InnoJin Inc., a startup originating from Juntendo University, applied for and was selected for the "FY2024 ICT Startup League," a program initiated by the Ministry of Internal Affairs and Communications' "Startup-Creating Seed Stage Research and Development Support Project."

The ICT Startup League, which started in FY2023, is initiated by the Ministry of Internal Affairs and Communications' "Startup-Creating Seed Stage Research and Development Support Project." It is a program in which the Ministry of Internal Affairs and Communications, along with experts, companies, and organizations from the private sector who have expertise in startups, work together to provide support and a platform for competition necessary for the establishment and growth of startups in the ICT field.

*ICT Startup League Official Website

https://ict.startupleague.go.jp/

The details of the selection for this project are as follows.

◆ Title of Selected Project

"Development of a pediatric amblyopia training software medical device using VR (Virtual Reality)"

◆ Research and Development Period

Late June 2024 – Late February 2025

◆ Background

Amblyopia is characterized mainly by poor vision in one or both eyes, with an incidence rate of approximately 1–5% in children. There are approximately 210,000 amblyopia patients in Japan, and the resulting social loss is estimated to be approximately 2.2 trillion yen. Treatment for amblyopia involves wearing fully corrective glasses and performing amblyopia training using occlusion therapy, such as an eye patch (covering the healthy eye and forcing the use of the amblyopic eye). However, the critical period for human visual development yields up to age 8, and adequate therapeutic effects cannot be expected unless appropriate treatment is initiated by this age.

Although amblyopia screening is conducted during the 3-year-old health checkup in Japan, it has been reported that about 60% of amblyopia patients are missed, with more than half of pediatric amblyopia cases discovered during subsequent school entrance or school health checkups. In addition, amblyopia training using occlusion with an eye patch requires a daily occlusion time that increases with the child's age, causing a greater physical and psychological burden. If the burden of amblyopia treatment is heavy, it leads to a reduction in treatment efficacy due to poor adherence, such as children refusing to wear the eye patch or parents discontinuing occlusion at their own discretion. Therefore, an alternative amblyopia training method with less physical and psychological burden and high therapeutic efficacy is highly desired.

◆ Content

During this support period, we will receive assistance for: 1) establishing the business and brushing up the business plan for the pediatric amblyopia training software medical device (this product) using VR (Virtual Reality), 2) studying strategies for creating new SaMD through medical applications of VR using this product as a foothold, and 3) pioneering a new market as a Japanese-born SaMD intended for DTx. Through this, we aim to grow into a startup that leads global digital health from Japan.

◆ Future Prospects

We will conduct safety verification trials and confirmatory investigator-initiated clinical trials of this product in children, aiming for market launch as a Class II software medical device.

By socially implementing this product, we aim to realize amblyopia treatment in a short period with less physical and psychological burden on pediatric patients compared to conventional treatment methods, creating a future where no child is left with a visual handicap.