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CVRx Announces Implementation of New Category I CPT Codes for Barostim Therapy
Globenewswire· 2026-01-06 13:30
MINNEAPOLIS, Jan. 06, 2026 (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, confirmed today that Category I Current Procedural Terminology (CPT) codes for baroreflex activation therapy using its Barostim device replaced the Category III codes as of Jan. 1, 2026. In the U.S. healthcare system, Category I CPT codes signify est ...
electroCore, Inc. (ECOR) Discusses Neuromodulation Platform, Business Evolution, and Strategic Priorities Transcript
Seeking Alpha· 2025-12-26 05:36
Company Overview - electroCore is a publicly traded neuromodulation company listed on NASDAQ under the symbol ECOR, focusing on non-invasive vagus nerve stimulation devices [3] - The company was founded in 2006 and has developed into a multi-indication business with 7 FDA authorizations for headache treatments [5] Product and Service Channels - The company operates across three main channels: prescription medical devices for headache and migraine, the Truvaga direct-to-consumer wellness brand, and a specialized military and government division featuring the ruggedized TAC-STIM product [4] - The nVNS platform delivers a two-minute therapy session aimed at rebalancing the autonomic nervous system [3] Market and Clientele - electroCore serves major customers including the U.S. Department of Veterans Affairs and the U.K.'s National Health Service, indicating a strong foothold in both governmental and healthcare sectors [5]
BWAY Shares Gain on Optum Expanding Deep TMS Coverage for Teens
ZACKS· 2025-12-23 18:11
Key Takeaways BWAY benefits as Optum expands Deep TMS coverage to adolescents with major depressive disorder.BWAY sees a wider reimbursable teen patient base, driving earlier treatment adoption and utilization growth.BWAY gains from broader insurer alignment that improves revenue visibility and encourages clinic investment.BrainsWay Ltd. (BWAY) recently announced an expansion of insurance coverage for its Deep TMS therapy in adolescent depression. The update signals growing payer confidence in non-drug neur ...
CVRx to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2025-12-22 13:30
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 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, at 3:45 p.m. (PT) [1] - Barostim™ is the first FDA-approved medical technology using neuromodulation to alleviate heart failure symptoms [3] Company Overview - CVRx specializes in developing, manufacturing, and commercializing neuromodulation solutions for patients with cardiovascular diseases [3] - Barostim is an implantable device that delivers electrical pulses to baroreceptors in the carotid artery, aimed at restoring balance to the autonomic nervous system [3] - Barostim has received FDA Breakthrough Device designation and is approved for heart failure patients in the U.S., as well as certified under EU Medical Device Regulation [3] Event Information - A live webcast of the J.P. Morgan Healthcare Conference presentation will be available at ir.cvrx.com, with an archived version accessible for a limited time [2]
CVRx to Participate at the Piper Sandler 37th Annual Healthcare Conference
Globenewswire· 2025-11-19 13:30
Core Insights - CVRx, Inc. is a commercial-stage medical device company focused on innovative neuromodulation solutions for cardiovascular diseases [3] - The management team will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025 [1] - The Barostim™ device is the first FDA-approved technology using neuromodulation to alleviate heart failure symptoms [3] Company Overview - CVRx specializes in developing, manufacturing, and commercializing neuromodulation solutions for patients with cardiovascular diseases [3] - Barostim™ is an implantable device that delivers electrical pulses to baroreceptors in the carotid artery, aimed at restoring balance to the autonomic nervous system [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 CE Mark approval for heart failure and resistant hypertension in the European Economic Area [3] Event Details - The fireside chat is scheduled for December 3, 2025, at 2:00 p.m. (ET) and will be available via webcast on the company's investor relations page [1][2]
BSX's Neuromodulation Prospect Looks Strong: What's Behind It?
ZACKS· 2025-11-19 13:26
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]
LivaNova (NasdaqGS:LIVN) 2025 Investor Day Transcript
2025-11-12 15:00
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]
Brainsway(BWAY) - 2025 Q3 - Earnings Call Presentation
2025-11-11 13:30
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. ...
CVRx to Present at the Jefferies Global Healthcare Conference in London
Globenewswire· 2025-11-04 13:30
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]
BrainsWay Reports National Institutes of Health Grant to Leading U.S. Research Team Investigating Accelerated Deep TMS for Treatment of Alcohol Use Disorder
Globenewswire· 2025-11-04 13:00
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]