Announces the PMDA preliminary comprehensive evaluation consultation for ExaMD\u2019s cognitive function AI diagnostic support app. Advancing fixed data for clinical trials and statistical analysis, aiming for manufacturing and marketing approval and early market introduction within FY2026. The impact on consolidated results for FY2027 is expected to be minor, with further assessment planned.<\/p>\n","protected":false},"comment_status":"open","ping_status":"closed","template":"","meta":{"Ticker":"","DATE":"","longName":"","company_name_ja":"","fullTimeEmployees":0,"address":"","phone":"","website":"","industry":"","sector":"","regularMarketPrice":0,"financialCurrency":"","marketCap":0,"fiftyTwoWeekLow":0,"fiftyTwoWeekHigh":0,"epsTrailingTwelveMonths":0,"epsForward":0,"bookValue":0,"totalRevenue":0,"OperatingIncome":0,"operatingMargins":0,"NetIncome":0,"profitMargins":0,"ebitda":0,"trailingPE":0,"forwardPE":0,"priceToBook":0,"returnOnEquity":0,"recommendationMean":0,"recommendationKey":"","targetMeanPrice":0,"numberOfAnalystOpinions":0,"analyst_earnings_data":"","dividendRate":0,"dividendYield":0,"payoutRatio":0,"totalEsg":0,"environmentScore":0,"socialScore":0,"governanceScore":0,"title":"","providerPublishTime":"","link":"","longBusinessSummary":"","longBusinessSummary_ja":"","quarterly_revenue":0,"quarterly_net_income":0,"quarterly_operating_profit":0,"enterprise_value":0,"company_officer_1_name":"","company_officer_1_title":"","company_officer_2_name":"","company_officer_2_title":"","company_officer_3_name":"","company_officer_3_title":"","company_officer_4_name":"","company_officer_4_title":"","company_officer_5_name":"","company_officer_5_title":"","company_officers_update_time":"","get_dividend_history_year1":0,"get_dividend_history_year2":0,"get_dividend_history_year3":0,"get_dividend_history_year4":0,"get_dividend_history_year5":0,"get_dividend_history_year6":0,"get_dividend_history_year7":0,"get_dividend_history_year8":0,"get_dividend_history_year9":0,"get_dividend_history_year10":0,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"jir_stock_code":"4259","jir_company_name":"ExaWizards, Inc.","jir_importance":"\u2605\u2605\u2605\u2606\u2606","jir_publication_date":"2026-08-20","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/08\/4259-20260820-01.pdf","jir_short_summary":"Announces the PMDA preliminary comprehensive evaluation consultation for ExaMD\u2019s cognitive function AI diagnostic support app. Advancing fixed data for clinical trials and statistical analysis, aiming for manufacturing and marketing approval and early market introduction within FY2026. The impact on consolidated results for FY2027 is expected to be minor, with further assessment planned.","jir_summary":"### Section Heading\nThis notice informs that ExaMD, the subsidiary, is developing a cognitive function AI diagnostic support SaMD, and that the PMDA has accepted and initiated the Preliminary Comprehensive Evaluation Consultation. Trials will continue data locking and statistical analysis, leveraging the priority review designation to accelerate preparations for approval submission. It outlines an outlook toward obtaining manufacturing and marketing approval and starting sales within FY2026, with the impact on FY2027 performance deemed minor at present.\n\n### Second Section Heading\nLooking ahead, by parallel with the start of the preliminary comprehensive evaluation consultation, evaluations of clinical and non-clinical data, QMS, and reliability will be organized with the PMDA in advance to streamline reviews and shorten review timelines. Data locking will promptly advance statistical analysis to maximize the benefits of the priority review designation. Financial impact is currently limited, and additional information will be disclosed as it becomes available.","jir_financial_highlights":"Impact on full-year consolidated results for FY2027: Unknown (expected to be minor but not confirmed)\nProgress of fixed data and statistical analysis for clinical trials: As of August 2026 (observation completed; moving to data lock and statistical analysis)","jir_category":"","jir_hashtags":"# ExaMD, # PreliminaryComprehensiveEvaluationConsultation, # CognitiveFunctionAIDiagnosticSupport","jir_key_figures":"Progress of fixed data and statistical analysis for clinical trials (observation completed, data locked, statistical analysis)\nAiming to obtain manufacturing and marketing approval and early market launch within FY2026\nImpact on FY2027 full-year consolidated results minor, no revisions","jir_meta_title":"ExaWizards: Preliminary Comprehensive Evaluation Consultation for ExaMD Started | Fixed Clinical Trial Data and Accelerated Approval","jir_meta_description":"ExaWizards subsidiary ExaMD begins PMDA preliminary comprehensive evaluation consultation. Fixed clinical trial data and statistical analysis are advancing toward manufacturing and marketing approval within FY2026 and early market launch. Impact on FY2027 is expected to be minor; additional information will be disclosed as available.","jir_og_title":"ExaMD: Preliminary Comprehensive Evaluation Consultation Commences | Accelerating Approval Process","jir_og_description":"ExaMD announces the PMDA preliminary comprehensive evaluation consultation for its cognitive function AI diagnostic support app. Progressing fixed clinical trial data and preparation for approval submission to target approval and market launch within FY2026.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":17334,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"m_and_a_alliance","footnotes":""},"sector":[],"importance":[],"class_list":["post-105627","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n