Universal Brain is working on developing a neuroscience-based psychiatric platform to establish the stratification and treatment of mental disorders. Pulse 2.0 interviewed Universal Brain founder and CEO Dr. Kazu Okuda to learn more about the company.
Dr. Kazu Okuda’s Background
What is Dr. Kazu Okuda’s background? Dr. Okuda said:
“As a physician turned entrepreneur, my journey into mental health innovation was deeply personal, rooted in my father’s battle with depression. This experience, coupled with my work at the university hospital, steered me toward psychiatry, where I was struck by the lack of precision involved in identifying and treating mental health conditions despite their complex and varied nature.”
“Recognizing the critical need for accessible brain function measures, I envisioned leveraging physiological data through electroencephalogram (EEG) and MRI to revolutionize psychiatric care. My mentor at the University Hospital in Japan, Dr. Shiganobu Kanba, a globally recognized and distinguished clinical scientist, played a pivotal role in refining this vision.”
“To turn my dream into reality, I embarked on a path of learning and discovery in the health-tech startup world. Joining Aillis, a medical-device AI startup, I was an advisor to the CEO/CFO’s office, helping raise $20 million and spearheading clinical research partnerships with university hospitals. This experience was instrumental in achieving marketing approval and reimbursement for our product in Japan, marking a significant milestone in our journey.”
“In 2022, I founded Universal Brain in the Bay Area, a culmination of my work and a step toward realizing our vision of developing a system that could leverage quantifiable brain-function measurement to advance precision psychiatry. Through Universal Brain, we aim to lead a transformative paradigm shift toward data-driven decision-making in mental health care, inspired by personal experience and driven by innovation.”
Formation Of Universal Brain
How did the idea for the company come together? Dr. Okuda shared:
“I founded Universal Brain after watching my own father battle depression in my youth and later seeing the same struggles in many of my patients. Due to the subjective nature of treatment, I didn’t see improvement in my father’s symptoms – and over time they only got worse. I founded Universal Brain with the goal of advancing precision psychiatry.”
“Our mission is rooted in the belief that leveraging the principles of neuroscience and incorporating objective brain function measures can revolutionize the way we understand and treat mental health conditions.”
“At the core of our commitment lies the development of neurotypes tailored to various mental health conditions, with a primary focus on depression. Our groundbreaking system combines the innovation of EEG wearables, ensuring that these technologies become more accessible to individuals seeking insights into their mental well-being. By harnessing the power of EEG and digital Event-Related Potential (ERP) insights, we can neurotype patients and provide users with valuable data to inform personalized and highly effective treatment decisions.”
Core Products
What are the company’s core products and features? Dr. Okuda explained:
“Universal Brain is advancing the emerging field of precision psychiatry. Our solution combines patient-friendly and affordable EEG wearables that measure electrical fluctuations in the brain called Event-Related Potentials (ERPs). These functional and interpretable brain measures identify data-driven neurotypes of patients within a condition, such as depression. Identifying these neurotypes enables clinicians to develop and deliver more patient-centric treatments.”
“In addition to supporting clinicians, our platform includes a neurofeedback solution that uses a patient-friendly EEG device and delivers at-home, scalable, drug-free treatment for patients. Based on data from the EEG, our neurofeedback solution uses a gamified user interface to help patients literally control their brain’s activity. The result has been sustained therapeutic effects without drugs, helping patients better control their brain’s activities from the comfort of their homes.”
Challenges Faced
What challenges have Dr. Okuda and the team faced in building the company? Dr. Okuda acknowledged:
“In 2020 – mid-2022, there was a significant global surge in interest in digital health and digital therapeutics. The approach of many startups was to secure large capital investments based on hefty valuations and rapidly advance product development to launch products into the market quickly. When I started my company, I initially planned a similar trajectory.”
“However, observing even the most impressive players in the field struggling with getting insurance reimbursement and establishing a viable business model, we decided to pivot our strategy. We focused on meticulously crafting our solution and developing compelling evidence that would be persuasive to all stakeholders, including patients, clinicians, insurance companies and investors.”
“As a result, we leveraged my psychiatric network in Japan, deepening collaborations with institutions like the Japan Imaging Center for Neurology and Psychiatry and the National Center of Neurology and Psychiatry. This partnership enabled us to validate the efficacy of our EEG-based solutions with fMRI studies and accelerate our clinical development process. Adding fMRI data to support EEG findings has repeatedly demonstrated the efficacy of our solution, holding it up to scientific scrutiny. Therefore, while the shifting market conditions significantly impacted our business plan, it ultimately led us to a better position, allowing us to focus on creating a valuable solution, a broader evidence base and a focused plan for commercialization and scale.”
Evolution Of Universal Brain’s Technology
How has the company’s technology evolved since launching? Dr. Okuda noted:
“Due to regulatory constraints, one characteristic challenge in medical device development is the difficulty of making significant changes to the system or user interface from the device used in clinical trials. Initially, my focus was on launching our solution as quickly as possible. Therefore, our development aimed to meet the minimum functional requirements for regulatory approval. Our first prototype was incredibly minimalistic, featuring a basic interface with minimal functionality.”
“However, it became clear that such an approach would not allow us to create a solution capable of generating the best evidence, including demonstrating patient engagement, before launch. Based on an advisor’s expert input and the market conditions, we decided to reset our development process with a focus on incorporating the desired actions for patients into a single product. As a result, Universal Brain’s solution has become extremely patient-oriented with recent clinical trials showing participants’ high adherence and satisfaction with our neurofeedback solution, as well as mental health outcome improvements.”
“This experience highlights the evolution from a minimalist and functionality-focused approach to a more patient-centered and evidence-driven development strategy. Looking ahead, we will enhance this focus on creating impactful, scientifically grounded products that engage patients, drive adherence and generate optimal outcomes.”
Significant Milestones
What have been some of the company’s most significant milestones? Dr. Okuda cited:
“Universal Brain accomplished a major milestone this year with the expansion of our executive team and the inception of a renowned scientific advisory board. Specifically, we recently appointed Greg Hajcak, PhD, as our chief scientific advisor. Dr. Hajcak has published more than 350 peer-reviewed publications and has been recognized with numerous prestigious awards.”
“Further, to strengthen our mission of using brain biomarkers to identify ‘neurotypes’ that allow clinicians to treat specific forms of depression and other psychiatric conditions, we have enlisted a scientific advisory board composed of renowned experts in the field.”
“In terms of business milestones, we have raised seed funding of $3.2 million and have advanced our product development and commercialization plan to close our Series A funding round by the end of the year.”
Differentiation From The Competition
What differentiates the company from its competition? Dr. Okuda affirmed:
“Most other digital solutions for mental health still fail to differentiate the wide heterogeneity within common mental health conditions. For example, 227 different combinations of symptoms meet the criteria for major depressive disorder, according to the American Psychiatric Association. At the same time, however, all newly diagnosed patients with depression typically receive the same treatment protocols, whether that is medication, cognitive behavioral therapy or a combination of interventions.”
“The absence of a data-driven approach to identify the numerous neurotpyes within a given mental health condition has produced unpredictable, often unsatisfactory outcomes that extend the patient journey. Common approaches typically involve a trial-and-error approach that can lead to long, frustrating patient journeys without improvement in symptoms or poor drug side effect management.“
“Using brain-function measurement, Universal Brain is driving change that enables better understanding of neurotypes that typically results in better treatment of mental health conditions. The Universal Brain solution targets heterogeneity and is driving the shift toward data-driven decision-making in mental health; in other words, precision psychiatry. Our key differentiator is that we are targeting the unaddressed heterogeneity within conditions and enabling personalization based on patients’ brain function measurements, accelerating improved patient outcomes.”
Future Company Goals
What are some of the company’s future goals? Dr. Okuda concluded:
“Universal Brain envisions a future where mental health is approached with precision, empathy, and innovation, both in clinical settings and in the comfort of one’s home.”
“The impact of our technology is expected to be far-reaching, not just in treatment, but also in the research and development of new treatments. Our comprehensive approach can support more effective clinical trials through more targeted recruitment of participants, which can be highly time-consuming and costly, especially for mental health therapies, given the heterogeneity within mental health conditions. Universal Brain enables recruitment based on neurotyping so pharmaceutical companies can identify and select ideal candidates for their research and development in less time. Neurotyping also helps pharmaceutical and life sciences companies develop and study personalized treatments to determine the efficacy of novel therapies through functional and interpretable brain measures.”
“As the platform evolves, it will become an invaluable care management tool for healthcare providers, as well. Quantifiable ERP data and scientifically validated home-based neurofeedback treatment can empower them to make more informed decisions about patient care and treatment selection.”
“Ultimately, by embracing a precision psychiatry approach, we will drive a new era in mental health care –– providing hope and relief for the millions of individuals struggling with debilitating conditions.”
