Core Insights - Vivani Medical, Inc. is spinning off its wholly-owned subsidiary Cortigent, which specializes in brain implant devices utilizing precision neurostimulation technology [1][3] - Cortigent has completed a 6-year Early Feasibility Study for its Orion® artificial vision system aimed at treating blindness [1][3] - The spin-off is expected to enhance strategic and operational flexibility for both Vivani and Cortigent, allowing each to focus on their respective business strategies [3][5] Company Overview - Cortigent is the only company with FDA approval for a device providing artificial vision for the profoundly blind [1] - The Orion® Visual Cortical Prosthesis System is designed to treat blindness from common conditions like glaucoma and diabetic retinopathy, and has received FDA Breakthrough Device designation [7] - Cortigent is also developing a medical device to improve arm and hand motion recovery in stroke patients [1][7] Spin-off Details - The record date for Vivani shareholders to receive common stock in Cortigent is set for October 8, 2025 [2] - Cortigent is expected to trade on the Nasdaq under the ticker symbol "CRGT" [2] - The spin-off is anticipated to be completed by late 2025, subject to regulatory approvals and other conditions [5] Management and Future Plans - Jonathan Adams, MBA, will continue as CEO of Cortigent post-spin-off [4] - The spin-off aims to position Cortigent among a select group of public companies focused on neuromodulation and brain-computer interface technologies [3][4] - Cortigent plans to advance its Orion pivotal clinical trial to seek FDA approval and conduct an Early Feasibility Study for its Stroke Recovery System [3]

Company Overview - LivaNova demonstrates strong and durable growth in its core businesses, which include neuromodulation for epilepsy treatment and cardiopulmonary solutions [1][2] - The company has a diversified portfolio and holds leadership positions in its respective markets [1][2] Market Expansion Strategy - LivaNova aims to expand into markets with significant unmet patient needs, focusing on high-growth areas where the company has competitive advantages [2]

Core Insights - BrainsWay Ltd. (BWAY) has made a strategic investment of $5 million in Neurolief Ltd., aiming to expand its presence in the mental health market, particularly in at-home treatment solutions [1][9][10] - Neurolief is developing Proliv Rx, a therapy targeting Major Depressive Disorder (MDD), which is a significant area of unmet medical need [2][11] - Following the investment announcement, BWAY's stock increased by 1.5%, and the company has seen a year-to-date stock surge of 59%, outperforming the industry and S&P 500 [3][5] Company Strategy - The investment allows BrainsWay to enter the at-home mental health treatment market, thereby expanding its total addressable market (TAM) beyond its existing Deep TMS platform [4][12] - By utilizing Neurolief's wearable neuromodulation technology, BrainsWay can diversify its revenue streams and enhance its competitive positioning in the treatment of depression [4][13] Financial Projections - BWAY currently has a market capitalization of $279.2 million and is projecting an earnings growth of 88.9% for the current year [5] - The investment includes future milestone-based funding, with potential additional investments contingent on FDA approval and revenue milestones for Neurolief [10] Industry Outlook - The global neuromodulation devices market is projected to grow from $5.80 billion in 2024 to $10.39 billion by 2030, with a compound annual growth rate (CAGR) of 8.51% from 2025 to 2030 [14] - The increasing prevalence of chronic pain, neurological disorders, and mental health conditions is expected to drive demand for innovative treatment solutions [14]

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]

Financial Data and Key Metrics Changes - The company reported record revenue of $23.5 million for Q2 2025, representing a 22% increase compared to $19.3 million in the prior year period [6][25]. - Gross margin was above 77%, with RNS gross margin exceeding 80%, reflecting strong operational discipline [6][9]. - Operating expenses, excluding one-time items, grew 13% year-over-year, significantly below the revenue growth rate [6][29]. Business Line Data and Key Metrics Changes - Revenue from the RNS System grew 16% in the quarter and 21% year-to-date in 2025, driven by increased sales and prescriber engagement [7][25]. - The company is winding down its distribution agreement with Dixie Medical, which is expected to phase out by the end of 2026 [26][29]. Market Data and Key Metrics Changes - The company is expanding access to RNS Therapy through new service sites and clinical indication expansion, contributing to the growth in prescribers and active accounts [5][6]. - Project CARE continues to drive growth by enabling referrals and implants in community settings, with sequential increases in site engagement and implant volumes [8][25]. Company Strategy and Development Direction - The company is focused on deepening adoption of RNS Therapy while expanding access through new clinical indications and service sites [5][6]. - The strategic direction includes enhancing the RNS platform with AI-powered tools and advancing clinical development programs [17][19]. - The company plans to continue engaging with CMS to advocate for improvements in reimbursement structures [20]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the durability and trajectory of growth, raising full-year revenue guidance to a range of $94 million to $98 million [9][26]. - The company anticipates total gross margin to trend towards 80% over time as RNS volumes scale and lower-margin sales phase out [27][28]. - Management remains optimistic about the long-term growth potential of the RNS system, expecting to achieve cash flow breakeven by 2027 [34][47]. Other Important Information - The company completed a refinancing of its existing debt, enhancing financial flexibility and removing near-term debt maturity concerns [9][34]. - The post-approval study of the RNS system has shown compelling results, particularly in reducing generalized tonic-clonic seizures [11][12]. Q&A Session Summary Question: FDA submission strategy for IgE - The company plans to pursue an indication involving the totality of data across the entire population, demonstrating clinically meaningful treatment effects [40][41]. Question: Outlook for gross margin - Management indicated that the higher gross margin performance was encouraging, and while guidance implies a potential decline, it reflects a conservative approach [42][45]. Question: Dynamics with existing base and Project CARE - The company reported strong implant growth from Project CARE, with existing accounts contributing positively to implant volumes [51][53]. Question: Long-range plan and RNS growth - Management remains confident in achieving a 20% growth rate for the RNS business, even with the divestiture of Dixie revenue [84][89]. Question: Development of next-gen RNS offering - The next-generation platform is on track, with ongoing testing and characterization of key components meeting or exceeding expectations [96][98]. Question: Therapeutic partnerships - The company is actively pursuing collaborations, including a recent agreement with UCB, and sees potential for future partnerships to expand [99][100].

Core Insights - CVRx, Inc. reported solid second quarter results for 2025, with a revenue increase of 15% year-over-year, reflecting strong business momentum and sales force transformation [3][4][9]. Financial Performance - Total revenue for Q2 2025 was $13.6 million, up from $11.8 million in Q2 2024, marking a $1.8 million increase [4][27]. - U.S. revenue was $12.2 million, also a 15% increase from $10.5 million in the same quarter last year [5][27]. - Heart Failure (HF) revenue in the U.S. reached $12.1 million, a 15% increase compared to $10.5 million in Q2 2024, with HF revenue units rising from 339 to 387 [5][9]. - European revenue was $1.3 million, a 19% increase from $1.1 million in Q2 2024, despite a slight decrease in revenue units from 63 to 61 [7][27]. - Gross profit for Q2 2025 was $11.5 million, a 16% increase from $9.9 million in Q2 2024, maintaining a gross margin of 84% [8][27]. - R&D expenses decreased by 11% to $2.5 million, while SG&A expenses increased by 11% to $23.4 million [8][9][10]. - The net loss for Q2 2025 was $14.7 million, or $0.57 per share, compared to a net loss of $14.0 million, or $0.65 per share, in Q2 2024 [12][27]. Operational Highlights - As of June 30, 2025, CVRx had 240 active implanting centers in the U.S., a 27% increase from 189 centers a year prior [6][9]. - The number of U.S. sales territories increased to 47, with two new territories added during the quarter [6][9]. - The company is advancing its clinical evidence strategy and strengthening its reimbursement position, with CMS proposing to keep Barostim in APC 1580 for 2026 [3][14]. Reimbursement Updates - CMS proposed to maintain the Barostim implant procedure in the New Technology APC 1580 for 2026, with an outpatient payment of approximately $45,000 [14][15]. - The transition to Category I CPT codes in January 2026 is expected to enhance reimbursement predictability and eliminate automatic denials associated with Category III codes [15]. Leadership Changes - Brent Binkowski has been appointed as the Chief Operating Officer, bringing over 20 years of experience in medical devices [16]. Business Outlook - For the full year of 2025, CVRx expects total revenue between $55.0 million and $57.0 million, with Q3 revenue projected between $13.7 million and $14.7 million [17][18].

Core Insights - CVRx, Inc. is a commercial-stage medical device company focused on innovative neuromodulation solutions for cardiovascular diseases [3] - The company will present at the Canaccord Genuity 45th Annual Growth Conference on August 12, 2025, at 3:00 PM Eastern Time [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] - The device 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] Conference Details - A live audio webcast of the conference presentation will be available on the investor relations page of the company's website [2]

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]

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].

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]