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].

Revenue Performance - Total revenue for Q3 2025 was $27.4 million, representing a 30% increase compared to $21.1 million in Q3 2024[4] - RNS® System revenue reached $22.6 million, reflecting a 31% growth year-over-year[5] - The company increased its full-year 2025 revenue guidance to between $97 million and $98 million, indicating a growth of 21% to 23% compared to $79.9 million in 2024[14] Profitability and Expenses - Gross margin improved to 77.4%, up from 73.2% in Q3 2024, driven by a favorable product mix and manufacturing efficiencies[6] - Operating expenses for Q3 2025 totaled $23.8 million, compared to $19.7 million in Q3 2024[6] - Net loss for Q3 2025 was $3.5 million, an improvement from a net loss of $5.5 million in Q3 2024[9] Cash Flow and Investments - Cash, cash equivalents, and short-term investments as of September 30, 2025, were $60.0 million, down from $62.1 million at the end of the previous quarter[10] - Cash used in operating activities for Q3 2025 was $1,944,000, slightly higher than $1,724,000 in Q3 2024, with total cash used in operating activities for the nine months at $11,512,000 compared to $13,152,000 in the prior year[22] - Cash provided by financing activities in Q3 2025 was $235,000, a decrease from $2,898,000 in Q3 2024, while total cash provided for the nine months was $18,965,000 compared to $3,479,000 in the same period of 2024[22] Accounts and Inventory Management - The number of active accounts, prescribers, and utilization reached record highs in Q3 2025[5] - The company experienced a decrease in accounts receivable by $1,383,000 in Q3 2025, compared to a decrease of $318,000 in Q3 2024, with total changes for the nine months showing a decrease of $2,087,000 versus an increase of $753,000 in the prior year[22] - Inventory write-downs for Q3 2025 were $47,000, down from $107,000 in Q3 2024, with total write-downs for the nine months at $140,000 compared to $196,000 in the same period of 2024[22] Future Plans and Developments - The company plans to submit the NAUTILUS PMA Supplement to the FDA for IGE indication expansion by year-end 2025[1] - NeuroPace submitted Seizure ID, an AI application aimed at improving clinical outcomes, to the FDA for approval[5] Non-Cash and Other Financial Metrics - The company reported stock-based compensation expense of $2,628,000 in Q3 2025, slightly up from $2,591,000 in Q3 2024, with total expenses for the nine months at $8,482,000 compared to $7,679,000 in the previous year[22] - The company incurred a non-cash interest expense of $73,000 in Q3 2025, down from $203,000 in Q3 2024, with total non-cash interest for the nine months at $463,000 compared to $743,000 in the previous year[22] - The company reported a gain on short-term investments of $82,000 in Q3 2025, an improvement from a loss of $219,000 in Q3 2024, with total gains for the nine months at $41,000 compared to a loss of $315,000 in the prior year[22]

Financial Performance & Growth - NeuroPace's 2024 revenue reached $79.9 million, demonstrating a 22% year-over-year growth[12] - Q3 2025 revenue was $27.4 million, a 30% increase year-over-year[15] - Gross margin in Q3 2025 was 77.4%, a 417 bps increase year-over-year[15] - FY 2025 revenue guidance is projected to be between $97 million and $98 million, representing an 18%-23% growth[64] RNS System & Clinical Data - The RNS System has been implanted in over 6,000 patients[12] - The RNS System demonstrated a 75% median seizure reduction at 9 years in the original FDA study results[28] - The FDA post-approval study results showed an 82% median seizure reduction at 3+ years[28] Market Opportunity & Expansion - The annual target market opportunity is estimated to be over $3.5 billion[12] - The company is targeting a $55 billion+ total addressable market (TAM) for drug-resistant epilepsy (DRE)[41] - There are approximately 1.2 million people in the U S with drug-resistant epilepsy[18]

Summary of NeuroPace Conference Call Company Overview - **Company**: NeuroPace (NPCE) - **Focus**: Development of implantable devices for treating drug-resistant epilepsy patients - **Key Product**: Responsive Neurostimulation (RNS) system, which monitors and tailors neurostimulation for individual patients [3][4] Market Size and Patient Demographics - **Epilepsy Patients in the U.S.**: Approximately 3.6 million diagnosed with epilepsy - **Drug-Resistant Patients**: About 1.2 million patients (one-third) do not respond satisfactorily to anti-seizure medications [5][6] - **Comprehensive Epilepsy Centers (CECs)**: 75,000 patients per year treated at level four CECs, with recent regulatory approval allowing RNS implantation in level three community settings [8][9] Competitive Landscape - **Focal Drug-Resistant Epilepsy**: 60% of drug-resistant patients have focal epilepsy; RNS is currently indicated for this group - **Generalized Drug-Resistant Epilepsy**: 40% of patients are generalized; NeuroPace is conducting the NAUTILUS trial to gain indications for this population [11][12] RNS Technology - **Unique Features**: RNS monitors seizure activity and provides stimulation only when needed, leading to better patient outcomes compared to other devices that operate on a fixed duty cycle [14][15] - **Clinical Data**: Median seizure reduction rates improved from 50-60% to over 80% post-approval, with low adverse event rates [17][21] Data Utilization and Partnerships - **Data Asset**: NeuroPace has 22 million individualized seizure records, which can be used for algorithm development and insights into brain physiology [19][20] - **Collaborations**: Partnerships with Rapport Therapeutics and UCB to utilize RNS data in clinical trials for new therapies [24] Project Care Initiative - **Objective**: Increase access to RNS by moving into community settings and educating healthcare professionals and patients [27][34] - **Progress**: High referral rates and total implants reported, with ongoing efforts to raise awareness about RNS [27][28] NAUTILUS Trial Update - **Trial Focus**: Evaluating RNS for idiopathic generalized epilepsy (IGE) patients, specifically those experiencing generalized tonic-clonic seizures (GTC) [37][38] - **Results**: Met primary safety endpoint; secondary endpoints showed nearly 80% reduction in GTC seizures at one year [40][41] - **Regulatory Engagement**: Ongoing discussions with the FDA regarding trial results and potential approval [44][49] Financial Outlook - **Growth Projections**: Anticipated growth of at least 20% over the next few years, with gross margins approaching 80% by 2026 [52][54] - **Cash Flow Breakeven**: Expected in 2027, with additional growth from expanded indications [53][54] Conclusion - **Overall Sentiment**: NeuroPace is optimistic about its growth trajectory, product pipeline, and the potential impact of its RNS technology on the epilepsy treatment landscape [55][56]

Company Performance - NeuroPace, Inc. reported a quarterly loss of $0.26 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.24, marking an earnings surprise of -8.33% [1] - The company posted revenues of $23.52 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 0.75% and showing an increase from $19.26 million in the same quarter last year [2] - Over the last four quarters, NeuroPace has surpassed consensus EPS estimates three times and topped consensus revenue estimates three times as well [2] Stock Performance - NeuroPace shares have declined approximately 20.6% since the beginning of the year, contrasting with the S&P 500's gain of 8.4% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.20 on revenues of $24.32 million, and for the current fiscal year, it is -$0.85 on revenues of $95.36 million [7] Industry Outlook - The Medical - Instruments industry, to which NeuroPace belongs, is currently ranked in the bottom 41% of over 250 Zacks industries, indicating potential challenges for stock performance [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact NeuroPace's stock performance [5]

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].