MINNEAPOLIS, Nov. 19, 2025 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced that the management team will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Wednesday, Dec. 3, 2025. The fireside chat is scheduled at 2:00 p.m. (ET) the same day via webcast. A live audio we ...

Core Insights - The demand for global neuromodulation devices is driven by increasing incidences of chronic pain, neurological disorders, and mental health conditions, with a projected CAGR of 8.51% through 2030 [1] - Boston Scientific (BSX) maintains a leading position in the neuromodulation market, supported by technological advancements and strong sales growth [1][9] Company Performance - In Q3 2025, Boston Scientific's Neuromodulation business achieved a sales growth of 9%, continuing its strong performance for the year [2][9] - The Brain franchise experienced low single-digit growth, bolstered by positive results from the INTREPID study on Deep Brain Stimulation (DBS) for Parkinson's disease [2] - The Pain franchise grew in the high single digits, driven by strong double-digit growth in the U.S. from the Intracept system [3] Acquisitions and Expansion - The acquisition of Relievant in 2023 is contributing to growth by adding the Intracept Intraosseous Nerve Ablation System for treating vertebrogenic pain [3] - Boston Scientific has entered into an agreement to acquire the remaining stake in Nalu Medical for approximately $533 million, expanding its Neuromodulation offerings into peripheral nerve stimulation [4] Peer Comparisons - Medtronic reported a 4.5% year-over-year growth in its Neuroscience Portfolio, reaching $2.56 billion, with Neuromodulation growing by 7% [5] - Abbott's Neuromodulation sales grew by 7% year-over-year, driven by the Eterna rechargeable spinal cord stimulation device [6] Stock Performance and Valuation - Over the past 12 months, Boston Scientific shares have increased by 10.1%, contrasting with a 0.6% decline in the industry [7] - The company's shares trade at a forward five-year Price-to-Sales (P/S) ratio of 6.68, significantly higher than the industry average of 2.98 [10] Earnings Estimates - Earnings estimates for Boston Scientific show an upward trend, with current estimates for Q4 2025 at $0.78 and for the full year at $3.04 [12][13]

Summary of LivaNova Investor Day Conference Call Company Overview - **Company**: LivaNova - **Industry**: Medical Technology, specifically in cardiopulmonary and neuromodulation therapies - **Market Position**: LivaNova is a global leader in cardiopulmonary and epilepsy markets, with nearly five decades of experience and a strong commitment to innovation and patient care [1][11][12] Key Points and Arguments Strategic Roadmap and Financial Outlook - LivaNova aims for steady revenue growth in core areas, with acceleration in obstructive sleep apnea (OSA) and epilepsy markets [5][6] - The company expects high single-digit revenue growth over the next five years, with an acceleration in the latter part of the plan [17] - Projected adjusted EPS CAGR is low double-digit to mid-teens through 2030, with operating income margins above 20% [18] Market Opportunities - **Cardiopulmonary**: LivaNova is the market leader, supporting over 70% of open-heart procedures globally. The cardiopulmonary market is expected to grow at mid-single digits due to aging populations and increasing patient complexity [12][33] - **Epilepsy**: The market for drug-resistant epilepsy (DRE) is currently valued at $700 million, with significant growth potential due to low penetration of non-drug therapies [19][20] - **Obstructive Sleep Apnea (OSA)**: The neuromodulation market for OSA is projected to reach $1 billion, with double-digit growth expected as awareness and diagnosis rates increase [21] Product Innovations and Launches - LivaNova has launched the Essence heart-lung machine, which has transformed the growth profile of its cardiopulmonary business [13] - Upcoming innovations include a next-generation oxygenator and advancements in neuromodulation therapies for OSA and DRE [39][40] - The company plans to launch seven new products over the next three years, aiming for a freshness index exceeding 40% by 2030 [25] Financial Performance - LivaNova reported 10% organic revenue growth and 17% adjusted EPS growth over the past 11 quarters, generating approximately $400 million in adjusted free cash flow [13] - The company has expanded oxygenator manufacturing capacity by nearly 25% over the last three years, contributing to market share growth [13] Organizational Changes and Leadership - LivaNova has undergone significant leadership changes, with over 40% of direct and above leaders replaced to bring in external expertise and promote internal talent [14] - The leadership team emphasizes accountability and a culture of collaboration, which is expected to drive future success [7][8] Challenges and Risks - The company faces challenges in the difficult-to-treat depression (DTD) market, contingent on CMS reimbursement decisions [6][22] - The transition period from 2019 to 2022 involved divesting low-growth assets, which temporarily slowed innovation efforts [14][15] Conclusion - LivaNova is well-positioned to leverage its market leadership in cardiopulmonary and epilepsy to drive future growth, with a clear strategy focused on innovation, market expansion, and addressing unmet medical needs [29][30] - The company aims to transform its growth profile into a benchmark medtech company by 2030, emphasizing sustainable growth and shareholder value [18][29]

Advanced Noninvasive Neurostimulation Treatments for Mental Health Disorders Investor Deck November 2025 Nasdaq/TASE: BWAY Investor Deck | November 2025 Safe Harbor and Non-GAAP/IFRS Financial Measures This presentation does not constitute an offer orinvitation to sell orissue, or any solicitation of an offerto subscribe for or acquire, any securities ofthe Company, norto participate in any investment. This presentation shall not constitute advertising or be construed as commercial or promotional in nature. ...

Core Insights - CVRx, Inc. is a commercial-stage medical device company focused on innovative neuromodulation solutions for cardiovascular diseases [3] - The management team will present at the Jefferies Global Healthcare Conference in London on November 18, 2025 [1] - The presentation will be available via live audio webcast on the company's investor relations page [2] Company Overview - CVRx specializes in developing, manufacturing, and commercializing neuromodulation solutions, with Barostim™ being its flagship product [3] - Barostim is the first FDA-approved medical technology that uses neuromodulation to alleviate symptoms in heart failure patients [3] - The device delivers electrical pulses to baroreceptors in the carotid artery, aiming to restore balance to the autonomic nervous system [3] - Barostim has received FDA Breakthrough Device designation and is approved for use in heart failure patients in the U.S. [3] - The device is also compliant with EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area [3]

Core Points - The U.S. National Institutes of Health (NIH) has awarded BrainsWay Ltd. a grant of approximately $2.5 million over five years for a clinical study on the efficacy of an accelerated Deep Transcranial Magnetic Stimulation (Deep TMS™) protocol for treating Alcohol Use Disorder (AUD) [1][2] - The study aims to evaluate the mechanism of action and potential efficacy of the treatment, utilizing BrainsWay's H7 Coil to target brain regions associated with addiction and relapse risk [2][3] - This grant marks the second major NIH funding awarded to the research team in two years, highlighting their leadership in neuromodulation for addiction [3] Research Details - The study will involve 100 adults with AUD in a randomized, double-blind, sham-controlled trial, with participants receiving three Deep TMS treatments per day for 10 consecutive business days, totaling 30 treatment sessions [6] - Neuroimaging assessments will be used to investigate neural activation in targeted brain regions, linking clinical outcomes such as days abstinent and heavy drinking days to observed brain changes [6] Company Background - BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, with a proprietary Deep TMS™ platform technology [5] - The company has received FDA clearance for multiple indications, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction, demonstrating clinically proven efficacy [5] - Recent developments include FDA clearance for the H1 Coil for accelerated treatment of major depressive disorder, indicating ongoing innovation in treatment protocols [4]

Core Insights - CVRx, Inc. plans to release its third quarter 2025 financial and operating results on November 5, 2025, after market close [1] - A conference call will be held at 4:30 p.m. Eastern Time on the same day to discuss the results [1] Company Overview - CVRx is a commercial-stage medical device company focused on developing, manufacturing, and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases [3] - The company's flagship product, Barostim™, is the first FDA-approved medical technology that uses neuromodulation to alleviate symptoms in heart failure patients [3] - Barostim is an implantable device that delivers electrical pulses to baroreceptors in the carotid artery, aiming to restore balance to the autonomic nervous system and reduce heart failure symptoms [3] - The device has received FDA Breakthrough Device designation and is approved for use in heart failure patients in the U.S., as well as being compliant with EU Medical Device Regulation and holding CE Mark for heart failure and resistant hypertension in the European Economic Area [3]

Summary of Medtronic's AltaViva™ Device Conference Call Company and Industry Overview - **Company**: Medtronic - **Industry**: Pelvic Health and Neuromodulation - **Product**: AltaViva™ device, recently FDA approved on September 18, 2023 Key Points and Arguments Product Launch and Market Opportunity - The AltaViva™ device is a significant product launch for Medtronic, expected to accelerate growth in the latter half of the fiscal year [8][44] - Approximately 16 million people in the U.S. suffer from urge urinary incontinence (UUI), with only 45% seeking treatment, indicating a large untapped market [9][10] - The addressable market for UUI is less than 10% penetrated, presenting a substantial opportunity for growth [7][12] - Medtronic aims to raise awareness among the 9 million individuals not currently seeking treatment [11][12] Device Features and Benefits - The AltaViva™ device offers a minimally invasive procedure with a 15-year battery life and same-day activation of therapy [15][19] - The procedure is designed to be simple, requiring only a 2-centimeter incision and can be performed in various care settings without sedation [13][18] - The device is MRI compatible, allowing patients to undergo scans without additional steps [19][25] - The proprietary battery technology ensures consistent performance over time, requiring only one or two recharges per year [20][19] Competitive Landscape - AltaViva™ competes with two other implantable tibial neuromodulation products: eCoin by Valencia Technologies and Revi by BlueWind Medical [23] - Key differentiators include immediate therapy activation, device longevity (15 years vs. 3-10 years for competitors), and MRI compatibility [24][25] - Clinical data from the TITAN 2 study showed that 80% of patients reported improvement after 12 months, with 61% experiencing a significant reduction in UUI episodes [27][28] Reimbursement and Market Access - Medicare provides coverage for implantable tibial devices, with ongoing efforts to secure broader market access and a Category I code [31][32] - Current coverage includes 21% at FDA approval and 27% based on medical necessity, with plans to address non-coverage through the Medtronic Patient Access Support Program [31][32] - The average payment for the procedure is comparable to sacral neuromodulation, facilitating easier adoption by healthcare providers [70] Marketing and Consumer Engagement - Medtronic is adopting a consumer-focused approach for the launch, including community events and advertising campaigns to raise awareness [35][41] - Initial feedback from physicians has been positive, with rapid training and patient treatment following the device's approval [39][40] - The marketing strategy aims to educate both patients and healthcare providers about the benefits of the AltaViva™ device [34][41] Additional Important Insights - The pelvic health market has been underserved, with significant stigma surrounding conditions like UUI and fecal incontinence [7][12] - Medtronic's commitment to patient education and awareness is seen as crucial for unlocking the potential of the AltaViva™ device [43][44] - The company is focused on ensuring that the launch of AltaViva™ does not cannibalize its existing sacral neuromodulation business but rather complements it by reaching a broader patient population [54][56] This summary encapsulates the key points discussed during the conference call regarding Medtronic's AltaViva™ device, its market potential, competitive advantages, and strategic approach to launch and reimbursement.

Core Viewpoint - Vivani Medical, Inc. has announced a temporary withdrawal of the previously set record date for the spin-off of its subsidiary Cortigent, due to delays caused by the U.S. federal government shutdown [1][2]. Group 1: Company Overview - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company focused on developing miniature, ultra long-acting drug implants [1]. - The company utilizes its proprietary NanoPortal™ platform to create biopharmaceutical implants aimed at delivering drug molecules steadily over extended periods, enhancing patient adherence and tolerance [3]. - Vivani is developing a portfolio of GLP-1 based implants targeting metabolic diseases such as obesity and type 2 diabetes [3]. Group 2: Cortigent Overview - Cortigent, a wholly-owned subsidiary of Vivani, is focused on developing brain implant devices that utilize advanced neuromodulation technology to aid patients in recovering critical body functions [2]. - The Orion Visual Cortical Prosthesis System, an investigational system by Cortigent, is designed to treat blindness from common conditions like glaucoma and diabetic retinopathy, and has received FDA Breakthrough Device designation [2]. - Cortigent's technology also aims to improve recovery of arm and hand motion in patients with paralysis due to stroke [2]. Group 3: Financial Advisory - ThinkEquity is serving as the exclusive financial advisor to Cortigent regarding the spin-off transaction [2].

Core Insights - Medtronic plc (MDT) has received FDA approval for the Altaviva device, a minimally invasive implantable tibial neuromodulation therapy aimed at treating urge urinary incontinence, marking a significant advancement in bladder control therapies [1][9] - The introduction of the Altaviva device positions MDT as the only company with a comprehensive portfolio of neuromodulation therapies for bladder control symptoms, which is expected to enhance revenue growth and improve stock performance [3][4] Company Developments - The Altaviva device features a 15-year battery life, quick recharging capabilities, and is MRI-compatible, making it a patient-friendly option for those suffering from urge urinary incontinence [6][9] - Medtronic's market capitalization stands at $121.80 billion, with a projected revenue growth of 6.8% for fiscal 2026 compared to fiscal 2025 [4] - The company has consistently outperformed earnings expectations in the past four quarters, with an average surprise of 2.20% [4] Industry Context - Bladder control issues affect approximately 43 million U.S. adults, with nearly 16 million experiencing urge urinary incontinence, indicating a substantial market for the Altaviva device [10] - The global urinary incontinence therapeutics market is expected to grow at a CAGR of 4.0% from 2024 to 2030, driven by an aging population and increased awareness [10]