Core Message - NeuroPace aims to transform the lives of individuals suffering from epilepsy by reducing or eliminating debilitating seizures, which is central to the company's mission and decision-making process [3]. Company Overview - NeuroPace is represented by CEO Joel Becker, who emphasizes the company's commitment to patients and clinicians involved in epilepsy care [2][3]. - The company is led by a strong team dedicated to its mission and operational goals [4].

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NeuroPace FY Conference Summary Company Overview - **Company**: NeuroPace (NasdaqGM: NPCE) - **Industry**: Medical Technology, specifically focused on epilepsy treatment through neurostimulation Key Highlights 1. **Mission Statement**: NeuroPace aims to transform the lives of people suffering from epilepsy by reducing or eliminating debilitating seizures, demonstrating a strong commitment to patients and clinicians [2][3] 2. **Strategic Positioning**: The company is well-positioned for growth with strong fundamentals, best-in-class technology, and a significant market opportunity in the neurostimulation space for drug-resistant epilepsy [3][4] 3. **Revenue Milestone**: NeuroPace achieved $100 million in revenue for the first time, marking a significant milestone with a 25% year-on-year growth for 2025 [5][6] 4. **Core Technology**: The RNS System is a unique cranial implant that continuously monitors and tailors therapy based on individual patient needs, leading to improved outcomes over time [4][11] 5. **Market Opportunity**: The total addressable market (TAM) for drug-resistant epilepsy is estimated to exceed $3 billion, with approximately 1.2 million patients in the U.S. suffering from drug-resistant epilepsy [5][11] Financial Performance 1. **2025 Results**: - Total revenue: $100 million - Core RNS revenue: $81.7 million, also reflecting a 25% growth [5][6] - Gross margins: 77.2% for the year [6] 2. **2026 Guidance**: Projected revenue of $98-$100 million with RNS revenue growth of $20-$22 million and gross margins between 81% and 82% [10][45] Growth Strategy 1. **Indication Expansion**: Plans to expand indications for idiopathic generalized epilepsy and pediatric patients, with a focus on leveraging real-world data for growth [9][10] 2. **Product Development**: Development of AI tools to enhance therapy effectiveness and efficiency, including remote programming capabilities and next-generation hardware [10][20] 3. **Market Development**: Expansion into community centers and Level 3 epilepsy centers to increase access to RNS therapy [35][36] Clinical Insights 1. **Patient Outcomes**: The RNS System has shown up to 82% median seizure reduction at three years, with best-in-class data supporting its efficacy [15][16] 2. **Unique Dataset**: NeuroPace has amassed over 24 million individualized EEG recordings, which will be utilized to develop AI algorithms for personalized therapy [17][18] Competitive Landscape 1. **Generalized Epilepsy Market**: There are currently no FDA-approved devices for drug-resistant idiopathic generalized epilepsy, presenting a significant opportunity for NeuroPace [41][42] 2. **Strategic Partnerships**: Collaborations with pharma and biotech companies to monitor biomarker responses in clinical trials, enhancing the value of the RNS device [43][44] Conclusion - NeuroPace is positioned for strong growth with a focus on expanding its market presence, enhancing its technology, and improving patient outcomes through innovative solutions in epilepsy treatment. The company is optimistic about its future, with a robust strategy in place for 2026 and beyond [49][50]

Financial Performance & Growth - Preliminary 2025 total revenue is expected to be approximately $100 million, representing a 25% year-over-year increase[12, 15, 18] - Core RNS System revenue grew by 25% in 2025, driven by sustained demand and increased utilization[12, 18] - Q4 2025 total revenue is estimated at $26.6 million, a 24% increase year-over-year[15] - Gross margin for 2025 is approximately 77.2%, an increase of 330 basis points year-over-year[15] - The company projects revenue between $98 million and $100 million for FY26, with RNS revenue growth of approximately 20-22% and gross margin around 81-82%[21] RNS System & Clinical Data - The RNS System has been used in over 8,000 patients[12] - The RNS System demonstrated a median seizure reduction of 75% at 9 years in the original FDA study results[35] - The RNS Post-Approval Study showed an 82% median seizure reduction at 3+ years[35, 37] - Preliminary NAUTILUS results showed an 18-month median seizure reduction of 77% in LGS patients[61] Market & Expansion - The annual target market opportunity is estimated at over $3.5 billion[12] - Approximately 1.2 million people in the U S have drug-resistant epilepsy (DRE)[25, 56] - The company is focused on expanding access to the RNS System in generalized epilepsy, pediatrics, and community channels[74]

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today announced that its management team will present at the 44th Annual J.P. Morgan Healthcare Conference at 3:00pm PT on Wednesday, January 14, 2026, in San Francisco, CA. Management will also host investor meetings during the conference. The presentation will be accessible via live webcast here. A webcast replay will be available f. ...

Core Insights - Baird Medical Investment Holdings Ltd. has appointed Mark Saxton as the new CEO of its U.S. subsidiary, aiming to enhance its market presence in the U.S. [1] - Saxton brings over 25 years of experience in the medical device industry, particularly in intravascular RF ablation technologies, and has a history of driving significant revenue growth and successful exits for medtech companies [1] - The company is focused on advancing its Microwave Ablation technology, which offers advantages in minimally invasive care, and aims to expand access for patients while creating shareholder value [1] Company Overview - Baird Medical specializes in minimally invasive diagnostics and treatment, with a commitment to research and development of surgical robotic systems and innovative surgical instruments [1] - The company is FDA 510(k)-certified and its solutions are utilized in over 30 prestigious hospitals and clinics in the U.S., including Mayo Clinic and UCSF Medical Center [1] - Baird Medical is a market leader in China for thyroid microwave ablation devices and is expanding its commercial presence in over 20 countries worldwide [1]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - SMX (Security Matters) Public Limited Company (SMX) increased by 52% to $2.24 [3] - Entravision Communications Corporation (EVC) rose by 33% to $2.66 [3] - Babcock & Wilcox Enterprises, Inc. (BW) saw a 28% increase to $4.79 [3] - NeuroPace, Inc. (NPCE) gained 24% reaching $11.71 [3] - Kennedy-Wilson Holdings, Inc. (KW) also increased by 24% to $9.30 [3] - Rigel Pharmaceuticals, Inc. (RIGL) rose by 22% to $34.72 [3] - Digital Turbine, Inc. (APPS) increased by 21% to $7.20 [3] - Lumentum Holdings Inc. (LITE) saw a 15% increase to $218.06 [3] - AsiaStrategy (SORA) rose by 14% to $3.63 [3] - Marine Petroleum Trust (MARPS) increased by 7% to $5.05 [3] Premarket Losers - Biohaven Ltd. (BHVN) decreased by 42% to $7.96 [4] - Trex Company, Inc. (TREX) fell by 34% to $30.65 [4] - Soleno Therapeutics, Inc. (SLNO) saw a 23% decline to $49.00 [4] - Axon Enterprise, Inc. (AXON) decreased by 19% to $572.00 [4] - Clover Health Investments, Corp. (CLOV) fell by 19% to $2.82 [4] - Pinterest, Inc. (PINS) decreased by 18% to $26.91 [4] - SSR Mining Inc. (SSRM) saw a 17% decline to $17.91 [4] - Upstart Holdings, Inc. (UPST) decreased by 16% to $38.81 [4] - WF International Limited (WXM) fell by 12% to $2.25 [4] - Corsair Gaming, Inc. (CRSR) decreased by 11% to $6.66 [4]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $27.4 million, representing a 30% year-over-year growth compared to $21.1 million in Q3 2024 [4] - RNS revenue was $22.6 million, reflecting a 31% year-over-year growth [4] - Gross margin for Q3 2025 was 77.4%, up from 73.2% in the prior year quarter [18] - Adjusted EBITDA was positive $0.1 million, a significant improvement from negative $1.6 million in Q3 2024 [26] Business Line Data and Key Metrics Changes - RNS System sales drove revenue growth, totaling $22.6 million, with increased procedural volumes and utilization across existing centers [15] - Dixie sales grew 8% to approximately $4 million, but the focus is shifting away from Dixie products as the distribution agreement winds down [16] - Research service revenue was approximately $770,000, tied to ongoing data collaborations [15] Market Data and Key Metrics Changes - All sales regions exceeded planned sales for the quarter, with prescribers, accounts, and utilization reaching all-time highs [5] - Growth was broad-based across geographies, customers, and programs, particularly from Level 4 centers [5] Company Strategy and Development Direction - The company aims for a long-term growth trajectory of at least 20% in its core RNS business [5] - Focus on expanding indications, including pediatric populations and idiopathic generalized epilepsy (IGE) [9][10] - The company is committed to leveraging AI and data analytics to enhance clinical outcomes and support drug development partnerships [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential, citing strong execution and positive market trends [31] - The company is raising its full-year revenue guidance to a range of $97 million to $98 million, reflecting continued strength in RNS sales [7] - Management highlighted the importance of the RNS system in the evolving landscape of epilepsy care, emphasizing its unique capabilities [11][27] Other Important Information - The company generated positive adjusted EBITDA for the first time in its history, indicating progress towards sustainable profitability [6] - The PMA supplement for the Nautilus study is on track for submission before year-end 2025 [8] Q&A Session Summary Question: Outlook for 2026 and RNS growth - Management indicated confidence in maintaining a growth rate of over 20% for the RNS business, despite the wind-down of Dixie revenues [30][32] Question: Feedback on partnerships and data utilization - Management noted that partnerships are leveraging the unique capabilities of the RNS system to support drug development and personalized medicine [36] Question: Implied growth for Q4 and Dixie impact - Management explained that the expected decline in Dixie sales is the primary reason for the lower implied growth in Q4, but RNS sales are off to a solid start [40][42] Question: PMA submission timeline for Nautilus - The PMA supplement for Nautilus is expected to be submitted before year-end 2025, with a potential approval timeline around mid-2026 [43] Question: Industry awareness and off-label use - Management clarified that there was no significant impact from off-label use related to Nautilus data in the current quarter [51] Question: Growth from market expansion vs. market share - Management believes growth is a combination of both market expansion and increased utilization of RNS technology [52]

Financial Performance - Revenue increased by $6.3 million, or 30%, to $27.4 million for the three months ended September 30, 2025, compared to $21.1 million for the same period in 2024[158]. - Revenue for the nine months ended September 30, 2025, increased by $15.0 million, or 26%, to $73.4 million compared to $58.4 million for the same period in 2024[167]. - Gross profit rose by $5.7 million, or 37%, to $21.2 million for the three months ended September 30, 2025, with a gross margin increase from 73.2% to 77.4%[159]. - Gross margin improved from 73.4% for the nine months ended September 30, 2024, to 77.2% for the same period in 2025[168]. - Net loss decreased by $1.96 million, or 36%, to $3.5 million for the three months ended September 30, 2025, compared to a net loss of $5.5 million for the same period in 2024[157]. Expenses - Sales and marketing expenses increased by $2.7 million, or 27%, to $12.6 million for the three months ended September 30, 2025, primarily due to personnel-related costs[160]. - Research and development expenses rose by $0.8 million, or 14%, to $6.6 million for the three months ended September 30, 2025, mainly due to personnel-related expenses[161]. - General and administrative expenses increased by $0.6 million, or 15%, to $4.6 million for the three months ended September 30, 2025, attributed to personnel-related costs[162]. - Total operating expenses for the nine months ended September 30, 2025, increased by $10.3 million, or 17%, to $71.2 million compared to $60.9 million for the same period in 2024[166]. Cash Flow and Financing - As of September 30, 2025, the company reported an accumulated deficit of $549.7 million and cash, cash equivalents, and short-term investments of $60.0 million[131]. - Net cash used in operating activities was $11.5 million for the nine months ended September 30, 2025, primarily due to a net loss of $18.7 million[192]. - Net cash provided by financing activities was $19.0 million for the nine months ended September 30, 2025, mainly from a follow-on offering of common stock and proceeds from the MidCap Term Loan[195]. - The company anticipates that its cash resources will fund operating expenses for at least twelve months from the issuance of its financial statements[188]. - Cash, cash equivalents, and short-term investments amounted to $60.0 million as of September 30, 2025, up from $52.8 million at December 31, 2024[203]. Loans and Debt - The CRG Term Loan had an interest rate of 13.5% per annum, with a PIK option elected for interest payments from March 2023 through June 2024[178]. - The MidCap Term Loan was established in June 2025, borrowing $60.0 million, with a revolving credit facility of up to $15.0 million, which has not been drawn upon as of September 30, 2025[181]. - Future minimum payments for the MidCap Term Loan total $89.6 million, with $6.1 million due within the next twelve months[185]. - The exit fee for the CRG Term Loan was reduced from 10% to 8% upon repayment in June 2025[180]. Product Development and Regulatory Affairs - The RNS System demonstrated a 62.5% median seizure reduction at six months and an 82.0% median seizure reduction at 36 months post-implant in drug-resistant focal epilepsy patients[127]. - The RNS System is currently indicated for adult patients with drug-resistant focal epilepsy, with ongoing studies to expand indications to younger patients[127][128]. - The company is actively engaging with the FDA to finalize a pathway for expanded indications for the RNS System by the end of 2025[128]. - The company plans to continue significant investments in research and development, clinical studies, and regulatory affairs to support ongoing and future regulatory submissions[132]. - The company expects to incur continued expenditures for commercialization efforts and investments in clinical studies and new product development[186]. Strategic Initiatives - The exclusive distribution agreement with DIXI Medical expired on September 30, 2025, and the company is in a wind-down period to sell remaining inventory[134]. - The company has initiated a pilot program to expand outreach to Level 4 comprehensive epilepsy centers in 2024 and is expanding these efforts through 2025[130]. - The company expects to continue incurring net losses and negative cash flows in the near term, potentially requiring additional funding[132]. - The gross margin is expected to improve as production volume increases, spreading fixed manufacturing costs over more units[150].