Nice to meet you all. My name is Chizu Shirakata, Representative Director and Chairperson of Social Services Co., Ltd. We are a healthcare and ag-tech venture currently developing nine Software as a Medical Device (SaMD) products. Today, I would like to introduce the SaMD digital application we are passionately developing to prevent and improve postpartum depression. We are currently in our seed stage.
First, let me share the profound personal experience that drove me to start this business.
For over a decade, our company has produced the official medical journal for the Japan Association of Obstetricians and Gynecologists. Through this, we spent more than 10 years supporting families of children born with severe congenital disabilities. We worked closely with medical associations and local facilities, facilitating lobbying efforts and visiting local centers to strengthen support networks.
During those visits to local disability care facilities, I heard a shocking truth.
"Among the children entering our facility today, the number of those with acquired disabilities caused by abuse from their biological parents after birth—leaving them unable to move, wearing headgear, and using wheelchairs—has surpassed the number of children with congenital disabilities."
Even more tragic, these children still deeply loved their mothers and begged to return home. Yet, when they did return home, they were subjected to even worse abuse and sent back to the facility in a devastated state.
Confronted with this heartbreaking reality, I realized that if we do not save the mothers' mental health at the earliest stage, we cannot save the children's lives. This was the origin of our partnership with the medical association to venture into perinatal mental health care.
In Japan, "perinatal depression" (postpartum depression) affects approximately 20% of healthy pregnant and postpartum women who have absolutely no history of mental illness. That is a staggeringly high rate of one in five mothers. Yet, they are left in the gaps of medical care, completely falling into the "pocket of unmet medical needs" where there are no proper consultation services or early treatment options. This is the severe reality of postpartum depression in Japan today.
To bridge this critical gap in medical care, we aimed to resolve the problem with a digital therapeutic application that acts as a surrogate for specialists.
The app we developed includes screening questions to visualize a mother's mental state, as well as methods to eliminate key causes of postpartum depression, such as a lack of understanding about babies and relationship stress with those around them.
We paid special attention to the Cognitive Behavioral Therapy (CBT) session function. Because many postpartum mothers strongly wish to breastfeed, they are highly reluctant to use pharmacotherapy, such as antidepressants. This makes digitalizing drug-free CBT exceptionally effective for managing mental health. Furthermore, to prevent tragic outcomes like self-harm or murder-suicide, we implemented alert functions for high-risk detection and a management dashboard for municipalities and doctors to track their status.
Because we operate in close proximity to clinical sites and academic societies, we were able to directly transplant the advanced individual care methods used by front-line specialists into the app's algorithm.
This initiative was certified as part of the Tokyo Metropolitan Government's "17th Transition Medicine Hub" project, granting us 30 million yen in subsidies for a 50 million yen project budget.
With this support, we passed the ethical review of the National Center of Neurology and Psychiatry (NCNP)—the highest authority in psychiatric research in Japan—and conducted a full-scale, physician-intervened clinical trial over two years.
The clinical trial demonstrated that using our app could reduce the risk of developing postpartum depression by approximately 10%.
Most notably, the app achieved an exceptionally high retention rate. Generally, while pregnant women have time, they become incredibly busy the moment they give birth and stop using smartphone apps entirely. However, our app achieved a high retention rate of over 80% and outstanding usability, which is unprecedented in Japan for postpartum mothers. We have received numerous expressions of deep gratitude from users saying they were truly saved.
Behind this overwhelming retention is a precise content design that directly addresses the nine real problems postpartum mothers face, such as "difficulty breastfeeding," "the baby won't stop crying," and "relationship deterioration with the partner." The specialized methods of Japan's top experts, who have dedicated their lives to researching postpartum depression, reside in every detail of this app. This is why it continues to capture the hearts of mothers.
Let me explain our roadmap and business model going forward.
Initially, we aimed to develop the app to obtain regulatory approval as a standalone Software as a Medical Device (SaMD). However, in Japan's healthcare system, obtaining approval for a new digital medical device faces high hurdles, such as the presence of medical fee points and the lack of standard treatment guidelines. For a venture company to break through this barrier requires massive time and capital.
Therefore, we have decided to pivot our strategy significantly starting next year.
While keeping regulatory approval as a SaMD as our final goal, we will target the public budgets of postpartum care and accompanying consultation support projects implemented by municipalities nationwide to secure immediate monetization and adoption.
Currently, the government allocates generous subsidies and budgets for child-rearing support to local governments. However, local governments only capture 7% of high-risk pregnant and postpartum women, meaning 93% receive no care due to resource shortages. We will deploy our app to municipalities as a surrogate tool to fill this 93% gap.
The business model consists of two stages.
In the first stage, municipalities contract the system using public funds, allowing local mothers to download the native app onto their smartphones for free.
In the second stage, after building a track record and collecting data in municipalities as a healthcare app, we will leverage our strength of building the app strictly in accordance with QMS (Quality Management System) standards to obtain insurance reimbursement as a prescribed SaMD through doctors' prescription codes.
The risk of maternal suicide and murder-suicide peaks during the critical period up to four months after birth, and a one-year continuous care period is recommended under the postpartum care framework. We will build an infrastructure to monitor mothers 24/7 during this high-risk year to prevent tragedies.
Our core team currently consists of only three members: myself, a physician specializing in AI analysis and engineering, and an administrative manager. However, behind us, we have strong guidance and backing from top obstetricians and psychiatrists, including the Japan Association of Obstetricians and Gynecologists and the NCNP.
We invite municipal officials and investors to partner with us in resolving postpartum depression, a massive social issue in Japan, and building an infrastructure to save the lives of mothers and children. Thank you very much.
Commentator (Mr. Fukutani): Thank you, Ms. Shirakata, for the wonderful presentation. I have a wife and child myself, so I understand the hectic nature and mental burden of the pre- and post-natal periods. Looking back, I feel I was unable to do anything meaningful to support my wife at the time. Therefore, I strongly feel that a service like this app, which prevents mothers from feeling isolated and provides a lifeline, is highly meaningful for society.
Regarding future business expansion, could you explain the details of your business model and how you plan to monetize and scale?
Ms. Shirakata: Thank you for the question. We have structured our monetization into a two-stage strategy.
The first step (First Stage) is a model targeting the public funds of the government's childcare and accompanying consultation support initiatives. Municipalities purchase the system, and pregnant and postpartum women in those regions download the native app onto their smartphones, enter the code issued by the municipality, and use it at zero personal cost.
The second step (Second Stage) is a business model where the app is introduced to medical institutions as a SaMD, prescribed by doctors, and eventually generates revenue through medical fees under national insurance reimbursement.
Mr. Fukutani): I see. Rather than mothers paying out of pocket, municipalities buy it with public funds to offer it to residents for free, and eventually, it will be prescribed by doctors and paid for by insurance.
However, mothers experiencing postpartum depression often do not realize they are depressed, or they lack the energy to search for and install an app. What kind of user acquisition channels and mechanisms have you designed to ensure this app reaches high-risk mothers who truly need care?
Ms. Shirakata: That is a very important point. Mothers do not search for and install this app thinking, "I am depressed, so I should use this."
Therefore, we introduce it as a practical problem-solving app to address nine real, specific challenges they inevitably face, such as "the baby won't stop crying," "difficulty breastfeeding," or "feeling frustrated with my partner." Because we approach them through daily child-rearing content rather than "depression treatment," we achieved a high retention rate of over 80% in our clinical trials.
Furthermore, we design a strong offline channel where public health nurses directly recommend installing the app during their home visits. By serving as an official, municipality-approved infrastructure, we reach not only the 7% of high-risk mothers already captured but also the 93% of hidden high-risk mothers.
Mr. Fukutani: I see. By framing it as a practical app for daily challenges and linking it with real-world home visits, you can reliably reach the high-risk population.
Lastly, how long do you expect mothers to use this app after giving birth? Please tell us the target usage period.
Ms. Shirakata: Medical data shows that the most tragic events, such as maternal suicide and murder-suicide, occur most frequently within four months after birth. Postpartum depression begins around one to two months, but physical and mental exhaustion peaks around the fourth month, leading to life-threatening situations. This is the critical warning period.
While the municipal postpartum care framework covers one year, and we recommend using it throughout that year, our primary target is to monitor and support mothers through the first four months, which represent the most dangerous phase.
Mr. Fukutani: I understand. Supporting mothers through the most dangerous four-month period using digital tools is a noble endeavor. I sincerely hope this service spreads rapidly to municipalities and those in need. Keep up the great work.
Ms. Shirakata: Thank you very much. We will do our utmost to save as many mothers and children as possible.