ExaMD, an ExaWizards Group Company, and EPS Group Establish Medical Device Industry’s First*¹ Value Chain for SaMD, from Clinical Development to Sales — Scheme to be Implemented for Medical AI Gait Analysis App “LocoStep” to Accelerate Future SaMD Sales —
ExaMD Inc. (Minato-ku, Tokyo; Representative Director, Koji Hazama; hereafter, “ExaMD”), a group company of ExaWizards Inc. (Minato-ku, Tokyo; Representative Director and President, CEO, Makoto Haruta, hereinafter, “ExaWizards”), that develops and provides AI services specializing in the health and medical fields, has entered into a business alliance agreement with EP-PharmaLine Co., Ltd. (Toshima-ku, Tokyo; President: Yutaka Ise), a subsidiary of EPNextS, Inc. regarding the sales of Software as a Medical Device (SaMD). This partnership completes the value chain for SaMD developed by ExaMD, from sales to credit management.
This collaboration also establishes a one-stop system from development to post-market sales, which is expected to shorten development-to-sales timelines and reduce costs. As the first initiative, this scheme will be introduced for the medical AI gait analysis app “LocoStep,”*² which launched on July 1, to accelerate its sales.
☑︎Purpose of Establishing the New Sales and Credit Management Scheme
While SaMD is anticipated to be a new market in the medical field with high potential for use in clinical settings, a sales and distribution model that maximizes its unique characteristics has yet to be established. For startups in particular, building a nationwide sales network targeting medical institutions and establishing a system for contracts, billing, and credit management pose significant burdens, becoming major obstacles to the widespread adoption of SaMD.
To address these challenges, ExaMD has combined its AI and digital service development capabilities with EP-PharmaLine’s extensive assets, expertise, and broad network cultivated in the medical industry to build an efficient and scalable sales and distribution scheme optimized for SaMD.
☑︎ Value and Innovation of the New Scheme
We believe the great value of this scheme lies in its ability to dramatically improve convenience for both the sales side and medical institutions by fully leveraging the characteristics of digital products, rather than relying on conventional, labor-intensive sales agency models. This is expected to enhance the productivity of SaMD development and sales.
・Innovative Collaboration Model: By integrating ExaMD’s AI technology with EP-PharmaLine’s extensive operational support assets, we will create a new supply chain optimized for the fast-evolving digital health sector.
・Drastic Reduction of Operational Burden: We will build and provide a digital service that handles all sales-related operations seamlessly, from promotion to user contracts with medical institutions, usage fee billing, and payment management. This will eliminate cumbersome administrative procedures for medical institutions, creating an environment where doctors and staff can focus on their core medical duties.
☑︎ Future Plans
As the first step, ExaMD and EP-PharmaLine will jointly begin operating this scheme for the sales of the medical AI gait analysis app “LocoStep.” Based on the insights gained, we will further evolve this scheme and aim to build a platform applicable not only to other SaMD developed by ExaMD but also to a wide range of digital health services. By establishing an integrated support system from clinical development to sales and distribution, ExaMD will contribute to the rapid social implementation of outstanding medical AI technologies.
☑︎ Past Initiatives of ExaMD and the EPS Group
Since the announcement of their business alliance in August 2024,*³ ExaMD and the EPS Group have been collaborating to achieve the industrialization of diagnostic SaMD. By leveraging their respective strengths, they have built a system that provides end-to-end support from AI development to sales, including the establishment of an optimized, low-cost clinical development scheme.*⁴ Going forward, both companies will continue to share information on their initiatives in post-clinical development phases, such as credit management and sales, to contribute to the overall development of the industry.
*1 Based on in-house research conducted in June 2025 in the medical device industry.
*2 ExaMD, an ExaWizards Group Company, Launches LocoStep, Japan’s First*1 AI Gait Analysis Application Covered by Reimbursement
*3 ExaMD, a Subsidiary of ExaWizards Group, Partners with EPNextS to Develop Digital Services
*4 ExaMD, a Member of the ExaWizards Group, Partners with EPS Group Launching Accelerated Clinical Development for Diagnostic SaMD Commercialization
【ExaMD Corporate Profile】
Company name: ExaMD Inc.
Location: 4-2-8 Shibaura, Minato-ku, Tokyo, 5F
Established: February 2024
Representative: Koji Hazama, Representative Director
Business: Planning, development, sales, and alliance of products and services using multi-modal AI technology to solve social issues related to healthcare
URL: https://examd.com/
【ExaWizards Corporate profile】
Company name: ExaWizards Inc
Location: 4-2-8 Shibaura, Minato-ku, Tokyo, 5F
Established: February 2016
Representative: Makoto Haruta, Representative Director & President CEO
Business: Industrial innovation and resolution of social issues via AI service development
URL: https://exawizards.com/en/
<Media Contact>
ExaWizards Inc. Public Relations: publicrelations@exwzd.com