NIA Small Business Showcase: Retain Health, Inc.

Alzheimer’s disease (AD) affects an estimated 47 million people in its preclinical stage — a critical window for intervention when symptoms are absent but the disease is actively progressing. Despite evidence that 45% of dementia cases are preventable through lifestyle changes, many individuals lack awareness of their risk factors or the tools to effectively manage them.

Retain Health has developed RetainYourBrain™, a mobile Software-as-a-Service (SaaS) platform that helps users proactively manage their AD risk through personalized, evidence-based lifestyle interventions. It leverages two-way text messaging driven by artificial intelligence (AI) to create meaningful and sustained behavior change — a critical component in AD risk reduction. The app assesses individual risk factors and delivers tailored recommendations across 10 key domains, including nutrition, exercise, cognitive activity, sleep, and stress management. The RetainYourBrain™ interactive two-way text messaging encourages users to adopt and sustain healthy behaviors. By guiding them in real time, it empowers individuals to take control of their cognitive health long before symptoms develop.

The market for direct-to-consumer early-stage AD solutions is estimated at $25 billion, driven by the 54 million Americans age 45 and older who have a family history of AD and are actively seeking ways to reduce their risk. The emergence of AD blood tests is expected to further accelerate demand for digital prevention tools, as individuals become more aware of their susceptibility to the disease. Early clinical trials of RetainYourBrain™ have demonstrated significant reductions in AD risk factors and high user engagement and retention rates, which provides strong validation for its effectiveness.

Company Milestones

Scientific & Clinical

2023: Launched recruitment for a clinical trial that targeted individuals aged 53+ with a family history of Alzheimer’s.
2024: Successfully enrolled 988 participants, which exceeded NIH cohort recruitment targets by 130%.
2024: Opened recruitment for an additional cohort (EARLY cohort), with no age or family history restrictions, because of high demand.
2024: Completed NIH cohort data collection; primary analysis shows significant Alzheimer’s risk reduction in the intervention group.
2024: Completed EARLY cohort data collection; analysis of the primary outcome is pending.
2025: Completed secondary analyses of the NIH cohort and primary analysis of the EARLY cohort, including exploratory predictive models for cognitive outcomes.

Business

2023: Established a Quality Management System (QMS) compliant with CFR 21 Part 11, in preparation for future regulatory submissions.
2023: Developed a trial-ready version of RetainYourBrain™.
2024: Secured written U.S. Food and Drug Administration (FDA) guidance that confirmed enforcement discretion for RetainYourBrain™, which allowed for an immediate consumer launch without regulatory barriers.
2024: Gained national visibility through a CNN feature, then generated a 35,000-member email list of potential users.
2025: Commercial launch of RetainYourBrain™ as a direct-to-consumer product, targeting $1 million annual recurring revenue in the first year.
2026: Upgrade QMS to CFR 21 Part 820 compliance in preparation for future FDA submissions.
2027: Develop a regulated version of RetainYourBrain™ to support randomized controlled trials and FDA Class II De Novo submission.

Financial Overview

To date, Retain Health has raised a $2.8 million Small Business Innovation Research (SBIR) Fast-Track award from NIA to support product development and clinical research, $2 million in seed funding from angel investors to drive product development and clinical validation, and $2 million in non-dilutive funding from BrainMind to advance research, including a substudy on the app’s impact on blood biomarkers for cognitive health. Retain Health is raising $4 million to support the commercialization of its clinically validated SaaS product, RetainYourBrain™. Retain Health plans to raise funds through a Series A round to support the next phase of growth and regulatory advancement. This funding will be used to conduct a pivotal clinical trial to demonstrate a treatment effect for our software intervention, and develop key features for physician engagement, including tools for remote therapeutic monitoring (RTM) reimbursement opportunities. Additionally, funds will support the creation of a predictive AI/machine learning (ML) model for cognitive decline, integration with blood-based biomarker test results, and further enhancement of diagnostic capabilities. These investments will position Retain Health for long-term success in Alzheimer’s prevention field.

Intellectual Property

Retain Health has one issued patent (U.S. Patent #11,275,903), which was published on March 15, 2022, and one pending patent (#20220367061). Six trademarks have been filed to protect the company name, product name, and logo. All patents and trademarks are owned by the company Retain Health, Inc.

Commercialization Strategy

Retain Health plans to launch a direct-to-consumer product with a freemium pricing model. Offering a free access tier to users with limited access to care will empower those to learn about personal risk factors and improve brain health. Premium users will enjoy advanced tracking and assessment features, exclusive content, and Q&As with providers. An online community will engage users, enhance retention, and provide insights. A consumer launch will support company goals to generate revenue, validate market demand, and collect data to attract strategic partners focused on real-world evidence (RWE). After the consumer launch, Retain Health will advance product features and conduct validation studies to strengthen regulatory claims and support the commercialization of clinically mediated devices.