Neuropace (NPCE) Stock News

NeuroPace (NASDAQ: NPCE), a medical device company specializing in epilepsy treatment, has announced a strategic CFO transition. Patrick F. Williams has been appointed as the new Chief Financial Officer effective June 20, 2025, replacing Rebecca Kuhn, who will serve in an advisory role for 12 months.

Williams brings over 25 years of financial and operational management experience in public medical device companies, having previously served as CFO at STAAR Surgical, Sientra, and ZELTIQ. The company's RNS System targets a significant market opportunity of approximately 1.2 million U.S. patients living with drug-resistant epilepsy.

NeuroPace (NPCE) has secured a new $75 million credit facility with MidCap Financial, comprising a $60 million term loan and a $15 million revolving credit facility. The financing replaces the company's existing term loan with CRG Partners IV and provides working capital for corporate purposes. The new agreement features favorable terms with reduced cash interest expense and a five-year maturity date. Interest rates are set at SOFR (minimum 2%) plus 5.5% for the term loan and 3.75% for the revolving loan. The non-dilutive capital will support NeuroPace's growth initiatives, including expanding access to their RNS System, developing new indications, implementing direct-to-consumer programs, and investing in product development and real-world evidence generation.

NeuroPace (NPCE) has announced preliminary one-year results from its NAUTILUS study evaluating the RNS® System for treating drug-resistant idiopathic generalized epilepsy (IGE). The study successfully met its primary 12-week safety endpoint, showing low serious adverse events. While the primary effectiveness endpoint didn't reach statistical significance in the overall population, a significant response was observed in a majority subgroup of patients with lower baseline seizure frequency. The study, involving 87 implanted patients across 23 US epilepsy centers, showed promising median seizure reduction rates exceeding those seen in the company's previous focal epilepsy trials. Notably, patients completing over 12 months showed continued clinical improvement. The company plans to discuss potential regulatory pathways with the FDA, including pursuing a targeted indication for patients with lower baseline seizure frequency.

NeuroPace (NPCE) reported strong Q1 2025 financial results with record quarterly revenue of $22.5 million, representing a 24% year-over-year growth. The company's RNS System revenue grew 26% year-over-year, or 29% excluding NAUTILUS study implants. Gross margin improved to 77.0%, exceeding guidance. Operating expenses increased 8% to $22.5 million, with R&D expenses rising to support product pipeline development. The company reported a net loss of $6.6 million, improved from $8.9 million in Q1 2024. NeuroPace increased its full-year 2025 revenue guidance to $93-97 million. The company's cash position strengthened to $66.3 million. Notable achievements include positive 3-year RNS System data showing 82% median seizure reduction and strategic portfolio refocusing on core RNS System products.

NeuroPace (NPCE) has provided an update regarding its exposure to implemented tariffs, stating that it expects minimal impact on its operations and financial results. The company attributes this exposure to manufacturing and selling the majority of its devices within the United States, with minimal international supply chain activities for its RNS System.

The company also expects no material impact on gross margin for DIXI Medical SEEG products and is reiterating its gross margin guidance for 2025. NeuroPace has previously announced the termination of its SEEG distribution agreement with DIXI Medical, effective October 1, 2025, followed by a six-month wind-down period through Q1 2026.

The company will report its Q1 2025 financial results on May 13, 2025, after market close, followed by a conference call at 1:30 p.m. Pacific Time.

NeuroPace (NPCE) has announced significant three-year effectiveness data from their Post-Approval Study (PAS) of the RNS® System at the 2025 AAN Annual Meeting. The study, involving 324 patients across 32 centers, represents the largest FDA-reviewed prospective neuromodulation trial for drug-resistant focal epilepsy.

Key findings include:

• 82% median seizure reduction at 3 years
• 62% median seizure reduction at 6 months
• 42% of patients remained seizure-free for 6+ months
• 1 in 3 patients did not require intracranial EEG monitoring

The RNS System, the only FDA-approved epilepsy device providing brain-responsive neurostimulation, addresses drug-resistant epilepsy (DRE), which affects approximately 1.2 million people in the U.S. The three-year safety and effectiveness data were submitted to the FDA in November 2024, with the study continuing to five years.

NeuroPace (NPCE) announced it will present three-year data from its Post-Approval Study (PAS) of the RNS® System at the 2025 American Academy of Neurology Annual Meeting in San Diego. The presentation will focus on results in adults treated with brain-responsive stimulation for drug-resistant focal epilepsy (DRE).

The RNS System, the first and only neuromodulation platform delivering personalized, real-time seizure treatment, will be showcased at booth #1642. Key presentations include an oral session on April 7 by Dr. Dawn Eliashiv, an Exhibitor Hall presentation on April 8 by Dr. Martha Morrell and Dr. Barbara Jobst, and encore webinars on April 8 and 11 for those unable to attend in person.

NeuroPace (NPCE) announced a strategic refocusing of its product portfolio, terminating its SEEG products distribution relationship with DIXI Medical in Q4 2025. The company will maintain its focus on its core RNS System product line.

The company reaffirmed its 2025 revenue guidance and long-range plan expectations, including:

• 20%+ revenue CAGR
• Cash flow breakeven target by end of 2027
• Gross margin improvement (RNS System >78% vs SEEG ~50%)

Key growth initiatives for 2026 include:

• Project CARE site of service expansion
• Indication expansion into drug-resistant idiopathic generalized epilepsy
• Expansion into pediatric focal epilepsy
• Launch of AI-enabled software products

NeuroPace (Nasdaq: NPCE), a medical device company specializing in epilepsy treatment solutions, has announced its upcoming participation in the 24th Annual Needham Virtual Healthcare Conference. The company's management team is scheduled to present on Tuesday, April 8, 2025, at 3:00 PM ET (12:00 PM PT).

The presentation will be available through a live webcast, and investors will have the opportunity to participate in one-on-one meetings with management during the conference. For those unable to attend live, a replay of the webcast will remain accessible for 90 days following the presentation in the Events section of NeuroPace's Investor website.