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Route 92 Medical Enrolls First Patient in SUMMIT RISE Study
SUMMIT RISE is expected to enroll up to 500 patients to evaluate the performance of Route 92 Medical’s neurovascular intervention device portfolio WEST JORDAN, Utah, March 9, 2026 – (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing […]
CRT26: Medtronic renal denervation system demonstrates significant, safe, and sustained blood pressure-lowering effect through three years
Nearly 9 out of 10 patients achieved meaningful health benefit in 3-year pooled analysis Additionally, pooled analysis shows radiofrequency RDN cuts hypertensive emergencies by nearly half, saving potentially $199 million per year in related healthcare costs SPYRAL CARE to expand evidence for radiofrequency RDN in real-world Medicare patients March 10, […]
AJPC Publishes POLY-ACS Trial Demonstrating Feasibility of Polypill Strategy After Acute Coronary Syndrome
BOULDER, Colo., March 10, 2026 /PRNewswire/ — The American Journal of Preventive Cardiology (AJPC) announces the publication of the POLY-ACS trial investigating the effectiveness of a polypill strategy, combining multiple evidence-based therapies into a single daily formulation,…
Dynamic Access Acquires PICC Stat in Minnesota
DALLAS, March 10, 2026 /PRNewswire/ — Dynamic Access, LLC announced today the acquisition of PICC Stat, a respected, family-owned vascular access provider based in Minneapolis and recognized for its commitment to high-quality, patient-centered care. PICC Stat built a strong reputation…
Egg Medical Presents CRT 2026 Data Demonstrating a Responsible Path to Light Lead and Lead-Apron Free Protection
WASHINGTON, March 10, 2026 (GLOBE NEWSWIRE) — Egg Medical, a leader in enhanced radiation protection devices (ERPD), today announced the results of a Late-Breaking Trial presented at the Cardiovascular Research Technologies (CRT) 2026 conference. The study, presented by Santiago Garcia, MD, of The Christ Hospital, confirms that the addition of the EggNest™ system reduces levels of scatter radiation to all members of the interventional team to the extent that users could do procedures safely without the use of lead aprons or wear ultralight aprons. “For decades, the interventional community has accepted a trade-off: protect your long-term health from the effects of radiation exposure by wearing heavy lead aprons at the cost of damaging your back and joints,” said Santiago Garcia, MD, the study’s lead presenter. “This data proves that we no longer must choose. By using the EggNest system, we can provide the entire team with protection that is superior to the status quo, by either going apron-free, or while wearing aprons that feel like a light vest. This is about ensuring that the next generation can have healthy careers without the physical toll.” The Key Study Findings: Annualized collar dose (in mrem) over lead aprons is 25.5 for the primary operator, 9.8 for assistant, and 10.2 for the nurse. When combined with ultralight aprons, total annualized body doses dropped to 1.41 for primary operator, 2.1 for assistant and 1.0 for the nurse.At these levels, a clinician would have to work for an entire career to receive the same radiation dose they currently receive in just one year under the standard of care.The study confirmed that whether clinicians choose to go apron-free, or wear aprons that are 55% lighter than standard lead, the entire team remained below traditional exposure levels using traditional methods. Modern labs are not one-size-fits-all. Under the banner of “Protection Is Personal,” the company is championing a responsible approach that allows clinicians to choose whether they want to go apron free. “Our goal is to give clinicians a choice—but one backed by rigorous, published data,” said Gavin Philipps, Chief Commercial Officer. “Choice isn’t a weakness; it’s how responsible safety programs operate. By providing personalized data through live dosimetry, the EggNest supports apron-free or ultralight apron workflows where approved, rather than forcing a specific behavior.” A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/548c258c-72cd-4a18-a8cb-e5066a8688cc CONTACT: Contact:
Susan Storm
sstorm@eggmedical.com
SS Innovations Reports Fourth Quarter and Full Year 2025 Financial Results
Strong growth in SSi Mantra installations, procedures and revenuesFORT LAUDERDALE, Fla., March 10, 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 and twelve months ended December 31, 2025. The Company also filed its Annual Report on Form 10-K for the year ended December 31, 2025, with the Securities and Exchange Commission on March 10, 2026. Fourth Quarter 2025 Overview Revenue increased 79.1% to $14.5 million from $8.1 million in the fourth quarter of 2024.Gross margin of 43.9% compared to 48.9% in the fourth quarter of 2024.Gross profit rose 60.7% to $6.4 million from $4.0 million in the fourth quarter of 2024.Net loss of $2.5 million, or $(0.01) per diluted share, compared to a net loss of $1.9 million, or $(0.01) per diluted share, in the fourth quarter of 2024.SSi Mantra surgical robotic system installations totaled 40, up 81.8% from 22 installations in the fourth quarter of 2024 and up 48.1% from 27 installations in the third quarter of 2025. Full Year 2025 Overview Revenue increased 105.7% to $42.5 million from $20.6 million in 2024.Gross margin expanded to 46.0% from 40.9% in 2024.Gross profit rose 131.2% to $19.5 million from $8.5 million in 2024.Net loss of $12.1 million, or $(0.06) per diluted share, compared to net loss of $19.2 million, or $(0.11) per diluted share, in 2024.SSi Mantra surgical robotic system installations totaled 103, up 119.1% from 47 installations in 2024. As of December 31, 2025 Long-term debt of $0.Cash and cash equivalents totaled $3.2 million, excluding restricted cash.SSi Mantra cumulative installed base totaled 168 across ten countries and cumulative surgeries reached 7,885, including 120 telesurgeries, 390 cardiac procedures and 121 pediatric surgeries. CEO Commentary Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “In the fourth quarter of 2025, we achieved strong growth in SSi Mantra installations, procedures and revenues, capping off a successful year for SS Innovations. Among our accomplishments in 2025, we gained significant share of the surgical robotics market in India, expanded into new global geographies, and progressed along the regulatory pathways required for entering the United States and European Union markets. We also continued to pioneer robotic telesurgery, attaining multiple new procedure milestones and unveiling cutting-edge innovations such as the Tele Surgeon Console and MantraM mobile robotic telesurgery unit. Finally, the uplisting of our shares to Nasdaq has enhanced market awareness of our growth story and expanded our audience of potential investors.” Dr. Srivastava continued, “After quarter-end we completed a private placement of common stock, which brings us new long-term oriented institutional investors and approximately $18.6 million of gross proceeds aimed to fuel SS Innovations’ growth in 2026 and beyond. Significant insider participation in this financing reflects our strong confidence in SS Innovations’ future. We will continue to invest in enhancements to our advanced, cost-effective SSi Mantra surgical robotic system and expand our capacity to lead the vast Indian market, penetrate underserved global geographies, and prepare for our entry into the United States and European Union. We anticipate that the U.S. Food and Drug Administration will complete its review of our 510(k) premarket notification for the SSi Mantra by mid-2026. We also continue along the pathway towards a European Union CE marking certification for the SSi Mantra, which we believe we can also obtain this year. In conclusion, we expect continuing strong growth in 2026 as we deploy the SSi Mantra in existing and new markets, increasing access to world-class surgical robotic care.” Select Business Highlights in Fourth Quarter 2025 On November 6, 2025, the Company announced the successful completion of the first telesurgery performed with the SSi Mantra Tele Surgeon Console.On December 5, 2025, the Company submitted a 510(k) premarket notification to the United States Food and Drug Administration (the “FDA”) for the SSi Mantra surgical robotic system, covering multiple indications including general, urological, colorectal, gynecological and cardiac surgeries. Subsequent Events On January 6, 2026, the Company announced the development of five new 5-millimeter surgical instruments for clinical use across multiple specialties, including pediatric, cardiac, and head and neck surgery, among other procedures involving smaller anatomical structures.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. Revenue Breakdown and Summary of Installations / Surgeries CategoryQ4 2024Q4 2025VariancePercentageSystem sales$7,735,005$13,364,153$5,629,14872.8%Instrument sales282,332844,279561,947199.0%Warranty sales80,769316,771236,002292.2%Lease income18,0879,280(8,807)(48.7)%Total revenue$8,116,193$14,534,483$6,418,29079.1% SSi Mantra installations22401881.8%Cumulative installed base165168103158.5% SSi Mantra surgeries6101,8281,218199.7%Cumulative surgeries12,7597,8855,126185.8% 1 at period end Category20242025VariancePercentageSystem sales$19,457,767$38,353,048$18,895,28197.1%Instrument sales942,5483,183,7572,241,209237.8%Warranty sales177,518877,033699,515394.1%Lease income71,69570,909(786)(1.1)%Total revenue$20,649,528$42,484,747$21,835,219105.7% SSi Mantra installations4710356119.1%SSi Mantra surgeries2,1395,0872,948137.8% 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 many 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. 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 utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery. The SSi Mantra has been clinically validated in India in more than 100 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 GroupKalle Ahl, CFAT: (303) 953-9878kahl@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.CONSOLIDATED BALANCE SHEETS(Audited) As of December 31, 2025 December 31, 2024 ASSETS Current Assets: Cash and cash equivalents $3,206,406 $466,500 Restricted cash 5,937,650 5,838,508 Accounts receivable, net 12,398,542 4,466,047 Inventory, net 17,064,002 10,206,898 Prepaids and other current assets 10,194,059 6,438,338 Total Current Assets 48,800,659 27,416,291 Property, plant, and equipment, net 9,100,546 5,385,955 Right of use asset 2,754,020 2,623,880 Deferred tax assets, net 533,727 – Accounts receivable, net 8,566,654 3,299,032 Restricted cash 458,964 318,527 Prepaids and other non current assets 4,011,647 3,341,528 Total Assets $74,226,217 $42,385,213 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities Bank overdraft facility $11,442,948 $7,994,906 Notes payable – 7,450,000 Current portion of operating lease liabilities 579,169 409,518 Accounts payable 5,127,193 2,312,382 Deferred revenue 3,266,686 1,278,602 Accrued expenses & other current liabilities 5,825,702 1,884,814 Total Current Liabilities 26,241,698 21,330,222 Operating lease liabilities, less current portion 2,337,697 2,349,118 Deferred Revenue 7,139,807 5,173,953 Other non current liabilities 288,764 74,817 Total Liabilities $36,007,966 $28,928,110 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 December 31, 2025 and December 31, 2024 1 1 Common stock, 250,000,000 shares authorized, $0.0001 par value, 194,165,141 shares and 171,579,284 shares issued and outstanding as of December 31, 2025 and December 31, 2024 respectively 19,416 17,157 Accumulated other comprehensive income (loss) (2,022,660) (749,625)Additional paid in capital 95,111,511 56,952,200 Capital reserve 899,917 899,917 Accumulated deficit (55,789,934) (43,662,547)Total stockholders’ equity 38,218,251 13,457,103 Total liabilities and stockholders’ equity $74,226,217 $42,385,213 SS INNOVATIONS INTERNATIONAL, INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Audited) For the three months endedDecember 31,2025 For the threemonths endedDecember 31,2024 REVENUES System sales 13,364,153 7,735,005 Instruments sale 844,279 282,332 Warranty sale 316,771 80,769 Lease income 9,280 18,087 Total revenue $14,534,483 $8,116,193 Cost of revenue (8,157,430) (4,147,202) GROSS PROFIT 6,377,053 3,968,991 OPERATING EXPENSES: Research & development expense 1,390,826 761,937 Stock compensation expense 2,023,433 2,338,887 Depreciation and amortization expense 309,491 145,926 Selling, general and administrative expense 3,388,300 2,560,927 TOTAL OPERATING EXPENSES 7,112,050 5,807,677 Loss from operations (734,997) (1,838,686) OTHER INCOME (EXPENSE): Interest Expense (335,296) (292,954)Interest and other income, net 364,566 208,249 TOTAL INCOME / (EXPENSE), NET 29,270 (84,705) LOSS BEFORE INCOME TAXES (705,727) (1,923,391)Income tax expense 1,765,653 – NET LOSS $(2,471,380) $(1,923,391) CONSOLIDATED STATEMENTS OF OTHER COMPREHENSIVE LOSS NET LOSS $(2,471,380) $(1,923,391) OTHER COMPREHENSIVE INCOME (LOSS) Foreign currency translation loss (685,735) (385,368)Retirement Benefit (net of tax) (48,444) (24,086)RECLASSIFICATION ADJUSTMENTS: Retirement Benefit (net of tax) 1,433 – Income tax effects relating to retirement benefit 14,912 – TOTAL OTHER COMPREHENSIVE LOSS (717,834) (409,454)TOTAL COMPREHENSIVE LOSS $(3,189,214) $(2,332,845) SS INNOVATIONS INTERNATIONAL, INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Audited) For The Year Ended December 31, 2025 December 31, 2024 REVENUES System sales 38,353,048 19,457,767 Instruments sale 3,183,757 942,548 Warranty sale 877,033 177,518 Lease income 70,909 71,695 Total revenue $42,484,747 $20,649,528 Cost of revenue (22,940,492) (12,197,162) GROSS PROFIT 19,544,255 8,452,366 OPERATING EXPENSES: Research & development expense 3,685,840 2,491,771 Stock compensation expense 8,128,103 14,342,784 Depreciation and amortization expense 1,075,907 436,005 Selling, general and administrative expense 14,848,439 10,157,768 TOTAL OPERATING EXPENSES 27,738,289 27,428,328 Loss from operations (8,194,034) (18,975,962) OTHER INCOME (EXPENSE): Interest Expense (1,108,637) (973,235)Interest and other income, net 1,141,724 798,000 TOTAL INCOME / (EXPENSE), NET 33,087 (175,235) LOSS BEFORE INCOME TAXES (8,160,947) (19,151,197)Income tax expense 3,966,440 – NET LOSS $(12,127,387) $(19,151,197) Net loss per share – basic and diluted $(0.06) $(0.11)Weighted average – basic shares 190,009,159 170,847,444 Weighted average – diluted shares 198,699,461 181,203,673 CONSOLIDATED STATEMENTS OF OTHER COMPREHENSIVE LOSS NET LOSS $(12,127,387) $(19,151,197) OTHER COMPREHENSIVE INCOME (LOSS): Foreign currency translation loss (1,225,696) (539,900)Retirement Benefit (68,809) (14,226)RECLASSIFICATION ADJUSTMENTS: Retirement Benefit 1,433 – Income tax effects relating to retirement benefit 20,037 – TOTAL OTHER COMPREHENSIVE LOSS (1,273,035) (554,126)TOTAL COMPREHENSIVE LOSS $(13,400,422) $(19,705,323) SS INNOVATIONS INTERNATIONAL, INC.CONSOLIDATED STATEMENTS OF CASH FLOWS(Audited) For the Year Ended December 31, 2025 December 31, 2024 Cash flows from operating activities: Net loss $(12,127,387) $(19,151,197)Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 1,075,907 436,005 Operating lease expense 827,521 753,449 Interest Expense 271,633 317,234 Interest and other income, net (625,883) (418,426)Property, plant and equipment written off – 48,456 Provision for credit loss reserve, net 324,345 955,762 Deferred income tax benefit (512,865) – Stock compensation expense 8,128,103 14,342,784 Provision for slow moving inventory (110,332) – Changes in operating assets and liabilities: Accounts receivable, net (13,037,284) (4,890,032)Inventory, net (8,070,786) (7,691,518)Deferred revenue 3,953,938 5,357,075 Prepaids and other assets (5,101,794) (1,411,621)Accounts payable 2,877,810 1,410,830 Income taxes payable, net 4,214,339 – Accrued expenses & other liabilities 161,914 1,144,037 Operating lease payment (792,166) (705,868)Net cash used in operating activities (18,542,987) (9,503,030) Cash flows from investing activities: Purchase of property, plant and equipment (3,659,058) (661,479)Net cash used in investing activities (3,659,058) (661,479) Cash flows from financing activities: Proceeds from bank overdraft facility (net) 3,448,042 1,975,980 Proceeds from issuance of promissory notes to principal shareholder – 3,000,000 Proceeds from issuance of convertible notes to principal shareholder 28,000,000 3,000,000 Proceeds from issuance of convertible notes to other investors – 1,450,000 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 26,166,556 9,425,980 Net change in cash 3,964,511 (738,529)Effect of exchange rate on cash (985,026) 274,219 Cash and cash equivalents at the beginning of the year 6,623,535 7,087,845 Cash and cash equivalents at end of the year $9,603,020 $6,623,535
Medtronic to acquire Scientia Vascular, marrying access and therapeutic portfolios for neurovascular care
Deal complements Medtronic’s Neurovascular portfolio, delivering simplicity and access when ‘time is brain’ GALWAY, Ireland, March 10, 2026 /PRNewswire/ — Medtronic today announced its entry into a definitive agreement to acquire Scientia Vascular, a company with critical, innovative…
Mineralys Therapeutics Announces FDA Acceptance of NDA for Lorundrostat for Treatment of Adults with Hypertension and Topline Explore-OSA Trial Results
– The FDA assigned a PDUFA target action date of December 22, 2026 – – The NDA is based on positive data from a successful clinical program demonstrating favorable safety and blood pressure reduction in adults with hypertension – – Topline results from the Phase 2 Explore-OSA exploratory trial did not reduce AHI; demonstrated a clinically meaningful reduction in blood pressure and favorable safety and tolerability in this population with difficult to control hypertension – RADNOR, Pa., March 09, 2026 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for lorundrostat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026. “The FDA’s acceptance of our NDA for lorundrostat marks an important milestone in our efforts to address the clinically significant need faced by millions of patients living with uncontrolled or resistant hypertension,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “While the Explore-OSA trial did not demonstrate a reduction in AHI, the blood pressure reductions and safety profile were clinically meaningful, especially for this difficult to control population. We believe lorundrostat has the potential to become an important new treatment option for resistant and uncontrolled hypertension, and we look forward to working with the FDA as we advance toward potential approval.” Explore-OSA Trial Topline Results The Explore-OSA trial was a Phase 2 exploratory trial of lorundrostat in forty-eight participants with an average body mass index (BMI) of 38.2 kg/m2, an average apnea-hypopnea index (AHI) of 48.5 events/hr and an average systolic blood pressure (BP) of 142.3 mmHg (range 131-175 mmHg). After four weeks of treatment, lorundrostat 50 mg dosed in the evening did not demonstrate a clinically meaningful difference relative to placebo on the apnea-hypopnea index (AHI), the primary endpoint. At week four, the trial demonstrated an 11.1 mmHg (p < 0.0001) and a 1.0 mmHg (p = NS) BP reduction with lorundrostat and placebo, respectively, in the pre-planned parallel arm analysis of the first period. There was a 6.2 mmHg placebo-adjusted reduction (p < 0.0003) in BP in the crossover analysis. Lorundrostat demonstrated a favorable safety profile and was well tolerated, with no serum potassium excursions above 5.5 mmol/L. Analysis is ongoing for other endpoints in the trial and will be reported in future publications or medical meetings. About Launch-HTN Launch-HTN (NCT06153693) was a global, randomized Phase 3 double-blind, placebo-controlled trial of adults whose blood pressure (BP) remained uncontrolled despite being on two to five antihypertensive medications. Participants were assigned to one of three groups: placebo; lorundrostat 50 mg once daily; or lorundrostat 50 mg once daily with the option to increase to 100 mg at week six. The primary endpoint was change from baseline in systolic BP at six weeks versus placebo, measured by automated office blood pressure monitoring. About Advance-HTN Advance-HTN (NCT05769608) was a randomized, double-blind, placebo-controlled Phase 2 clinical trial that evaluated the efficacy and safety of lorundrostat for the treatment of uncontrolled or resistant hypertension, when used as an add-on therapy to a standardized background treatment of two or three antihypertensive medications in adult participants. Participants who met screening criteria had their existing hypertension medications discontinued and started on a standard regimen of an angiotensin II receptor blocker (ARB) and a diuretic, if previously on two medications, or a standard regimen of ARB, diuretic and calcium channel blocker if previously on three to five medications. Participants who remained hypertensive despite the standardized regimen were then randomized into three cohorts and treated for twelve weeks: lorundrostat 50 mg once daily, lorundrostat 50 mg once daily and an option to titrate to 100 mg once daily at week four based on defined criteria, or placebo. The trial’s primary endpoint was the change in 24-hour ambulatory systolic blood pressure at week twelve from baseline for active cohorts versus placebo. About Explore-OSA The Explore-OSA trial (NCT06785454) was a Phase 2 randomized, double-blind, placebo-controlled, crossover trial. This proof-of-concept trial was designed to evaluate the efficacy, safety, and tolerability of lorundrostat in overweight or obese adults with moderate-to-severe OSA and hypertension. Participants in Explore-OSA received 50 mg of oral, once daily (QD) lorundrostat and placebo in sequential treatment periods, with continuous monitoring of BP during overnight polysomnography. The primary efficacy endpoint of the trial was absolute change from baseline in apnea-hypopnea index (AHI) after four weeks of active treatment compared to placebo. The first secondary endpoint was AOBP, and additional endpoints were nighttime BP and sleep and cardiovascular health measures. About Obstructive Sleep Apnea OSA is characterized by repetitive overnight hypoxic episodes and subsequent sleep fragmentation due to a complete or partial collapse of the upper airway. Moderate to severe OSA is associated with increased production of aldosterone and increased nighttime BP; standard treatment with positive airway pressure is not sufficient for BP reduction. OSA impacts almost one billion people globally, including 425 million moderate-to-severe cases. Around 80% of adults with OSA are undiagnosed. As of 2025, untreated OSA is estimated to cost the United States more than $150 billion annually when considering direct medical expenses, productivity losses and accident-related costs. Between 30-50% of adults with hypertension have OSA, and this number increases to between 70-80% in adults with resistant hypertension (rHTN). Additionally, untreated moderate-to-severe OSA increases the risk of rHTN. Along with hypertension, OSA is a major risk factor of cardiovascular disease, type-2 diabetes mellitus and stroke. About Hypertension Having sustained, elevated blood pressure (BP or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019. Less than 50% of hypertension patients achieve their BP goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients. About Lorundrostat Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as CKD and OSA. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive participants. The Company has now completed five successful Phase 2/3 clinical trials of lorundrostat supporting the efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. This includes two pivotal, registrational trials, including the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic BP by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile. About Mineralys Mineralys Therapeutics is a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky. Forward Looking Statements Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the timing and results of review of additional endpoints evaluated in the Explore-OSA clinical trial; the anticipated timing of the FDA’s review of the Company’s accepted NDA and any subsequent regulatory approval of lorundrostat; and the planned future clinical development of lorundrostat and the timing thereof; Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; any delays in the FDA’s review of our accepted NDA, including as a result of a government shutdown or reductions in agency funding or personnel, the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for regulatory approval of lorundrostat; later developments with the FDA may be inconsistent with the feedback from prior meetings, including whether the proposed pivotal program will support registration of lorundrostat following submission of an NDA and the FDA’s review of the same; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies;; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs and other trade policies, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Tanabe Pharma Corporation to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact:Investor Relationsinvestorrelations@mineralystx.com Media RelationsMelyssa WeibleElixir Health Public RelationsEmail: mweible@elixirhealthpr.com
Stereotaxis Reports 2025 Full Year Financial Results
ST. LOUIS, March 09, 2026 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the fourth quarter and full year ended December 31, 2025.



