The Latest Cardiac and Vascular News
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
Orchestra BioMed targeting enrollment completion of BACKBEAT Global Pivotal Trial (“BACKBEAT Trial”) by the end of Q3 2026Medtronic (NYSE: MDT) and Orchestra BioMed intend to pursue late-breaking clinical trial presentation at major cardiology conference in Q2 2027 and subsequent marketing application submission to FDA and global regulatory agencies, assuming primary endpoints are met FDA granted a second Breakthrough Device Designation (“BDD”) for AVIM Therapy specific to patients with uncontrolled hypertension despite the use of anti-hypertensive medications, and an indication for a pacemakerVirtue Trial sites progressing with site activation and patient enrollment acceleration continuing throughout 2026Cash runway projected into Q4 2027 and through achievement of key upcoming clinical and regulatory milestones NEW HOPE, Pa., May 12, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the first quarter ended March 31, 2026, and provided a business update highlighting momentum across the Company’s pivotal-stage programs for Atrioventricular Interval Modulation (“AVIM”) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”) supported by the Company’s strong balance sheet. David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed stated, “We continued to make meaningful advancements across our late-stage cardiovascular pipeline during the first quarter. Along with the achievement of recently announced important regulatory, clinical and financing milestones, we are pleased to provide clarity on the expected timeline for the BACKBEAT Trial highlighting objectives for enrollment completion, late-breaking clinical trial presentation, and plans for potential regulatory submissions by our strategic collaborator Medtronic. With increasingly strong momentum continuing in the BACKBEAT Trial and the AVIM Therapy program, and great progress for the Virtue Trial and Virtue SAB, our team is excited about the significant value inflection points that lie ahead for Orchestra BioMed.” Q1 2026 and Recent Business Highlights: Provided overall update on the BACKBEAT Trial timeline, targeting enrollment completion by the end of the third quarter of 2026 and announced plans with Medtronic to pursue presentation of primary endpoint data as a late-breaking clinical trial presentation at a major cardiovascular conference in the second quarter of 2027, assuming primary endpoints are met. The updated timeline is supported by FDA approval of a reduction in sample size for the BACKBEAT Trial to a target total of 284 evaluable randomized subjects, with a total enrollment target of 316 patients accounting for potential loss to follow-up. FDA granted AVIM Therapy a second FDA Breakthrough Device Designation (“BDD”) specific to patients with uncontrolled hypertension despite the use of anti-hypertensive medications, and an indication for a pacemaker. The BDDs granted to AVIM Therapy collectively apply to indications that encompass both the broader population of patients with uncontrolled hypertension despite medication and increased cardiovascular risk, as well as the specific pacemaker-indicated population with uncontrolled hypertension being evaluated in the BACKBEAT Trial, representing a U.S. population of over 7.7 million patients.BDD can support enhanced reimbursement pathways, including potential eligibility for New Technology Add-on Payment and Transitional Pass-Through payment, which can facilitate broader, more timely patient access and provider adoption. Received $35 million in strategic capital under previously disclosed agreements with Medtronic and Ligand (Nasdaq: LGND). Received $20 million from Medtronic as payment for a secured subordinated promissory note convertible to capped prepaid revenue share, fulfilling Medtronic’s previously disclosed funding commitment. This brings Medtronic’s total capital contribution to Orchestra BioMed to nearly $82 million including prior equity investments, supporting the planned completion of the BACKBEAT Trial.Received $15 million tranche payment from Ligand associated with the previously disclosed Royalty Purchase Agreement, bringing total capital received from Ligand to $40 million to date in exchange for tiered royalty interest in certain future AVIM Therapy and Virtue SAB revenue, as well as an equity investment. Presented AVIM Therapy clinical and mechanistic data at HRS 2026, including pre-randomization data from the MODERATO II pilot study in which AVIM Therapy demonstrated a mean immediate reduction in office systolic blood pressure of 13.2 mmHg upon activation, with 97% of patients achieving a 5 mmHg or greater blood pressure reduction upon AVIM Therapy activation.Advanced site activation and patient enrollment in the Virtue Trial, a multi-center, prospective, randomized head-to-head IDE registrational clinical trial comparing Virtue SAB with the commercially available AGENT™ paclitaxel-coated balloon for the treatment of coronary in-stent restenosis. Financial Results for the First Quarter Ended March 31, 2026 Cash and cash equivalents and Marketable securities totaled $94.4 million as of March 31, 2026. On May 1, 2026, we received $35 million, which includes $20 million from Medtronic and $15 million from Ligand pursuant to the terms of agreements with those parties.Net cash used in operating activities and for the purchase of fixed assets was $22.4 million during the first quarter of 2026, compared with $16.7 million for the first quarter in 2025, with the primary drivers being increased research and development costs, including clinical trial activities, as well as personnel and consulting expenditures, which include non-recurring payments, during the first quarter of 2026.Revenue for the first quarter of 2026 was $0.1 million, compared with $0.9 million for the first quarter in 2025. The decrease was primarily due to the elimination of recognized revenue from our prior distribution agreement with Terumo, which was terminated in October 2025.Research and development expenses for the first quarter of 2026 were $15.8 million, compared with $13.5 million for the first quarter in 2025, which represents an increase of 17%. The increase was primarily due to additional costs associated with the ongoing BACKBEAT Trial and to advance the Virtue SAB program, including the Virtue Trial.Selling, general and administrative expenses for the first quarter of 2026 were $6.4 million, compared with $6.3 million for the first quarter of 2025, which represents an increase of 2%. The increase was primarily due to an increase in professional fees.Net loss attributable to common stockholders for the first quarter of 2026 was $20.7 million, or ($0.33) per share, compared with a net loss attributable to common stockholders of $18.8 million, or ($0.49) per share, for the first quarter of 2025, which represents an increase of 10%. Net loss attributable to common stockholders for the first quarter of 2026 included $2.9 million in non-cash stock-based compensation expense as compared to $3.0 million for the same period in 2025. About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered by a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world and the global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designations for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind non-coated drug delivery angioplasty balloon system designed to deliver a large liquid dose of proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary in-stent restenosis, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. About AVIM Therapy AVIM Therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM Therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM Therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal trial is evaluating the safety and efficacy of AVIM Therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM Therapy has been granted two Breakthrough Device Designations by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. About Virtue SAB Virtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™ through a non-coated microporous AngioInfusion™ Balloon that protects the drug in transit to consistently deliver a large liquid dose overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center prospective, independent core lab-adjudicated pilot clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the enrollment, timing, implementation, results and design of the Company’s ongoing pivotal trials, the timing of the presentation of clinical data, the timing of regulatory submissions, realizing the clinical and commercial value of AVIM Therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, the potential benefits of Breakthrough Device Designation, the ability of the Company’s partnerships to accelerate clinical development and the Company’s projected cash runway. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 12, 2026. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor Contact:Silas NewcombOrchestra BioMedsnewcomb@orchestrabiomed.com Media Contact:Kelsey KirkOrchestra BioMedkkirkellis@orchestrabiomed.com ORCHESTRA BIOMED HOLDINGS, INC.Condensed Consolidated Balance Sheets(in thousands, except share and per share data)(Unaudited) March 31, December 31, 2026 2025ASSETS CURRENT ASSETS: Cash and cash equivalents $28,367 $34,690 Marketable securities 66,033 71,822 Accounts receivable, net 84 95 Inventory 277 310 Prepaid expenses and other current assets 1,448 994 Total current assets 96,209 107,911 Property and equipment, net 1,848 1,715 Right-of-use assets 1,337 1,496 Strategic investments — 2,495 Deposits and other assets 1,264 1,240 TOTAL ASSETS $100,658 $114,857 LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $6,313 $6,095 Accrued expenses and other liabilities 6,594 9,890 Operating lease liability, current portion 785 751 Total current liabilities 13,692 16,736 Royalty purchase agreement 17,787 16,482 Loan payable 14,333 14,268 Derivative liability 2,784 2,749 Operating lease liability, less current portion 730 936 Other long-term liabilities 367 308 TOTAL LIABILITIES 49,693 51,479 Series A Preferred Stock, $0.0001 par value per share; 200,000 issued and outstanding at March 31, 2026 and December 31, 2025; aggregate liquidation preference of $20,000 9,773 9,808 STOCKHOLDERS’ EQUITY Preferred stock, $0.0001 par value, 10,000,000 shares authorized; — — Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 58,630,715 and 57,032,963 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively. 6 6 Additional paid-in capital 424,496 416,083 Accumulated other comprehensive (loss) income (40) 60 Accumulated deficit (383,270) (362,579)TOTAL STOCKHOLDERS’ EQUITY 41,192 53,570 TOTAL LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY $100,658 $114,857 ORCHESTRA BIOMED HOLDINGS, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(Unaudited) Three Months Ended March 31, 2026 2025Revenue: Partnership revenue $— $732 Product revenue 110 136 Total revenue 110 868 Expenses: Cost of product revenues 32 44 Research and development 15,781 13,482 Selling, general and administrative 6,373 6,263 Total expenses 22,186 19,789 Loss from operations (22,076) (18,921)Other (expense) income: Interest (expense) income, net (821) 166 Change in the fair value of derivative liability (35) — Gain on sale of strategic investments 2,241 — Total other income 1,385 166 Net loss (20,691) (18,755)Adjustment to carrying value of Series A Preferred Stock 35 — Net loss attributable to common stockholders $(20,656) $(18,755) Net loss attributable to common stockholders per share Basic and diluted $(0.33) $(0.49)Weighted-average shares used in computing net loss attributable to common stockholders per share, basic and diluted 62,721,869 38,235,409 Comprehensive loss Net loss $(20,691) $(18,755)Unrealized loss on marketable securities (100) (15)Comprehensive loss $(20,791) $(18,770)
Proprietary robotically-navigated MAGiC catheter received U.S. FDA approval in January and is now being utilized at multiple sites across the United States as well as EuropeSynchrony digital operating room system received U.S. FDA clearance in April and initial orders and shipments are ongoingDefinitive agreement to acquire Robocath creates a leading robotic platform, combining complementary technologies to deliver next-generation fully-integrated robotic solutions for the full spectrum of endovascular procedures ST. LOUIS, May 12, 2026 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported business updates and financial results for the first quarter ended March 31, 2026. “Stereotaxis is in one of the most exciting periods of its history. We are achieving significant regulatory approvals, executing strategic acquisitions, and witnessing the initial green shoots of commercial success with our new product ecosystem,” said David Fischel, Stereotaxis Chairman and CEO. “The operational and commercial friction to ramp up manufacturing and implement new products makes progress gradual, but we are efficiently driving broad-based progress on many fronts in parallel towards an attractive business built on solid foundations.” “The streak of regulatory success that began last year continued in the first part of this year with two essential FDA approvals for the MAGiC cardiac ablation catheter and Synchrony digital surgery system. These regulatory approvals brought to market an entirely new foundational product ecosystem that structurally changes our commercial opportunity. We essentially developed a fresh start-up company on the shoulders of our legacy technology and funded by our legacy business.” “The transformational agreement to acquire Robocath gives Stereotaxis a fully complementary and separate robotic mechanism of action for endovascular device navigation. The combination of our technologies offers a clear vision for how our robotic solution, including the full ecosystem of digital innovations, will enable remote, automated and fully robotic treatment for electrophysiology, interventional cardiology and neurointerventions.” “The still minor revenue contribution from our new catheters is being countered by the headwind of winding down our relationship with Johnson & Johnson. Demand for MAGiC far exceeds supply, and we are rolling out the catheter in both Europe and the US in line with the manufacturing ramp, which continues to progress towards an expected 500 catheters a month by year end. Initial green shoots of adoption demonstrate the strength of our strategy to build a synergistic portfolio of catheters, with disposable revenue per procedure several fold higher than previously. This structural transformation to our disposable business model is taking place as we simultaneously structurally transform our capital business and prepare for multiple GenesisX placements.” 2026 First Quarter Financial ResultsRevenue for the first quarter of 2026 totaled $6.3 million compared to $7.5 million in the prior year first quarter. System revenue of $1.3 million and recurring revenue of $5.0 million compared to $2.0 million and $5.5 million respectively, in the prior year first quarter. System revenue in the quarter reflects partial revenue recognition on the installation of one Genesis system and other ancillary systems. Recurring revenue is pressured by the transition away from the dependency on legacy J&J catheters with still modest contributions from Stereotaxis’ new proprietary catheters. Gross margin for the first quarter of 2026 was 60% of revenue. Recurring revenue gross margin was 66%, and system gross margin was 39%. Operating expenses in the quarter of $9.8 million included $3.1 million in non-cash charges for stock compensation expense, mark-to-market adjustment for acquisition related contingent earnout consideration, and amortization of acquired intangible assets. Excluding these non-cash charges, adjusted operating expenses were $6.7 million, compared to the prior year adjusted operating expenses of $6.8 million. Operating loss and net loss in the first quarter of 2026 were ($6.0) million and ($5.9) million, respectively, compared with ($5.9) million and ($5.8) million in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding non-cash charges, were ($2.9) million and ($2.8) million, respectively, compared with ($2.7) million and ($2.6) million in the previous year quarter. Negative free cash flow for the first quarter was ($3.5) million, compared to ($1.8) million in the previous year. Cash Balance and LiquidityAt March 31, 2026, Stereotaxis had cash and cash equivalents of $14.6 million and no debt. Forward Looking ExpectationsStereotaxis anticipates double digit revenue growth for the full year 2026, with annual revenue expected to surpass $40 million. Revenue will grow sequentially over the course of the year in line with manufacturing increases for GenesisX and MAGiC, with revenue in both the third and fourth quarters expected to exceed $10 million. Stereotaxis believes it can advance its strategy, integrate Robocath, and grow significantly without having to subject investors to substantial dilution. The Company expects its balance sheet to allow it to advance its transformative product ecosystem to market, fund its commercialization, and achieve profitability. Conference Call and WebcastStereotaxis will host a conference call and webcast today, May 12, 2026, at 4:30 p.m. Eastern Time. To access the conference call, dial 800-715-9871 (US and Canada) or 646-307-1963 (International) and give the participant pass code 6082771. To access the live and replay webcast, please visit the investor relations section of the Stereotaxis website at www.Stereotaxis.com. About StereotaxisStereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.Stereotaxis.com. This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s products in the marketplace, the effect of global economic conditions, including tariffs, on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, statements relating to our recent acquisitions, including any benefits expected from the acquisitions, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled. Company Contacts: David L. FischelChairman and Chief Executive Officer Kimberly R. Peery Chief Financial Officer 314-678-6100Investors@Stereotaxis.com Stereotaxis, Inc.CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited) (in thousands, except share and per share amounts)Three Months EndedMarch 31, 2026 2025 Revenue: Systems$1,319 $1,964 Disposables, service and accessories 4,972 5,508 Total revenue 6,291 7,472 Cost of revenue: Systems 804 1,667 Disposables, service and accessories 1,693 1,741 Total cost of revenue 2,497 3,408 Gross margin 3,794 4,064 Operating expenses: Research and development 2,397 2,350 Sales and marketing 2,617 3,148 General and administrative 4,761 4,495 Total operating expenses 9,775 9,993 Operating loss (5,981) (5,929) Other income (5) – Interest income, net 125 106 Net loss$(5,861) $(5,823)Cumulative dividend on convertible preferred stock (311) (314)Net loss attributable to common stockholders$(6,172) $(6,137) Net loss per share attributed to common stockholders: Basic$(0.06) $(0.07)Diluted$(0.06) $(0.07) Weighted average number of common shares and equivalents: Basic 98,891,179 87,769,366 Diluted 98,891,179 87,769,366 STEREOTAXIS, INC.CONSOLIDATED BALANCE SHEETS (in thousands, except share amounts)March 31, 2026 December 31, 2025 (Unaudited) Assets Current assets: Cash and cash equivalents$14,616 $13,421 Accounts receivable, net of allowance of $630 and $541 at 2026 and 2025, respectively 5,303 5,847 Insurance receivable 4,316 4,316 Inventories, net 10,495 9,567 Prepaid expenses and other current assets 1,297 698 Total current assets 36,027 33,849 Property and equipment, net 2,956 3,019 Goodwill 3,764 3,764 Intangible assets, net 6,193 6,429 Operating lease right-of-use assets 4,760 4,912 Prepaid and other non-current assets 330 278 Total assets$54,030 $52,251 Liabilities and stockholders’ equity Current liabilities: Accounts payable$4,823 $4,768 Accrued liabilities 1,478 2,065 Accrued legal liabilities 4,316 4,316 Deferred revenue 6,541 5,675 Current contingent consideration 5,266 4,894 Current portion of operating lease liabilities 662 642 Total current liabilities 23,086 22,360 Long-term deferred revenue 523 555 Long-term contingent consideration 5,108 4,724 Operating lease liabilities 4,618 4,794 Other liabilities 1,097 1,097 Total liabilities 34,432 33,530 Series A – Convertible preferred stock: Convertible preferred stock, Series A, par value $0.001; 10,000,000 shares authorized, 21,008 shares outstanding at 2026 and 2025 5,240 5,240 Stockholders’ equity: Common stock, par value $0.001; 300,000,000 shares authorized, 97,491,248 and 95,339,628 shares issued at 2026 and 2025, respectively 97 95 Additional paid-in capital 603,696 596,960 Treasury stock, 4,015 shares at 2026 and 2025 (206) (206)Accumulated deficit (589,229) (583,368)Total stockholders’ equity 14,358 13,481 Total liabilities and stockholders’ equity$54,030 $52,251
IRVINE, Calif., May 12, 2026 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy® Transcatheter Heart Valve (THV) System, today announced the appointment of Dave Haan as Vice President of Clinical Affairs. Dave will lead the company’s clinical affairs strategy, overseeing the continued execution of JenaValve’s clinical programs — including the ARTIST randomized controlled trial and the JENA-VAD Registry. His appointment strengthens the company’s clinical leadership during a pivotal period of organizational growth and commercial expansion following the recent FDA approval of the Trilogy THV System for symptomatic, severe aortic regurgitation (ssAR).
Orchestra BioMed targeting enrollment completion of BACKBEAT Global Pivotal Trial (“BACKBEAT Trial”) by the end of Q3 2026 Orchestra BioMed and Medtronic plc. (NYSE: MDT, “Medtronic”), the Company’s strategic collaborator for the BACKBEAT Trial, intend to submit primary endpoint results for consideration as a late-breaker at a major cardiology conference in Q2 2027Medtronic plans to submit AVIM Therapy-related marketing application for FDA approval after primary endpoint data analyses and reports are complete and pursue subsequent global regulatory approvals, assuming primary safety and efficacy endpoints are met NEW HOPE, Pa., May 12, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced an update to the overall clinical and regulatory timeline for the BACKBEAT Trial evaluating Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) in pacemaker-indicated patients with uncontrolled hypertension despite medications. The Company is targeting completion of enrollment by the end of the third quarter of 2026. Further, the Company and Medtronic, its strategic collaborator for the BACKBEAT Trial and the commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in patients indicated for a pacemaker, plan to submit the primary endpoint data for a late-breaking clinical trial presentation at a major cardiovascular conference in the second quarter of 2027. Lastly, assuming primary safety and efficacy endpoints are met, Medtronic plans to submit a marketing application for FDA approval after primary endpoint data analyses and reports are complete, and subsequently to pursue global regulatory approvals. The updated BACKBEAT Trial timeline is supported by FDA approval of a reduction in the sample size for the clinical trial to a target total of 284 evaluable randomized subjects with the total enrollment target of 316 patients accounting for potential loss to follow up. The primary efficacy endpoint (between-group difference in 24-hour ambulatory systolic blood pressure “aSBP” at 3-month follow up) and primary safety endpoint (freedom from unanticipated serious adverse device events in the AVIM Therapy arm at 3-month follow up) remain robustly powered ( >90% statistical power) at the revised sample size for the trial. The sample size is designed to detect a between group difference of at least 5 mmHg in aSBP. The change in sample size reflects collaboration among Orchestra BioMed, Medtronic and the FDA under the Breakthrough Devices program, and follows FDA approval of an amendment to the BACKBEAT Trial protocol received on May 8, 2026 by Orchestra BioMed. David Hochman, Chairman, Chief Executive Officer of Orchestra BioMed, commented, “We are delighted to provide clarity on the anticipated overall timeline for the BACKBEAT Trial, which reflects ongoing global enrollment momentum and FDA alignment with a streamlined sample size that remains highly powered to assess AVIM Therapy’s efficacy and safety at the 3-month primary endpoints. We believe BACKBEAT has the potential to be a landmark pivotal trial that can open up an entirely new therapeutic modality for patients at increased risk from high blood pressure and hypertensive heart disease.” Robert C. Kowal, M.D., Ph.D., Vice President and General Manager for Cardiac Pacing Therapies in the Medtronic Cardiac Rhythm Management operating unit, stated, “For decades, cardiac pacing has been foundational in the management of rhythm disorders. With the BACKBEAT Trial, Medtronic and Orchestra BioMed are investigating whether AVIM Therapy can extend the benefits of pacing to the field of hypertension management in high-risk patients. This update reflects our shared confidence in progress toward the completion of enrollment, the submission of data to the FDA, and the presentation of clinical evidence.” About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered by a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world and the global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designations for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind non-coated drug delivery angioplasty balloon system designed to deliver a large liquid dose of proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary in-stent restenosis, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. About AVIM TherapyAVIM Therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM Therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM Therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study is evaluating the safety and efficacy of AVIM Therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM Therapy has been granted two Breakthrough Device Designations by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the enrollment, timing, implementation, results and design of the Company’s ongoing pivotal trials, the timing of regulatory submissions, realizing the clinical and commercial value of the Company’s product candidates, the potential safety and efficacy of the Company’s product candidates, and the ability of the Company’s partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 12, 2026. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor Contact:Silas NewcombOrchestra BioMedSnewcomb@orchestrabiomed.com Media Contact:Kelsey KirkOrchestra BioMedkkirkellis@orchestrabiomed.com
