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Becton sees 2026 profit slightly above estimates on strong demand for drug delivery devices
Reuters· 2025-11-06 13:58
Core Viewpoint - Medical device maker Becton Dickinson exceeded Wall Street estimates for fourth-quarter adjusted profit and provided a forecast for 2026 earnings that is slightly above expectations, driven by steady demand for its products [1] Financial Performance - Becton Dickinson reported fourth-quarter adjusted profit that surpassed Wall Street estimates, indicating strong financial performance [1] - The company’s earnings forecast for 2026 is slightly above expectations, suggesting confidence in future growth [1] Market Demand - Steady demand for Becton Dickinson's products has been a key factor supporting its financial results and outlook [1]
The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Baxter International, Inc.(BAX) Shareholders
Prnewswire· 2025-11-06 13:45
Core Viewpoint - Baxter International, Inc. is facing a class action lawsuit due to allegations of issuing misleading statements regarding the safety and efficacy of its Novum LVP product, which reportedly has systemic defects leading to serious patient risks [1]. Group 1: Allegations and Issues - The lawsuit claims that Baxter's Novum LVP product suffered from systemic defects causing malfunctions such as underinfusion, overinfusion, and non-delivery of fluids, posing risks of serious injury or death to patients [1]. - Baxter was allegedly aware of multiple device malfunctions, injuries, and deaths related to these defects but failed to adequately address the issues through customer alerts [1]. - The company’s statements regarding the safety, efficacy, product rollout, customer feedback, and sales prospects of the Novum LVPs are claimed to be materially false and misleading [1]. Group 2: Class Action Details - The class period for the lawsuit is defined as February 23, 2022, to July 30, 2025, and shareholders are encouraged to register for participation [2]. - The deadline for shareholders to seek lead plaintiff status is December 15, 2025, with no cost or obligation to participate in the case [2]. Group 3: Law Firm's Role - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and fraud [3]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [3].
SS Innovations Announces Successful Completion of First Telesurgery Performed with the Company's SSi Mantra Tele Surgeon Console
Prism Media Wire· 2025-11-06 13:32
Core Insights - SS Innovations has successfully completed the first telesurgery using its SSi Mantra Tele Surgeon Console (TSC), marking a historic milestone in robotic telesurgery [1][4][5] Group 1: Product Overview - The SSi Mantra Tele Surgeon Console is a compact, self-contained, chair-based system designed for telesurgery, allowing operations from various locations, including physician offices [2][4] - The TSC features 3D visualization, magnetic sensor controls, and a smaller footprint compared to traditional operating room setups, enhancing flexibility for surgical experts [7][9] Group 2: Surgical Achievement - Dr. Sudhir Srivastava performed a robotic-assisted coronary artery bypass surgery remotely from New Delhi on a patient located 185 miles away in Jaipur, demonstrating the TSC's capability to extend surgical expertise globally [3][5] Group 3: Company Vision and Future Plans - SS Innovations aims to make robotic surgery affordable and accessible to a broader global population, with plans to expand its presence and technological offerings [8] - The company has refined the TSC since its initial showcase at the Society of Robotic Surgery Meeting in June 2024, indicating ongoing innovation and development [5]
Enovis(ENOV) - 2025 Q3 - Earnings Call Presentation
2025-11-06 13:30
Q3 2025 Performance - Enovis reported a net sales increase to $549 million, a +9% growth, with +7% organic growth[17,8] - Reconstructive segment sales reached $258 million, showing +12% year-over-year growth and +9% organic growth[10] - Prevention & Recovery (P&R) segment sales were $291 million, with +6% year-over-year growth and +4% organic growth[15] - Adjusted gross profit increased to $331 million, resulting in a margin of 603%, compared to $298 million and 589% respectively in Q3 2024[17] - Adjusted EBITDA was $95 million, with a margin of 173%, compared to $90 million and 179% respectively in Q3 2024[17] - Adjusted EPS increased to $075, compared to $073 in Q3 2024[17] Full Year 2025 Outlook - Enovis anticipates full year reported revenue between $224 billion and $227 billion[23] - The company projects adjusted EBITDA between $395 million and $405 million[23] - Enovis estimates adjusted EPS to be between $310 and $325[23] Strategic Actions - Enovis divested its Footcare business, which represented 48% of Prevention and Recovery and 24% of Enovis revenues, impacting Q4 2025 revenue guidance by approximately $15 million[20] - The total transaction value for the Footcare divestiture is up to $60 million, including an upfront cash payment of $45 million and milestone payments up to $15 million[22]
Vivos Inc. Issues Shareholder Update Letter
Globenewswire· 2025-11-06 13:30
Core Insights - Vivos Inc. is focused on obtaining FDA Investigational Device Exemption (IDE) approval to start human clinical studies at Mayo Clinic, having engaged with over 40 FDA reviewers to address their inquiries [1][3] - The company is preparing a second Pre-Submission to the FDA, targeting high-impact areas identified in previous feedback, which will help streamline the IDE submission process [4][5] - Vivos has established Vivos Scientific India LLP (VISL) to facilitate regulatory approvals and manufacturing in India, aiming to tap into the $2 billion human oncology and $100 million veterinary therapy markets [6][7][8] Regulatory Strategy - The company has hired regulatory expert John Smith to guide its IDE approval process, leveraging his extensive experience with brachytherapy devices [3][5] - A proactive approach is being taken with the second Pre-Submission to address recurring FDA feedback on radiation dosimetry and clinical protocol design [4][5] International Expansion - Vivos is expanding its presence in India with plans for clinical trials and a manufacturing center, which will support both human and veterinary applications of RadioGel [7][8] - The company is also exploring international markets with unmet needs in oncology and veterinary care, aiming to establish a global platform for RadioGel [9][10] Veterinary Market Growth - The IsoPet division has seen an 800% year-over-year increase in administered therapies, indicating strong demand and adoption in the veterinary sector [11] - A strategic partnership with Exubrion Therapeutics aims to promote IsoPet in the equine oncology segment, which presents significant growth opportunities [13] Manufacturing and Technology - Vivos plans to transition from fully outsourced manufacturing to establishing its own production centers, with operations expected to begin in the second quarter of 2026 [14] - The company maintains a comprehensive intellectual property portfolio, including patents and developmental data related to its hydrogel technologies [15]
SS Innovations Announces Successful Completion of First Telesurgery Performed with the Company’s SSi Mantra Tele Surgeon Console
Globenewswire· 2025-11-06 13:30
Core Insights - SS Innovations International, Inc. has successfully completed its first telesurgery using the SSi Mantra Tele Surgeon Console (TSC), demonstrating the console's capability to facilitate surgeries from various locations, including physician offices [1][2][3] Company Overview - SS Innovations is focused on developing innovative surgical robotic technologies aimed at making robotic surgery affordable and accessible globally [4] - The company is headquartered in India and plans to expand its global presence with user-friendly and cost-effective surgical robotic solutions [4] Product Details - The SSi Mantra Tele Surgeon Console is a compact, self-contained chair-based system that allows for telesurgeries without the need for a full operating room [1][3] - The TSC features inbuilt electronics, lightweight glasses, a magnified 3D view, and magnetic sensor-based controls, making it suitable for remote surgical procedures [3] - The SSi Mantra surgical robotic system includes modular robotic arms, a 3D 4K monitor, and supports over 40 types of robotic endo-surgical instruments for various specialties, including cardiac surgery [5]
OSR Holdings Announces Woori IO's Noninvasive Glucose Monitor Demonstrates High Accuracy and Precision in Company-Sponsored Pilot Study
Prnewswire· 2025-11-06 13:30
Accessibility StatementSkip Navigation BELLEVUE, Wash., Nov. 6, 2025 /PRNewswire/ -- OSR Holdings, Inc. (NASDAQ: OSRH) today announced the key findings from a company-sponsored pilot study conducted by Woori IO, an OSR Company, in collaboration with Korea University Guro Hospital. The study, which took place from May 9 to September 12, 2023, evaluated the performance of the Glucheck blood glucose measurement system and validated its accuracy, stability, and usability across a representative participant grou ...
Haemonetics(HAE) - 2026 Q2 - Earnings Call Presentation
2025-11-06 13:00
Second Quarter Fiscal 2026 Results November 6, 2025 © 2025 Haemonetics Corporation Q2 Fiscal 2026 Conference Call Detail Conference call will take place at 8:00 a.m. ET on November 6, 2025, and can be accessed via live webcast: Link or teleconference: Link The financial release, accompanying slides, and a replay of the conference call (beginning at 11:00 AM ET) are available online at www.haemonetics.com. Conference call speakers: Chris Simon President & CEO James D'Arecca EVP, Chief Financial Officer Olga ...
Dentsply Sirona Reports Third Quarter 2025 Results
Globenewswire· 2025-11-06 13:00
Core Insights - Dentsply Sirona reported a net sales decrease of 5.0% to $904 million in Q3 2025, with a net loss of $427 million, an improvement from a loss of $494 million in Q3 2024 [2][3][7] - The company introduced a Return-to-Growth action plan aimed at improving performance and achieving sustained, profitable growth over the next 24 months [3][4] Financial Performance - Q3 2025 net sales of $904 million decreased by 5.0% year-over-year, with a constant currency decrease of 8.0% [2][9] - Adjusted earnings per diluted share were $0.37, down from $0.50 in Q3 2024, while adjusted EBITDA margin improved to 18.4% from 17.9% [2][11][45] - The company recorded a non-cash goodwill impairment charge of $263 million in Q3 2025, compared to $504 million in Q3 2024 [15][41] Return-to-Growth Action Plan - The action plan focuses on four key pillars: enhancing customer experience, reigniting U.S. business growth, empowering employees, and evolving operations for innovation [4][10] - Leadership changes have been made to support the action plan, including the appointment of a new Chief Commercial Officer and a Chief Transformation Officer [5][10] Revised Outlook - Dentsply Sirona revised its 2025 outlook, projecting net sales between $3.6 billion and $3.7 billion, with adjusted EPS expected to be approximately $1.60 [5][6] - The company anticipates a year-over-year sales decline of 5% to 4% in constant currency for 2025 [5] Segment and Geographic Performance - In Q3 2025, the Orthodontic and Implant Solutions segment saw a significant sales decline of 15.0%, while Wellspect Healthcare experienced a growth of 15.6% [12][13] - Geographic performance showed a 22.2% decline in the U.S., contrasted with a 9.9% increase in Europe [13][39] Cash Flow and Liquidity - Operating cash flow for Q3 2025 was $79 million, down from $141 million in Q3 2024, primarily due to unfavorable working capital changes [14] - The company had $363 million in cash and cash equivalents as of September 30, 2025 [14][21]
Insulet (PODD) - 2025 Q3 - Earnings Call Presentation
2025-11-06 13:00
Company Overview - Insulet's 2024 revenue reached $2.1 billion[21] - The company has over 500,000 active Podders globally[21] - Approximately 365,000 users are utilizing Omnipod 5[21] Financial Performance and Growth - The company is growing revenue beyond $2.5 billion[25] - The company anticipates approximately 24% compound annual growth rate (CAGR)[25] - The company is experiencing greater than 660 basis points (bps) expansion in leading gross margin[25] - The company is experiencing approximately 1,010 bps expansion in adjusted operating margin[25] Omnipod 5 Impact and Market - Omnipod 5 demonstrated a 20%-23% increase in time in range for adults with Type 1 and Type 2 diabetes, respectively[28] - The company estimates a total addressable market of approximately 14 million patients[41] - U S Type 1 Diabetes market penetration is approximately 40%[40]