The Latest Cardiac and Vascular News
WASHINGTON, May 14, 2026 /PRNewswire/ — DeepQure, a clinical-stage medical device company, announced the completion of its featured presentation at the American Urological Association (AUA) Innovation Nexus Forum, held during the AUA Annual Meeting. DeepQure was selected to present the…
Strategic Investment Fuels FDA Regulatory Path and Global Commercialization; Company to Showcase Technology at AUA 2026 BOSTON and YOKNEAM, Israel, May 14, 2026 /PRNewswire/ — Butterfly Medical, developer of a proprietary non-surgical solution for BPH (benign prostatic hyperplasia), today announced the successful completion of its Series C funding round, raising $21 million. The strong […]
HAYWARD, Calif.–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE), developer of nPulse™ technology using proprietary nanosecond pulsed field ablation (nsPFA™) energy, today announced its Co-Chairmen of the Board, Robert Duggan and Chief Executive Officer Paul LaViolette, completed purchases of Pulse Biosciences’ common stock through its at-the-market equity offering program (ATM) during the […]
This focus issue examines the “diagnostic odyssey,” evolving risk stratification, and the use of AI tools to reveal patterns in infiltrative and inflammatory cardiomyopathies. WASHINGTON, May 14, 2026 /PRNewswire/ — Inflammatory and infiltrative cardiomyopathies remain among the most…
BRENTWOOD, Tenn. & LEXINGTON, Mass.–(BUSINESS WIRE)–Ardent Health (NYSE: ARDT), a leading provider of healthcare in growing mid-sized urban communities across the U.S., has partnered with FUJIFILM Healthcare Americas Corporation to implement its Synapse® enterprise imaging solutions across Ardent’s acute care hospital footprint across six states. Fujifilm’s Synapse Enterprise Imaging solutions will provide Ardent clinicians with a single, holistic view of patient imaging data across various d
MINNEAPOLIS, May 14, 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, announced today that Humana has 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 new policy covers Barostim for patients meeting its current FDA-approved indication as well as patients enrolled in the BENEFIT-HF trial, the landmark heart failure study evaluating Barostim in a significantly expanded patient population initiated earlier this year. “We are pleased to receive this Medicare Advantage coverage policy from Humana, which represents the first coverage policy for Barostim and marks an important milestone in our efforts to expand access to the therapy for patients living with heart failure,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “Humana’s policy reflects continued progress in educating payers on the clinical outcomes and patient benefits of Barostim therapy. We believe this policy validates our commercial strategy, supports ongoing discussions with other regional and national payers, and will help accelerate adoption of Barostim through more consistent coverage.” This coverage policy follows two other positive reimbursement developments for Barostim this year. Effective Jan. 1, 2026, Category I CPT codes went into effect for the Barostim procedure. In addition, that same month, the Centers for Medicare & Medicaid Services (CMS) approved Category B IDE coverage for patients enrolled in the BENEFIT-HF trial. 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. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com
LATHAM, N.Y.–(BUSINESS WIRE)–AngioDynamics, Inc. (NASDAQ: ANGO), a medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced two-year results from the PRESERVE pivotal trial (NCT04972097) demonstrating durable oncologic control and a sustained safety profile for the NanoKnife System in the focal ablation of intermediate-risk prostate cancer. The data will be discus
MINNEAPOLIS and BRISBANE, Australia, May 13, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, announced the appointment of Ms. Susan Knight and Mr. Stephen Denaro to serve on the Board of Directors (the “Board”). “On behalf of the management team and Board, I am delighted to welcome Sue to the Company,” commented John Seaberg, Chairman of Anteris. “I am also delighted to welcome back Stephen, whose familiarity with our business and strong governance expertise make him a tremendous asset to the Board. Together, they further strengthen our leadership at an exciting time for the Company as we advance the DurAVR® global, pivotal trial (the “PARADIGM Trial”) and prepare to bring this technology to patients worldwide.” Ms. Knight will serve as a Class I Director, with a term expiring at the Company’s 2028 annual meeting of stockholders and will serve on the Audit and Risk Committee of the Board. Mr. Denaro will serve as a Class II Director, with a term expiring at the Company’s 2026 annual meeting of stockholders. Ms. Knight most recently served as the Board Chair of Surmodics, Inc., a medical device provider, a position she held from 2015 until November 2025. She has served on corporate boards of directors since 2008 and has broad audit committee experience, including serving as committee chair at Surmodics, Inc., Greater Metropolitan Housing Corporation and Plato Learning. During her professional career, Ms. Knight was the Senior Vice President and Chief Financial Officer of MTS Systems Corporation from 2011 to 2014 and its Chief Financial Officer from 2001 to 2011. Prior to MTS Systems Corporation, Ms. Knight was the Vice President of Finance of the Home and Building Control Business of Honeywell, Inc. from 1994 to 2001. She also held various other management and executive financial positions during her 24-year career at Honeywell, Inc. Ms. Knight earned a BSBA in Accounting from Creighton University. Mr. Denaro rejoins the Board with deep knowledge of the Company and its strategic priorities. Together these appointments reinforce the Company’s governance and strategic capabilities as it advances its global clinical and commercial objectives towards the anticipated U.S. and EMA licensure of the DurAVR® THV for patients with aortic stenosis. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (“THV”), was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. For more information: Investor RelationsInvestor Relations (US)investors@anteristech.com mchatterjee@bplifescience.com Debbie OrmsbyMalini Chatterjee, Ph.D.Anteris Technologies Global Corp.Blueprint Life Science Group+61 1300 550 310 | +61 7 3152 3200+1 917 330 4269 Websitewww.anteristech.com X@AnterisTechLinkedInhttps://www.linkedin.com/company/anteristech
Record quarterly revenue driven by strong growth in SSi Mantra installations and proceduresFORT LAUDERDALE, Fla., May 13, 2026 (GLOBE NEWSWIRE) — SS Innovations International, Inc. (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced unaudited financial results for the three months ended March 31, 2026. The Company also filed its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, with the Securities and Exchange Commission on May 13, 2026. First Quarter 2026 Overview Revenue increased 116.8% to $11.1 million from $5.1 million in the first quarter of 2025.Gross margin expanded to 48.0% from 21.2% in the first quarter of 2025.Gross profit rose 390.0% to $5.3 million from $1.1 million in the first quarter of 2025.Net loss of $3.6 million, or $(0.02) per diluted share, compared to a net loss of $5.7 million, or $(0.03) per diluted share, in the first quarter of 2025.SSi Mantra surgical robotic system installations totaled 26, up 73.3% from 15 installations in the first quarter of 2025. As of March 31, 2026 Long-term debt of $0.Cash and cash equivalents totaled $16.0 million, excluding restricted cash.SSi Mantra cumulative installed base totaled 194 across eleven countries and cumulative surgeries reached 9,744, including 157 telesurgeries, 482 cardiac procedures and 161 pediatric surgeries. CEO Commentary Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “In the first quarter of 2026 we reported record quarterly revenue of $11.1 million, up 117% year over year, driven by robust growth in SSi Mantra installations and procedures. Strong adoption by hospitals and physicians reflects the SSi Mantra’s cutting-edge surgical robotic technology, differentiated features, user friendliness, training capabilities, and cost efficiency. Among other developments in the quarter, we received regulatory approval for the SSi Mantra for multiple indications in Sri Lanka and Kenya and for telesurgery in Indonesia and the Philippines. We also successfully completed a private placement in March 2026 that provided SS Innovations with approximately $18.6 million in gross proceeds to fuel growth initiatives.” Dr. Srivastava continued, “Looking ahead, we aim to fortify our position as a leader in the substantial Indian market, expand our global footprint in underserved countries, and secure entry into the United States and European Union markets. We expect the U.S. Food and Drug Administration to complete its review of our 510(k) premarket notification for the SSi Mantra this year. Separately, we continue along the pathway towards a European Union CE marking certification for the SSi Mantra, which we believe we can also obtain in 2026. We are very excited about the growth runway ahead and remain steadfast in our commitment to democratizing access to advanced surgical robotic care.” Select Business Highlights in First Quarter 2025 In January 2026, the Company received regulatory approval for the SSi Mantra from the National Medicines Regulatory Authority (“NMRA”) in Sri Lanka and from the Pharmacy and Poisons Board (“PPB”) in Kenya.On March 9, 2026, the Company announced the completion of a private placement of its common stock, generating approximately $18.6 million in gross proceeds before deducting offering expenses, to support growth initiatives. In the offering, the Company offered and sold a total of 5,774,839 shares of common stock consisting of: an aggregate of 1,300,006 shares of common stock at an average price of $4.00 per share to certain of the Company’s directors and executive officers, or a total of approximately $5.2 million; and an aggregate of 4,474,833 shares of common stock at $3.00 per share, or approximately $13.4 million cumulatively, to non-affiliate investors.On March 18, 2026, the Company announced that the SSi Mantra surgical robotic system received approval for telesurgeries in Indonesia and the Philippines. Revenue Breakdown and Summary of Installations / Surgeries CategoryQ1 2025Q1 2026VariancePercentageSystem sales$4,502,482$9,575,370$5,072,888 112.7%Instrument sales 477,208 1,151,228 674,020 141.2%Warranty sales 122,504 357,686 235,182 192.0%Lease income 18,416 17,082 (1,334)(7.2)%Total revenue$5,120,610$11,101,366$5,980,756 116.8% SSi Mantra installations 15 26 11 73.3%Cumulative installed base1 78 194 116 148.7% SSi Mantra surgeries 787 1,859 1,072 136.2%Cumulative surgeries1 3,568 9,744 6,176 173.1% 1 at period end About SS Innovations SS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The Company’s product range includes its proprietary “SSi Mantra” surgical robotic system and its comprehensive suite of “SSi Mudra” surgical instruments, which support a variety of robotic surgical procedures including cardiac surgery. An American company headquartered in India, SS Innovations plans to expand the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. Visit the Company’s website at ssinnovations.com or LinkedIn for more information and updates. About the SSi Mantra The SSi Mantra surgical robotic system is a user-friendly, modular, multi-arm system with advanced technology features, including: 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch panel monitor for all patient related information display, a virtual real-time image of the robotic patient side arm carts, and the ability for superimposition of 3D models of diagnostic imaging. The optional SSi MantrAsana Tele Surgeon Console is a portable, compact alternative to the SSi Mantra’s standard surgeon command center that provides equivalent control functionality while enabling enhanced portability, ergonomic flexibility, and telesurgery capability. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery, and 5mm instruments for the pediatric population and ENT surgeries. A vision cart provides the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra has been clinically validated in India in more than 170 different types of surgical procedures. Forward Looking StatementsThis press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “assume,” “believe,” “estimate,” “expect,” “will,” “intend,” “may,” “plan,” “project,” “should,” “could,” “seek,” “designed,” “potential,” “forecast,” “target,” “objective,” “goal,” or the negatives of such terms or other similar expressions to identify such forward-looking statements. These statements relate to future events or SS Innovations’ future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Investor Contact:The Equity Group Kalle Ahl, CFA T: (303) 953-9878 kahl@theequitygroup.com Devin Sullivan, Managing Director T: (212) 836-9608dsullivan@theequitygroup.com Media Contact:RooneyPartners LLCKate BarretteT: (212) 223-0561kbarrette@rooneypartners.com SS INNOVATIONS INTERNATIONAL, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited) As of March 31,2026 December 31,2025 ASSETS Current Assets: Cash and cash equivalents $15,979,714 $3,206,406 Restricted cash 7,631,336 5,937,650 Accounts receivable, net 14,054,376 12,398,542 Inventory 17,066,091 17,064,002 Prepaids and other current assets 11,530,000 10,166,823 Total Current Assets 66,261,517 48,773,423 Property, plant, and equipment, net 8,831,423 9,100,546 Right of use asset, net 2,499,490 2,754,020 Deferred tax assets, net 805,750 533,727 Accounts receivable, net-non current 7,265,911 8,566,654 Restricted cash- non current 394,630 458,964 Prepaids and other non current assets 4,488,168 4,038,883 Total Assets $90,546,889 $74,226,217 LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY Current Liabilities Bank overdraft facility $11,156,147 $11,442,948 Current portion of operating lease liabilities 576,237 579,169 Accounts payable 4,403,170 5,127,193 Deferred revenue 3,582,631 3,266,686 Accrued expenses & other current liabilities 6,326,818 5,825,702 Total Current Liabilities 26,045,003 26,241,698 Operating lease liabilities, less current portion 2,086,534 2,337,697 Deferred Revenue- non current 7,501,283 7,139,807 Other non current liabilities 390,656 288,764 Total Liabilities $36,023,476 $36,007,966 Commitments and contingencies Stockholders’ equity: Preferred stock, authorized 5,000,000 shares of Series A, Non-Convertible Preferred Stock, $0.0001 par value per share; 1,000 shares issued and outstanding as of March 31, 2026, and December 31, 2025 1 1 Common stock, 250,000,000 shares authorized, $0.0001 par value, 200,131,535 shares and 194,165,141 shares issued and outstanding as of March 31, 2026 and December 31, 2025 respectively 20,013 19,416 Accumulated other comprehensive income (loss) (3,573,137) (2,022,660)Additional paid in capital 116,549,124 95,111,511 Capital reserve 899,917 899,917 Accumulated deficit (59,372,505) (55,789,934)Total stockholders’ equity 54,523,413 38,218,251 Total liabilities and stockholders’ equity $90,546,889 $74,226,217 SS INNOVATIONS INTERNATIONAL, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Unaudited) For The Three months ended March 31,2026 March 31,2025 REVENUES System sales 9,575,370 4,502,482 Instruments sale 1,151,228 477,208 Warranty sale 357,686 122,504 Lease income 17,082 18,416 Total revenue $11,101,366 $5,120,610 Cost of revenue (5,774,145) (4,033,402) GROSS PROFIT 5,327,221 1,087,208 OPERATING EXPENSES: Research & development expense 995,440 1,010,095 Stock compensation expense 3,144,315 2,379,212 Depreciation and amortization expense 323,747 208,882 Selling, general and administrative expense 4,502,476 3,410,872 TOTAL OPERATING EXPENSES 8,965,978 7,009,061 Loss from operations (3,638,757) (5,921,853) OTHER INCOME (EXPENSE): Interest Expense (284,051) (379,905)Interest and other income, net 491,589 620,405 TOTAL INCOME, NET 207,538 240,500 LOSS BEFORE INCOME TAXES (3,431,219) (5,681,353)Income tax expense 151,352 – NET LOSS $(3,582,571) $(5,681,353) CONSOLIDATED STATEMENTS OF OTHER COMPREHENSIVE LOSS NET LOSS $(3,582,571) $(5,681,353) OTHER COMPREHENSIVE INCOME (LOSS): Foreign currency translation loss (1,557,111) 6,876 Retirement Benefit 4,781 15,838 RECLASSIFICATION ADJUSTMENTS: Retirement Benefit (1) 3,056 – Income tax effects relating to retirement benefit (1,203) – TOTAL OTHER COMPREHENSIVE LOSS (1,550,477) 22,714 TOTAL COMPREHENSIVE LOSS $(5,133,048) $(5,658,639) (1)These are reclassified to net loss and are included in other expenses in the condensed consolidated statements of operations. SS INNOVATIONS INTERNATIONAL, INC.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(Unaudited) For The Three months ended March 31, 2026 March 31, 2025 Cash flows from operating activities: Net loss $(3,582,571) $(5,681,353)Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 323,747 208,882 Operating lease expense 220,493 205,275 Interest Expense 43,555 155,015 Interest and other income, net (415,465) (140,928)Deferred income tax benefit (301,036) – Stock compensation expense 3,144,315 2,379,212 Provision for / (Reversal of) credit loss reserve, net 230,616 (422,711)Provision for slow moving inventory (6,248) – Changes in operating assets and liabilities: Accounts receivable, net (245,111) 1,275,750 Inventory, net 4,159 (5,082,673)Deferred revenue 677,421 823,947 Prepaids and other assets (2,066,322) (1,003,604)Accounts payable (704,764) 1,329,028 Income taxes payable, net 323,014 – Accrued expenses & other liabilities 256,441 48,331 Operating lease payment (214,180) (197,545)Net cash used in operating activities (2,311,936) (6,103,374) Cash flows from investing activities: Purchase of property, plant and equipment (54,189) (872,804)Net cash used in investing activities (54,189) (872,804) Cash flows from financing activities: Proceeds from bank overdraft facility (net) (286,801) (312,495)Proceeds from Private Investment in Public Equity, net of transaction costs 18,446,498 – Proceeds from issuance of convertible notes to principal shareholder – 28,000,000 Repayment of convertible notes to principal shareholder, including interest – (4,212,637)Repayment of convertible notes to other investors, including interest – (1,068,849)Net cash provided by financing activities 18,159,697 22,406,019 Net change in cash 15,793,572 15,429,841 Effect of exchange rate on cash (1,390,012) 25,412 Cash and cash equivalents at the beginning of the year 9,603,020 6,623,535 Cash and cash equivalents at end of the year $24,005,680 $22,078,788
MINNEAPOLIS and BRISBANE, Australia, May 12, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today reported financial results for the quarter ended March 31, 2026, and provided a corporate update. Q1 2026 Highlights Completed aggregate capital raises totalling $320 million in January 2026 to support execution of the PARADIGM Trial and advance the Company toward global commercialization of the DurAVR® THV SystemAdvanced PARADIGM Trial recruitment, supported by ongoing regulatory and operational work to activate additional countries and sites – post quarter-end, U.S. enrollment commencedPresented clinical data from the ongoing EMBARK Study and U.S. Early Feasibility Study (EFS) at Cardiovascular Research Technologies (CRT 2026) and Sydney Valves 2026, supporting ongoing scientific engagement and exchange with the clinical community “Q1 2026 reflects strong execution across the PARADIGM Trial, with patient enrollment ongoing in Europe and continued progress on key recruitment activities globally. With the U.S. now on line and first patients enrolled, we are firmly executing our strategy and building momentum toward the commercial launch of DurAVR®,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. Business & Operations Following initiation of our global pivotal trial in Q4 2025, we are seeing continued progress across Europe, and the United States where patient enrollment has recently commenced. Clinical centers are advancing through key start up milestones, including ethics and regulatory approvals, site initiation visits and investigator training, alongside active patient screening and enrollment at activated sites. In the United States, recent coverage determination by the Centers for Medicare and Medicaid Services (CMS) is expected to facilitate patient recruitment by supporting reimbursement and facilitating site-level adoption. Eligible procedures performed at participating U.S. study sites are covered under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32. Collectively, these activities are supporting growing enrollment momentum as additional sites come on line and contribute to trial execution. Financial Results The financial results for Anteris for the quarter ended March 31, 2026, are presented below. All amounts in $ refer to U.S. dollars. The Company’s net operating cash outflows for the three months ended March 31, 2026, were $28.7 million, attributable to clinical, regulatory and manufacturing requirements to support the PARADIGM Trial. This clinical focus is reflected in the Company’s operating expenditures, with R&D expenses of $17.5 million driven by the upscaling of manufacturing and quality capabilities, including process design and validation activities and the expansion of headcount, and activities linked to the PARADIGM Trial, including clinical costs associated with the enrollment of additional patients and the scaling of our field-based clinical team. These were partly offset by reduced DurAVR® THV product research costs. Anteris refers to the detailed financial information contained in its Form 10-Q filing including the Management Discussion & Analysis and the Risks. ENDS About the PARADIGM Trial The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR® Transcatheter Heart Valve (“THV”) compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study will enrol approximately 1,000 patients in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure. For further information, please refer to ClinicalTrials.gov NCT07194265. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® THV, was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements, including statements regarding the expectation that achievement of CMS coverage will facilitate U.S. site activation, accelerating operational momentum across participating centers, and the PARADIGM Trial. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. For more information: Global Investor RelationsInvestor Relations (US)investors@anteristech.com mchatterjee@bplifescience.com Debbie OrmsbyMalini Chatterjee, Ph.D.Anteris Technologies Global Corp.Blueprint Life Science Group+61 1300 550 310 | +61 7 3152 3200+1 917 330 4269 Websitewww.anteristech.com X@AnterisTechLinkedInhttps://www.linkedin.com/company/anteristech
