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CVRx to Report Second Quarter 2025 Financial and Operating Results and Host Conference Call on August 4, 2025
Globenewswire· 2025-07-21 20:30
Core Insights - CVRx, Inc. plans to release its second quarter 2025 financial and operating results on August 4, 2025, after market close [1] - A conference call will be held at 4:30 PM 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]
Helius Announces Positive Outcome of the Portable Neuromodulation Stimulator PoNS® Stroke Registrational Program and Upcoming Submission to FDA Under Breakthrough Designation
Globenewswire· 2025-07-21 11:00
Core Viewpoint - Helius Medical Technologies, Inc. announced positive outcomes from the PoNS Stroke Registrational Program, supporting a planned FDA submission for treating gait and balance deficits in chronic stroke patients under the Breakthrough Device Designation [1][2]. Group 1: Clinical Trials and Results - The PoNS Stroke Registrational Program included two pivotal clinical studies: a double-blind, randomized controlled trial and a single-arm trial, initiated in April 2024, following positive FDA interaction [2][3]. - A total of 159 patients were enrolled across the three studies, with 130 completing both the treatment and follow-up phases, conducted at 10 clinical sites in the US and Canada [3]. - The primary endpoints focused on improving gait and balance deficits after 12 weeks, with secondary endpoints assessing fall risk and durability of effect, showing statistically significant improvements with active PoNS therapy [4][7]. Group 2: Market Potential and Future Plans - Over 7 million stroke patients experience symptoms, with approximately 80% suffering from balance and gait deficits, indicating a substantial market opportunity [5]. - Helius plans to submit an application to the FDA for stroke indication during Q3 2025, aiming to provide an impactful treatment for stroke survivors [5][10]. Group 3: Product Overview - The Portable Neuromodulation Stimulator (PoNS) is a non-implantable device that delivers neurostimulation through a mouthpiece, used in conjunction with physical rehabilitation to improve balance and gait [6][10]. - PoNS has received authorization in Canada for treating gait deficits due to stroke and is also approved in Australia for similar uses [9].
CVRx Announces Positive News on Outpatient Payment for Barostim
Globenewswire· 2025-07-16 11:30
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]
NeuroPace (NPCE) Earnings Call Presentation
2025-06-19 14:11
Financial Performance & Growth - NeuroPace's revenue grew by 24% to $22.5 million in Q1 2025[10] - Excluding NAUTILUS study implants in Q1 2024, RNS System revenue grew by 29%[10] - The company anticipates revenue between $93 million and $97 million for 2025, representing a 16%-21% year-over-year growth[71] - Gross margin for Q1 2025 was 77%[71] - Operating expenses for Q1 2025 were $22.5 million[71] - Total cash balance was $66.3 million as of March 31, 2025[69] Market Opportunity & Expansion - The total U S addressable market is >$55 billion[9] - The annual core market opportunity within Comprehensive Epilepsy Centers (CECs) is >$2 billion[9] - Approximately 40% of Drug-Resistant Epilepsy (DRE) patients have generalized epilepsy[57, 61, 66] - Project CARE aims to expand access to the RNS System outside of Level 4 CECs, targeting an additional 1,800 epileptologists and all functional neurosurgeons[53, 61, 66]
BSX's Neuromodulation Arm Sees Growth: Q1 Highlights
ZACKS· 2025-06-18 14:16
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]
Helius Medical Technologies, Inc. Announces Claim Authorization by CignaHealth, for its Portable Neuromodulation Stimulator (PoNS®) Device
Globenewswire· 2025-06-16 11:00
Core Insights - CignaHealth has authorized claims for the PoNS Device at an out-of-network adjusted negotiated list price of $19,161, marking it as the fifth major payer to do so, following Anthem Multiplan's authorization at a similar price of $19,160 [1][2] - The authorization from five major commercial healthcare payers is expected to enhance access for multiple sclerosis (MS) patients to the PoNS device, reinforcing its value and supporting efforts for broader reimbursement from CMS [2] Group 1: PoNS Device Overview - The Portable Neuromodulation Stimulator (PoNS) is a non-implantable therapy that delivers neurostimulation through a mouthpiece, primarily used at home alongside physical rehabilitation exercises to improve balance and gait [3] - The PoNS device is indicated for short-term treatment of gait deficits due to mild-to-moderate symptoms from MS, and is prescribed for patients aged 22 and over [3] Group 2: Effectiveness and Authorization - PoNS has demonstrated effectiveness in treating gait and balance issues, significantly reducing the risk of falls in stroke patients in Canada, where it is authorized for three indications related to stroke and traumatic brain injury [4] - The device is also authorized for sale in Australia for short-term use by healthcare professionals as an adjunct to therapeutic exercise programs [4] Group 3: Company Background - Helius Medical Technologies is a leading neurotech company focused on neurologic deficits, utilizing an orally applied technology platform to enhance the brain's compensatory mechanisms and promote neuroplasticity [5] - The company's first commercial product is the Portable Neuromodulation Stimulator, aimed at improving the lives of individuals with neurologic diseases [5]
Positive PoNSTEP Study Results Presented at Consortium of Multiple Sclerosis Centers Annual Meeting
Globenewswire· 2025-06-12 11:00
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]
Helius Medical Technologies, Inc. Compliant with Nasdaq Bid Price Rule Listing Criteria
Globenewswire· 2025-06-04 11:00
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]
NeurAxis (NRXS) 2025 Conference Transcript
2025-05-29 14:30
Summary of Neuraxis Investor Conference Call Company Overview - Neuraxis is a growth-stage med tech company focused on neuromodulation therapies for chronic gastrointestinal (GI) conditions in pediatrics, with plans to expand into the adult market later in 2025 [3][4] - The company has developed proprietary neuromodulation technology targeting disorders of gut-brain interaction [3] Financial Performance - Neuraxis reported revenue of approximately $2.7 million last year, representing only 0.1% of the total market for their therapies [4] - Gross margins were at 88% last year, with expectations for improvement as insurance coverage increases [5] - Recent revenue growth was reported at 40% in Q3, 43% in Q4, and 39% in Q1, attributed to increased insurance coverage and guideline responses [7] Market Potential - The total addressable market includes approximately 1 million children in the U.S. suffering from functional abdominal pain and functional dyspepsia, with a potential revenue of $5,000 per patient [13][14] - Neuraxis has secured a category one CPT code, effective January 1, 2026, which is expected to enhance reimbursement and revenue growth [25][38] Product Development and Indications - Neuraxis has recently expanded its indications to include functional dyspepsia and nausea symptoms, effectively doubling its addressable market [8][33] - The company is also in the research stage for cyclic vomiting syndrome [14] Competitive Advantage - Neuraxis is the first to market with its technology and has established significant intellectual property (IP) protections, with U.S. patents running through 2039 [24] - The technology offers a non-pharmacological alternative to existing treatments, which often have serious side effects [16][21] Insurance and Reimbursement - The company currently has coverage for 51 million lives and expects this to increase to over 100 million by the end of December [4] - The upcoming publication of academic society guidelines is anticipated to facilitate broader insurance policy coverage [36][37] Capital Structure and Financial Health - Neuraxis recently raised $5 million, enhancing its cash position to $6.8 million, which is expected to sustain operations for over a year at the current burn rate [30][40] - The management team is focused on executing business operations without the need for immediate capital raising [41][42] Conclusion - Neuraxis is positioned for significant growth with a clear path to profitability, driven by expanding market opportunities, strong financial performance, and a robust product pipeline [12][26]
CVRx to Present at the William Blair 45th Annual Growth Stock Conference
Globenewswire· 2025-05-28 20:30
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]