Appoints Patrick F. Williams as Chief Financial Officer Williams Brings a Track Record of Leading Medical Device Public Companies as CFO Rebecca Kuhn Departing Company and Will Remain in Advisory Role MOUNTAIN VIEW, Calif., June 24, 2025 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today announced the appointment of Mr. Patrick F. Williams as Chief Financial Officer, effective June 20, 2025. Ms. Rebecca Kuhn h ...

Group 1 - The Schall Law Firm is investigating claims on behalf of investors of NeuroPace, Inc. for potential violations of securities laws [1] - The investigation centers on whether NeuroPace made false or misleading statements or failed to disclose important information to investors [2] - NeuroPace's press release on May 27, 2025, revealed that the NAUTILUS study did not achieve statistical significance for its primary effectiveness endpoint, leading to a nearly 28.4% drop in shares on the same day [2]

Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices involving NeuroPace, Inc. and its officers or directors [1]. Group 1: Company Performance - On May 27, 2025, NeuroPace announced the preliminary one-year results of the NAUTILUS study, which evaluated the safety and effectiveness of the RNS System for treating drug-resistant idiopathic generalized epilepsy (IGE) [3]. - The study did not achieve statistical significance for its primary effectiveness endpoint, which aimed to demonstrate a longer time to a second generalized tonic-clonic seizure in the active stimulation group compared to the sham stimulation group [3]. - Following the announcement, NeuroPace's stock price dropped by $5.02 per share, representing a decline of 28.39%, closing at $12.66 per share on the same day [3]. Group 2: Legal Investigation - Pomerantz LLP is reaching out to investors of NeuroPace to gather information related to the investigation of potential securities fraud [1]. - The firm is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [4].

Core Viewpoint - NeuroPace, Inc. has secured a new $75 million credit facility with MidCap Financial to enhance its financial flexibility and support growth initiatives in the epilepsy treatment market [1][2]. Financing Details - The credit facility consists of a $60 million term loan and a $15 million revolving credit facility, with proceeds from the term loan used to repay an existing loan with CRG Partners IV, L.P. [1][2] - The new loan agreement has a maturity date of five years, with an annual interest rate tied to SOFR, subject to a floor of 2%, plus 5.5% for the term loan and 3.75% for the revolving loan [2]. Strategic Goals - The company aims to use the proceeds to expand patient access to its RNS System, invest in site-of-service expansion, explore new indications, develop direct-to-consumer programs, and generate real-world evidence [2]. - NeuroPace's RNS System is the first commercially available brain-responsive platform designed to provide personalized treatment for drug-resistant epilepsy [4]. Company Background - NeuroPace is based in Mountain View, California, and focuses on transforming the lives of individuals with epilepsy by reducing or eliminating seizures through innovative medical devices [4]. - The company has a unique position in the market with its differentiated RNS System, which aims to improve care standards for patients suffering from various brain disorders [4]. Partner Information - MidCap Financial specializes in providing senior debt solutions to middle-market companies and manages approximately $55 billion in commitments as of March 31, 2025 [5].

Core Viewpoint - NeuroPace, Inc. is under investigation for potential securities fraud and unlawful business practices following disappointing results from a clinical study [1][3]. Group 1: Company Performance - On May 27, 2025, NeuroPace announced the preliminary one-year results of the NAUTILUS study, which evaluated the safety and effectiveness of the RNS System for treating drug-resistant idiopathic generalized epilepsy (IGE) [3]. - The study did not achieve statistical significance for its primary effectiveness endpoint, which aimed to demonstrate a longer time to a second generalized tonic-clonic seizure in the active stimulation group compared to the sham stimulation group [3]. - Following the announcement, NeuroPace's stock price dropped by $5.02 per share, or 28.39%, closing at $12.66 per share on the same day [3]. Group 2: Legal Investigation - Pomerantz LLP is investigating claims on behalf of NeuroPace investors regarding possible securities fraud or other unlawful business practices by the company and its officers and/or directors [1]. - Investors are encouraged to contact Pomerantz LLP for more information about the investigation and potential class action [1].

Core Insights - NeuroPace announced promising preliminary one-year results from its pivotal NAUTILUS trial, evaluating the RNS System for idiopathic generalized epilepsy (IGE), marking a significant milestone in neuromodulation therapy [1][2] - The trial's strong enrollment and retention rates position NeuroPace to expand its therapeutic reach and enhance its clinical value proposition, supporting potential FDA submission [2][4] Company Performance - Following the announcement, NeuroPace's shares fell by 28.4%, closing at $12.66, although the stock has gained 13.1% year-to-date compared to the industry's 11.2% decline [3] - The company currently has a market capitalization of $579.9 million and expects earnings to improve by 6.5% in 2025 year-over-year [5] NAUTILUS Trial Details - The NAUTILUS trial is a pivotal Phase 3 study assessing the safety and effectiveness of the RNS System in patients aged 12 and older with drug-resistant seizures, with 87 patients enrolled across 23 centers [6][8] - The trial met its primary safety endpoint, reporting a low incidence of serious adverse events, while a subgroup with lower baseline seizure frequency showed significant therapeutic benefits [9][10] Clinical Outcomes - The one-year data from the trial demonstrated consistent clinical improvements, including a robust median seizure reduction and increased responder rates, with improvements continuing into the second year [10]

Core Insights - NeuroPace, Inc. released preliminary one-year results from the NAUTILUS study, which evaluated the safety and effectiveness of the RNS System for drug-resistant idiopathic generalized epilepsy (IGE) [1] - The study met its primary safety endpoint, showing a low rate of serious adverse events related to the device and implant procedure [1][2] - However, the primary effectiveness endpoint did not reach statistical significance for the overall study population, although a significant response was observed in a subgroup with lower baseline seizure frequency [2][3] Study Results - The study demonstrated clinically meaningful improvements in median percent seizure reduction, responder rates, and seizure-free days over the first year of treatment, continuing into the second year for those who progressed [4] - The company plans to engage with the FDA to discuss regulatory pathways based on the data, potentially focusing on patients with lower baseline seizure frequency [5] Financial Performance - NeuroPace reported a 24% increase in sales to $22.5 million in Q1 2025, with RNS System revenue growing by 29% excluding revenue from the NAUTILUS study [6] - The company raised its fiscal year 2025 sales guidance from $92 million-$96 million to $93 million-$97 million, compared to the consensus of $93.64 million [7] - Increased sales of the RNS System were the primary driver of revenue growth, alongside continued revenue from SEEG products [6][7] Stock Performance - NPCE stock experienced a decline of 33.90%, trading at $11.68 at the last check [7]

NeuroPace (NPCE) Update Summary Company Overview - **Company**: NeuroPace (NPCE) - **Industry**: Medical Devices, specifically focused on epilepsy treatment Key Points and Arguments 1. **NAUGHTLIST Study Results**: Preliminary one-year results from the NAUGHTLIST study were released, supporting an expanded clinical indication for idiopathic generalized epilepsy (IGE) [2][5] 2. **Safety and Effectiveness**: The trial met its primary safety endpoint but did not reach statistical significance for its primary effectiveness endpoint. However, there was observed efficacy in a clinically meaningful subgroup of patients [5][11] 3. **Patient Improvement**: Patients experienced improvements over time, with a median percent reduction in seizures after one year of RNS treatment higher than that observed in focal epilepsy trials leading to FDA approval [6][13] 4. **Clinical Need**: The data provides new hope for the IGE community, which has historically had limited treatment options [6][15] 5. **Study Design**: The NAUGHTLIST study was a prospective, multicenter, randomized, single-blind, sham-controlled trial involving 100 participants, with a focus on patients with drug-resistant IGE [8][9] 6. **Long-term Efficacy**: Data on longer-term seizure outcomes is encouraging, with median percent seizure reductions showing progressive improvement over time [12][14] 7. **FDA Engagement**: NeuroPace plans to submit the full dataset to the FDA in the second half of 2025 and is committed to engaging with the FDA regarding the potential for labeling aligned with the substantial subpopulation showing therapeutic benefit [15][18] 8. **Market Opportunity**: The total market for generalized epilepsy is estimated at around $800 million, with a significant portion likely represented by the subgroup that showed the highest clinical benefit [22][23] 9. **Growth Strategy**: The company’s base business is growing over 20% year over year, and the long-term strategy remains focused on expanding access to personalized therapy for epilepsy patients [19][70] Additional Important Content 1. **Forward-Looking Statements**: The call included forward-looking statements regarding projections, business opportunities, and market conditions, which involve risks and uncertainties [3][4] 2. **Patient Population Insights**: The trial included patients with severe IGE, and the majority had a lower frequency of generalized tonic-clonic seizures, which is reflective of the real-world patient population [25][62] 3. **Ongoing Analysis**: Further analyses are being conducted to understand patient characteristics that differentiate responses to treatment [12][38] 4. **Regulatory Designation**: The FDA granted breakthrough designation for the trial, recognizing it as a novel therapy addressing an unmet clinical need [64] 5. **Long-term Guidance**: The company’s long-term guidance remains unchanged, with ongoing discussions with the FDA and a commitment to advancing treatment options for IGE patients [70][71]

Industry Overview - The medical instruments industry is experiencing a transformative phase driven by the rapid adoption of generative artificial intelligence (genAI) and digital therapeutics, which are expected to significantly impact the healthcare sector [1] - Since early 2023, there has been mass adoption of AI and the Internet of Medical Things in digital healthcare options across hospitals and healthcare settings [1] Generative AI Impact - GenAI is demonstrating its capabilities in various healthcare fields, including administrative tasks, technological discovery, and clinical trials, by analyzing complex genetic and molecular data [2] - The technology is anticipated to enhance predictive treatment options and smart hospital systems [2] Investment Opportunities - It is advisable to invest in stocks from the Zacks-defined Medical Instrument industry that have a favorable Zacks Rank, with five selected stocks showing double-digit returns amid market volatility [3][4] Selected Stocks - **DexCom Inc. (DXCM)**: Benefiting from strong performance in the Sensor segment, with expected revenue and earnings growth rates of 14.3% and 23.2% respectively for the current year [7][8] - **IDEXX Laboratories Inc. (IDXX)**: Demonstrating robust strategic execution with expected revenue and earnings growth rates of 5.8% and 14% respectively for the current year [9][11] - **NeuroPace Inc. (NPCE)**: Focused on developing a brain-responsive neuromodulation system for treating drug-resistant focal epilepsy, with expected revenue and earnings growth rates of 18.1% and 15.1% respectively for the current year [12][13] - **Fresenius Medical Care AG (FMS)**: Benefiting from strong organic growth and operational improvements, with expected revenue and earnings growth rates of 1.6% and 28.3% respectively for the current year [14][15] - **ClearPoint Neuro Inc. (CLPT)**: Specializing in minimally invasive surgical procedures in the brain, with expected revenue and earnings growth rates of 24.1% and 11.4% respectively for the current year [16][17]

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