Core Insights - The CAPTAIN trial is the first randomized controlled trial comparing MRI-guided transurethral ultrasound ablation (TULSA) to robotic radical prostatectomy (RP), successfully recruiting to target [1][4] - Dr. Pejman Ghanouni received the Cum Laude award for his presentation on the CAPTAIN trial at the RSNA Annual Meeting, highlighting the significance of the study [1][2] - The TULSA Procedure offers a quicker recovery time compared to robotic RP, with patients feeling better the day after the procedure, while robotic RP patients take nearly three weeks [3] Company Overview - Profound Medical Corp. specializes in AI-powered, MRI-guided, incision-free therapies for tissue ablation, with a focus on the TULSA Procedure [1][5] - The TULSA-PRO system is the only AI-powered, MRI-guided robotic system for prostate therapy, allowing real-time monitoring and personalized treatment [3][6] - Profound is also commercializing Sonalleve, a therapeutic platform for various conditions, including uterine fibroids and bone metastases [7] CAPTAIN Trial Details - The CAPTAIN trial is a multi-center study comparing the safety and efficacy of TULSA with RP in men with organ-confined, intermediate-risk prostate cancer [4] - As of January 2025, 210 patients were randomized, with 69% receiving TULSA and 31% receiving RP, ensuring balanced baseline characteristics [4] - The trial commenced in 2022 across 20 sites in the U.S., two in Canada, and one in Europe, with the last patient treatment occurring in August 2025 [4]

CooperCompanies | | | | FY26 Guidance | Q1 2026 Guidance | | --- | --- | --- | --- | --- | | | Total | $4,299 - | $4,338 | $1,019 - $1,030 | | | | (4.5% - | 5.5% organic growth) | (3% - 4% organic growth) | | e | | | | | | u n e | CooperVision | $2,900 - | $2,925 | $693 - $700 | | v | | (4.5% - | 5.5% organic growth) | (3.5% - 4.5% organic growth) | | e R | | | | | | | CooperSurgical | $1,399 - | $1,413 | $327 - $330 | | | | (4% - | 5% organic growth) | (2% - 3% organic growth) | | P | | | | | | A A | EPS | ...

Core Viewpoint - Cooper Companies is initiating a formal strategic review to identify opportunities for enhancing long-term shareholder value, resulting in an 11.7% increase in shares during extended trading [1] Group 1 - The strategic review aims to enhance long-term shareholder value [1] - The announcement led to a significant increase in the company's share price by 11.7% in after-hours trading [1]

Core Points - CooperCompanies has appointed Colleen Jay as the new Chair of the Board, effective January 2, 2026, succeeding Robert Weiss, who will remain on the Board for reelection [1][2] - The company is undergoing a formal strategic review to identify opportunities for enhancing long-term shareholder value [1][4] Leadership Changes - Colleen Jay has been on the Board since 2016 and has a strong background in global operational leadership, having retired from Procter & Gamble in 2017 after 32 years [2] - Robert Weiss has been a significant figure in CooperCompanies' success for nearly five decades, serving in various leadership roles including CEO from 2007 to 2018 [3] Strategic Review - The strategic review aims to improve performance in core markets, expand market share, enhance operational efficiency, and generate strong returns through disciplined capital deployment [4] - The company plans to focus on share repurchases under a $2 billion share repurchase program during this review period [4] Company Overview - CooperCompanies operates in the medical device sector with two main business units: CooperVision, a leader in the contact lens industry, and CooperSurgical, focused on fertility and women's healthcare [5] - The company has a workforce of over 15,000 and sells products in more than 130 countries, positively impacting over 50 million lives annually [5]

Core Insights - CooperCompanies reported strong financial results for fiscal year 2025, exceeding consensus expectations for revenue, earnings, and free cash flow, with a focus on long-term shareholder value through growth and profitability initiatives [2][5]. Financial Performance - Fourth quarter revenue reached $1,065.2 million, a 5% increase year-over-year, with organic growth of 3% [5][6]. - Fiscal year 2025 revenue totaled $4.1 billion, also up 5% from the previous year, with organic growth of 4% [5][13]. - GAAP diluted earnings per share (EPS) for Q4 was $0.43, down 27%, while fiscal year GAAP diluted EPS was $1.87, down 4% [5][27]. - Non-GAAP diluted EPS for Q4 was $1.15, up 11%, and for the fiscal year, it was $4.13, up 12% [5][27]. Segment Performance - CooperVision (CVI) revenue for Q4 was $709.6 million, a 5% increase year-over-year, with organic growth of 3% [6][59]. - CooperSurgical (CSI) revenue for Q4 was $355.6 million, up 4% year-over-year, with organic growth also at 4% [12][59]. Margins and Costs - Gross margin for Q4 was 61%, down from 67% in the previous year, primarily due to reorganization costs [6][13]. - Non-GAAP gross margin was 66%, down 70 basis points from last year [6][13]. - Operating margin for Q4 was 13%, compared to 19% in the previous year, while non-GAAP operating margin improved to 27% [6][13]. Cash Flow and Share Repurchase - Cash provided by operations was $247.8 million, leading to free cash flow of $149.8 million after capital expenditures of $98.0 million [6][13]. - The company repurchased $197.3 million of common stock in Q4 and $290.1 million for the fiscal year, with a total share repurchase authorization of $2 billion [13][14]. Future Guidance - For fiscal year 2026, the company expects total revenue between $4.299 billion and $4.338 billion, with organic growth of 4.5% to 5.5% [20]. - Non-GAAP diluted EPS guidance for fiscal 2026 is projected to be between $4.45 and $4.60 [20].

NEW YORK, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Inspire Medical Systems, Inc. ("Inspire Medical Systems, Inc." or the "Company") (NYSE: INSP) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Inspire Medical Systems, Inc. investors who were adversely affected by alleged securities fraud between August 6, 2024 and August 4, 2025. Follow the link below to get more information and be contacted by a member of our team ...

Core Viewpoint - Securities class action lawsuits have been filed against DexCom, Inc. for alleged misleading statements and undisclosed material changes to its glucose monitoring systems during the specified Class Period [1]. Group 1: Allegations Against DexCom - Defendants allegedly made false and misleading statements regarding unauthorized design changes to the G6 and G7 continuous glucose monitoring systems, which compromised their reliability [2]. - The design changes reportedly posed a material health risk to users who relied on these devices for accurate glucose readings [2]. - DexCom is accused of overstating the enhancements and reliability of the G7 device, while downplaying the severity of issues related to adulterated devices [2]. - The company faces increased regulatory scrutiny and potential legal, reputational, and financial harm due to these allegations [2]. Group 2: Legal Process for Investors - Investors in DexCom have until December 26, 2025, to seek appointment as lead plaintiff representatives in the class action [3]. - A lead plaintiff acts on behalf of all class members and selects counsel to represent the class, with the ability to share in any recovery not affected by the decision to serve as lead plaintiff [3]. Group 3: Firm Background - Kessler Topaz Meltzer & Check, LLP has a reputation for prosecuting class actions and has recovered billions for victims of corporate misconduct [5].

INVESTOR ALERT: The Inspire Medical Systems, Inc. Securities Fraud Class Action is Pending, Investors Urged to Contact BFA Law by January 5 DeadlineDecember 04, 2025 3:46 PM EST | Source: Bleichmar Fonti & AuldNew York, New York--(Newsfile Corp. - December 4, 2025) - Leading securities law firm Bleichmar Fonti & Auld LLP announces that a class action lawsuit has been filed against Inspire Medical Systems, Inc. (NYSE: INSP) and certain of the Company's senior executives for securities fraud aft ...

Ekso Bionics Holdings, Inc. (EKSO) shares fell 12.75 percent, sliding $0.5802 to $3.97 on Thursday, after the company announced it will become the exclusive U.S. sales agent and distributor for MediTouch's BalanceTutor rehabilitation system. The uses a patented 4D perturbation treadmill to simulate real-world balance challenges, supporting patient safety while improving rehabilitation outcomes.Ekso Bionics is trading at $3.97 versus a previous close of $4.5502 on the Nasdaq. The stock opened at $4.25 and h ...

Key Takeaways HIMS will acquire YourBio Health to enhance its user-focused blood sampling capabilities.The buyout adds TAP and HALO tech to HIMS' portfolio, offering bladeless, pain-free blood sampling.The move supports HIMS' broader push into routine diagnostics and personalized healthcare tools.Yesterday, Hims & Hers Health, Inc. (HIMS) entered into a definitive agreement to acquire Boston-based YourBio Health, Inc. The transaction is expected to close in early 2026, subject to customary regulatory approv ...