Workflow
Medical Technology
icon
Search documents
Medtronic(MDT) - 2026 Q1 - Earnings Call Presentation
2025-08-19 12:00
Financial Performance - Medtronic reported Q1 FY26 revenue of $8.539 billion, a 6.7% increase compared to Q1 FY25, with organic revenue growth of 4.8%[24] - Adjusted diluted EPS was $1.26, a 2.4% increase year-over-year[24] - The company is raising FY26 EPS guidance and expects high-single digit EPS growth in FY27[15, 58] Segment Performance - Cardiovascular segment revenue reached $3.285 billion, with 7.0% organic growth[21, 40] - Cardiac Ablation Solutions experienced nearly 50% global growth, including over 70% US growth[15, 32, 39] - Neuroscience segment revenue was $2.416 billion, with 3.1% organic growth[21, 45] - Medical Surgical segment revenue totaled $2.083 billion, with 2.4% organic growth[21, 50] - Diabetes segment revenue was $721 million, with 7.9% organic growth[21, 55] Strategic Initiatives - Medtronic is executing strategic portfolio management, including Diabetes separation within 15 months[15, 55] - The company anticipates a net FY26 tariff impact of approximately $185 million, a decrease from the previous estimate of $200-350 million[15] Future Outlook - Medtronic expects revenue growth to accelerate in the second half of the fiscal year due to significant product launches[14, 31] - Cardiac Ablation Solutions is expected to grow even faster in Q2 and H2 due to PFA supply expansion[15]
Medtronic reports first quarter fiscal 2026 financial results
Prnewswire· 2025-08-19 10:45
Core Insights - Medtronic plc reported its first quarter fiscal 2026 financial results, achieving mid-single digit organic revenue growth for the 11th consecutive quarter, with expectations to accelerate growth in the second half of the fiscal year [1][2][3] Financial Performance - The company reported worldwide revenue of $8.578 billion, an increase of 8.4% as reported and 4.8% on an organic basis [3][4] - GAAP operating profit was $1.445 billion with an operating margin of 16.8%, reflecting a 13% increase and a 70 basis point improvement [3][4] - Non-GAAP operating profit was $2.016 billion with a margin of 23.6%, showing a 3% increase but an 80 basis point decrease [3][4] Earnings and Guidance - GAAP net income was $1.040 billion, with diluted earnings per share (EPS) at $0.81, remaining flat, while non-GAAP diluted EPS increased by 2% to $1.26 [4][8] - The company raised its FY26 EPS guidance to a range of $5.60 to $5.66, up from the previous range of $5.50 to $5.60, and reiterated its organic revenue growth guidance of approximately 5% [7][8][9] Segment Performance - Cardiac Ablation Solutions revenue surged nearly 50%, with a 72% increase in the U.S. driven by pulsed field ablation products [4][5] - The Cardiovascular Portfolio generated $3.285 billion in revenue, a 9.3% increase as reported and 7.0% organic [5][19] - The Diabetes business reported revenue of $721 million, an increase of 11.5% as reported and 7.9% organic [5][19] International and U.S. Revenue - International revenue reached $4.354 billion, a 13.6% increase, while U.S. revenue was $4.224 billion, reflecting a 3.5% increase [22][19] - The Cardiovascular segment in the international market grew by 12.6%, with notable increases in Cardiac Rhythm & Heart Failure and Structural Heart & Aortic categories [22][19] Operational Efficiency - The company is focused on improving efficiencies in manufacturing, supply chain, and operating expenses to drive earnings growth while increasing investments in R&D, sales, and marketing [9][8]
Resmed Announces Election of Nicole Mowad-Nassar to Board of Directors and Upcoming Retirement of Rich Sulpizio
Globenewswire· 2025-08-18 20:15
Core Insights - Resmed has elected Nicole Mowad-Nassar to its board of directors, effective August 15, 2025, while thanking Rich Sulpizio for his two decades of service as he retires from the board [1][5]. Group 1: Board Changes - Nicole Mowad-Nassar is currently the President of Specialty and U.S. Therapeutics Operations at AbbVie, managing a $6 billion commercial portfolio across 17 therapeutic areas and overseeing a workforce of 6,000 [2]. - Rich Sulpizio has served on Resmed's board since 2005, chairing the Compensation Committee and serving on the Audit Committee and Nominating and Governance Committee [5][6]. - Mowad-Nassar will serve as an independent director and has been appointed to the Compensation and Leadership Development Committee, standing for reelection at the 2025 Annual Meeting of Stockholders [4]. Group 2: Professional Background - Mowad-Nassar has over 30 years of experience in strategic, commercial, and operational roles within the pharmaceutical and healthcare sectors, with a focus on digital innovation [7]. - At AbbVie, she played a key role in the commercial integration of the $63 billion Allergan acquisition, ensuring continuity in product launches while minimizing operational disruption [3]. Group 3: Leadership Perspectives - Mick Farrell, Resmed's Chairman and CEO, highlighted Mowad-Nassar's extensive experience and commitment to patient access and digital engagement, indicating her potential to enhance the board's strategic direction [4]. - Farrell expressed gratitude for Sulpizio's contributions, noting his energy and people-first mindset during board discussions [6].
ONWARD Medical Receives FDA IDE Approval to Initiate the Empower BP Pivotal Study with the ARC-IM System
Globenewswire· 2025-08-18 16:30
Core Viewpoint - ONWARD Medical N.V. has received FDA approval for an investigational device exemption for its ARC-IM System, enabling the initiation of the Empower BP pivotal study to evaluate the safety and efficacy of its implantable spinal stimulation system for managing blood pressure instability after spinal cord injury (SCI) [2][7]. Group 1: Study Details - The Empower BP study is the second global pivotal study for ONWARD and the first to assess the ARC-IM System, involving approximately 20 leading neurorehabilitation and neurosurgical centers across the US, Canada, and Europe, with patient enrollment expected by year-end [3][7]. - The study will focus on participants with spinal cord injuries at levels C2-T6, with injury severities of AIS A-D, and those experiencing chronic orthostatic hypotension and episodes of autonomic dysreflexia [3]. Group 2: Market Need and Impact - Over 50% of individuals with SCI experience blood pressure instability, affecting nearly 350,000 people in the US and Europe, which can threaten neurological recovery and negatively impact cardiovascular health and quality of life [4][5]. - Addressing blood pressure instability is critical for improving long-term outcomes for SCI patients, as it is a significant but often unrecognized complication that can lead to increased cardiovascular disease risk [5][8]. Group 3: Technology Overview - The ARC-IM System is an implanted neuromodulation platform designed to deliver targeted spinal cord stimulation, specifically aimed at managing blood pressure instability in SCI patients [5][9]. - The system includes the ONWARD Neurostimulator and the ARC-IM Thoracic Lead, which is optimized for placement in the thoracic spinal cord's "Hemodynamic Hotspot," a location identified through research partnerships [5][6]. Group 4: Previous Results and Future Outlook - In December 2022, ONWARD announced positive interim clinical results from feasibility studies showing improved blood pressure regulation and hemodynamic stability after SCI, with participants reporting enhanced well-being and reduced symptoms of orthostatic hypotension [6]. - The FDA has awarded ONWARD one of its 10 Breakthrough Device Designations for the ARC-IM System, indicating its potential to address significant unmet medical needs and providing regulatory and reimbursement advantages [8].
NeuroOne® Receives FDA 510(k) Clearance for OneRF® Trigeminal Nerve Ablation System to Treat Facial Pain
Globenewswire· 2025-08-18 12:30
Core Viewpoint - NeuroOne Medical Technologies Corporation has received FDA clearance for its OneRF Trigeminal Nerve Ablation System, which offers a minimally invasive alternative for treating trigeminal neuralgia, a chronic pain condition affecting approximately 150,000 people annually in the U.S. [1][2] Group 1: Product and Technology - The OneRF Trigeminal Nerve Ablation System utilizes a proprietary RF generator platform to create radiofrequency lesions for pain treatment and functional neurosurgical procedures [1][2] - This system features a unique multi-contact RF probe that allows for precise localization and tailored ablation of nerve tissue, enhancing safety and accuracy during procedures [3] - The technology aims to reduce procedural time, improve patient comfort, and enhance overall patient safety [3] Group 2: Market Potential and Strategy - The company plans a limited commercial launch of the OneRF system in the fourth quarter of 2025, with expectations to generate revenues from trigeminal nerve ablation by late 2025 [1][4] - NeuroOne's technology platform has potential applications across various neurological disorders and pain management functions, including lower back pain [4] - Current users of the OneRF brain ablation system may also adopt the nerve ablation procedures, justifying further investment in the technology [4] Group 3: Company Overview - NeuroOne Medical Technologies Corporation focuses on developing minimally invasive solutions for various neurological disorders, including epilepsy and chronic pain [5] - The company is exploring additional therapeutic applications, such as treatments for depression, mood disorders, and high blood pressure [5]
Ventripoint Diagnostics Appoints Thomas Brown as Director of Congenital Heart Defect Program
Thenewswire· 2025-08-18 12:10
Core Insights - Ventripoint Diagnostics Ltd. has appointed Thomas Brown as Director of the Congenital Heart Defect (CHD) Program to enhance its market leadership in pediatric cardiology [1][3] - Mr. Brown has over 20 years of experience in medical imaging sales and market expansion, previously serving as Vice President of North American Sales at Intelligent Ultrasound [2][5] - The appointment aims to accelerate the adoption of Ventripoint's VMS+™ technology in the CHD segment and related markets such as cardio-oncology and heart failure [3][4] Company Strategy - The appointment of Mr. Brown is part of Ventripoint's multi-segment growth strategy, focusing on innovative imaging solutions [4] - Ventripoint's VMS+™ technology offers MRI-comparable cardiac volumetric analysis using standard 2D ultrasound, which reduces costs and wait times for clinicians and patients [4][7] - The company aims to expand its product applications across various ultrasound systems, supported by regulatory approvals in the U.S., Europe, and Canada [7]
OneMedNet initiates new Subscription Revenue model in partnership with Circle CVI
Globenewswire· 2025-08-18 11:30
Company Overview - OneMedNet Corporation is a leader in AI-powered Real-World Data (RWD) and has established a long-term strategic partnership with Circle Cardiovascular Imaging Inc. to enhance cardiac diagnostics and treatment planning [1][4] - Circle CVI selected OneMedNet's iRWD™ platform for access to diverse and regulatory-grade cardiovascular datasets, which includes data from over 1,750 provider sites and over 131 million exams [2][4] Partnership Details - The collaboration allows Circle CVI to expand its research and development capabilities while aligning with evolving regulatory and clinical evidence standards [4] - Circle CVI's CEO highlighted the exceptional quality and regulatory readiness of OneMedNet's data, indicating a commitment to a long-term partnership [3][5] Industry Implications - This partnership exemplifies a growing industry shift towards utilizing real-world evidence as a foundation for medical innovation [4] - OneMedNet's platform is positioned to revolutionize how healthcare companies access and utilize Real-World Data, which is critical for driving innovation in various medical fields [5]
Cell:“读心术”来了!脑接机口实时解读“内心独白”,自带密码保护,防止隐私泄漏
生物世界· 2025-08-17 05:03
Core Viewpoint - The article discusses a breakthrough in brain-computer interface (BCI) technology that allows for the decoding of internal speech, providing a promising tool for individuals with speech impairments [2][3]. Group 1: Technology Overview - The newly developed BCI system can decode internal speech by relying on signals from the supramarginal gyrus, a brain area closely related to language [2]. - This BCI can achieve a decoding accuracy of 74% for imagined speech, comparable to previous systems that required vocalization [4][8]. - The system incorporates a password protection feature, ensuring that decoding only occurs when the user thinks of a pre-set password, thus safeguarding privacy [3][4]. Group 2: Research Methodology - The research involved four participants with speech difficulties, including one stroke survivor and three individuals with motor neuron disease, who were instructed to either attempt to speak or imagine speaking specific words [6]. - The study found that both attempted speech and internal speech originate from the same brain region, producing similar neural signals, albeit with weaker signals for internal speech [7]. - An AI model was trained using the collected neural data to identify phonemes, enabling real-time assembly of words and sentences from a vocabulary of 125,000 words [9]. Group 3: Key Findings - The study concluded that there are shared representations of attempted speech, internal speech, and perceived speech in the motor cortex [15]. - The BCI can decode general sentences and improve user experience, while also interpreting aspects of personal internal speech during cognitive tasks like counting [15]. - The high-fidelity solution effectively prevents the unintended decoding of personal internal speech, addressing privacy concerns [15].
Biotricity (BTCY) Upgraded to Buy: Here's Why
ZACKS· 2025-08-15 17:01
Core Viewpoint - Biotricity Inc. (BTCY) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Institutional investors utilize earnings estimates to determine the fair value of stocks, leading to buying or selling actions that affect stock prices [4]. Business Improvement Indicators - The upgrade in Zacks Rank for Biotricity suggests an improvement in the company's underlying business, which could lead to increased stock prices as investors respond positively [5][10]. - Over the past three months, the Zacks Consensus Estimate for Biotricity has increased by 17.9%, indicating a positive trend in earnings expectations [8]. Zacks Rank System Overview - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [7][9]. - Biotricity's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].
TMO Receives FDA Approval for Oncomine Dx Target Test
ZACKS· 2025-08-15 14:15
Company Overview - Thermo Fisher Scientific (TMO) received FDA approval for its Oncomine Dx Target Test as a companion diagnostic for identifying patients eligible for HERNEXEOS (zongertinib tablets), a tyrosine kinase inhibitor [1][2] - The Oncomine Dx Target Test enables multi-biomarker analysis from a single tissue sample, providing results in as little as four days, and is fully reimbursed by Medicare and top commercial payers in the U.S. [3] Product Details - The Oncomine Dx Target Test checks for HER2/ERBB2 tyrosine kinase domain activating mutations in NSCLC tumors, reducing the need for second biopsies and avoiding suboptimal therapy selection [3] - The test has received global approvals, including its first FDA approval in 2017, and is reimbursed by insurers covering over 550 million lives globally [4] Market Insights - Lung cancer is the second most common cancer in the U.S., with NSCLC accounting for 85-90% of cases, and approximately 2-4% of NSCLC patients carry a HER2 mutation [5] - The global market for NSCLC treatments is projected to reach $66.04 billion by 2032, growing at a CAGR of 10.3% from 2024 to 2032 [5] Competitive Landscape - Thermo Fisher faces competition from MedTech players like Illumina, which is expanding its NGS oncology portfolio, and Guardant Health, which is enhancing its liquid biopsy and NGS-based testing offerings [7][9] - Illumina's TruSight Oncology assay continues to gain utilization, while Guardant Health's Guardant360 test provides comprehensive tumor profiling from a single blood draw [7][9] Recent Developments - Thermo Fisher also announced FDA approval for the Oncomine Dx Express Test as an in vitro diagnostic assay for use as a companion diagnostic for Dizal's ZEGFROVY (sunvozertinib) [6]