected to include epistaxis, hemoglobin, hematologic support, and other endpoints relevant to HHT. Phase 1b and Phase 2 trials are planned to run in parallel, with the Phase 2 trial anticipated to begin in early 2027.TX45 APEX Phase 2 Trial Ongoing with Topline Results Expected Early Q1 2027: The global, randomized, placebo-controlled 24-week APEX Phase 2 trial is ongoing, evaluating subcutaneous TX45 in patients with PH-HFpEF, including an enriched population with combined pre- and post-capillary pulmonary hypertension (CpcPH). The primary endpoint is change in pulmonary vascular resistance (PVR) from baseline in the CpcPH subgroup (PVR ≥3 Wood Units). APEX patient enrollment is complete with topline results expected early Q1 2027. Overview of Financial and Operating Results Cash Position: As of June 30, 2026, cash and cash equivalents were $227.1 million, compared to $236.9 million as of March 31, 2026. Tectonic anticipates that, based on current operating assumptions, its current cash and cash equivalents will provide a cash runway into Q1 2029, including through the Phase 2 topline readouts of TX45 in PH-HFpEF and PH-ILD, and through significant clinical milestones in the TX2100 development program.Research and Development Expenses: Research and development expenses were $18.0 million for the three months ended June 30, 2026, as compared to $17.2 million for the three months ended June 30, 2025. The increase was primarily the result of contract research and contract development and manufacturing organizations costs related to the ongoing Phase 2 clinical trials of TX45 and employee-related expenses due to an increase in non-cash, stock-based compensation expense and increase in headcount.General and Administrative Expenses: General and administrative expenses were $6.2 million for the three months ended June 30, 2026, as compared to $5.2 million for the three months ended June 30, 2025. The increase was primarily the result of higher employee-related expenses driven by higher non-cash, stock-based compensation.Net Loss: For the three months ended June 30, 2026, the Company had a net loss of $22.3 million compared to a net loss of $20.0 million for the three months ended June 30, 2025. ¹ Baseline characteristics are preliminary and subjective to change. About Group 2 Pulmonary Hypertension in HFpEFThe World Health Organization has defined 5 groups of pulmonary hypertension (“PH”). Tectonic is focused on the Group 2 subtype, a condition that develops due to left-sided heart disease, specifically PH-HFpEF. In patients with PH-HFpEF, chronic heart failure leads to increased blood pressure in the pulmonary arteries, exerting severe strain on the right side of the heart, which adapts poorly to the increased pressure. This increased pulmonary pressure gradually causes worsening exercise capacity, shortness of breath and right-sided heart failure, which can lead to death. PH-HFpEF is further segmented based on pulmonary hemodynamics into Isolated, post-capillary PH (“IpcPH”) and CpcPH. CpcPH is more severe, accounts for about one third to one half of the 1.4 million PH-HFpEF patients in the U.S. and is characterized by additional, abnormal changes to the pulmonary vasculature, leading to an increase in PVR. Although several Group 1 PH (Pulmonary Arterial Hypertension, “PAH”) medications have been explored in Group 2 PH, to date, no medications have been approved for its treatment. About Group 3 Pulmonary Hypertension and PH-ILDGroup 3 is PH due to chronic lung disease and Tectonic is focused on a Group 3 subtype, called PH-ILD where PH develops in patients who have ILD. ILD is a group of rare conditions causing inflammation and scarring in the lungs. It is believed that a combination of factors leads to the formation of PH-ILD, including lung fibrosis, chronic hypoxia, vascular remodeling and other factors that lead to worsening exercise capacity. PH-ILD has worse survival than ILD without PH. There are currently two approved treatments for PH-ILD, both of which contain the active ingredient treprostinil administered via nebulizer or dry powder inhaler. About TX45, a long-acting Fc-relaxin fusion proteinTX45 is an Fc-relaxin fusion protein with optimized pharmacokinetics and biophysical properties that activates the RXFP1 receptor, the G-protein coupled receptor target of the hormone relaxin. Relaxin is an endogenous protein, expressed at low levels in both men and women that is a pulmonary and systemic vasodilator with lusitropic, anti-fibrotic and anti-inflammatory activity. In normal human physiology, relaxin is upregulated during pregnancy where it exerts vasodilative effects, reduces systemic and pulmonary vascular resistance and increases cardiac output to accommodate the increased demand for oxygen and nutrients from the developing fetus. Relaxin also exerts anti-fibrotic effects on pelvic ligaments to facilitate delivery of the baby. About Hereditary Hemorrhagic Telangiectasia (HHT)HHT is a rare, inherited vascular disorder affecting an estimated 75,000 people in the United States. HHT is the second most common inherited bleeding disorder and a disease for which there are currently no approved therapies. It is characterized by fragile, abnormal blood vessels that lead to recurrent bleeding, which can reduce quality of life, result in emergency room visits and hospitalizations, as well as chronic anemia requiring frequent iron infusions and/or blood transfusions. Many patients with HHT also develop arteriovenous malformations (AVMs) in vital organs such as the lungs, brain, and liver that, if left untreated, are at risk of rupturing and can result in serious and potentially life-threatening complications including lung or brain hemorrhage, stroke, heart failure, or death. Despite being a rare disease and the second most common inherited bleeding disorder, there are currently no approved therapies. About TX2100, a VHH-Fc fusion antagonist antibodyTX2100, is a VHH-Fc fusion antagonist antibody that binds to the APJ receptor (also known as the apelin receptor; APLNR), a GPCR that mediates signaling by the pro-angiogenic peptide hormone apelin. APJ represents a differentiated approach for the potential treatment of HHT. APJ is a selective anti-angiogenic target that is primarily expressed in endothelial cells and is generally quiescent under normal physiological conditions, but is upregulated during pathologic angiogenesis, including in HHT preclinical models. TX2100 is designed as a selective APJ antagonist intended to inhibit disease-associated angiogenic signaling with the goal of providing a more favorable safety profile compared to less selective anti-angiogenic approaches. Anti-angiogenic agents have demonstrated activity in HHT preclinical models and in patients, and APJ antagonism has shown activity in multiple HHT preclinical models, supporting development of TX2100 for this indication. About TectonicTectonic Therapeutic is a clinical-stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of GPCRs. Leveraging its proprietary technology platform called GEODe™ (GPCRs Engineered for Optimal Discovery), Tectonic is focused on developing biologic medicines that overcome the existing challenges of GPCR-targeted drug discovery and harness the human body to modify the course of disease. Tectonic focuses on areas of significant unmet medical need, often where therapeutic options are poor or nonexistent, as these are areas where new medicines have the potential to improve patient quality of life. Tectonic is headquartered in Watertown, Massachusetts. For more information, please visit https://tectonictx.com/ and follow @TectonicTx on X (formerly Twitter) and LinkedIn. Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are “forward-looking statements.” These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the design, objectives, initiation, timing, progress and results of current and future preclinical studies and clinical trials of Tectonic’s product candidates, including the ongoing Phase 2 clinical trials for its lead product candidate, TX45, in Group 2 PH-HFpEF and in Group 3 PH-ILD and the ongoing Phase 1 clinical trial for TX2100; and the Company’s expected cash runway. These forward-looking statements are based on Tectonic’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Tectonic’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including the conflict in Ukraine and the conflict in the Middle East, heightened inflation and uncertain credit and financial markets, on Tectonic’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; Tectonic’s ability to realize the benefits of its collaborations and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. Other factors that may cause Tectonic’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified under the heading “Risk Factors” in Tectonic’s quarterly report on Form 10-Q filed for the quarter ended June 30, 2026 and in other filings that Tectonic makes and will make with the SEC in the future. Tectonic expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Contacts: Investors:Dan FerryLifeSci Advisorsdaniel@lifesciadvisors.com(617) 430-7576 Media:Kathryn MorrisThe Yates Networkkathryn@theyatesnetwork.com(914) 204-6412 Tectonic Therapeutic, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except per share data)(unaudited) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating expenses: Research and development $18,048 $17,185 $38,919 $30,221 General and administrative 6,170 5,147 12,600 10,409 Total operating expenses 24,218 22,332 51,519 40,630 Loss from operations (24,218) (22,332) (51,519) (40,630)Other income (expense), net: Interest income 2,021 3,389 4,202 5,833 Interest expense (6) (17) (14) (37)Other expense (5) (48) (118) (80)Total other income, net 2,010 3,324 4,070 5,716 Loss before income tax (22,208) (19,008) (47,449) (34,914)Income tax expense (77) (976) (77) (976)Net loss (22,285) (19,984) (47,526) (35,890)Other comprehensive (loss) income: Foreign currency translation adjustment — (51) 37 (58)Comprehensive loss $(22,285) $(20,035) $(47,489) $(35,948)Net loss per share, basic and diluted $(1.18) $(1.07) $(2.52) $(2.00)Weighted-average common shares outstanding, basic and diluted 18,964,008 18,680,042 18,867,044 17,923,056 Tectonic Therapeutic, Inc.Select Condensed Consolidated Balance Sheet Data(in thousands)(unaudited) June 30, 2026 December 31, 2025 Cash and cash equivalents $227,068 $253,798Working capital* 220,729 247,693Total assets 237,034 261,038Total stockholders’ equity 223,846 251,329 *Working capital is defined as current assets less current liabilities
U.S. News and World Report Ranks MedStar Health Hospitals #1 in the D.C. Region for Cancer, Cardiology, Heart & Vascular Surgery, and Rehabilitation
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Merit Medical Reports Second Quarter 2026 Results And Updates Full-Year 2026 Guidance
Financial Highlights† Reported revenue of $418.8 million, up 10%Constant currency revenue* and constant currency revenue, organic* up 9% and up 9%, respectivelyGAAP operating margin of 14.4%, compared to 12.3% in prior year periodNon-GAAP operating margin* of 22.6%, compared to 21.2% in prior year periodGAAP EPS $0.65, up 20%Non-GAAP EPS* $1.19, up 18%Cash flow from operations of $110.0 million year-to-date, down 11%Free cash flow* generation of $76.6 million year-to-date, down 14% † Comparisons above are calculated for the current quarter compared with the second quarter of 2025, unless otherwise specified. Amounts stated in this release are rounded, while percentages are calculated from the underlying amounts. * Constant currency revenue; constant currency revenue, organic; non-GAAP gross profit and margin; non-GAAP operating income and margin; non-GAAP net income; non-GAAP EPS; and free cash flow figures (used here and below) are non-GAAP financial measures. A reconciliation of these financial measures to their most directly comparable GAAP financial measures is included under the heading “Non-GAAP Financial Measures” below. SOUTH JORDAN, Utah, July 30, 2026 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced financial results for the three and six-month periods ended June 30, 2026. “Merit delivered second quarter financial results that exceeded the high end of our expectations, driven primarily by 9% organic, constant currency revenue growth, excluding the impact of a strategic divestiture,” said Martha G. Aronson, Merit’s President and CEO. “We experienced improving revenue growth trends across our global business in Q2, as expected, with notable strength in sales to customers in the U.S. which increased 10% year-over-year, well ahead of our expectations. We also delivered improvement in both our non-GAAP operating margin and our non-GAAP earnings per share, which increased by 140 basis points and 18%, respectively, year-over-year.” Ms. Aronson continued: “We have increased our 2026 revenue and non-GAAP earnings per share guidance to reflect the stronger-than-expected results over the first half of 2026 and remain confident in our team’s ability to execute, with attractive constant currency growth, improving profitability, and solid cash flow generation this year. Our team remains focused on delivering our Continued Growth Initiative financial targets for the three-year period ending December 31, 2026, and, in parallel, we are developing our longer-term strategic plan focused on identifying opportunities to better position the company for sustainable growth, enhanced profitability and value creation for our shareholders.” Merit’s revenue by product category for the three and six-month periods ended June 30, 2026 and 2025 was as follows (unaudited; in thousands, except for percentages): Three Months Ended Reported Constant Currency* June 30, Impact of foreign June 30, 2026 2025 % Change exchange 2026 % ChangeFoundational Access $161,786 $152,122 6 % $(2,340) $159,446 5 %OEM 48,338 43,218 12 % (29) 48,309 12 %Procedural Solutions 27,949 31,741 (12)% 140 28,089 (12)%Vascular Intervention 41,652 34,955 19 % (409) 41,243 18 %Other 1,236 346 257 % 1,102 2,338 576 %Total Foundational 280,961 262,382 7 % (1,536) 279,425 6 % Therapeutic Cardiac Therapies 28,510 22,930 24 % (479) 28,031 22 %Endoscopy 23,647 18,400 29 % 37 23,684 29 %OEM 12,797 9,735 31 % (20) 12,777 31 %Oncology 25,774 23,943 8 % (171) 25,603 7 %Renal Therapies 12,713 12,817 (1)% (164) 12,549 (2)%Vascular Intervention 34,441 32,255 7 % (654) 33,787 5 %Total Therapeutic 137,882 120,080 15 % (1,451) 136,431 14 % Total $418,843 $382,462 10 % $(2,987) $415,856 9 % Six Months Ended Reported Constant Currency * June 30, Impact of foreign June 30, 2026 2025 % Change exchange 2026 % ChangeFoundational Access $312,910 $286,520 9 % $(7,520) $305,390 7 %OEM 87,878 86,641 1 % (264) 87,614 1 %Procedural Solutions 54,437 60,310 (10)% (18) 54,419 (10)%Vascular Intervention 80,690 67,804 19 % (1,472) 79,218 17 %Other 525 1,489 (65)% 2,749 3,274 120 %Total Foundational 536,440 502,764 7 % (6,525) 529,915 5 % Therapeutic Cardiac Therapies 55,914 43,489 29 % (1,694) 54,220 25 %Endoscopy 45,339 34,951 30 % 20 45,359 30 %OEM 20,276 20,877 (3)% (50) 20,226 (3)%Oncology 49,282 45,994 7 % (526) 48,756 6 %Renal Therapies 24,225 26,206 (8)% (392) 23,833 (9)%Vascular Intervention 69,244 63,532 9 % (1,756) 67,488 6 %Total Therapeutic 264,280 235,049 12 % (4,398) 259,882 11 % Total $800,720 $737,813 9 % $(10,923) $789,797 7 % Financial Summary: GAAP gross margin was 51.4%, compared to 48.2% for the second quarter of 2025. Non-GAAP gross margin* was 55.8%, compared to 53.2% for the second quarter of 2025. GAAP operating margin was 14.4%, compared to 12.3% for the second quarter of 2025. Non-GAAP operating margin* was 22.6%, compared to 21.2% for the second quarter of 2025. GAAP net income was $38.8 million, or $0.65 per share, compared to $32.6 million, or $0.54 per share, for the second quarter of 2025. Non-GAAP net income* was $71.3 million, or $1.19 per share, compared to $61.0 million, or $1.01 per share, for the second quarter of 2025. As of June 30, 2026, Merit had cash and cash equivalents of $448.7 million and total debt obligations of $747.5 million, compared to cash and cash equivalents of $446.4 million and total debt obligations of $747.5 million as of December 31, 2025. Merit had available borrowing capacity of approximately $697 million as of June 30, 2026. Fiscal Year 2026 Financial Guidance Based upon the information currently available to Merit’s management, for the twelve-month period ending December 31, 2026, absent the potential impact of trade policies and related actions implemented by the U.S. and other countries subsequent to today’s date, material acquisitions, non-recurring transactions or other factors beyond Merit’s current expectations, Merit anticipates the following financial results: Revenue and Earnings Guidance* Updated GuidancePrior Guidance(2) Year Ending% ChangeYear Ending% ChangeFinancial Measure December 31, 2026Y/YDecember 31, 2026Y/YTotal Revenue $1.631 – $1.643 billion8% – 8%$1.612 – $1.634 billion6% – 8% Non-GAAP Earnings Per Share(1) $4.25 – $4.3511% – 14%$4.01 – $4.155% – 8% *Percentage figures approximated; dollar figures may not foot due to rounding. (1) Merit’s non-GAAP earnings per share reflect the dilutive impact of its 3.00% Convertible Senior Notes due 2029 (the “Convertible Notes”) calculated using the if-converted method of approximately $0.03 per share for the year ending December 31, 2026. Any offsetting impacts of the capped call associated with the Convertible Notes are not considered. (2) “Prior Guidance” reflects Merit’s full-year 2026 financial guidance, previously introduced on April 30, 2026. Merit does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures (other than revenue) because Merit is unable to predict with reasonable certainty the financial impact of various items which could impact Merit’s future financial results, such as expenses attributable to acquisitions or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain employee termination benefits, performance-based stock compensation expenses, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, governmental proceedings, and changes in governmental or industry regulations. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, Merit is unable to address the significance of the unavailable information, which could be material to future results. Specifically, Merit is not, without unreasonable effort, able to reasonably predict the amount and impact of these items and Merit believes inclusion of the most comparable GAAP financial measure, and a reconciliation of these forward-looking non-GAAP measures to their GAAP counterparts could be confusing to investors or cause undue reliance. Merit’s financial guidance for the year ending December 31, 2026 is subject to risks and uncertainties identified in this release and Merit’s filings with the SEC. This guidance is based on information and estimates available to Merit as of July 30, 2026. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results will likely vary, and could vary materially, from past results and those anticipated, estimated or projected. CONFERENCE CALL As previously announced, Merit will hold its investor conference call today, Thursday, July 30, 2026, at 4:30 p.m., Eastern Time, to discuss its results for the second quarter and provide an operational update. To access the conference call, please pre-register using the following link. Registrants will receive confirmation with dial-in details. A live webcast and slide deck will also be available at merit.com. CONSOLIDATED BALANCE SHEETS(in thousands) June 30, December 31, 2026 2025ASSETS (Unaudited) Current Assets Cash and cash equivalents $448,699 $446,404 Trade receivables, net 224,237 203,710 Other receivables 23,960 17,773 Inventories 374,112 333,705 Prepaid expenses and other assets 33,496 31,493 Prepaid income taxes 5,033 4,941 Income tax refund receivables 2,701 2,128 Total current assets 1,112,238 1,040,154 Property and equipment, net 436,749 428,401 Intangible assets, net 612,026 537,654 Goodwill 539,772 506,837 Deferred income tax assets 7,200 7,049 Operating lease right-of-use assets 83,776 87,600 Other assets 71,859 78,227 Total Assets $2,863,620 $2,685,922 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities Trade payables $70,737 $60,551 Accrued expenses 172,185 159,486 Current operating lease liabilities 10,921 10,876 Income taxes payable 11,090 8,851 Total current liabilities 264,933 239,764 Long-term debt 736,258 734,038 Deferred income tax liabilities 39,704 19,665 Liabilities related to unrecognized tax benefits 2,248 2,248 Deferred compensation payable 19,297 17,542 Deferred credits 1,347 1,398 Long-term operating lease liabilities 72,942 76,658 Other long-term obligations 47,087 10,306 Total liabilities 1,183,816 1,101,619 Stockholders’ Equity Common stock 783,892 763,909 Retained earnings 903,828 824,030 Accumulated other comprehensive loss (7,916) (3,636)Total stockholders’ equity 1,679,804 1,584,303 Total Liabilities and Stockholders’ Equity $2,863,620 $2,685,922 CONSOLIDATED STATEMENTS OF INCOME(Unaudited, in thousands except per share amounts) Three Months Ended Six Months Ended June 30, June 30, 2026 2025 2026 2025 Net sales $418,843 $382,462 $800,720 $737,813 Cost of sales 203,677 197,975 400,757 381,306 Gross profit 215,166 184,487 399,963 356,507 Operating expenses: Selling, general and administrative 129,229 113,097 247,439 220,583 Research and development 25,389 24,367 47,998 46,845 Contingent consideration expense (benefit) 145 143 (34) 1,166 Total operating expenses 154,763 137,607 295,403 268,594 Income from operations 60,403 46,880 104,560 87,913 Other income (expense): Interest income 3,752 3,761 7,652 7,551 Interest expense (12,118) (6,775) (18,644) (13,343)Other (expense) income — net (723) (487) 11,292 (784)Total other (expense) income — net (9,089) (3,501) 300 (6,576) Income before income taxes 51,314 43,379 104,860 81,337 Income tax expense 12,511 10,798 25,062 18,609 Net income $38,803 $32,581 $79,798 $62,728 Earnings per common share Basic $0.65 $0.55 $1.34 $1.06 Diluted $0.65 $0.54 $1.33 $1.03 Weighted average shares outstanding Basic 59,679 59,140 59,595 59,019 Diluted 60,006 60,611 60,010 60,945 CONSOLIDATED STATEMENTS OF CASH FLOWS(Unaudited, in thousands) Six Months Ended June 30, 2026 2025 CASH FLOWS FROM OPERATING ACTIVITIES: Net income $79,798 $62,728 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 61,538 60,313 Gain on disposition of a business (12,557) (249)Amortization of right-of-use operating lease assets 5,779 5,766 Fair value adjustments related to contingent consideration liabilities (34) 1,166 Stock-based compensation expense 21,876 19,951 Other adjustments 4,388 3,173 Changes in operating assets and liabilities, net of acquisitions and divestitures (50,831) (28,969)Total adjustments 30,159 61,151 Net cash, cash equivalents, and restricted cash provided by operating activities 109,957 123,879 CASH FLOWS FROM INVESTING ACTIVITIES: Capital expenditures for property and equipment (33,340) (34,812)Proceeds from asset and business dispositions 25,555 294 Cash paid for notes receivable and other investments — (14,617)Cash paid in acquisitions, net of cash acquired (92,997) (122,555)Other investing, net (1,617) (1,296)Net cash, cash equivalents, and restricted cash used in investing activities (102,399) (172,986) CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from issuance of common stock 4,623 20,014 Contingent payments related to acquisitions (2,991) (2,567)Payment of taxes related to an exchange of common stock (6,973) (6,145)Net cash, cash equivalents, and restricted cash (used in) provided by financing activities (5,341) 11,302 Effect of exchange rates on cash 140 2,953 Net increase (decrease) in cash, cash equivalents and restricted cash 2,357 (34,852) CASH, CASH EQUIVALENTS AND RESTRICTED CASH: Beginning of period 448,549 378,767 End of period $450,906 $343,915 RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH TO THE CONSOLIDATED BALANCE SHEETS: Cash and cash equivalents 448,699 341,819 Restricted cash reported in prepaid expenses and other current assets 2,207 2,096 Total cash, cash equivalents and restricted cash $450,906 $343,915 Non-GAAP Financial Measures Although Merit’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”), Merit’s management believes that the non-GAAP financial measures referenced in this release may provide investors with useful information regarding the underlying business trends and performance of Merit’s ongoing operations and can be useful for period-over-period comparisons of such operations. Non-GAAP financial measures used in this release include: constant currency revenue;constant currency revenue, organic;non-GAAP gross profit and margin;non-GAAP operating income and margin;non-GAAP net income;non-GAAP earnings per share; andfree cash flow. Merit’s management team uses these non-GAAP financial measures to evaluate Merit’s profitability and efficiency, to compare operating and financial results to prior periods, to evaluate changes in the results of its operating segments, and to measure and allocate financial resources internally. However, Merit’s management does not consider such non-GAAP measures in isolation or as an alternative to measures determined in accordance with GAAP. Readers should consider non-GAAP measures used in this release in addition to, not as a substitute for, financial reporting measures prepared in accordance with GAAP. These non-GAAP financial measures generally exclude some, but not all, items that may affect Merit’s net income. In addition, they are subject to inherent limitations as they reflect the exercise of judgment by management about which items are excluded. Merit believes it is useful to exclude such items in the calculation of non-GAAP gross profit and margin, non-GAAP operating income and margin, non-GAAP net income, and non-GAAP earnings per share (in each case, as further illustrated in the reconciliation tables below) because such amounts in any specific period may not directly correlate to the underlying performance of Merit’s business operations and can vary significantly between periods as a result of factors such as acquisition or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain employee termination benefits, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, governmental proceedings or changes in tax or industry regulations, gains or losses on disposal of certain assets, equity method investment loss (income) from equity investees, and debt issuance costs. Merit may incur similar types of expenses in the future, and the non-GAAP financial information included in this release should not be viewed as a statement or indication that these types of expenses will not recur. Additionally, the non-GAAP financial measures used in this release may not be comparable with similarly titled measures of other companies. Merit urges readers to review the reconciliations of its non-GAAP financial measures to their most directly comparable GAAP financial measures included herein, and not to rely on any single financial measure to evaluate Merit’s business or results of operations. Constant Currency Revenue Merit’s constant currency revenue is prepared by converting the current-period reported revenue of subsidiaries whose functional currency is a currency other than the U.S. dollar at the applicable foreign exchange rates in effect during the comparable prior-year period and adjusting for the effects of hedging transactions on reported revenue, which are recorded in the U.S. dollar. The constant currency revenue adjustment of $(3.0) million and $(10.9) million to reported revenue for the three and six-month periods ended June 30, 2026 was calculated using the applicable average foreign exchange rates for the three and six-month periods ended June 30, 2025. Constant Currency Revenue, Organic Merit’s constant currency revenue, organic, is defined, with respect to prior fiscal year periods, as GAAP revenue less revenue from certain divestitures. For the three and six-month periods ended June 30, 2025, Merit’s constant currency revenue, organic, excludes revenues attributable to the DualCap® product line which Merit sold to Health Line International Corporation (“Health Line”) on February 17, 2026 (the “DualCap Divestiture”). With respect to current fiscal year periods, constant currency revenue, organic, is defined as constant currency revenue (as defined above), less revenue from certain acquisitions and divestitures. For the three and six-month periods ended June 30, 2026, Merit’s constant currency revenue, organic, excludes revenues attributable to products acquired in connection with (i) Merit’s acquisition of View Point Medical, Inc. (“View Point”) in April 2026 (the “View Point Merger”), (ii) the assets acquired from Pentax of America, Inc. related to the C2 CryoBalloon™ device in November 2025 (the “C2 Acquisition”) and (iii) Merit’s acquisition of Biolife Delaware, L.L.C. (“Biolife”) in May 2025 (the “Biolife Merger”). For the six-month period ended June 30, 2026, Merit’s constant currency revenue, organic, excludes revenues attributable to the DualCap Divestiture. Non-GAAP Gross Profit and Margin Non-GAAP gross profit is calculated by reducing GAAP cost of sales by amounts recorded for amortization of intangible assets and inventory mark-up related to acquisitions. Non-GAAP gross margin is calculated by dividing non-GAAP gross profit by reported net sales. Non-GAAP Operating Income and Margin Non-GAAP operating income is calculated by adjusting GAAP operating income for certain items which are deemed by Merit’s management to be outside of core operations and vary in amount and frequency among periods, such as expenses related to acquisitions or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain employee termination benefits, performance-based stock compensation expenses, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, governmental proceedings, and changes in governmental or industry regulations, as well as other items referenced in the tables below. Non-GAAP operating margin is calculated by dividing non-GAAP operating income by reported net sales. Non-GAAP Net Income Non-GAAP net income is calculated by adjusting GAAP net income for the items set forth in the definition of non-GAAP operating income above, as well as for expenses related to Merit’s long-term debt, gains or losses on disposal of certain assets, equity method investment loss (income) from equity investees, and other items set forth in the tables below. Non-GAAP EPS Non-GAAP EPS is defined as non-GAAP net income divided by the diluted shares outstanding for the corresponding period. Free Cash Flow Free cash flow is defined as cash flow from operations calculated in accordance with GAAP, less capital expenditures for property and equipment calculated in accordance with GAAP, as set forth in the consolidated statement of cash flows. Other Non-GAAP Financial Measure Reconciliations The following tables set forth supplemental financial data and corresponding reconciliations of non-GAAP financial measures to Merit’s corresponding financial measures prepared in accordance with GAAP, in each case, for the three and six-month periods ended June 30, 2026 and 2025. The non-GAAP income adjustments referenced in the following tables do not reflect non-performance-based stock compensation expense of $6.3 million and $5.0 million for the three-month periods ended June 30, 2026 and 2025, respectively, and $9.5 million and $9.3 million for the six-month periods ended June 30, 2026 and 2025, respectively. Reconciliation of GAAP Net Income to Non-GAAP Net Income(Unaudited, in thousands except per share amounts) Three Months Ended June 30, 2026 Pre-Tax Tax Impact After-Tax Per Share Impact GAAP net income $51,314 $(12,511) $38,803 $0.65 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 18,718 (4,419) 14,299 0.24 Operating Expenses Contingent consideration expense 145 (33) 112 0.00 Amortization of intangibles 2,496 (589) 1,907 0.03 Performance-based share-based compensation (a) 6,621 (756) 5,865 0.10 Corporate restructuring (b) 2,159 (510) 1,649 0.03 Acquisition-related 2,568 (194) 2,374 0.04 Medical Device Regulation expenses (c) 1,452 (342) 1,110 0.02 Other (Income) Expense Long-term debt costs (e) 6,477 (1,529) 4,948 0.08 Other non-operating loss (f) 294 (82) 212 0.00 Non-GAAP net income $92,244 $(20,965) $71,279 $1.19 Diluted shares 60,006 Three Months Ended June 30, 2025 Pre-Tax Tax Impact After-Tax Per Share ImpactGAAP net income $43,379 $(10,798) $32,581 $0.54 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 18,980 (4,485) 14,495 0.24 Inventory mark-up related to acquisitions 67 (16) 51 0.00 Operating Expenses Contingent consideration expense 143 25 168 0.00 Amortization of intangibles 2,543 (601) 1,942 0.03 Performance-based share-based compensation (a) 5,879 (345) 5,534 0.09 Corporate restructuring (b) 2,587 (611) 1,976 0.03 Acquisition-related 2,140 (14) 2,126 0.04 Medical Device Regulation expenses (c) 1,634 (385) 1,249 0.02 Other (d) 50 (12) 38 0.00 Other (Income) Expense Long-term debt costs (e) 1,414 (334) 1,080 0.02 Gain on disposal of business unit (249) — (249) (0.00) Non-GAAP net income $78,567 $(17,576) $60,991 $1.01 Diluted shares 60,611 Note: Certain per-share impacts may not sum to totals due to rounding. Reconciliation of GAAP Net Income to Non-GAAP Net Income(Unaudited, in thousands except per share amounts) Six Months Ended June 30, 2026 Pre-Tax Tax Impact After-Tax Per Share ImpactGAAP net income $104,860 $(25,062) $79,798 $1.33 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 36,945 (8,722) 28,223 0.47 Operating Expenses Contingent consideration benefit (34) 5 (29) (0.00)Amortization of intangibles 4,950 (1,168) 3,782 0.06 Performance-based share-based compensation (a) 12,429 (1,062) 11,367 0.19 Corporate restructuring (b) 2,159 (510) 1,649 0.03 Acquisition-related 6,811 (905) 5,906 0.10 Medical Device Regulation expenses (c) 2,070 (488) 1,582 0.03 Other (Income) Expense Long-term debt costs (e) 7,891 (1,863) 6,028 0.10 Gain on disposal of business unit (12,502) 1,520 (10,982) (0.18)Other non-operating loss (f) 825 (207) 618 0.01 Non-GAAP net income $166,404 $(38,462) $127,942 $2.13 Diluted shares 60,010 Six Months Ended June 30, 2025 Pre-Tax Tax Impact After-Tax Per Share ImpactGAAP net income $81,337 $(18,609) $62,728 $1.03 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 36,586 (8,645) 27,941 0.46 Inventory mark-up related to acquisitions 67 (16) 51 0.00 Operating Expenses Contingent consideration expense 1,166 34 1,200 0.02 Amortization of intangibles 4,937 (1,167) 3,770 0.06 Performance-based share-based compensation (a) 10,653 (931) 9,722 0.16 Corporate restructuring (b) 2,587 (611) 1,976 0.03 Acquisition-related 2,156 (18) 2,138 0.04 Medical Device Regulation expenses (c) 3,228 (762) 2,466 0.04 Other (d) 29 (7) 22 0.00 Other (Income) Expense Long-term debt costs (e) 2,828 (668) 2,160 0.04 Gain on disposal of business unit (249) — (249) (0.00) Non-GAAP net income $145,325 $(31,400) $113,925 $1.87 Diluted shares 60,945 Note: Certain per-share impacts may not sum to totals due to rounding. Reconciliation of Reported Operating Income to Non-GAAP Operating Income (Unaudited, in thousands except percentages) Three Months Ended Three Months Ended Six Months Ended Six Months Ended June 30, 2026 June 30, 2025 June 30, 2026 June 30, 2025 Amounts % Sales Amounts % Sales Amounts % Sales Amounts % SalesNet Sales as Reported $418,843 $382,462 $800,720 $737,813 GAAP Operating Income 60,403 14.4% 46,880 12.3% 104,560 13.1 % 87,913 11.9%Cost of Sales Amortization of intangibles 18,718 4.5% 18,980 5.0% 36,945 4.6 % 36,586 5.0%Inventory mark-up related to acquisitions — — 67 0.0% — — 67 0.0%Operating Expenses Contingent consideration expense (benefit) 145 0.0% 143 0.0% (34) (0.0)% 1,166 0.2%Amortization of intangibles 2,496 0.6% 2,543 0.7% 4,950 0.6 % 4,937 0.7%Performance-based share-based compensation (a) 6,621 1.6% 5,879 1.5% 12,429 1.6 % 10,653 1.4%Corporate restructuring (b) 2,159 0.5% 2,587 0.7% 2,159 0.3 % 2,587 0.4%Acquisition-related 2,568 0.6% 2,140 0.6% 6,811 0.9 % 2,156 0.3%Medical Device Regulation expenses (c) 1,452 0.3% 1,634 0.4% 2,070 0.3 % 3,228 0.4%Other (d) — — 50 0.0% — — 29 0.0% Non-GAAP Operating Income $94,562 22.6% $80,903 21.2% $169,890 21.2 % $149,322 20.2% Note: Certain percentages may not sum to totals due to rounding. (a) Represents performance-based share-based compensation expense, including stock-settled and cash-settled awards. (b) Includes employee termination benefits associated with activities related to corporate restructuring initiatives and costs to terminate certain distribution contracts from the Biolife Merger. (c) Represents incremental expenses incurred to comply with the E.U. Medical Device Regulation. (d) Represents costs to comply with Merit’s corporate integrity agreement with the U.S. Department of Justice. (e) Represents costs associated with the Convertible Notes including the amortization of debt issuance costs and a one-time charge for additional interest incurred pursuant to Merit’s obligation to remove restrictive legends. (f) Includes equity method investment loss from equity investees. Reconciliation of Reported Revenue to Constant Currency Revenue (Non-GAAP), and Constant Currency Revenue, Organic (Non-GAAP)(Unaudited, in thousands except percentages) Three Months Ended Six Months Ended June30, June30, % Change 2026 2025 % Change 2026 2025 Reported Revenue 9.5%$418,843 $382,462 8.5%$800,720 $737,813 Add: Impact of foreign exchange (2,987) — (10,923) — Constant Currency Revenue (a) 8.7%$415,856 $382,462 7.0%$789,797 $737,813 Less: Revenue from certain acquisitions (4,660) — (13,704) — Less: Revenue from divestitures (b) — (5,296) (1,644) (10,212) Constant Currency Revenue, Organic (a) 9.0%$411,196 $377,166 6.4%$774,449 $727,601 (a) A non-GAAP financial measure. For a definition of this and other non-GAAP financial measures, see the section of this release entitled “Non-GAAP Financial Measures.” (b) On February 17, 2026, Merit sold certain assets relating to the DualCap product line to Health Line for $28 million, of which $25.5 million was paid to Merit at closing. Reconciliation of Reported Gross Margin to Non-GAAP Gross Margin (Non-GAAP)(Unaudited, as a percentage of reported revenue) Three Months Ended Six Months Ended June30, June30, 2026 2025 2026 2025 Reported Gross Margin 51.4% 48.2% 50.0% 48.3% Add back impact of: Amortization of intangibles 4.5% 5.0% 4.6% 5.0%Inventory mark-up related to acquisitions —% 0.0% —% 0.0% Non-GAAP Gross Margin 55.8% 53.2% 54.6% 53.3% Note: Certain percentages may not sum to totals due to rounding. Reconciliation of Reported Cash Flow from Operations to Free Cash Flow (Non-GAAP) (Unaudited, in thousands) Six Months Ended June30, 2026 2025 Reported Cash Flow from Operations $109,957 $123,879 Less: Capital Expenditures (33,340) (34,812) Free Cash Flow $76,617 $89,067 Reconciliation of 2026 Net Sales Guidance – % Change from Prior Year (Constant Currency) Updated Guidance Prior Guidance(1) Low High Low High2026 Net Sales Guidance – % Change from Prior Year (GAAP) 7.6% 8.4% 6.3% 7.8%Estimated impact of foreign currency exchange rate fluctuations (0.8%) (0.8%) (0.8%) (0.8%)2026 Net Sales Guidance – % Change from Prior Year (Constant Currency) 6.8% 7.6% 5.6% 7.0% Note: Certain percentages may not sum to totals due to rounding. (1) “Prior Guidance” reflects Merit’s full-year 2026 financial guidance, previously introduced on April 30, 2026. ABOUT MERIT Founded in 1987, Merit is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves customers worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,500 people worldwide. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This 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 include, among others: statements preceded or followed by, or that include the words, “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “intends,” “seeks,” “believes,” “estimates,” “projects,” “forecasts,” “potential,” “target,” “continue,” “upcoming,” “optimistic” or other forms of these words or similar words or expressions, or the negative thereof or other comparable terminology;statements that address Merit’s future operating performance or events or developments that Merit’s management expects or anticipates will occur, including, without limitation, any statements regarding Merit’s projected revenues, earnings or other future financial measures, Merit’s plans and objectives for future operations, Merit’s proposed new products or services, the integration, development or commercialization of the business or any assets acquired from other parties, future economic conditions or performance, the implementation of, and results which may be achieved through, Merit’s Continued Growth Initiatives Program or other business optimization initiatives, and any statements of assumptions underlying any of the foregoing; andstatements regarding Merit’s past performance, efforts, or results about which inferences or assumptions may be made, including statements proceeded or followed by the words “preliminary,” “initial,” “potential,” “possible,” “diligence,” “industry-leading,” “compliant,” “indications” or “early feedback” or other forms of these words or similar words or expressions, or the negative thereof or other comparable terminology. The forward-looking statements contained in this release are based on Merit management’s current expectations and assumptions regarding future events or outcomes. If underlying expectations or assumptions prove inaccurate, or risks or uncertainties materialize, actual results will likely differ, and may differ materially, from Merit’s expectations reflected in any forward-looking statements. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results. Investors are cautioned not to unduly rely on any such forward-looking statements. The following are some of the important risks and uncertainties that could cause Merit’s actual results to differ from management’s expectations in any forward-looking statements: risks and uncertainties arising from the conflict among the United States, Israel and Iran and related geopolitical instability; risks and uncertainties associated with Merit’s acquisition of View Point and the OneMark® Detection Imaging System and related technology; risks and uncertainties associated with Merit’s integration of the View Point business, assets and operations into its operations and its ability to achieve anticipated financial results, product development and other anticipated benefits of the acquisition; uncertainties as to whether Merit will achieve revenue or other financial performance consistent with its forecasts projected for the View Point Merger; risks and uncertainties associated with Merit’s executive succession planning activities and leadership transition; risks and uncertainties regarding trade policies or related actions implemented by the U.S. or other countries, including existing, proposed, prospective or invalidated tariffs, duties or other measures; risks and uncertainties associated with Merit’s integration of businesses or assets acquired from third parties, including View Point in April 2026, the business and assets acquired in the C2 Acquisition in November 2025 and Biolife in May 2025, and Merit’s ability to achieve the anticipated financial results, product development and other anticipated benefits of such acquisitions; effects of the Convertible Notes on Merit’s net income and earnings per share performance; restrictions and limitations set forth in the Convertible Notes and Indenture, which could affect Merit’s ability to operate its business as well as its liquidity; disruptions in Merit’s supply chain, manufacturing or sterilization processes; U.S. and global political, economic, competitive, reimbursement and regulatory conditions; modification or limitation of, or policies and procedures associated with, governmental or private insurance reimbursement policies; reduced availability of, and price increases associated with, components and other raw materials; increases in transportation expenses; risks relating to Merit’s potential inability to successfully manage growth through acquisitions generally, including the inability to effectively integrate acquired operations or products or commercialize technology developed internally or acquired through completed, proposed or future transactions; prospective financial obligations or other uncertainties associated with the DualCap Divestiture completed in February 2026; fluctuations in interest or foreign currency exchange rates and inflation; cybersecurity events; government scrutiny and regulation of the medical device industry; difficulties relating to development, testing and regulatory approval, clearance and maintenance of Merit’s products; the safety, efficacy and patient and physician adoption of Merit’s products; the ability to fully enroll and the outcomes of ongoing and future clinical trials and market studies relating to Merit’s products; litigation and other legal proceedings affecting Merit; risks and possible effects of Merit’s failure to comply with U.S. and foreign laws and regulations; restrictions on Merit’s liquidity or business operations resulting from its debt agreements; infringement of Merit’s technology or the assertion that Merit’s technology infringes the rights of other parties; product recalls and product liability claims; potential for significant adverse changes in governing regulations; changes in tax laws and regulations in the United States or other jurisdictions or exposure to additional tax liabilities which may adversely affect Merit’s effective tax rate; termination of relationships with Merit’s suppliers, or failure of such suppliers to perform; development of new products and technology that could render Merit’s existing or future products obsolete; market acceptance of new products; failure to comply with applicable environmental laws; changes in key personnel; labor shortages and increases in labor costs; price and product competition; extreme weather events; and geopolitical events. For a further discussion of the risks and uncertainties and other factors that may affect Merit’s business, operations and financial condition, see Part I, Item 1A. “Risk Factors” in Merit’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC, which Merit updated in Part II, Item 1A. “Risk Factors” in Merit’s Quarterly Reports on Form 10-Q for each of the quarters ended March 31, 2026 and June 30, 2026. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results. Those estimates and all other forward-looking statements included in this release are made only as of the date of this release, and except as otherwise required by applicable law, Merit assumes no obligation to update or disclose revisions to estimates and all other forward-looking statements. TRADEMARKS Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors. Contacts: PR/Media Inquiries:Investor Inquiries: Sarah ComstockMike Piccinino, CFA, IRC Merit MedicalICR Healthcare +1-801-432-2864+1-443-213-0509 sarah.comstock@merit.com mike.piccinino@icrhealthcare.com
InspireMD Appoints Carotid Intervention Commercial Leader Kathleen Kennedy as Senior Vice President of Global Sales and Marketing
Ms. Kennedy returns to InspireMD having previously served as Sales Director supporting the initial U.S. launch of CGuard PrimeMIAMI, July 30, 2026 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced the appointment of accomplished commercial leader Kathleen Kennedy as Senior Vice President of Global Sales and Marketing, reporting to CEO Marvin Slosman. Ms. Kennedy brings more than 30 years of medical device sales leadership experience, including significant expertise in carotid intervention and carotid stenting. Having previously led regional sales efforts supporting the U.S. launch of CGuard Prime, she returns to InspireMD with deep relationships across the vascular, neurovascular and cardiovascular physician communities, as well as extensive experience working with health systems that are key to driving adoption of carotid therapies. “Kathy’s appointment reflects our continued commitment to building a highly talented and productive commercial team in anticipation of the planned U.S. commercialization of the CGuard platform, and I am very pleased to welcome her back to InspireMD,” stated Marvin Slosman, Chief Executive Officer. “As we prepare for the potential U.S. approval and commercial relaunch of the CGuard platform, including CGuard Prime 80cm for TCAR procedures, Kathy’s deep expertise in carotid intervention, proven commercial leadership and established relationships throughout the field make her invaluable to our U.S. commercial organization and scaling our commercial growth.” “I have seen firsthand the impact CGuard and its proprietary MicroNet mesh technology can have for patients,” said Ms. Kennedy. “The strength of the clinical data, combined with the significant opportunity in the U.S. carotid intervention market, made the decision to return to InspireMD an easy one. I am excited to work with our commercial organization, physician partners and hospital customers to expand access to this important technology.” Throughout her career, Ms. Kennedy has held commercial leadership positions in cardiovascular, vascular and neurovascular medical technologies, building extensive experience in physician engagement, market development, and sales execution. Ms. Kennedy re-joins InspireMD from Omniscient Neurotechnology, where she served briefly as Vice President of Sales for North America. Prior to that, she served as Sales Director at InspireMD, as Senior Area Director at Silk Road Medical, and as Chief Commercial Officer at CAE Healthcare (now Elevate Healthcare). Earlier in her career, Ms. Kennedy held commercial positions of increasing responsibility at several healthcare companies, including Cordis, Biomet, Guidant Corporation (now Boston Scientific), and Angiodynamics. She earned a BA in Communications Studies from Northern Illinois University. About InspireMD, Inc.InspireMD seeks to utilize its proprietary MicroNet™ mesh technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on Nasdaq under the ticker symbol NSPR. We routinely post information that may be important to investors on the Company’s website. For more information, please visit www.inspiremd.com. Forward-looking StatementsThis press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding future events, future financial performance, strategies, expectations, competitive environment and regulation. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. In particular, forward-looking statements in this press release include expectations regarding potential FDA approvals for CGuard Prime Carotid Stent System 80 cm implant for use in TCAR procedures. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with the Company’s history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of its liquidity to pursue its complete business objectives, and substantial doubt regarding its ability to continue as a going concern; the Company’s need to raise additional capital to meet its business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; the clinical development, commercialization and market acceptance of the Company’s products; whether the clinical trial results for the Company’s products will be predictive of real-world results; an inability to secure and maintain regulatory approvals for the sale of the Company’s products; negative clinical trial results or lengthy product delays in key markets; the Company’s ability to maintain compliance with the Nasdaq listing standards; the Company’s ability to generate significant revenues from its products; estimates of the Company’s expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the ongoing commercial launch of its products; the Company’s dependence on a single manufacturing facility and its ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from the Company’s current and planned clinical trials may not be sufficient to demonstrate that its technology is an attractive alternative to other procedures and products; intense competition in the Company’s industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than it does; entry of new competitors and products and potential technological obsolescence of the Company’s products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with the Company’s research and products and potential product liability claims; product malfunctions; price increases for supplies and components; whether access to the Company’s products is achieved in a commercially viable manner and whether its products receive adequate reimbursement by governmental and other third-party payers; the Company’s efforts to successfully obtain and maintain intellectual property protection covering its products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that the Company conducts business in multiple foreign jurisdictions, exposing it to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; security, political and economic instability in the Middle East that could harm the Company’s business, including due to the current security situation in Israel; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; and changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements and the impact of such policies on the Company, its customers and suppliers, and the global economic environment. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Investor Contacts:Jeff WarrenLifeSci Advisorsjwarren@lifesciadvisors.cominvestor-relations@inspiremd.com
HeartSciences Files Preliminary Proxy Statement for Business Combination with Fortitude Mining Holdings; Provides Business Update and Reports Fiscal 2026 Financial Results
Company believes proposed Fortitude Mining Holdings business combination represents a significant value creation opportunity for the Company’s shareholders Fiscal 2026 saw the full commercial launch of the MyoVista Insights platform and submission of the MyoVista wavECG device to the FDA for 510(k) clearance Southlake, TX, July 29, 2026 (GLOBE NEWSWIRE) — HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company focused on advancing electrocardiography (“ECG” or “EKG”) through the integration of artificial intelligence (“AI”), today announced that it has filed its preliminary proxy statement (the “Proxy Statement”) with the U.S. Securities and Exchange Commission (the “SEC”) in connection with the previously announced proposed business combination (the “Proposed Transaction”) with Fortitude Mining Holdings, Inc. (“Fortitude”) and is providing a business update and its financial results for the fiscal year ended April 30, 2026 (“Fiscal 2026”), which follow the filing of HeartSciences’ Annual Report on Form 10-K (the “Form 10-K”) for Fiscal 2026 with the SEC on July 23, 2026. Each of the Proxy Statement and Form 10-K is available at www.sec.gov and on the Company’s website at www.heartsciences.com. Fiscal 2026 and Business Highlights Fiscal 2026, and the period since, has been one of transformational change for HeartSciences. We believe the Proposed Transaction with Fortitude offers a compelling opportunity for our shareholders to own a stake in a company that is a meaningful part of the Zcash ecosystem. In our view, Zcash has been among the best-performing large-cap digital assets over the past year and is attracting growing institutional interest. In addition, we made significant progress, with the full commercial launch of its MyoVista Insights platform and deployment contracts with healthcare institutions, together with the submission of its MyoVista wavECG device to the FDA for 510(k) clearance, which is currently under review. Proposed Transaction with Fortitude Since the Company’s IPO in 2022 and despite significant commercial progress, the Company has experienced sustained pressure on its share price, has had to navigate repeated Nasdaq listing deficiencies and has often lacked the cash runway to make long-term strategic and operational decisions. Although the initial decision to evaluate strategic alternatives was, in part, a defensive one, the process that followed was not. The Company’s Board of Directors reviewed a range of potential alternatives and had genuine choices available. We chose Fortitude because we believe it is a highly attractive partner and the Proposed Transaction presents a significant opportunity for us to create both short- and long-term value for our shareholders, including for the following reasons: Zcash shares the foundational properties that have made Bitcoin compelling to investors but introduces enhanced privacy technology and quantum computing resilience.Fortitude is based, and operates solely, in the United States. Over many years it has developed into what is believed to be one of the largest and longest-tenured operators in the Zcash ecosystem, providing significant competitive advantage. In the six months ended June 30, 2026, it mined 72,696 ZEC, representing approximately 28% of overall ZEC production. Fortitude’s belief that its competitive positioning translates into meaningful benefits, including deep knowledge of mining ZEC at scale, status as a preferred buyer of mining equipment to support significant growth aspirations, and efficient and profitable mining operations.Fortitude has undertaken a number of actions to underpin growth, including its announcement yesterday of the energization of its new facility in Grand Island, Nebraska, which brings its owned power portfolio to over 60MW. The facility is expected to contribute to Fortitude’s planned trajectory of lowering its Zcash direct cash mining cost from approximately $70 per coin toward approximately $40 per coin, assuming successful equipment deployment and stable power, network, and market conditions. It has also executed purchase orders for a significant number of new machines with an expected payback of less than 12 to 18 months (assuming a hashprice of at least $0.021/kSol/day).Together, these advantages underpin a significant, business. At Zcash prices in excess of $500, Fortitude currently estimates that its run-rate adjusted EBITDA would be over $50 million, once new machines are delivered and hashing. Proxy Statement Our unaudited pro forma condensed combined statement of financial position set out in the Proxy Statement: assumes the issuance of approximately 107.6 million shares of our new to be designated Class V Common Stock to Digital Currency Group (“DCG”), the parent company of Fortitude, in connection with the Proposed Transaction; andshows our pro forma combined total shareholders’ equity of $70.0 million. The above is qualified in its entirety by reference to our unaudited pro forma condensed combined statement of financial position included in the Proxy Statement. Our shareholders will also note that the Proxy Statement includes a proposal to authorize our Board of Directors to complete, at its discretion, a reverse stock split, at a ratio to be determined by our Board of Directors and mutually agreed to by HeartSciences and Fortitude, within a range of between 1-for-2 and 1-for-5. This proposal is driven by Nasdaq listing requirements for the combined company if the Proposed Transaction is completed. Our Board of Directors currently expects that any reverse stock split would be implemented only if considered necessary to support the combined company’s Nasdaq listing in connection with the Proposed Transaction. Recognizing shareholder sensitivity around reverse splits, the ratio range has been carefully considered. Further details are available in the Proxy Statement (See Proposal 4). MyoVista Insights™ Healthcare IT Software Platform The past year saw MyoVista Insights move from an R&D project to full commercial application. We achieved product launch, version upgrades, Epic Toolbox designation and interoperability compliance, launched a first AI-ECG algorithm on the platform, and have begun deployments with a number of healthcare institutions.As we have consistently said, the field of AI-ECG is now moving forward at pace and has progressed significantly over the past 18 months. There have been multiple regulatory clearances of algorithms in the U.S. and internationally and the beginning of meaningful clinical use.We believe this validates our decision to focus on a cost-effective solution for cloud-based ECG management, which provides straightforward delivery of AI-ECG into today’s clinical workflows. In developing and commercializing MyoVista Insights, we are drawing on the successes of best-in-class radiology AI platforms and seeking to replicate those in ECG.The future strategy is straightforward: (i) add AI-ECG algorithms to the MyoVista Insights platform from world-leading algorithm companies with which we are in discussion; and (ii) convert the broad pipeline of ongoing customer discussions into further commercial contracts. MyoVista wavECG device HeartSciences submitted its MyoVista wavECG device to the FDA for 510(k) premarket clearance in December 2025, and the submission is currently going through the FDA review process. HeartSciences elected to separate the FDA submissions for the MyoVista wavECG device and its impaired cardiac relaxation AI-ECG algorithm following updated guidance published by the American Society of Echocardiography (“ASE”) regarding the assessment of Left Ventricular Diastolic Dysfunction (“LVDD”), including revised age-based thresholds for cardiac relaxation (e’). Fiscal 2026 Financial Results The Company reported no meaningful revenue for Fiscal 2026. As of April 30, 2026, the Company had approximately $1.7 million in cash and cash equivalents, and $0.2 million in shareholders’ equity. Complete financial results have been filed in the Form 10-K, which is available at www.sec.gov and on the Company’s website at www.heartsciences.com. Management Commentary “Fiscal 2026 was a year of transformational change for HeartSciences,” said Andrew Simpson, CEO of HeartSciences. “MyoVista Insights moved from development into full commercial use, with our platform launch, our first AI-ECG algorithm and commercial deployments with healthcare institutions, and our MyoVista wavECG device is under FDA review for 510(k) clearance. The proposed combination with Fortitude builds on that progress. It offers our shareholders continued ownership in a business operating at scale and generating meaningful revenue, anchored in Zcash, one of the best-performing large-cap digital assets of the past year. Fortitude is among the largest and longest-tenured operators in the Zcash ecosystem, and we believe the combination represents a significant value creation opportunity. We encourage all shareholders to read the Proxy Statement and look forward to their support at the special meeting.” For more information, please visit: https://www.heartsciences.com. X: @HeartSciences About Fortitude Fortitude, currently wholly-owned by DCG, is an institutional-scale, vertically integrated venture mining platform operating across the Proof-of-Work ecosystem and anchored in Zcash. Fortitude pairs self-mining operations with an owned data center footprint, a diversified power portfolio backed by competitive long-term contracts, and disciplined capital allocation to identify and scale high-conviction opportunities in emerging Proof-of-Work ecosystems, beginning with its meaningful position in the Zcash network. Fortitude is led by an experienced team of operators, capital markets professionals, and digital asset specialists with a track record of identifying and scaling high-conviction opportunities and building privacy-preserving digital asset infrastructure. For more information, visit www.fortitudemining.com and follow Fortitude on X at @FortitudeCrypto. About HeartSciences HeartSciences is a healthcare information technology company advancing the use of ECG/EKGs through the integration of artificial intelligence. HeartSciences’ MyoVista Insights™ Platform is a device-agnostic, next-generation ECG management system designed to improve clinical efficiency and decision-making. Its MyoVista wavECG device is designed to deliver conventional ECG functionality while supporting on-device AI-enabled solutions. For more information, please visit: www.heartsciences.com and follow HeartSciences on X at @HeartSciences. Cautionary Note Regarding Forward-Looking Information This press release contains forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “will,” “would,” “believe,” “estimate,” “goal,” “intend,” and other words of similar meaning, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, express or implied statements relating to the timing and completion of the Proposed Transaction, the potential benefits of the Proposed Transaction, including access to the public markets and listing on Nasdaq, Fortitude’s plans and expectations concerning the Grand Island Facility including expected cost savings and other benefits, the timing and expected benefits of and the pay-back period related to Fortitude’s new mining machines, future plans for the MyoVista Insights platform, expectations related to the potential reverse stock split. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements are based on management’s current expectations and assumptions as of the date of this press release and are subject to a number of known and unknown risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied by such statements, including, without limitation, the following: the risk that the Proposed Transaction may not be completed on the anticipated timeline or at all; the failure to satisfy the conditions to the closing of the Proposed Transaction, including obtaining the requisite approval of the HeartSciences shareholders; market, macroeconomic, or other conditions that could adversely affect either HeartSciences or Fortitude, or the combined company; risks related to the integration of the two companies and the management of a newly public company; risks relating to Fortitude’s operations and business, including the highly volatile nature of the price of Zcash and other cryptocurrencies; risks related to Nasdaq review of the initial listing application of the combined company; risks related to the potential reverse stock split; and risks relating to significant legal, commercial, regulatory and technical uncertainty regarding digital assets generally. Additional factors that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release are discussed in HeartSciences’ preliminary proxy statement on Schedule 14A, filed with the U.S. Securities and Exchange Commission (the “SEC”) on July 27, 2026 in connection with the Proposed Transaction, HeartSciences’ 2026 Annual Report on Form 10-K, filed with the SEC on July 23, 2026, and other reports filed with the SEC from time to time. Readers are cautioned not to place undue reliance on these forward-looking statements. Each of HeartSciences and Fortitude expressly disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law. All forward-looking statements are made as of the date of this press release. About Non-GAAP Financial Measures We have presented certain financial measures in this press release that are not recognized under GAAP. Specifically, we have presented “EBITDA” and “Adjusted EBITDA” (each as further described below). References to “EBITDA” mean earnings before interest, taxes, depreciation and amortization and “Adjusted EBITDA” means EBITDA, adjusted for non-recurring Proposed Transaction related expenses and non-recurring expenses including advisory, legal, accounting, and regulatory fees related to the spin-out of Fortitude’s business from Foundry in October 2024 to form a standalone business. We use non-GAAP measures in our operational and financial decision making and believe that such non-GAAP numbers are more representative of the performance of the business and thus instructive for our strategic planning. Specifically, with respect to Adjusted EBITDA, we believe it is useful to exclude certain items in order to allow for period-over-period comparisons on a more consistent basis and to focus on what we regard to be a more meaningful indicator for evaluating the underlying operating performance of the business. We believe that these non-GAAP financial measures, while not a substitute for GAAP financial measures, provide investors with (i) an improved ability to evaluate our underlying performance and (ii) greater transparency of the key performance metrics used by management with respect to operational and financial decision making. In evaluating Adjusted EBITDA, you should be aware that in the future we may incur expenses that are the same as or similar to some of the adjustments in such presentation. The non-GAAP financial measures presented herein are provided as supplemental information to our performance measures calculated in accordance with GAAP and should not be considered in isolation or as a substitute for GAAP. Non-GAAP measures have limitations as an analytical tool. Some of these limitations are: (i) Adjusted EBITDA excludes certain transaction-related expenses and non-recurring legal expenses we have incurred, such as litigation costs and one-time accounting charges; (ii) although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and the cash requirements for such replacements are not reflected in Adjusted EBITDA; (iii) the omission of the amortization expense associated with our intangible assets further limits the usefulness of Adjusted EBITDA; and (iv) Adjusted EBITDA does not include the payment of taxes, which is a necessary element of our operations. Because of these limitations, such non-GAAP measures should not be considered as an alternative to profit or loss for the period determined in accordance with GAAP or operating cash flows determined in accordance with GAAP. Management compensates for these limitations by not viewing the non-GAAP measures in isolation and specifically by using other GAAP measures to measure our operating performance. Further, non-GAAP financial measures do not have any standardized meaning prescribed under GAAP and therefore may not be comparable to other issuers. As a result, you should not consider such performance measures in isolation from, or as a substitute analysis for, our results of operations as determined in accordance with GAAP. With respect to projected full Fiscal 2027 Adjusted EBITDA, a quantitative reconciliation is not available without unreasonable efforts due to the high variability, complexity and low visibility with respect to purchase accounting adjustments, Proposed Transaction-related charges and legal settlement reserves excluded from Adjusted EBITDA. We expect that the variability of these items to have a potentially unpredictable, and potentially significant, impact on our future GAAP financial results. Additional Information About the Proposed Transaction and Where to Find It This press release may be deemed solicitation material in respect of the Proposed Transaction. In connection with the Proposed Transaction, HeartSciences has filed and may file additional relevant materials with the SEC, including a preliminary proxy statement on Schedule 14A. Following the filing of a definitive proxy statement with the SEC, HeartSciences will mail the definitive proxy statement and a proxy card to each shareholder entitled to vote at the special meeting relating to the Proposed Transaction. INVESTORS AND SHAREHOLDERS OF HEARTSCIENCES ARE URGED TO READ THESE MATERIALS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS IN CONNECTION WITH THE PROPOSED TRANSACTION THAT HEARTSCIENCES WILL FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT HEARTSCIENCES AND THE PROPOSED TRANSACTION. THIS PRESS RELEASE DOES NOT CONTAIN ALL THE INFORMATION THAT SHOULD BE CONSIDERED CONCERNING THE PROPOSED TRANSACTION AND RELATED MATTERS AND IS NOT INTENDED TO PROVIDE THE BASIS FOR ANY INVESTMENT DECISION OR ANY OTHER DECISION IN RESPECT OF SUCH MATTERS. The preliminary proxy statement, the definitive proxy statement and other relevant materials in connection with the Proposed Transaction (when they become available), and any other documents filed by HeartSciences with the SEC, may be obtained free of charge at the SEC’s website at www.sec.gov. In addition, investors and shareholders may obtain free copies of the documents filed with the SEC by sending a request to the HeartSciences Investor Relations Department at investorrelations@heartsciences.com. Participants in the Solicitation HeartSciences and Fortitude, their respective directors and executive officers, and certain executive officers of Digital Currency Group may be deemed to be participants in the solicitation of proxies from HeartSciences’ shareholders with respect to the Proposed Transaction. Information regarding the identity of the potential participants, and their direct or indirect interests in the Proposed Transaction, by security holdings or otherwise, is set forth in the preliminary proxy statement and other materials that have been or may be filed with the SEC in connection with the Proposed Transaction. No Offer or Solicitation This press release and the information contained herein is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the Proposed Transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. The Proposed Transaction will be implemented solely pursuant to the terms and conditions of the merger agreement, which contain the full terms and conditions of the Proposed Transaction. Investor Relations: Integrous CommunicationsMark Komonoski, PartnerPhone: 877 255 8483Email: mkomonoski@integcom.us
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