Financial Data and Key Metrics Changes - The operating revenue for FY 2025 was USD 21.8 million, reflecting a 6% year-on-year increase [10] - Total laboratory throughput decreased by 11.5% year-on-year to 28,894 tests, but remained stable in the second half of the year [10] - The average U.S. sales price increased to USD 5.94 from USD 5.84 the previous year [11] Business Line Data and Key Metrics Changes - The company achieved significant milestones, including the inclusion of CX-beta Triage in the AUA's MicroHematuria guidelines with a Grade A evidence rating [6][7] - The draft pricing from Medicare for TriagePlus was set at USD 10.18 per test, a substantial increase from the previous USD 760 [8] - The transition from CX Bladder Detect to Triage was noted, with volumes remaining relatively stable despite the loss of one salesperson [12] Market Data and Key Metrics Changes - Medicare coverage loss accounted for approximately 56% of FY 2025 revenues, leading to a strategic shift towards commercial payers [9][27] - Non-Medicare volumes represented 47% of U.S. commercial volumes in FY 2025, up from 40% in the prior half [40] - The company is experiencing a shift in payer mix towards more commercial insurance, reducing reliance on Medicare [41][48] Company Strategy and Development Direction - The company aims to leverage the AUA guidelines to enhance sales, marketing, and reimbursement activities [68] - Plans include raising capital to support the commercialization of Triage and TriagePlus, and to maintain investment in clinical research [14] - The strategy focuses on increasing throughput and sales efficiency while adapting to the changing reimbursement landscape [69] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment over the loss of Medicare coverage but highlighted resilience in financial performance [10] - The inclusion of AUA guidelines is expected to drive test adoption and deepen clinician engagement [12] - Future plans include seeking reimbursement through the Medicare appeals process and expanding access to TriagePlus [30][48] Other Important Information - The company raised USD 16.1 million through institutional placements and USD 4.7 million through a share purchase plan [14] - The CEO emphasized the importance of evidence generation in changing clinical practice and securing reimbursement [25] - The company is working towards developing an in vitro diagnostic (IVD) product for international markets [66] Q&A Session Summary Question: How do auditors ensure the management's claims are valid in a scientific company? - The audit procedures remain consistent regardless of the industry, focusing on financial reporting and validation processes [82][84] Question: What is the significance of the AUA guidelines for the company? - The AUA guidelines enable the use of urine-based biomarkers for intermediate risk patients, enhancing market opportunities and reducing unnecessary procedures [20][22]

Core Viewpoint - NeuroPace, Inc. has responded positively to the Centers for Medicare & Medicaid Services (CMS) decision not to finalize the proposed reassignment of epilepsy neurostimulator cases in the FY 2026 Inpatient Prospective Payment System (IPPS) rule, maintaining the current reimbursement structure for its RNS System procedures [1][2]. Company Overview - NeuroPace, Inc. is a medical technology company based in Mountain View, California, focused on improving the lives of individuals with epilepsy by reducing or eliminating seizures through its innovative RNS System [3]. - The RNS System is the first and only commercially available brain-responsive platform that provides personalized, real-time treatment at the source of seizures, aiming to enhance care for patients with drug-resistant epilepsy and potentially benefiting those with other brain disorders [3]. Regulatory Engagement - The company appreciates CMS's willingness to consider public comments and its decision to retain the existing MS-DRG assignment for RNS System procedures, which supports hospitals serving Medicare beneficiaries with epilepsy [2]. - NeuroPace plans to continue collaborating with CMS on improvements related to MS-DRG and reimbursement policies to ensure access to the RNS System for all eligible patients [2].

"The Health Tech Investment Act reflects a shift in national health policy toward supporting intelligent, patient- centered innovations," said Mark White, CEO of Nexalin. "Our Gen-3 HALO Clarity™ device exemplifies that approach — combining precision neurostimulation with AI-driven tools that improve care coordination, monitoring, and adherence. This legislation provides a reimbursement path that recognizes and supports this model of care." Proposed bipartisan legislation would expand Medicare reimbursement ...