Financial

Anteris Announces Results for the First Quarter of 2026

Financial by 0 comments

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 

Continue Reading →

Orchestra BioMed Reports First Quarter 2026 Financial Results and Highlights Recent Business Updates

Financial by 0 comments

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)

Continue Reading →

Stereotaxis Reports 2026 First Quarter Financial Results & Business Updates

Financial by 0 comments

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     

Continue Reading →

JenaValve Appoints Dave Haan as Vice President of Clinical Affairs

Financial by 0 comments

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).

Continue Reading →

Adagio Medical Reports First Quarter 2026 Results and Meaningful Clinical Progress

Financial by 0 comments

LAGUNA HILLS, Calif.–(BUSINESS WIRE)—- $ADGM #ARRHYTHMIA–Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced financial results for the first quarter ended March 31, 2026. Recent Business Highlights: Pivotal results from the FULCRUM-VT trial presented in late-breaking session at Heart Rhythm Society 2026 – the first large-scale, rigorously executed pivotal trial in patients with bot

Continue Reading →

NeuWire Medical Appoints Ramin Mousavi as Executive Chairman Following Stroke Journal Publication.

Financial by 0 comments

DALLAS–(BUSINESS WIRE)–NeuWire Medical, a medical device company advancing the development of a targeted plasticity therapy platform for individuals living with chronic ischemic stroke, today announced the appointment of Ramin Mousavi as Executive Chairman of the Board. His arrival marks an important step in the company’s next phase of growth as NeuWire Medical prepares to advance its clinical, regulatory, and financing strategy. Ramin joins NeuWire Medical following his role as President, Ch

Continue Reading →

CVRx Reports First Quarter 2026 Financial and Operating Results

Financial by 0 comments

MINNEAPOLIS, May 11, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced its financial and operating results for the first quarter of 2026. Recent Highlights Total revenue for the first quarter of 2026 was $14.8 million, an increase of approximately 20% over the prior year quarterU.S. revenue for the first quarter of 2026 was $13.7 million, an increase of 22% over the prior year quarterActive implanting centers in the U.S. grew to 257 as of March 31, 2026, as compared to 227 as of March 31, 2025First site activated and first patient enrolled in BENEFIT-HF clinical trial “We delivered a strong start to 2026, with U.S. revenue growing 22% as the investments we made in our team and programs throughout 2025 begin to translate into results,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “We are seeing continued progress from our sales organization and the successful activation of the first site and our first patient enrolled in our BENEFIT-HF clinical trial. Together, these developments reinforce our confidence in the path ahead and in our ability to make Barostim more accessible to heart failure patients.” First Quarter 2026 Financial and Operating Results Revenue was $14.8 million for the three months ended March 31, 2026, an increase of $2.4 million, or 20%, over the three months ended March 31, 2025. Revenue generated in the U.S. was $13.7 million for the three months ended March 31, 2026, an increase of $2.4 million, or 22%, over the three months ended March 31, 2025. Revenue units in the U.S. totaled 429 and 359 for the three months ended March 31, 2026 and 2025, respectively. The increases were primarily driven by continued growth in the U.S. HF business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of Barostim. As of March 31, 2026, the Company had a total of 257 active implanting centers in the U.S., as compared to 252 as of December 31, 2025. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. The number of sales territories in the U.S. increased by three to a total of 56 during the three months ended March 31, 2026. Revenue generated in Europe was $1.1 million for the three months ended March 31, 2026, a decrease of $27,000, or 2%, over the three months ended March 31, 2025. Total revenue units in Europe decreased to 56 for the three months ended March 31, 2026 from 59 in the prior year period. The number of sales territories in Europe remained consistent at five for the three months ended March 31, 2026. Gross profit was $12.9 million for the three months ended March 31, 2026, an increase of $2.6 million, or 25%, over the three months ended March 31, 2025. Gross margin was 87% and 84% for the three months ended March 31, 2026 and March 31, 2025, respectively. R&D expenses increased $0.6 million, or 23%, to $3.1 million for the three months ended March 31, 2026 compared to the three months ended March 31, 2025. This change was driven by a $0.4 million increase in consulting expenses, a $0.3 million increase in compensation expenses, and a $0.1 million increase in non-cash stock-based compensation expenses, partially offset by a $0.2 million decrease in clinical trial expenses. SG&A expenses increased $0.7 million, or 3%, to $22.0 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025. This change was primarily driven by a $1.0 million increase in compensation expenses and a $0.3 million increase in non-cash stock-based compensation expenses, partially offset by a $0.3 million decrease in consulting expenses and a $0.3 million decrease in advertising expenses. Interest expense increased $0.1 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, driven by the increased borrowings under the term loan agreement with Innovatus Capital Partners. Other income, net was $0.6 and $1.1 million for the three months ended March 31, 2026 and 2025, respectively. These balances consisted of interest income on our interest-bearing accounts. The decrease was primarily driven by the lower cash balance. Net loss was $13.1 million, or $0.50 per share, for the three months ended March 31, 2026, compared to a net loss of $13.8 million, or $0.53 per share, for the three months ended March 31, 2025. Net loss per share was based on 26.4 million weighted average shares outstanding for three months ended March 31, 2026 and 25.9 million weighted average shares outstanding for the three months ended March 31, 2025. As of March 31, 2026, cash and cash equivalents were $72.3 million. Net cash used in operating and investing activities was $12.3 million for the three months ended March 31, 2026 as compared to $12.9 million for the three months ended March 31, 2025. BENEFIT-HF Clinical Trial Update On March 31, 2026, the first site was activated in the BENEFIT-HF trial and the first patient was enrolled in the second quarter of 2026. This trial, as previously disclosed, is a landmark randomized controlled trial designed to evaluate Barostim’s impact on all-cause mortality and heart failure decompensation events in an expanded population of heart failure patients with left ventricular ejection fractions up to 50% and NT-proBNP levels up to 5,000 pg/mL. If successful, the BENEFIT-HF trial could expand the indicated patient population for Barostim approximately three times, significantly broadening access to this proven neuromodulation-based approach to heart failure management. Business Outlook For the full year of 2026, the Company maintained its revenue and expense guidance, and updated its guidance range for gross margin, as follows: Total revenue between $63.0 million and $67.0 million;Gross margin between 85% and 87%, compared to prior guidance of 84% and 86%;Operating expenses between $103.0 million and $107.0 million. For the second quarter of 2026, the Company expects to report total revenue between $15.1 million and $16.1 million. Webcast and Conference Call Information The Company will host a conference call to review its results at 4:30 p.m. Eastern Time today. A live webcast of the investor conference call will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-877-704-4453 for U.S. callers, or 1-201-389-0920 for international callers, approximately ten minutes prior to the start time. About CVRx, Inc. CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding our future financial performance (including our financial guidance regarding full year and second quarter 2026 results), our anticipated growth strategies (including statements regarding the expected timing, enrollment, scope and outcomes of the BENEFIT-HF clinical trial, potential expansion of the Barostim indication, and anticipated benefits of Barostim therapy), anticipated trends in our industry, our business prospects and our opportunities. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “outlook,” “guidance,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our expectations regarding enrollment in BENEFIT-HF and the resulting impact on our addressable market; our history of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to continue demonstrating to physicians and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product, including those resulting from the BENEFIT-HF trial; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily Meyers CVRx, Inc. 763-416-2853emeyers@cvrx.com CVRx, INC.Condensed Consolidated Balance Sheets(In thousands, except share and per share data)(Unaudited)         March 31, December 31,  2026 2025Assets      Current assets:      Cash and cash equivalents $72,303  $75,708 Accounts receivable, net of allowances of $869 and $871, respectively  9,104   10,665 Inventory  12,403   12,205 Prepaid expenses and other current assets  2,940   3,069 Total current assets  96,750   101,647 Property and equipment, net  2,159   2,243 Operating lease right-of-use asset  793   878 Other non-current assets  26   26 Total assets $99,728  $104,794 Liabilities and Stockholders’ Equity      Current liabilities:      Accounts payable $2,998  $3,833 Accrued expenses  6,488   9,484 Total current liabilities  9,486   13,317 Long-term debt  58,490   49,514 Operating lease liability, non-current portion  544   638 Other long-term liabilities  2,099   2,001 Total liabilities  70,619   65,470 Commitments and contingencies      Stockholders’ equity:      Common stock, $0.01 par value, 200,000,000 authorized as of March 31, 2026 and December 31, 2025; 26,428,767 and 26,311,607 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively  264   263 Additional paid-in capital  632,820   629,916 Accumulated deficit  (603,772)  (590,652)Accumulated other comprehensive loss  (203)  (203)Total stockholders’ equity  29,109   39,324 Total liabilities and stockholders’ equity $99,728  $104,794  CVRx, 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 $14,769  $12,348 Cost of goods sold  1,888   2,036 Gross profit  12,881   10,312 Operating expenses:      Research and development  3,084   2,517 Selling, general and administrative  21,958   21,232 Total operating expenses  25,042   23,749 Loss from operations  (12,161)  (13,437)Interest expense  (1,551)  (1,457)Other income, net  593   1,123 Loss before income taxes  (13,119)  (13,771)Benefit (provision) for income taxes  (1)  5 Net loss  (13,120)  (13,766)Cumulative translation adjustment  —   — Comprehensive loss $(13,120) $(13,766)Net loss per share, basic and diluted $(0.50) $(0.53)Weighted-average common shares used to compute net loss per share, basic and diluted  26,355,591   25,876,062 

Continue Reading →

Cytokinetics Announces Closing of Public Offering of Common Stock and Full Exercise of the Underwriters’ Option to Purchase Additional Shares for Gross Proceeds of $805 Million

Financial by 0 comments

SOUTH SAN FRANCISCO, Calif., May 08, 2026 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the closing of an underwritten public offering of 11,338,028 shares of its common stock, including the full exercise of the underwriters’ option to purchase up to 1,478,873 additional shares, at a price to the public of $71.00 per share, before underwriting discounts and commissions. The gross proceeds to Cytokinetics from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Cytokinetics, were approximately $805 million. All of the shares of common stock in the offering were sold by Cytokinetics. Morgan Stanley, Goldman Sachs & Co. LLC, J.P. Morgan and Jefferies acted as joint book-running managers for the offering. Mizuho acted as lead co-manager for the offering and Citizens Capital Markets, Needham & Company, B. Riley Securities and H.C. Wainwright & Co. acted as co-managers for the offering. The securities described above were offered by Cytokinetics pursuant to a shelf registration statement (including a base prospectus) filed on February 27, 2025 with the Securities and Exchange Commission (SEC), which has become automatically effective. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and can be accessed for free on the SEC’s website at http://www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by telephone at 866-718-1649 or by email at prospectus@morganstanley.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone at (866) 471-2526 or by email at Prospectus-ny@ny.email.gs.com; J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., Europe and China for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757

Continue Reading →
1 2 3 4 5 … 485