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]

For now, the evidence for neuromodulation products is slim https://t.co/KFG1teVZZB ...

Market Opportunity & Disease Burden - Heart failure affects over 6 million people in the U S [9], leading to over 1 1 million hospital discharges and over 1 3 million emergency room visits annually [11] - The annual costs associated with heart failure are expected to reach $70 billion by 2030 in the U S [11] - The U S annual net addressable market for Barostim is estimated at $2 2 billion, assuming an average selling price (ASP) of $29,000 [37] Barostim Therapy & Clinical Evidence - Barostim is presented as a neuromodulation therapy designed to improve heart failure symptoms [8] - Barostim implantation is a 60-minute procedure with a 97% freedom from major complications [46, 48] - Real-world evidence demonstrates an 85% relative reduction in hospital visits per year post-Barostim implant (average 1 92 years) compared to pre-implant (12 months) [67] Financial Performance & Guidance - Worldwide revenue for 2024 was $51 3 million, representing 31% growth [87, 88] - The gross margin for 2024 was 84% [87, 88] - The company's revenue guidance for full year 2025 is $55 0 – $58 0 million, with a gross margin of 83% – 84% and operating expenses of $95 0 – $98 0 million [90]

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 - NeurAxis, Inc. announced medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, IB-Stim, with two health insurers, impacting approximately 700,000 members in Connecticut and Massachusetts, bringing total national coverage to about 53 million [1][3] Company Overview - NeurAxis, Inc. is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults [4] - The company's IB-Stim technology is FDA-cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) and Pediatric Functional Dyspepsia in adolescents aged 8-21 [2][4] Technology and Market Position - IB-Stim is a non-surgical device that delivers gentle electrical impulses to cranial nerve bundles in the ear, addressing a significant gap as there are currently no FDA-approved drug therapies for children with abdominal pain-related disorders [2] - The technology has been incorporated into treatment guidelines by a leading pediatric academic society, which is expected to enhance policy coverage and reimbursement [3] Future Developments - The activation of a Category I CPT code for PENFS, effective January 1, 2026, is anticipated to improve reimbursement and encourage broader adoption in children's hospitals [3] - NeurAxis is currently conducting additional clinical trials for PENFS across various pediatric and adult conditions with significant unmet healthcare needs [4]

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]

CARMEL, Ind., June 10, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. ("NeurAxis," or the "Company") (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, today announced that its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology has been officially incorporated into newly released clinical practice guidelines issued by the leading pediatric academic society for the treatment ...

The Panel further reminded the Company that it is also required to regain compliance with the equity requirement in Listing Rule 5550(b)(1) (the "Equity Rule") by June 30, 2025 under the extension previously granted by the Panel. Accordingly, the Nasdaq Listing Qualifications hearing process will remain open until the Company has demonstrated compliance with all of The Nasdaq Stock Market's continued listing requirements. About Helius Medical Technologies, Inc. Helius Medical Technologies is a leading neuro ...

NeurAxis (NRXS) 2025 Conference May 29, 2025 09:30 AM ET Speaker0 Hello, everyone, and thank you all for joining us during the Lithium Partners Spring twenty twenty five Investor Conference. Our next presentation is from Neuraxis. My name is Ben Shamsian, vice president of Lithium Partners. And today, we welcome Brian Karako, CEO, who'll be taking us through a slide presentation followed by a q and a discussion afterwards. Neuraxis trades under the ticker NRXS. Now let's get started. Brian, welcome, and I'l ...

Company Overview - CVRx, Inc. 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] Recent Developments - CVRx management will present at the William Blair 45 Annual Growth Stock Conference on June 4, 2025, at 10:00 am Central Time via webcast [1] - A live audio webcast of the conference presentation will be accessible on the investor relations page of the company's website [2] Regulatory Approvals - Barostim has received FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. [3] - The device has also obtained the CE Mark for heart failure and resistant hypertension in the European Economic Area [3]