New York, New York--(Newsfile Corp. - December 15, 2025) - Leading securities law firm Bleichmar Fonti & Auld LLP announces that a class action lawsuit has been filed against Integer Holdings Corporation (NYSE: ITGR) and certain of the Company's senior executives for securities fraud after a significant stock drop resulting from the potential violations of the federal securities laws. If you invested in Integer, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases/i ...

New York, New York--(Newsfile Corp. - December 15, 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 after a significant stock drop resulting from the potential violations of the federal securities laws. If you invested in Inspire, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases/ ...

Summary of Trisalus Life Sciences Conference Call Company Overview - **Company**: Trisalus Life Sciences (NasdaqGM: TLSI) - **Focus**: Improving outcomes for patients with solid tumors in the liver, pancreas, and other areas through innovative delivery technologies [2][3] Core Technology and Market Opportunity - **Technology**: A catheter-based system that modulates pressure and flow to enhance drug delivery directly into tumors, minimizing off-target effects [3][4] - **Market Size**: The company operates in a market opportunity of approximately $500 million, with less than 10% market share currently [3][4] - **Growth Potential**: Rapid growth anticipated due to the versatility of the technology for various embolization applications [4] Innovations in Treatment - **Thyroid Artery Embolization**: A new approach developed by Dr. Juan Camacho, aimed at treating multinodular goiter as a minimally invasive alternative to surgery [10][12] - **Patient Outcomes**: The technology has shown a 50% reduction in post-procedure readmissions due to fewer complications [8][9] Multinodular Goiter Insights - **Prevalence**: Approximately 12% of the adult population worldwide has multinodular goiter, with a significant number undergoing thyroidectomies annually [17][18] - **Surgical Risks**: Many surgeries are performed by general surgeons, leading to disparities in outcomes compared to specialized surgeons [18][19] - **Symptoms and Complications**: Patients often experience significant morbidity, including hyperthyroidism and compressive symptoms [21][23] Treatment Paradigms - **Minimally Invasive Options**: Options include radioactive iodine, percutaneous ethanol injection, ablation, and thyroid artery embolization [25][31] - **Volume Considerations**: Larger nodules (>20 mL) are more effectively treated with thyroid artery embolization due to high recurrence rates with other methods [27][28] Clinical Evidence and Results - **Efficacy of Embolization**: Studies indicate that thyroid artery embolization can reduce thyroid volume by approximately 50% and improve hormone levels without causing hypothyroidism [36][37] - **Quality of Life Improvements**: Significant improvements in quality of life reported post-procedure, with a high euthyroid conversion rate in patients with hyperthyroidism [38][39] Future Directions - **Research and Guidelines**: Ongoing efforts to build robust clinical data and establish guidelines for patient selection and treatment protocols [54][56] - **Awareness and Training**: Emphasis on increasing awareness of the procedure among patients and healthcare providers, and ensuring proper training for practitioners [64][65] Conclusion - **Emerging Treatment**: Pressure-enabled thyroid artery embolization presents a promising alternative for patients with large goiters, particularly when surgery poses high risks [52][53] - **Multidisciplinary Approach**: Collaboration among various specialties is crucial for optimizing patient care and integrating this technology into standard practice [64][65]

Core Viewpoint - Rosen Law Firm is reminding investors who purchased Baxter International Inc. common stock between February 23, 2022, and July 30, 2025, of the December 15, 2025, lead plaintiff deadline for a class action lawsuit [1] Group 1: Class Action Details - Investors who bought Baxter common stock during the specified Class Period may be eligible for compensation without any out-of-pocket fees through a contingency fee arrangement [2] - To participate in the class action, investors can visit the provided link or contact the law firm for more information [3][6] - A lead plaintiff must file a motion with the Court by December 15, 2025, to represent other class members in the litigation [3] Group 2: Law Firm Credentials - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions [4] - The firm has achieved significant settlements, including the largest securities class action settlement against a Chinese company at the time, and has consistently ranked highly in securities class action settlements [4] - In 2019, the firm secured over $438 million for investors, showcasing its capability in recovering funds for clients [4] Group 3: Case Allegations - The lawsuit alleges that Baxter misled investors by failing to disclose systemic defects in the Novum IQ Large Volume Pump, which led to serious malfunctions and risks to patient safety [5] - Baxter was reportedly aware of multiple device malfunctions and injuries but did not take adequate remedial measures, leading to a heightened risk of product recalls and halting new sales [5] - The firm claims that Baxter's statements regarding the safety and efficacy of the Novum LVPs were materially false and misleading, resulting in investor damages when the truth was revealed [5]

Investors with a lot of money to spend have taken a bullish stance on Intuitive Surgical (NASDAQ:ISRG).And retail traders should know.We noticed this today when the trades showed up on publicly available options history that we track here at Benzinga.Whether these are institutions or just wealthy individuals, we don't know. But when something this big happens with ISRG, it often means somebody knows something is about to happen.So how do we know what these investors just did? Today, Benzinga's options scann ...

Core Insights - Olympus Corporation has committed $150 million to establish OIV Fund II, targeting investments in promising medtech startups within the gastrointestinal, urology, and respiratory sectors [1] - The fund is described as 'stage-agnostic', focusing on early to growth-stage companies globally that offer therapeutic solutions for specific medical specialties [2] - OIV Fund I, the inaugural fund, had a capital allocation of $50 million and invested in nine medtech startups, including On Target Laboratories and Universal Diagnostics [3] Investment Strategy - OIV Fund II aims to create a pipeline of M&A opportunities, partnerships, and valuable market insights [1] - The fund will continue to support existing portfolio companies from OIV Fund I, which was launched in 2021 [2] - Olympus's chief strategy officer emphasized the commitment to investing in startup teams developing unique solutions in endoscopy-enabled care [4] Management and Partnerships - Cerity Partners Ventures will continue to manage OIV's second fund, having partnered with Olympus since the launch of the first fund [4] - The collaboration aims to leverage technical strengths, industry relationships, and expertise to support leading entrepreneurs [5] Market Positioning - Olympus is focusing on carving out a position in the market with its investments in GI startups, including the establishment of Swan EndoSurgical Robotics, which aims to develop an endoluminal surgical robotics platform [5][6] - Swan's goal is to enhance minimally invasive treatment options for GI tract lesions or tumors by addressing ergonomic limitations of manual endoscopy [6]

Summary of CytoSorbents Fireside Chat - December 15, 2025 Company Overview - **Company**: CytoSorbents (NasdaqCM:CTSO) - **Industry**: Biotechnology, specifically medical devices focused on blood purification - **Key Products**: - **CytoSorb**: Removes cytokines and toxic substances from blood - **DrugSorb-ATR**: Investigational product aimed at removing blood thinners Core Points and Arguments - **Product Mechanism**: CytoSorb utilizes a highly porous polymer bead technology to extract toxic materials from blood without the need for affinity agents, making it compatible with existing hospital blood pumps [6][7] - **Market Presence**: CytoSorb is EU-approved and sold in over 70 countries, with more than 300,000 human treatments conducted to date, generating approximately $37 million in trailing 12-month revenue [9][10] - **Gross Margins**: The product has a gross margin of about 71%, with potential for higher margins as the U.S. market is pursued [10] - **Regulatory Strategy**: The company is focusing on the U.S. market for DrugSorb, which has received two FDA breakthrough device designations due to the significant unmet medical need for managing perioperative bleeding in patients on blood thinners [11][22] - **Clinical Trials**: The START trial, a randomized controlled trial involving 140 patients, aimed to demonstrate the efficacy of DrugSorb in reducing perioperative bleeding but missed its primary endpoint due to trial design issues [41][51] - **Regulatory Discussions**: The FDA has acknowledged the safety of the device and is open to a new De Novo submission that includes real-world evidence to support efficacy [58][62] Financial Management - **Cash Flow Strategy**: The company aims to achieve cash flow break-even by early 2026, with a refinancing agreement providing additional cash and extending the interest-only period on debt [70][71] - **Market Opportunity**: The total addressable market for DrugSorb is estimated at $300 million, potentially growing to over $1 billion as additional blood thinners and surgeries are included [26] Pipeline and Future Prospects - **Product Pipeline**: In addition to CytoSorb and DrugSorb, the company has products like VetRescue for animals and HemoDefend-BGA for universal plasma, indicating a broadening of its product offerings [12][13] - **Launch Strategy**: Upon FDA approval, the company plans a targeted launch in the U.S., focusing on clinical sites that have shown interest in the product [73][74] - **Regulatory Outlook**: The company expects to submit a new De Novo application in early 2026, with the potential for approval within the same year [64][65] Additional Insights - **Market Challenges**: The company faces challenges typical of microcap biotech firms, including the need for substantial resources for clinical trials and regulatory approvals [51][52] - **Surgeon Interest**: There is significant interest from surgeons in the U.S. for a solution to manage bleeding risks associated with blood thinners during surgeries, which could facilitate a successful product launch [74] This summary encapsulates the key points discussed during the fireside chat, highlighting the company's current status, regulatory strategies, financial management, and future prospects in the biotechnology industry.

Core Insights - Abbott Laboratories (ABT) has launched Lingo, its first over-the-counter biowearable continuous glucose monitor (CGM), for Android devices, significantly expanding its user base [2][8] - Lingo targets adults not on insulin, helping them understand how diet, exercise, and stress affect their blood sugar levels, thereby promoting healthier lifestyle choices [3][4] - The introduction of Android support aligns with Abbott's strategy to position CGMs as mainstream wellness tools for diabetes and prediabetes management [3][6] Company Developments - The rollout of Lingo on Android devices enhances its scalability, allowing Abbott to reach a larger audience and remove previous limitations tied to device compatibility [9] - Lingo features user-friendly tools like Lingo Count, which helps users track glucose spikes and improve metabolic health over time [9] - Abbott has reported that users who decrease their Lingo Count can halve the time spent above healthy glucose levels and reduce average glucose by 10% within three months [9] Market Position and Trends - Abbott's market capitalization stands at $218.16 billion, reflecting its strong position in the healthcare sector [7] - The CGM device market is projected to reach $5.74 billion by 2025, with a compound annual growth rate (CAGR) of 7.1% through 2034, driven by the rising prevalence of diabetes and demand for preventive measures [12] - Abbott's strategic focus on metabolic awareness positions it well to capitalize on the growing consumer interest in preventing prediabetes and related health conditions [11]

Key Takeaways Data at ASHP 2025 shows BAX EMR integration reduced safety alerts and improved IV infusion setup.BAX data shows hard limit alerts fell 50.3% and soft limits dropped 30.4% across UTMB hospitals.BAX auto-programming cut median setup time from 10 to 4 seconds and sped alert resolution.Baxter International Inc. (BAX) recently shared real-world data at the American Society of Health-System Pharmacists (“ASHP”) 2025 Midyear Clinical Meeting, highlighting the benefits of integrating smart infusion pu ...

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