MINNEAPOLIS, Jan. 29, 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, today announced that it plans to release fourth quarter 2025 financial and operating results after market close on Thursday, Feb. 12, 2026. The Company will host a conference call to review its results at 4:30 p.m. Eastern Time the same day. A live w ...

Fourth quarter revenue expected to be $15.9 million to $16.1 million, representing growth of 4% to 5%Full year revenue expected to be $56.5 million to $56.7 million, representing growth of 10% to 11%Fiscal 2026 revenue expected to be between $63 million and $67 million, representing growth of 11% to 18%Category I CPT codes and the related favorable physician fee payment levels took effect on Jan. 1, 2026FDA approved the BENEFIT-HF trial design in November and the Company has since applied to CMS for coverag ...

Core Insights - BrainsWay's strategic investment in Neurolief has led to the FDA granting Premarket Approval for the Proliv™Rx system, the first at-home neuromodulation device for major depressive disorder (MDD) patients who have not responded to previous antidepressants [1][2][3] Company Overview - BrainsWay is a leader in noninvasive brain stimulation technologies, focusing on advanced treatments for mental health disorders [5] - The company utilizes its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform to provide effective treatments for various mental health conditions, including MDD, obsessive-compulsive disorder, and smoking addiction [5] Neurolief Overview - Neurolief is a pioneering company in neuromodulation, known for developing the first wearable, non-invasive, multi-channel brain neuromodulation system designed for home use [4] - The Proliv™Rx device is indicated for adults with MDD who have not achieved satisfactory improvement from at least one prior antidepressant [4] Regulatory Milestone - The FDA's approval of Proliv™Rx marks a significant advancement in the treatment landscape for refractory MDD, allowing for treatment in both home and clinical settings [2][3] Strategic Positioning - BrainsWay's investment in Neurolief, which includes an option to acquire the company, aims to enhance its market value and expand its addressable market by providing access to patients who may struggle to visit clinics [3]

Core Insights - The FDA has granted Premarket Approval for Neurolief's Proliv™Rx system, making it the first at-home neuromodulation treatment for patients with major depressive disorder (MDD) who have not responded to previous antidepressant medications [1][2] Group 1: FDA Approval and Market Impact - The approval signifies a major regulatory milestone, expanding treatment options for refractory MDD patients beyond traditional in-clinic care [2] - Proliv™Rx is now recognized as an adjunctive treatment for MDD, indicating its potential to improve patient access to care [4] Group 2: Strategic Positioning of BrainsWay - BrainsWay's investment in Neurolief, which includes an option to acquire the company, aims to enhance its market value and expand its total addressable market [3] - The FDA approval validates BrainsWay's investment strategy and reinforces its commitment to data-driven mental health care [3] Group 3: Company Backgrounds - Neurolief is focused on developing innovative therapies for mental health and neurological disorders, with its Proliv™Rx device designed for home use [4] - BrainsWay is a leader in noninvasive neurostimulation treatments, with a proprietary Deep TMS™ platform and multiple FDA-cleared indications for mental health disorders [5]

Core Insights - CVRx, Inc. has transitioned to Category I Current Procedural Terminology (CPT) codes for its Barostim device, effective January 1, 2026, replacing the previous Category III codes, which is expected to enhance adoption, coverage, and reimbursement for the therapy [1][2][3] Company Overview - CVRx, Inc. is a commercial-stage medical device company that specializes in developing, manufacturing, and commercializing neuromodulation solutions for patients with cardiovascular diseases [3] - The Barostim device is the first FDA-approved medical technology that utilizes neuromodulation to alleviate symptoms in heart failure patients [3] - Barostim functions by delivering electrical pulses to baroreceptors in the carotid artery, aiming to restore balance to the autonomic nervous system and reduce heart failure symptoms [3] Regulatory and Market Impact - The new Category I CPT codes are anticipated to provide more predictable and consistent reimbursement for healthcare professionals and patients using Barostim therapy [3] - The Barostim 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 approval for heart failure and resistant hypertension in the European Economic Area [3]

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]

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 ...

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]

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]

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]