Key Takeaways BrainsWay invested $5M in Neurolief to enter the at-home mental health treatment market.Neurolief's Proliv Rx targets treatment-resistant depression and awaits FDA approval.The deal includes future milestone-based funding and a call option for full acquisition.BrainsWay Ltd. (BWAY) recently took a strategic step to expand its reach in the mental health market through a $5 million investment in Neurolief Ltd., a developer of wearable, non-invasive neuromodulation devices. The investment positio ...

Core Insights - Autonomix Medical, Inc. has advanced its proprietary sensing catheter through a final design review, preparing for human clinical trials aimed at supporting a De Novo FDA application [1][3] - The innovative sensing catheter is the first intravascular device designed to detect and differentiate nerve signals in real time, enhancing treatment precision and reducing the risks of incomplete denervation or overtreatment [2][3] - The technology has the potential to transform neuromodulation and pain treatment, with applications across various therapeutic areas including cardiology, hypertension, and chronic pain management [3][6] Company Overview - Autonomix Medical, Inc. focuses on advancing innovative technologies for diagnosing and treating diseases involving the nervous system, utilizing a catheter-based microchip sensing array [5][6] - The company is initially developing its technology for treating pain associated with pancreatic cancer, a condition that currently lacks reliable treatment options [6] Development Milestones - The company is executing an operational plan to submit an Investigational Device Exemption (IDE) and commence U.S. clinical trials for the Autonomix Sensing and RF Ablation System, specifically targeting pancreatic cancer pain [4][6] - Completion of the design review milestone is seen as a significant step towards delivering safer and more effective treatment options for patients, while also creating value for shareholders [3]

NeuroPace (NPCE) Q2 2025 Earnings Call August 12, 2025 04:30 PM ET Speaker0As a reminder, this conference is being recorded.It is now my pleasure to introduce your host, Scott Shaver, Head of Investor Relations at Neuropace Inc. Please go ahead.Speaker1Good afternoon. Thank you for joining us for Neuropace's second quarter twenty twenty five financial and operating results conference call. On today's call, we will hear from Joel Becker, Chief Executive Officer and Patrick Williams, Chief Financial Officer. ...

MINNEAPOLIS, Aug. 04, 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 its financial and operating results for the second quarter of 2025. Recent Highlights Total revenue for the second quarter 2025 was $13.6 million, an increase of 15% over the prior year quarterU.S. Heart Failure (HF) revenue for the s ...

MINNEAPOLIS, July 29, 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 present at the Canaccord Genuity 45th Annual Growth Conference on Tuesday, August 12, 2025. The Company is scheduled to present at 3:00pm Eastern Time the same day via webcast. A live audio webcast of th ...

MINNEAPOLIS, July 21, 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 it plans to release second quarter 2025 financial and operating results after market close on Monday, August 4, 2025. The Company will host a conference call to review its results at 4:30pm Eastern Time the same day.A live webcas ...

Core Insights - CVRx, Inc. announced that the Centers for Medicare and Medicaid Services (CMS) proposed to maintain the Barostim implant procedure under the New Technology Ambulatory Payment Classification (APC) 1580, with an outpatient payment of approximately $45,000 [1] - The proposal follows positive reimbursement developments, including Barostim's assignment to a higher paying MS-DRG for inpatient procedures and its transition from Category III to Category I CPT codes for physician payments starting January 1, 2026 [2] - The updates in reimbursement are expected to enhance access to Barostim for patients with heart failure, supporting its broader market adoption and long-term growth [3] Company Overview - CVRx is a commercial-stage medical device company focused on innovative neuromodulation solutions for cardiovascular diseases [4] - Barostim is the first FDA-approved medical technology that uses neuromodulation to alleviate symptoms in heart failure patients, delivering electrical pulses to baroreceptors in the carotid artery [4] - Barostim has received FDA Breakthrough Device designation and is compliant with EU Medical Device Regulation, holding CE Mark approval for heart failure and resistant hypertension in the European Economic Area [4]

Core Insights - Boston Scientific's Neuromodulation business focuses on developing devices for neurological movement disorders and chronic pain management, emphasizing innovation and strategic acquisitions for long-term growth [1] Financial Performance - In Q1 2025, the Neuromodulation segment achieved 6.8% year-over-year operational sales growth, with the Brain franchise growing mid-single digits and the Pain franchise experiencing high-single digits growth [2][7] - The Intracept procedure for chronic vertebrogenic low back pain showed strong double-digit growth, supported by five-year clinical data demonstrating long-term efficacy and cost-effectiveness [2] - The Neuromodulation segment is expected to improve throughout 2025, with contributions from recent acquisitions like Relievant and Axonics [3][7] Competitive Landscape - Abbott's Neuromodulation segment made strategic advancements, including the initiation of the TRANSCEND clinical trial for DBS in treatment-resistant depression, expanding its applications into mental health [4] - Medtronic's Neuromodulation business grew low-double digits year-over-year in fiscal Q4 2025, driven by strong product launches, particularly the Inceptiv spinal cord stimulation device and the Percept RC with BrainSense technology [5] Stock Performance - Boston Scientific's shares increased by 33.3% over the past year, outperforming the industry growth of 9.6% and the S&P 500's growth of 9.1% [6] Valuation Metrics - Boston Scientific trades at a forward 12-month price-to-earnings ratio (P/E) of 33.11X, which is above the industry average of 21.09X [8] Earnings Estimates - The Zacks Consensus Estimate for Boston Scientific's earnings has been rising over the past 60 days, indicating positive market sentiment [10]

Core Insights - The PoNS Therapeutic Experience Program (PoNSTEP) study demonstrates long-term benefits of PoNS Therapy for gait deficits in individuals with Multiple Sclerosis (MS) [1][2] - The study results were presented at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, highlighting the importance of treatment adherence for achieving clinically meaningful improvements [2][3] Study Details - The PoNSTEP study is an open-label, observational, interventional multi-center research study assessing adherence to PoNS Therapy for gait deficits in MS patients [5] - The study involved 43 MS participants and was conducted at six Centers of Excellence across the United States [5] - The primary endpoint is the maintenance of gait improvement from the end of supervised therapy to the end of unsupervised therapy, with secondary endpoints including maintenance of improvement over six months [5] Treatment and Mechanism - PoNS Therapy combines the Portable Neuromodulation Stimulator (PoNS) device with physical therapy, applied for 100-120 minutes per day [5][7] - The PoNS device delivers mild electrical impulses to the tongue and is indicated for short-term treatment of gait deficits due to mild-to-moderate MS symptoms [7][8] Clinical Impact and Recognition - The study provides the first clinical trial evidence of PoNS Therapy's long-term benefits for functional rehabilitation in the MS population [3] - There is growing recognition of PoNS Therapy's direct effect on the central nervous system and its targeted mechanism of action compared to other interventions [3] Reimbursement and Access - Helius Medical Technologies has successfully obtained initial reimbursement from federal and private payers, which is expected to lower barriers to prescribing PoNS Therapy [4] - The company is actively engaging with health insurance providers to expand access to PoNS Therapy for all individuals with MS [3][4]

Core Points - Helius Medical Technologies has demonstrated full compliance with Nasdaq's minimum bid price requirement as of June 3, 2025 [1] - The company is required to regain compliance with the equity requirement by June 30, 2025, as per the extension granted by the Nasdaq Hearings Panel [2] - Helius Medical Technologies focuses on neurologic deficits through its Portable Neuromodulation Stimulator (PoNS) product [3]