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Woori IO, an OSR Company, Highlights FDA Clarification on Non-Medical Wearables as a Catalyst for Accelerated Commercial Launch
Prnewswire· 2026-01-22 14:55
Phased Commercial Strategy Aligned with Global Platform Partnerships Woori IO is pursuing a two-phase commercialization strategy designed to balance speed, regulatory discipline, and long-term clinical ambition: The FDA has clarified that consumer wearable products providing non-medical, wellness-oriented health insights—when appropriately labeled and marketed—generally fall outside the scope of medical device pre- market review. Woori IO believes this regulatory clarity enables the Company to meaningfully ...
Abbott Labs Stock Hits 52-Week Low As Outlook Disappoints
Benzinga· 2026-01-22 14:48
Core Insights - Abbott Laboratories reported fourth-quarter 2025 sales of $11.46 billion, slightly below the consensus estimate of $11.80 billion, with a sales increase of 4.4% on a reported basis and 3% on an organic basis [2][10] - The company provided a first-quarter 2026 earnings outlook of $1.12-$1.18 per share, lower than the consensus of $1.20, and projected fiscal 2026 adjusted earnings of $5.55-$5.80 per share compared to Wall Street's expectation of $5.67 [10] Earnings Snapshot - Adjusted earnings for the quarter were reported at $1.50, aligning with Wall Street estimates [2] - Medical Devices segment sales increased by 12.3% on a reported basis and 10.4% on an organic basis, totaling $5.68 billion [3] Segment Performance - Sales growth in Medical Devices was driven by double-digit growth in electrophysiology, heart failure, diabetes care, and rhythm management [4] - Diabetes Care sales of continuous glucose monitors reached $2.0 billion, growing 15% [5] - Global Diagnostics sales decreased by 2.5% to $2.46 billion, with COVID-19 testing-related sales at $89 million, down from $176 million a year ago [6] - Worldwide Nutrition sales fell by 8.9% to $1.94 billion, attributed to lower sales volumes and strategic pricing actions [7] - Established Pharmaceuticals sales increased by 9% to $1.38 billion [7] Strategic Developments - In December 2025, the FDA approved Abbott's Volt PFA System for treating atrial fibrillation [5] - Abbott announced a $21 billion acquisition of Exact Sciences Corp, marking a significant deal in the healthcare sector [8] Guidance - The company anticipates organic sales growth of 6.5% to 7.5% for 2026 [10] Stock Performance - Abbott Laboratories shares fell by 7.37% to $111.63, reaching a new 52-week low [11]
Integer Holdings Corporation (ITGR) Deadline Approaching: Berger Montague Advises Investors of Deadline in Securities Fraud Lawsuit
TMX Newsfile· 2026-01-22 14:19
Core Viewpoint - A class action lawsuit has been filed against Integer Holdings Corporation for allegedly making misleading statements and failing to disclose material adverse facts regarding its business performance during the specified Class Period [1][3]. Group 1: Lawsuit Details - The lawsuit is on behalf of investors who acquired Integer securities from July 25, 2024, to October 22, 2025 [1][2]. - Investors have until February 9, 2026, to seek appointment as lead plaintiff representatives [2]. Group 2: Allegations Against the Company - The complaint alleges that Integer overstated its competitive position and did not adequately disclose sales deterioration in its electrophysiology devices [3]. - The lawsuit claims that the company mischaracterized its growth drivers, leading to a significant decline in stock price following the revelation of these issues [3]. Group 3: Impact of Disclosures - On October 23, 2025, Integer reduced its sales guidance and disclosed an expected sales decline, resulting in a stock price drop of $35.22 per share, which is over 32% in a single trading day [3].
Biostem Technologies (OTCPK:BSEM) M&A announcement Transcript
2026-01-22 14:02
Summary of BioStem Technologies Conference Call Company Overview - **Company**: BioStem Technologies, Incorporated - **Acquisition**: BioTissue Holdings' surgical and wound care business - **Date of Announcement**: January 22, 2026 Key Points Industry and Market Expansion - The acquisition doubles BioStem's addressable market by entering the acute wound care market with leading skin substitute products and a robust commercial infrastructure [3][4] - The transaction is seen as a transformation of scale, capability, and market reach, aligning with long-term goals of diversifying end markets and expanding product portfolio [3][4] Financial Aspects - The acquisition cost includes an upfront cash payment of approximately $15 million, with potential additional payments of up to $10 million upon regulatory clearance and royalty payments of 7% of sales, capped at $15 million [12][54] - The acquired assets generated approximately $29 million in sales in 2025, expected to be growth and EBITDA accretive for BioStem in 2026 [13][45] Product Portfolio and Integration - BioStem's product portfolio will be expanded to include BioTissue's NEOX and Claryx product families, which are recognized in surgical and wound care [6][7] - The integration of BioTissue's products is expected to enhance BioStem's offerings in both chronic and acute wound care, particularly in hospital settings [4][6] Commercial Strategy - Barry Hassett has been appointed as Chief Commercial Officer to lead the next phase of growth, focusing on expanding the commercial footprint through BioTissue's experienced sales force [9][10] - The new sales team includes approximately 20 direct sales representatives and over 30 independent sales agents, aimed at establishing a presence in acute market settings [10][39] Operational Excellence - BioStem's vertically integrated manufacturing facility is expected to deliver industry-leading margins and high-quality performance, with plans to onboard acquired products to its facility after a 12-month transition period [11][12] - The company aims to achieve gross margin expansion as it transitions manufacturing in-house [11][54] Regulatory and Milestones - The BioTissue team submitted a 510(k) application for a flow-based product, with a milestone payment of $10 million contingent on its approval [42][43] - Key performance indicators (KPIs) for the acquisition will include revenue growth, market share expansion, and team growth [33][34] Market Dynamics - Changes in CMS reimbursement policies are expected to favor higher-quality products in hospital settings, allowing for a per-square-centimeter reimbursement structure [5][24] - The acquisition positions BioStem to leverage GPO contracts, enhancing access to major networks and strengthening its presence across various care settings [10][26] Conclusion - The acquisition is viewed as a strategic move to solidify BioStem's leadership in the wound care market, supporting a full continuum of wound healing from acute surgical repair to chronic wounds [14][57]
Abbott(ABT) - 2025 Q4 - Earnings Call Presentation
2026-01-22 14:00
Fourth-quarter and full-year 2025 results | Adjusted diluted EPS | | | | --- | --- | --- | | Fourth quarter | $1.501 | ↑12% | | Full year | $5.152 | % ↑10 | | W orldwide sales | Organic* sales growth for underlying base business** | 5 Full-year 2026 guidance | | $11.5B | ↑3.8%3 | 6.5% to 7.5% | | Fourth quarter | | Organic sales growth | | $44.3B | ↑6.7%4 | $5.55 to $5.80 | | Full year | | Adjusted diluted EPS | Key business units | Fourth-quarter sales Expanding in the fast-growing pulsed field ablation (P ...
ITGR STOCK DROP: Integer Holdings Corporation Hit with Securities Class Action after Stock Plummets 32% -- Contact BFA Law by February 9 if You Lost Money
Globenewswire· 2026-01-22 13:46
Core Viewpoint - A class action lawsuit has been filed against Integer Holdings Corporation and its senior executives for securities fraud following a significant stock drop due to alleged violations of federal securities laws [1]. Company Overview - Integer Holdings Corporation specializes in designing and manufacturing cardiac rhythm management and cardiovascular products, including electrophysiology devices that diagnose and treat arrhythmias [4]. Allegations of Securities Fraud - The lawsuit claims that Integer misrepresented the demand and revenue for its electrophysiology products, which had reportedly fallen sharply, contradicting the company's public statements about sales growth and market position [5][4]. Stock Performance and Guidance - On October 23, 2025, Integer revised its 2025 sales guidance down to between $1.840 billion and $1.854 billion, significantly below analysts' expectations, and projected poor net sales growth of -2% to 2% for 2026 [6]. - The announcement led to a drastic decline in Integer's stock price, dropping $35.22 per share, or over 32%, from $109.11 on October 22, 2025, to $73.89 on October 23, 2025 [6].
Cannabix Marijuana Breath Test Featured on the Cover of AlcoPro’s 2026 Product Catalog
Globenewswire· 2026-01-22 13:45
VANCOUVER, British Columbia, Jan. 22, 2026 (GLOBE NEWSWIRE) -- Cannabix Technologies Inc. (CSE: BLO) (OTCID: BLOZF) (Frankfurt: 8CT) (the “Company” or “Cannabix”) a developer of marijuana and alcohol breath-testing devices, is pleased to announce that its Marijuana Breath Test (“MBT”) will be featured on the cover of the 2026 AlcoPro Inc. product catalogue (see Figure 1). AlcoPro Inc. (“AlcoPro”), based in Knoxville, TN, is a leading U.S. supplier of professional drug and alcohol testing instruments, kits, ...
Cannabix Marijuana Breath Test Featured on the Cover of AlcoPro's 2026 Product Catalog
Globenewswire· 2026-01-22 13:45
VANCOUVER, British Columbia, Jan. 22, 2026 (GLOBE NEWSWIRE) -- Cannabix Technologies Inc. (CSE: BLO) (OTCID: BLOZF) (Frankfurt: 8CT) (the “Company” or “Cannabix”) a developer of marijuana and alcohol breath-testing devices, is pleased to announce that its Marijuana Breath Test (“MBT”) will be featured on the cover of the 2026 AlcoPro Inc. product catalogue (see Figure 1). AlcoPro Inc. (“AlcoPro”), based in Knoxville, TN, is a leading U.S. supplier of professional drug and alcohol testing instruments, kits, ...
What You Need To Know Ahead of Insulet’s Earnings Release
Yahoo Finance· 2026-01-22 13:24
Core Insights - Insulet Corporation specializes in innovative diabetes management solutions, particularly known for its Omnipod Insulin Management System, a tubeless, wearable pump that delivers continuous insulin for up to three days [1][2] Company Overview - Insulet is headquartered in Acton, Massachusetts, and operates globally, leveraging advanced manufacturing for scalable production and research and development [2] - The company has a market capitalization of $20 billion [2] Financial Performance - Insulet is expected to report a profit of $1.48 per share for Q4 fiscal 2025, representing a 28.7% year-over-year growth [4] - For the full fiscal year 2025, analysts anticipate Insulet's diluted EPS to grow by 50.9% to $4.89, followed by a 26.4% increase to $6.18 in fiscal 2026 [4] Stock Performance - Over the past 52 weeks, Insulet's stock has gained 3.2%, while the S&P 500 Index has increased by 13.7% during the same period, indicating underperformance [5] - The stock gained 2.9% intraday on November 6, 2025, following better-than-expected third-quarter results, with revenue increasing by 29.9% year-over-year to $706.30 million [6] - Insulet's total Omnipod revenue rose by 31% to $699.20 million, and its non-GAAP EPS increased by 37.8% to $1.24 [6] Guidance - Based on recent growth, the company raised its fiscal 2025 revenue guidance from a growth range of 24%-27% to 28%-29% [6]
Catheter Precision Receives First Purchase Order for LockeT in Germany
Globenewswire· 2026-01-22 13:00
Company Overview - Catheter Precision, Inc. is a US-based medical device company focused on developing advanced products for the cardiac electrophysiology market [5] - The company aims to improve the treatment of cardiac arrhythmias through innovative technology and collaboration with physicians [5] Product Launch - Catheter Precision has received a purchase order for its LockeT suture retention device from Universitätsklinikum Frankfurt, marking its entry into the German market [1][2] - The LockeT device is designed to enhance workflow efficiency after venous catheter access while being cost-effective [2][4] Market Significance - Germany is highlighted as the largest healthcare market in Europe, with the Electrophysiology Devices Market valued at over $900 million in 2024 [3] - The partnership with a prestigious university hospital in Germany is seen as a pivotal moment for Catheter Precision, establishing a foothold in a market known for innovation and high medical standards [3] Strategic Implications - The implementation of LockeT at Universitätsklinikum Frankfurt will serve as a reference site for future expansions across Germany and Europe [3] - This purchase order validates the clinical value of Catheter Precision's technology and supports its expansion strategy in the region [3]