NPCE — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-11

• and the FDA to pursue the use of real-world data to support expanded labeling for patients ages 12 to 17. These efforts continue into 2026.

• As previously announced, our exclusive distribution agreement with DIXI Medical USA Corp., or DIXI Medical, expired on September 30, 2025. Under the agreement, entered into in August 2022, we served as the exclusive U.S. distributor of DIXI Medical’s stereo electroencephalography, or Stereo EEG, pro…

• We continue to perform under our collaboration agreement with Rapport Therapeutics, Inc., or Rapport, including the extension executed in June 2025, to provide data, biomarker monitoring, and analysis services in support of Rapport’s clinical trial. The arrangement is expected to continue through th…

• gross margin such as the cost of materials, components and subassemblies, pricing, procedure mix, and geographic sales mix to the extent that we commercialize our RNS System outside of the United States.

• We concluded that the abandonment of our DIXI Medical product operations constituted a strategic shift in our business. Accordingly, the historical operating results attributable to the DIXI Medical product operations have been presented as discontinued operations, and the related assets and liabili…

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• As previously announced, our exclusive distribution agreement with DIXI Medical USA Corp., or DIXI Medical, expired on September 30, 2025. Under the agreement, entered into in August 2022, we served as the exclusive U.S. distributor of DIXI Medical’s stereo electroencephalography, or Stereo EEG, pro…

• We continue to perform under our collaboration agreement with Rapport Therapeutics, Inc., or Rapport, including the extension executed in June 2025, to provide data, biomarker monitoring, and analysis services in

• support of Rapport’s clinical trial. The arrangement is expected to continue through the first half of 2028. There were no material changes to the agreement during the three months ended March 31, 2026.

• inventories based on assumptions about future demand, past usage, changes to manufacturing processes and overall market conditions.

• Comparison of the Three Months Ended March 31, 2026 and 2025

Text added vs the prior filing · source: 10-Q · 2026-08-11

• •We rely on the proper function, security and availability of our information technology systems and data, as well as those of third parties throughout our supply chain and our customer base, to operate our business, and a security breach, cyber-attack or other disruption to these systems or data co…

• or develop opportunities outside of Level 4 CECs, in the community setting, our sales, business, financial condition and results of operations would be harmed.

• Our commercial success will depend in large part on continued referrals of appropriate patients from treating primary care physicians, neurologists, and other healthcare providers to epileptologists, neurosurgeons, and other clinicians, primarily at Level 4 CECs. We cannot predict how quickly, if at…

• adjust our manufacturing operations to reduce fixed costs, which could lead to uncertainty and delays in manufacturing times and quality during any transition period.

• The manufacturing, sterilization and distribution of our products are technically challenging. Changes that our suppliers may make, or additional requirements from regulatory agencies, outside of our direct control can have an impact on our processes, on quality and on the successful or timely deliv…

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• Our commercial success will depend in large part on continued referrals of appropriate patients from treating primary care physicians, neurologists, and other healthcare providers to epileptologists, neurosurgeons, and other clinicians, primarily at Level 4 CECs. We cannot predict how quickly, if at…

• at the Level 4 CECs and in the community setting to build a pipeline through our sales and marketing efforts and whether primary care physicians, neurologists, and other healthcare providers, as well as whether caregivers will support use of our RNS System in the community setting or patient referra…

• The manufacturing, sterilization and distribution of our products are technically challenging. Changes that our suppliers may make, or additional requirements from regulatory agencies, outside of our direct control can have an impact on our processes, on quality and on the successful or timely deliv…

• party, including single source, suppliers, subjects us to a number of risks that could impact our ability to manufacture our products and harm our business, financial condition, and results of operations, including:

• These components, materials, and services, which also include silicone adhesive, integrated circuits and other components, are critical, and there are relatively few alternative sources of supply. We believe our single-source suppliers are capable of continuing to meet our specifications and maintai…

Text added vs the prior filing · source: 10-Q · 2026-08-11

• During the three months ended June 30, 2026, Lisa Andrade, a director of the Company, adopted a written trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act. The plan was adopted on June 3, 2026 and provides for the exercise of up to 27,380 sto…

• No other director or officer (as defined in Rule 16a-1(f) under the Exchange Act) adopted, modified or terminated any contracts, instructions, or written plans for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Excha…

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• During the quarter ended March 31, 2026, none of our directors and officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted, modified or terminated any contracts, instructions, or written plans for the purchase or sale of our securities that was intended to satisfy the affirmative defen…