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SHAREHOLDER ACTION REMINDER: Faruqi & Faruqi, LLP Announces that Inspire Medical Systems Investors Have Opportunity to Lead Class Action Lawsuit
Prnewswire· 2025-12-23 15:39
Core Insights - Inspire Medical Systems faced significant setbacks in the launch of its new Inspire V device, revealing that the rollout was delayed due to incomplete training and onboarding at treatment centers [3] - The company also encountered billing and reimbursement challenges, as necessary software updates for claims processing were not implemented until July 1, affecting the ability of implanting centers to bill for procedures [3][4] - Inspire reported weak demand and excess inventory for the Inspire V, leading to a drastic cut in its 2025 earnings guidance by over 80% [4] Financial Impact - Following the announcement of these issues, Inspire's stock price plummeted by more than 32%, dropping from $129.95 per share on August 4, 2025, to $87.91 per share on August 5, 2025, resulting in a loss of approximately $1.2 billion in market capitalization [4] Legal Proceedings - A class action lawsuit has been initiated against Inspire Medical Systems, alleging that the company and its executives made false and misleading statements regarding the market demand for Inspire V and the steps taken for its successful launch [2][5] - The lead plaintiff in the lawsuit is the investor with the largest financial interest in the relief sought, who will oversee the litigation on behalf of the class [5]
Coty downgraded, Spruce Biosciences initiated: Wall Street's top analyst calls
Yahoo Finance· 2025-12-23 14:33
Upgrades - CFRA upgraded Pool Corp. (POOL) to Buy from Hold with a price target of $304 [2] - Piper Sandler upgraded SEI Investments (SEIC) to Overweight from Neutral with a price target of $102, increased from $93, citing SEI as a "clear beneficiary" of the expanding alternatives landscape [2] - TD Cowen upgraded Ametek (AME) to Buy from Hold with a price target of $230, up from $180, noting that backlog remains near highs and is expected to grow [3] Downgrades - TD Cowen downgraded Janus Henderson (JHG) to Hold from Buy with a price target of $49 after the company agreed to be acquired for $7.4 billion or $49.00 per share [4] - Piper Sandler downgraded Clearwater Analytics (CWAN) to Neutral from Overweight with a price target of $24.55, down from $27, following its agreement to be acquired for $24.55 per share in cash [4] - BMO Capital downgraded Brown & Brown (BRO) to Market Perform from Outperform with a price target of $88, down from $90, due to lower consensus organic growth estimates for 2026 [5] - Evercore ISI downgraded Coty (COTY) to In Line from Outperform with a price target of $7, citing a lack of visibility on timing and catalysts for potential value unlock [6] Initiations - Oppenheimer initiated coverage of Spruce Biosciences (SPRB) with an Outperform rating and a price target of $283, supported by FDA confirmation of compelling clinical biomarker data [7] - LifeSci Capital initiated coverage of Sionna Therapeutics (SION) with an Outperform rating and a price target of $60, highlighting multiple quality shots on goal with its therapies [7] - Oppenheimer initiated coverage of Aardvark Therapeutics (AARD) with an Outperform rating and a price target of $35, noting the company's differentiated obesity franchise [7] - JonesResearch initiated coverage of Septerna (SEPN) with a Buy rating and a price target of $43, forecasting $2.5 billion in unadjusted U.S. peak sales in 2035 [7] - Loop Capital initiated coverage of Malibu Boats (MBUU) with a Buy rating and a price target of $34, indicating the marine industry is in the late stages of inventory rationalization [7]
Merit Medical to Participate at the J.P. Morgan Healthcare Conference
Globenewswire· 2025-12-23 14:00
Core Insights - Merit Medical Systems, Inc. will participate in the 44th Annual J.P. Morgan Healthcare Conference from January 12-15, 2026, in San Francisco, California [1] - The company will provide an overview and update on January 13th at 4:30 pm Pacific Time / 7:30 pm Eastern Time [2] - Presentation materials will be available on the investor relations website, along with a live audio webcast and a replay for approximately 90 days [3] Company Overview - Merit Medical, founded in 1987, develops, manufactures, and distributes proprietary medical devices for interventional, diagnostic, and therapeutic procedures, focusing on cardiology, radiology, oncology, critical care, and endoscopy [4] - The company has a global presence with a sales force and clinical support team of over 800 individuals and employs approximately 7,400 people worldwide [4]
Class Action Filed Against Inspire Medical Systems, Inc. (INSP) Seeking Recovery for Investors - Contact Levi & Korsinsky
Prnewswire· 2025-12-23 14:00
CASE DETAILS: According to the filed complaint, defendants made false statements and/or concealed that: In truth, the launch of the Company's new product, Inspire V, was a disaster because demand for Inspire V was poor, as providers had significant amounts of surplus inventory and were reluctant to transition to a new treatment. Moreover—and contrary to defendants' statements assuring investors that Inspire had taken all necessary steps to ensure a successful launch and, later, that the launch was in fact p ...
February 9, 2026 Deadline: Contact Levi & Korsinsky to Join Class Action Suit Against ITGR
Prnewswire· 2025-12-23 14:00
Core Viewpoint - A class action securities lawsuit has been filed against Integer Holdings Corporation, alleging securities fraud that negatively impacted investors between July 25, 2024, and October 22, 2025 [1][2]. Group 1: Allegations of Fraud - The lawsuit claims that Integer Holdings materially overstated its competitive position in the electrophysiology manufacturing market [2]. - It is alleged that despite claims of strong customer demand visibility, the company faced a sustained decline in sales for two of its electrophysiology devices [2]. - The company mischaracterized its electrophysiology devices as long-term growth drivers for its cardio & vascular segment, leading to misleading positive statements about its business and prospects [2]. Group 2: Legal Process and Participation - Investors who suffered losses during the specified timeframe have until February 9, 2026, to request appointment as lead plaintiff, although participation in any recovery does not require this role [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees, with no obligation to participate [3]. Group 3: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and is recognized as one of the top securities litigation firms in the United States [4].
Autonomix Medical, Inc. (NASDAQ: AMIX) Highlights Expanding IP Portfolio and Multi-Indication Platform Strategy in Virtual Investor CEO Connect Segment
Globenewswire· 2025-12-23 13:45
Core Insights - Autonomix Medical, Inc. is focused on advancing precision nerve-targeted treatments and has recently participated in a Virtual Investor CEO Connect segment [2][3] - The CEO, Brad Hauser, highlighted two main priorities: strengthening intellectual property protection and exploring applications beyond pancreatic cancer, including cardiovascular, pulmonary, and interventional pain management [3] Company Overview - Autonomix is a medical device company that aims to revolutionize the diagnosis and treatment of diseases involving the nervous system through innovative technologies [4] - The company's platform technology features a catheter-based microchip sensing array designed to detect and differentiate neural signals with greater sensitivity than existing technologies [4] - Initial development efforts are focused on treating pain associated with pancreatic cancer, a condition currently lacking reliable treatment options [5] Technology and Applications - The technology has the potential to address a wide range of indications, including cardiology, hypertension, and chronic pain management [5] - The platform is still investigational and has not yet received marketing clearance in the United States [5]
ITGR INVESTORS: Integer Holdings Corporation Stock Drops 32% after Weak Demand Announced – Contact BFA Law by February 9 Securities Class Action Deadline
Globenewswire· 2025-12-23 13:36
Core Viewpoint - A class action lawsuit has been filed against Integer Holdings Corporation and its senior executives for securities fraud following a significant drop in stock price due to alleged violations of federal securities laws [1][3]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the Southern District of New York, titled West Palm Beach Firefighters' Pension Fund v. Integer Holdings Corporation, et al., No. 1:25-cv-10251 [3]. - Investors have until February 9, 2026, to request to be appointed to lead the case [3]. Group 2: Company Background - Integer Holdings Corporation designs and manufactures cardiac rhythm management and cardiovascular products, including electrophysiology devices that diagnose and treat arrhythmias [4]. - The company had previously claimed strong sales growth and market position for its EP devices, which is now being challenged [4]. Group 3: Financial Performance - Integer lowered its 2025 sales guidance to a range of $1.840 billion to $1.854 billion, down from $1.850 billion to $1.876 billion, which is below analysts' expectations [6]. - The company anticipates poor net sales growth of -2% to 2% and organic sales growth of 0% to 4% for 2026 [6]. - Following the announcement, Integer's stock price fell by $35.22 per share, a decline of over 32%, from $109.11 on October 22, 2025, to $73.89 on October 23, 2025 [6][5].
INSP INVESTORS: Inspire Medical Systems, Inc. Stock Drops 32% after Inspire V Delays Announced – Contact BFA Law by January 5 Securities Class Action Deadline
Globenewswire· 2025-12-23 13:36
Core Viewpoint - A class action lawsuit has been filed against Inspire Medical Systems, Inc. and certain senior executives for securities fraud following a significant stock drop due to potential violations of federal securities laws [1]. Company Overview - Inspire Medical Systems develops and manufactures an implantable medical device for the treatment of sleep apnea, with the latest version being Inspire V, which received FDA approval on August 2, 2024 [4]. Lawsuit Details - The lawsuit asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors in Inspire stock, with the case pending in the U.S. District Court for the District of Minnesota [3]. - Investors have until January 5, 2026, to request to be appointed to lead the case [3]. Stock Performance and Issues - Inspire assured investors that it had taken necessary steps for the launch of Inspire V, but failed to prepare clinicians and payors, leading to significant delays and weak demand [5][6]. - On August 4, 2025, Inspire disclosed an "elongated timeframe" for the Inspire V launch and reduced its 2025 earnings per share guidance by over 80%, attributing this to undisclosed factors including incomplete training at implanting centers and poor demand due to excess inventory of older devices [7]. - Following this announcement, Inspire's stock price dropped by $42.04 per share, or more than 32%, from $129.95 on August 4, 2025, to $87.91 on August 5, 2025 [8].
Inspira Technologies Reaffirms $49.5 Million in Binding Purchase Orders and Aligns Execution with 2026 Regulatory and Deployment Milestones - Inspira Technologies Oxy (NASDAQ:IINN)
Benzinga· 2025-12-23 13:30
Core Viewpoint - Inspira Technologies has reaffirmed binding purchase orders totaling $49.5 million, with payment activities set to commence in the 2026 fiscal cycle, aligning with regulatory and deployment milestones [1][2]. Group 1: Purchase Orders and Execution - The company confirmed that the purchase orders remain valid and the distributor plans to advance these orders during 2026 [2]. - The payment framework for the binding purchase orders is structured to align with the company's revenue recognition framework, starting in the 2026 fiscal cycle [2][4]. - The updated schedule reflects necessary regulatory sequencing and technical implementation requirements, which are standard for large-scale healthcare deployments [3]. Group 2: Coordination and Risk Management - Inspira is actively coordinating with distribution partners, regulators, and funding organizations to advance execution milestones and finalize delivery schedules [4]. - This alignment aims to reduce execution risk, enhance operational visibility, and support a phased rollout across target markets [4]. - The company expects to provide updates regarding upcoming execution and deployment milestones [4]. Group 3: Company Overview - Inspira Technologies specializes in advanced respiratory support and real-time blood monitoring solutions, with FDA-cleared products including the INSPIRA™ ART100 system [5]. - The company is developing the INSPIRA ART500, a next-generation system designed for oxygenation while patients remain awake [5]. - Inspira is also advancing the HYLA™ blood sensor platform, which offers continuous, non-invasive monitoring, positioning the company as an attractive player in the MedTech landscape [5].
Inspira Technologies Reaffirms $49.5 Million in Binding Purchase Orders and Aligns Execution with 2026 Regulatory and Deployment Milestones
Globenewswire· 2025-12-23 13:30
Core Insights - Inspira Technologies has reaffirmed binding purchase orders totaling $49.5 million, with payment activities expected to commence in the 2026 fiscal cycle, aligning with regulatory and deployment milestones [1][2]. Group 1: Purchase Orders and Revenue Recognition - The company confirmed that the purchase orders remain valid and that the distributor plans to advance these orders toward execution in 2026 [2]. - The payment framework for the binding purchase orders is structured to align with the company's revenue recognition framework, which is set to begin in the 2026 fiscal cycle [2][4]. Group 2: Execution and Coordination - The updated schedule for execution reflects necessary regulatory sequencing, technical implementation requirements, and coordination with institutional capital allocations for deliveries [3]. - Inspira is actively coordinating with distribution partners, regulators, and funding organizations to advance execution milestones and finalize delivery schedules, aiming to reduce execution risk and enhance operational visibility [4]. Group 3: Company Overview - Inspira Technologies is a commercial-stage medical device company specializing in advanced respiratory support and real-time blood monitoring solutions, with FDA-cleared products including the INSPIRA™ ART100 system [5]. - The company is developing the INSPIRA ART500 system for oxygenation while patients remain awake and is advancing the HYLA™ blood sensor platform for continuous, non-invasive monitoring [5].