Neuropace Inc（NPCE）资讯与事件NPCENeuropace Inc

FY26 Guidance Raised to $99.91 Million

Consensus is $99.91M. Other FY26 guidance: Increase full year non-GAAP gross margin to between 82.0% and 83.0%, an increase compared to 81.5% to 82.5% previously; Reiterate full year non-GAAP operating expenses to be between $90 million and $92 million, excluding approximately $10 million in stock-based compensation, a non-cash expense; Increase Adjusted EBITDA to be between ($7.5) million and ($8.5) million compared to previous guidance between ($8.5) million to ($9.5) million.

NeuroPace Reports Q2 Revenue of $22.83M, Beating Consensus

Reports Q2 revenue $22.83M, consensus $22.65M. Second-quarter performance showed continued momentum in our core RNS business driven by increased adoption within our current focal epilepsy indication," said Joel Becker, Chief Executive Officer of NeuroPace. "We also maintained strong financial discipline while continuing to invest in the long-term growth of the business and advance our product roadmap. The launch of ECoG Assistant marked an important first-of-its-kind step in extending the differentiated capabilities of the RNS System, building on NeuroPace's unique ability to continuously monitor and record each patient's intracranial EEG data, efficiently identify ECoGs of interest and support more individualized therapy, reinforcing a data advantage that other neuromodulation platforms cannot replicate. Looking ahead, we remain focused on sustaining momentum in our core business. Additionally, we look forward to continuing our engagement with the FDA regarding the path forward for our IGE PMA Panel Track supplement and remain on track with our clinical and regulatory timelines."

NeuroPace Updates on FDA Review Progress

NeuroPace on Tuesday provided an update on the U.S. Food and Drug Administration review of the company's Premarket Approval Panel Track Supplement seeking to expand the labeled indication for the RNS System to include patients with antiseizure medication-resistant idiopathic generalized epilepsy. NeuroPace has received a communication from FDA indicating that the PMA Supplement is not approvable in its current form. Following receipt of the communication, NeuroPace met with FDA to discuss the Agency's feedback and the additional information needed to place the PMA Supplement in approvable form. At the recommendation of FDA and based on that discussion, the company will be submitting a Submission Issue Request to further discuss its planned approach with FDA and intends to amend its submission with supplemental information, including additional data and context regarding the patient populations evaluated in the NAUTILUS clinical trial. "We received communication from FDA on the PMA-S target due date indicating that our submission was not approvable in its current form due to questions that remained under review. Having reviewed FDA's written communications and having had subsequent discussions with the Agency, we believe there is a path for approval of the submission. Our interactions are now focused on providing the information needed to answer FDA's remaining requests. While we are disappointed with not receiving an initial approval, we were encouraged by our subsequent discussion with the Agency, and importantly, their interest in engaging interactively, their request for additional information to address certain questions, and their willingness to work collaboratively to bring the RNS indication expansion for drug-resistant IGE patients to market," said Joel Becker, President and CEO of NeuroPace.