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MiniMed Group(MMED) - Prospectus
2025-12-19 21:03
As filed with the Securities and Exchange Commission on December 19, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MiniMed Group, Inc. (Exact name of registrant as specified in its charter) (Primary Standard Industrial Classification Code Number) Delaware 3841 33-3985981 (I.R.S. Employer Identification Number) 18000 Devonshire St. Northridge, CA 91325 (763) 514-4000 (Address, including zip ...
Boston Scientific's Global Expansion: What's Behind the Growth?
ZACKS· 2025-12-18 14:31
Key Takeaways BSX focuses on expanding its global presence, with EMEA, APAC and Latin America at 35% of 2025 revenues.BSX is globalizing R&D from a largely U.S.-based model, accelerating product development worldwide.BSX's Interventional Cardiology business generates nearly 70% of revenues from overseas markets.Boston Scientific (BSX) focuses on expanding its global presence to pursue growth opportunities in net sales and market share outside the United States. This includes Emerging Markets, defined as all ...
MDT Stock Set to Benefit From the FDA Clearance of Hugo RAS System
ZACKS· 2025-12-05 14:51
Core Insights - Medtronic plc (MDT) has received FDA approval for the Hugo robotic-assisted surgery (RAS) system, enhancing urologic surgical procedures and providing a versatile platform for minimally invasive care [1][9]. Company Developments - The Hugo RAS system builds on Medtronic's existing surgical offerings, including the Touch Surgery ecosystem, to create a connected operating room environment [2]. - Following the announcement on December 3, MDT shares increased by 0.02%, closing at $101.99, indicating a positive market reaction [3]. - Medtronic's current market capitalization stands at $130.73 billion, with an earnings yield of 5.5%, significantly higher than the industry average of 0.1% [4]. Product Features - The Hugo RAS system features a modular design that allows for flexible deployment across various care settings, enhancing utilization and customization for surgeons [5]. - The system includes an open surgeon console that improves situational awareness, reduces physical strain, and offers better training opportunities for surgical teams [5][6]. - It integrates with the Touch Surgery ecosystem, providing pre-operative training, remote tele-proctoring, and AI-driven post-operative insights, making Medtronic the only company to support all surgical modalities [6]. Market Potential - The global urology robotic surgery market is valued at $2 billion in 2024, with a projected CAGR of 8.7% through 2033, driven by the demand for minimally invasive surgeries [10]. - Medtronic plans to expand the Hugo RAS system's applications in the U.S. to include general and gynecologic surgical procedures following its initial urology clearance [7]. Stock Performance - Over the past six months, MDT shares have increased by 16.6%, outperforming the industry, which saw a decline of 1.3% [12].
Medtronic's Q2 Earnings & Revenues Beat Estimates, Stock Climbs
ZACKS· 2025-11-18 15:36
Core Insights - Medtronic plc (MDT) reported second-quarter fiscal 2026 adjusted earnings per share (EPS) of $1.36, a 7.9% increase year-over-year, exceeding the Zacks Consensus Estimate by 3.82% [1] - The company's worldwide revenues for the quarter reached $8.96 billion, reflecting a 6.6% year-over-year increase and surpassing the Zacks Consensus Estimate by 1.11% [2] Revenue Breakdown - MDT's revenues are categorized into four segments: Cardiovascular, Medical Surgical, Neuroscience, and Diabetes [3] - Cardiovascular revenues grew 9.3% organically to $3.44 billion, with Cardiac Rhythm & Heart Failure sales increasing 14.3% year-over-year to $1.83 billion [4][5] - Medical Surgical sales totaled $2.17 billion, up 1.3% year-over-year, with Surgical & Endoscopy revenues at $1.68 billion, a 1.1% increase [5] - Neuroscience revenues reached $2.56 billion, a 3.9% year-over-year increase, with Neuromodulation revenues growing 7.3% to $520 million [6] - Diabetes segment revenues rose 7.1% organically to $757 million [6] Margin Performance - The gross margin expanded by 90 basis points to 65.8%, despite a 3.9% increase in the cost of products sold [7] - Research and development expenses increased by 8.2% year-over-year to $754 million, while selling, general, and administrative expenses rose 7.5% to $2.97 billion [7] - The adjusted operating margin improved by 50 basis points year-over-year to 24.3% [7] Fiscal 2026 Outlook - Medtronic raised its fiscal 2026 organic revenue growth projection to 5.5% from approximately 5% [10] - The company expects full-year adjusted EPS in the range of $5.62-$5.66, up from the previous range of $5.60-$5.66 [10] - The Zacks Consensus Estimate for fiscal 2026 worldwide revenues is $35.83 billion [10] Strategic Developments - The quarter marked the strongest Cardiovascular revenue growth in over a decade, excluding the pandemic [11] - Medtronic received FDA approval for the Altaviva device and the MiniMed 780G system, enhancing its product offerings [11] - The company anticipates further revenue growth acceleration driven by several enterprise growth drivers, including new therapies and technologies [12]
Abbott Gains Diabetes Tech Expansion Opportunity Following Earnings Beat and Insider Sale
Yahoo Finance· 2025-10-01 21:28
Core Insights - Abbott Laboratories (NYSE:ABT) is recognized as one of the 12 Set-It-and-Forget-It Stocks to buy now, driven by a positive second quarter performance and an executive sale, alongside an expansion opportunity from Medtronic [1] Financial Performance - Abbott reported a 6.9% increase in sales for Q2 2025, with an Adjusted EPS of $1.26, surpassing consensus estimates [2] - The company is progressing in its biosimilars portfolio and expects multiple launches in 2026 [2] Executive Activity - Following the Q2 results, Philip P Boudreau, Executive Vice President and CFO, sold 5,550 shares valued at $746,752 on August 11, 2025, indicating potential negative sentiment [3] Market Opportunities - The FDA cleared Medtronic's MiniMed 780G system on September 2, 2025, which integrates with Abbott's Instinct sensor, providing an opportunity for expansion in diabetes technology [3] Company Overview - Abbott Laboratories has a significant market capitalization of $232.44 billion, establishing a strong presence in the healthcare industry [4] - The company, headquartered in Illinois and operational since 1888, develops and sells a diverse range of medical devices, diagnostics, nutritional products, and branded generic pharmaceuticals globally [4]
Medtronic Receives FDA Nod for Altaviva Device: Stock to Gain?
ZACKS· 2025-09-24 14:01
Core Insights - Medtronic plc (MDT) has received FDA approval for the Altaviva device, a minimally invasive implantable tibial neuromodulation therapy aimed at treating urge urinary incontinence, marking a significant advancement in bladder control therapies [1][9] - The introduction of the Altaviva device positions MDT as the only company with a comprehensive portfolio of neuromodulation therapies for bladder control symptoms, which is expected to enhance revenue growth and improve stock performance [3][4] Company Developments - The Altaviva device features a 15-year battery life, quick recharging capabilities, and is MRI-compatible, making it a patient-friendly option for those suffering from urge urinary incontinence [6][9] - Medtronic's market capitalization stands at $121.80 billion, with a projected revenue growth of 6.8% for fiscal 2026 compared to fiscal 2025 [4] - The company has consistently outperformed earnings expectations in the past four quarters, with an average surprise of 2.20% [4] Industry Context - Bladder control issues affect approximately 43 million U.S. adults, with nearly 16 million experiencing urge urinary incontinence, indicating a substantial market for the Altaviva device [10] - The global urinary incontinence therapeutics market is expected to grow at a CAGR of 4.0% from 2024 to 2030, driven by an aging population and increased awareness [10]
Medtronic plc (MDT) Announces FDA Approval for SmartGuard Algorithm as Automated Glycemic Controller
Yahoo Finance· 2025-09-10 08:53
Core Insights - Medtronic plc has received FDA approval for its SmartGuard algorithm as an interoperable automated glycemic controller, which integrates with Abbott's Instinct sensor for type 1 diabetes [2] - The MiniMed 780G system has also been approved for adults with insulin-requiring type 2 diabetes, marking a significant advancement in automated insulin delivery systems [3] - Clinical trials supporting these products indicate improved HbA1c levels, greater time in range, and reduced diabetes distress for patients [3] Company Developments - The collaboration with Abbott aims to create a smarter dosing ecosystem to enhance daily management and improve the quality of life for diabetes patients [4] - Medtronic is recognized as a global healthcare technology leader, providing innovative therapies and devices for over 70 health conditions [4] Market Position - Despite the advancements and potential of Medtronic, it is listed among stocks recommended for sale, indicating a cautious outlook from some analysts [1][4] - There is a suggestion that certain AI stocks may offer better investment opportunities with higher upside potential and lower downside risk compared to Medtronic [5]
MDT Stock May Benefit From New Regulatory Wins for Its MiniMed 780G
ZACKS· 2025-09-05 13:50
Core Insights - Medtronic plc (MDT) has achieved two significant regulatory milestones for its MiniMed 780G system, including FDA clearance for the SmartGuard algorithm and approval for use in adults with insulin-requiring type 2 diabetes [1][9]. Regulatory Achievements - The FDA has cleared the SmartGuard algorithm as an interoperable automated glycemic controller, allowing integration with Abbott's Instinct sensor for type 1 diabetes [1][5]. - The MiniMed 780G system is now approved for adults aged 18 and above with insulin-requiring type 2 diabetes, making it the first AID system with Meal Detection technology for this demographic [7][9]. Market Performance and Growth - Following the announcement, MDT shares experienced a slight decline of 1.2%, closing at $92.25 [3]. - The Diabetes business is growing above the company average, driven by the MiniMed 780G system and Simpler Sync sensor in international markets [3]. - Medtronic has a market capitalization of $118.33 billion, with a projected revenue growth of 6.8% for fiscal 2026 compared to fiscal 2025 [4]. Product Integration and Future Plans - The Instinct sensor, designed by Abbott, is the world's smallest integrated CGM, with a wear time of up to 15 days, and will be integrated with the MiniMed 780G system [5][6]. - Medtronic and Abbott are finalizing compliance documentation for sensor integration, with pre-orders for the Simplera Sync sensor expected to open soon [6][11]. Industry Prospects - The global diabetes device market was valued at $32.74 billion in 2024 and is projected to grow at a compound annual growth rate of 7.7% through 2034 [12]. - Key factors driving market growth include rising obesity rates, increased health consciousness, and advancements in diabetes monitoring technology [13]. Recent Developments - In July, Medtronic received CE Mark approval to expand the MiniMed 780G system's indications for use in individuals aged two years and older, during pregnancy, and for type 2 insulin-requiring diabetes [14].
Trinity Biotech's Redesigned CGM Sensor Favored by New Clinical Data
ZACKS· 2025-08-15 15:01
Company Overview - Trinity Biotech plc (TRIB) is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [2] Key Developments - Trinity Biotech announced positive clinical trial results for its next-generation continuous glucose monitoring (CGM) technology, CGM+, confirming accurate glucose readings over a 15-day wear period without finger-stick calibration [1][8] - The redesigned proprietary needle-free glucose sensor reduces disposable components, significantly lowering the cost of care compared to current leading market products [1][8] - The CGM+ platform is designed to enhance accessibility and increase utilization of CGM technology, addressing the high cost of existing devices that hinders widespread adoption [3] Technical Achievements - The elimination of finger-stick calibration is considered the most significant technical achievement for TRIB, aligning its glucose sensor with market leaders while offering a differentiated product that is more affordable, reusable, and sustainable [4] Market Potential - The global CGM market is projected to grow from $13 billion in 2025 to $28 billion by 2030, driven by rising diabetes prevalence and demand for real-time health data, which is expected to provide a significant boost to Trinity Biotech's business [5] Product Development - Trinity Biotech unveiled its new flagship product, CGM+, which is positioned for the $260 billion AI wearables market and combines multi-sensor data with real-time analytics to meet the demands of AI-powered healthcare [6] Competitive Landscape - Medtronic plc (MDT) and Abbott Laboratories (ABT) are notable peers in the diabetes management space, with both companies making advancements in CGM technology and reporting robust growth in their respective diabetes care segments [7][9] - DexCom, Inc. (DXCM) also reported strong revenue growth and received FDA clearance for its Dexcom G7 15 Day CGM System, showcasing extensive clinical evidence for its usage in various diabetes conditions [10]
DXCM's Access Gains and Operational Strength Offset Margin Pressures
ZACKS· 2025-06-20 14:26
Core Insights - DexCom (DXCM) reported strong first-quarter 2025 results driven by high demand, record new patient growth, and progress in strategic initiatives [1] - The company’s shares have increased by 18.6% quarter to date, outperforming the industry’s decline of 4.5% [2] - DexCom has a market capitalization of $31.76 billion and projects a 23.1% growth rate over the next five years [2] Access Gain and Market Penetration - Significant expansion in reimbursement coverage for type 2 diabetes (T2D) patients, particularly non-insulin users, is expected to unlock access for nearly 6 million individuals [4] - The first quarter of 2025 saw a record increase in new patient starts from this cohort, the highest in DexCom's history [4] - The over-the-counter CGM, Stelo, is capturing a broader audience, including prediabetes patients and those interested in wellness [5][8] Innovation and Commercial Execution - The launch of the 15-Day G7 system is anticipated to enhance accuracy and product differentiation, potentially improving gross margins [10] - DexCom is optimizing its sales force and expanding its international presence, particularly in France and Japan [11] - The company has a strong cash position of $2.7 billion and announced a $750 million share buyback, indicating confidence in long-term cash flow [12] Estimate Trend - The Zacks Consensus Estimate for 2025 earnings per share remains stable at $2.03, with the second-quarter revenue estimate at $1.12 billion, reflecting an 11.8% year-over-year improvement [13][15] Navigating Near-Term Challenges - Gross margin guidance for fiscal 2025 has been revised down to nearly 62% due to supply-chain disruptions and increased freight costs [16] - DexCom is addressing an FDA warning letter from 2024 inspections, which requires ongoing resource allocation but does not restrict product approvals [17] - The company is advocating for Medicare coverage for non-insulin T2D users, contingent on a trial set to report results in late 2025 or early 2026 [18] CGM Competition on the Rise - DexCom faces increasing competition from Abbott Laboratories, Medtronic, and Senseonics, which are innovating rapidly in the CGM market [19] - Abbott's expansion with its FreeStyle Libre family and OTC devices directly challenges DexCom's Stelo strategy [20] - Medtronic's integration of CGM with insulin pumps and Senseonics' long-wear implantable CGM are also competitive threats [21][22]