ExaMD

Name

ExaMD

Legal name

株式会社ExaMD

Website

https://examd.com

Company type

Private

Founded year

2024

Operating status

Operating

Ownership category

akta.pro rank

Product category

Medical AI Software

NAICS

Offices of Physical, Occupational and Speech Therapists, and Audiologists (62134)

SIC

Services-Health Services (8000)

akta.pro primary industry

SaMD – Imaging & Signal Analysis (AI/ML) (HLACANAG)

akta.pro secondary industry

Neurological Monitoring (EEG, Seizure/Sleep/Neuro Wearables) (HLAHACAE)

Keywords

• Medical AI software
• Gait analysis app
• Dementia diagnostics
• Software as medical device
• Cognitive function assessment

Headquarters

HQ city

Tokyo

HQ country

Japan

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Personnel, Marketing or Sales, Operations

Revenue model

1. Medical Device Sales (LocoStep): Sale of the LocoStep AI gait analysis app to healthcare institutions. Insurance reimbursable under Japanese national health insurance (250 points per analysis under D250 balance function examination, 5-motion analysis test). Revenue from per-use or subscription fees after free trial registration.
2. SaMD Development and Commercialization: CogniVoice and Dual-Task dementia diagnosis AI programs in development as Software as a Medical Device (SaMD). Once approved, revenue from sale of the medical device programs to healthcare institutions.
3. Clinical Development & Commercialization Support Services: End-to-end support services for SaMD development from software development, clinical development, regulatory affairs (pharmaceutical affairs), quality control, distribution, and manufacturing/commercialization. Also provides healthcare AI business development support from new business conception through product design, verification, regulatory compliance, quality management, and market introduction.
4. API / AI Model Licensing: CogniTalk offered via API integration to enterprise customers (insurance, finance, telecommunications companies), allowing embedding of cognitive function scoring into existing platforms. Also offered as edge AI for on-premises deployment and custom solution development.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels5 records

Core offering

ExaMD develops and commercializes multimodal AI software for healthcare assessment. Its flagship LocoStep is a Class I medical device smartphone app that quantifies gait function from short walking videos using markerless AI. CogniTalk is a voice AI service that scores cognitive function on a 10-point scale from 30 seconds of conversation. Two additional SaMD programs (CogniVoice and Dual-Task) for dementia diagnosis are in regulatory consultation with PMDA. The company also provides SaMD and medical AI business development support services.

Product overview

ExaMD operates as a medical device and digital health company offering a portfolio of AI-powered products for gait analysis and dementia/cognitive function assessment. Core products include LocoStep (commercially available gait analysis medical app), CogniTalk (healthcare voice AI service), and two SaMD programs under development for dementia diagnosis support (CogniVoice and Dual-Task). These products utilize multimodal AI technology combining speech/audio processing and computer vision to quantify health metrics from smartphone-captured data. The portfolio is complemented by business development support services for SaMD commercialization and medical/health AI market entry.

Differentiator

Problem solved

Functional benefit

Brands

• LocoStep: AI歩行分析アプリ - スマホで撮影した歩行動画からAIが歩行機能を可視化する医療用アプリ（一般医療機器クラス1）
• CogniTalk
• CogniVoice
• デュアルタスク 認知症診断AIプログラム

Products and services

• LocoStep (ロコステップ) AI gait analysis medical app that quantifies gait function from ~5m walking videos captured on a smartphone/tablet using markerless computer vision. Extracts 17 skeletal points to analyze gait speed, balance, step time, pelvic position, foot position, and other biomechanical indicators. Registered as a Class I General Medical Device and insurance-reimbursable under Japanese national health insurance (D250, 250 points per analysis). Used by physicians and physical therapists at clinics and hospitals for diagnosis, rehabilitation, and pre/post-surgical evaluation.
• CogniTalk Healthcare voice AI service that visualizes cognitive function through analysis of 30 seconds of conversational voice, producing a 10-level cognitive function score with approximately 90% accuracy. Delivered via REST API integration, edge AI for on-premises deployment, iOS application, or custom solution development. Only voice AI program medical device designated as innovative technology by Japan's Ministry of Health, Labour and Welfare. Security design compliant with Three Ministries and Two Guidelines (3省2ガイドライン) for healthcare/medical data handling.
• CogniVoice (会話音声 認知症診断支援AIプログラム) Program medical device (SaMD) under development for dementia diagnosis support via analysis of approximately 1 minute of free conversational voice using proprietary AI technology. Co-developed with Showa University and Kanazawa University. Designated for priority review by MHLW under the innovative program medical device system. Clinical studies demonstrated accuracy of 0.950, sensitivity 0.875, specificity 1.000, AUC 0.990 (PLOS ONE peer-reviewed publication).
• Dual-Task Dementia Diagnosis AI Program (デュアルタスク 認知症診断支援AIプログラム) Program medical device (SaMD) under development for dementia diagnosis support co-developed with Osaka University Institute of Industrial Science. Combines a simple stepping exercise with arithmetic tests simultaneously, analyzed by proprietary AI to support dementia diagnosis. Clinical research demonstrated over 90% accuracy. Currently in PMDA pre-consultation for regulatory approval in Japan.
• SaMD Business Development Support Services (SaMD事業化支援) End-to-end SaMD commercialization support service covering software development, clinical development, pharmaceutical affairs (regulatory), quality control, distribution, and manufacturing/sales. Standardizes and industrializes the SaMD value chain to achieve speed and cost optimization for medical device commercialization. Enabled by ExaMD's EPS Group partnership achieving the first complete SaMD value chain from clinical development to sales in Japan's medical device industry.
• Medical/Health AI Business Development Support Services (医療健康領域AI事業化支援) Business development support service integrating AI development expertise with knowledge from collaborative research with medical institutions and academia. Supports new business conceptualization, product design, verification, regulatory compliance, quality management, and market introduction for medical and healthcare AI products.

Quantifiable outcome

• ~90% accuracy in dementia diagnosis from ~1 minute of free conversation (CogniVoice SaMD)
• +3 more outcomes

Named customers5 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

AI capability9 records

Feature5 records

Partnerships

Seven partnerships are on record, tiered flagship and core.

• EPS GroupflagshipStrategic or Co-development Partner · 1 July 2025ExaMD and EPS Group achieved the first complete SaMD value chain from clinical development to sales in Japan's medical device industry. This partnership enables end-to-end commercialization of SaMD products from development through manufacturing, clinical trials, regulatory approval, and market distribution.
• Juntendo University (順天堂大学)coreStrategic or Co-development Partner · 1 May 2025ExaMD and Juntendo University co-developed the LocoStep AI gait analysis app. Prof. Tamura Yoshifumi from Juntendo University's Graduate School of Medicine serves as the supervising physician for LocoStep. Clinical validation and medical expertise provided by the university's sports medicine and endocrinology department.
• Okinawa Innovation Ecosystem (沖縄イノベーション・エコシステム)flagshipStrategic or Co-development Partner · 1 January 2025ExaMD participates in Okinawa Prefecture's Health Longevity Revival Ecosystem initiative. Working with Ryukyu University venture company Ryuwell and intra/extra-prefectural industry-academia-medicine partners, ExaMD validates CogniTalk's AI voice analysis technology for dementia prevention and early screening, aiming to build a nationally scalable preventive healthcare model.
• Showa University (昭和大学)coreStrategic or Co-development Partner · 1 June 2023ExaMD co-developed the CogniVoice conversation-voice dementia diagnosis AI SaMD with Showa University. Clinical-level accuracy (~95%) was confirmed through clinical studies at Showa University, forming the basis for PMDA consultation and subsequent publication in PLOS ONE.
• Osaka University Industrial Science Research Institute (大阪大学 産業科学研究所)coreStrategic or Co-development Partner · 1 May 2023ExaMD entered a joint research agreement with Osaka University Industrial Science Research Institute to develop the Dual-Task dementia diagnosis AI SaMD. The collaboration aims to use voice, language, and image analysis technologies for early disease detection and progression monitoring.
• Kanazawa University (金沢大学)coreStrategic or Co-development Partner · 1 January 2023ExaMD co-developed dementia diagnosis AI with Kanazawa University. Research findings from collaboration with Showa University and Kanazawa University were published in PLOS ONE, demonstrating AUC 0.990, sensitivity 0.875, specificity 1.000 in cognitive impairment detection.
• Kite Corporation (カイト株式会社)flagshipTechnology or IntegrationExaMD provides CogniTalk API to Kite Corporation, which operates 'Oshiruko,' an SNS app exclusively for people aged 50 and older. CogniTalk API is embedded in the AI conversation service to visualize cognitive function of elderly users during natural app interactions, enabling scalable early dementia screening through an existing social platform.

Scale indicators5 records

Recent moves7 records

Expansion highlights5 records

Emerging players

• Kintsugi: Kintsugi uses voice biomarker AI to detect depression and mental health conditions from short voice clips. An emerging player in voice-based health AI that overlaps with ExaMD's voice analysis expertise, though focused on mental rather than cognitive health.
• Akili Interactive: Akili Interactive develops prescription digital therapeutics for cognitive dysfunction (ADHD, multiple sclerosis, depression). Comparable to ExaMD in the cognitive-health digital therapeutic category, though focused on treatment rather than screening.

Broad incumbents

• Click Therapeutics: Click Therapeutics is a prescription digital therapeutics company developing software-based treatments across neurology, psychiatry, and cardiology. Comparable to ExaMD as a regulated SaMD/digital therapeutics player, though with broader therapeutic scope and US-centric commercialization.
• Huma (formerly Medopad): Huma is a broader digital health platform combining remote patient monitoring, SaMD, and AI biomarkers across multiple therapeutic areas. Overlaps with ExaMD on SaMD commercialization capabilities and remote monitoring, but operates a much wider portfolio across geographies and conditions.

Direct peers

• Ellipsis Health: Ellipsis Health builds voice biomarker technology to detect depression, anxiety, and cognitive conditions from short speech samples. Comparable to CogniTalk/CogniVoice in modality (voice AI), output (clinical scoring), and target customers (healthcare, payers).
• Sonde Health: Sonde Health develops voice-based AI biomarkers for cognitive and mental health conditions, with multiple enterprise and clinical deployments. It is directly comparable to ExaMD's CogniTalk and CogniVoice, both leveraging short voice samples analyzed by proprietary AI to detect cognitive decline.
• Modality.AI: Modality.AI provides AI-powered speech-based cognitive and neurological assessment for clinical trials and remote patient monitoring. It competes head-to-head with ExaMD's voice-based cognitive screening technology, targeting pharma and healthcare customers.
• Cognivue: Cognivue develops FDA-cleared digital cognitive assessment devices for early detection of memory impairment and dementia. Directly comparable to ExaMD's dementia screening products (CogniTalk, CogniVoice) in clinical purpose and target user (primary care and specialists screening for cognitive decline).
• BioSensics: BioSensics develops wearable sensors and AI algorithms for gait, balance, and fall-risk assessment in clinical and home settings. Directly comparable to ExaMD's LocoStep in terms of gait analysis and fall-prevention clinical use cases, though using dedicated wearables rather than a smartphone-only approach.
• Kinesis Health Technologies: Kinesis Health Technologies produces QTUG, an evidence-based falls and mobility assessment technology used in clinical and eldercare settings. Comparable to LocoStep in gait/falls clinical use case and target customer (clinicians, eldercare providers).

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about ExaMD