AvailDX, Inc.

The Alzheimer's Crisis

The Alzheimer's crisis is an escalating global emergency, silently eroding the very fabric of societies as it ravages minds, families, and economies. Despite billions of dollars spent over the last decade, there is no cure in sight and existing treatments offering only fleeting relief, we stand at a precipice where the soaring prevalence of this insidious disease threatens to overwhelm healthcare systems and devastate the quality of life for millions worldwide. Urgent action is imperative to confront this crisis head-on, bolstering support for caregivers, and fostering innovation to unlock the elusive keys to early detection and active prevention. Time is not a luxury we can afford, the time to change is now.

At AvailDX, we are inspired to make an impact in the lives of patients, physicians, families and society.

Impact to Healthcare Systems

The rising cost of healthcare is an ever-growing concern, especially as the prevalence of Alzheimer's disease continues to increase. Alzheimer's, a progressive neurological disorder, not only poses immense challenges for affected individuals and their families but also exerts a significant financial burden on healthcare systems worldwide.

One of the primary reasons for this escalating cost is the late detection of Alzheimer's disease. By the time symptoms become noticeable, the disease has often progressed to advanced stages, requiring extensive medical care, long-term support, and specialized treatments. These interventions come with hefty price tags, contributing to the overall strain on healthcare budgets.

However, there's a crucial opportunity to mitigate these escalating costs: early detection and proactive intervention. Detecting Alzheimer's in its early stages enables healthcare providers to implement preventive measures and interventions that can potentially slow down the progression of the disease, delay the onset of severe symptoms, and improve overall quality of life for patients.

Early detection allows for better planning and allocation of resources, including healthcare infrastructure, support services, and caregiver training, thereby optimizing the efficiency and effectiveness of healthcare delivery for individuals with Alzheimer's and their families.

There is a shortage of dementia specialists such as geriatricians, neurologists, geriatric psychiatrists, and neuropsychologists as another barrier to timely evaluation and diagnosis. The average wait time for a neurologist visit is at an all-time high, with even longer wait times projected now given the increase in demand among the aging population. Time spent waiting for a specialist visit is precious as cognitive decline may continue during these weeks and months, and a lack of diagnosis means a delay in treatments, care delivery, and supportive services

Addressing the increasing cost and wait times of cognitive healthcare in the face of rising rates of Alzheimer's disease requires a proactive approach centered on early detection and preventive intervention. By prioritizing efforts to identify and support individuals at risk or in the early stages of the disease, we can not only improve outcomes for patients but also alleviate the financial strain on healthcare systems, ultimately leading to a more sustainable and equitable healthcare future.

AvailDX Solution - Comprehensive Platform Approach

The AvailDX Cognitive Assessment Platform (AVAIL-CAP) envisions a future where cognitive health is proactively baselined, monitored yearly and risks are timely managed with precision, revolutionizing the approach to Alzheimer's disease.

In addition to routine checkups, the AVAIL-CAP would offer a cost-effective solution that can be seamlessly incorporated into an annual wellness visit (AWV) in the point-of-care environment for individuals aged 45 years and older as a comprehensive Alzheimer's screening assessment test. 

The platform offers multi-modal, state-of-the-art digital cognitive assessments with advanced non-invasive biomarker quantification, facilitating early detection of symptoms and negative biological changes that may indicate the earliest stages of cognitive decline. This integration enables the generation of risk-based preliminary clinical findings reports, the crafting of personalized intervention plans, and the annual monitoring of cognitive health.

AvailDX is dedicated to supporting our healthcare professionals with innovative, diagnostic solutions that enhance patient care, streamline clinical workflows, and reduce the burden on our healthcare systems.

Market Opportunity

The market opportunity for a comprehensive Alzheimer's screening test for early detection is substantial, driven by increasing demand, rising prevalence, healthcare cost pressures, technological advancements, patient empowerment, regulatory support, and global reach. Investing in the development and commercialization of such a test presents a compelling opportunity to address a critical unmet need in Alzheimer's disease management while generating significant value for stakeholders.

Go-to-Market

AvailDX has the potential to revolutionize cognitive healthcare with our innovative suite of products: Mind Health Snapshot, Cognitive Wellness Journey, and Alzheimer's Shield. As the prevalence of cognitive disorders continues to rise, there is an urgent need for accessible and comprehensive assessment tools that empower both patients and healthcare providers. Our go-to-market strategy is designed to address this critical demand, starting with a targeted 6-month limited launch.

Mind Health Snapshot offers quick, reliable cognitive assessments that integrate seamlessly into primary care settings, enabling early detection and intervention. Cognitive Wellness Journey provides personalized, ongoing cognitive health management, helping individuals maintain and enhance their mental well-being. Alzheimer's Shield is our proactive approach to identifying and mitigating the risk of Alzheimer's disease, combining cutting-edge technology with evidence-based practices.

Together, these solutions form a holistic approach to cognitive health, designed to improve patient outcomes and support healthcare professionals in delivering high-quality care. Join us in helping advance the future of cognitive wellness with AvailDX.

Commercialization

The commercialization strategy for AVAIL-CAP targeting health clinics and medical groups, including primary care physicians (PCPs) and neurologists, revolves around a customer success journey comprising adoption, retention, expansion, and advocacy.

AvailDX aims to garner clinician advocacy. Our commercial vision entails clinicians becoming advocates for the Avail Cognitive Assessment Platform within their professional circles and organizations. They'll share success stories and positive outcomes, emphasizing the platform's role in enhancing diagnostic accuracy, patient outcomes, and overall healthcare efficiency. Through these advocacy efforts, the platform can gain widespread recognition and adoption, catalyzing positive changes in cognitive assessment standards for Alzheimer's disease and beyond.

Reimbursement Landscape

CPT codes, or Current Procedural Terminology codes, are a standardized set of codes used to describe medical, surgical, and diagnostic services provided by healthcare providers in the United States. These codes were developed and are maintained by the American Medical Association (AMA). CPT codes serve important functions within the healthcare system:

Billing and Reimbursement: CPT codes are used to accurately report the procedures and services provided to patients. They are essential for healthcare providers to submit claims to insurance companies, Medicare, and Medicaid for reimbursement. Each CPT code corresponds to a specific medical procedure or service, along with associated fees or reimbursement rates.

Competitive Assessment

Our competitive assessment matrix highlights the varying levels of confidence and predictive power across different cognitive assessment methods, considering both completed clinical studies/FDA clearance and the ability to predict escalated risk of developing Alzheimer's disease.

AvailDX aims to commercialize the only comprehensive cognitive assessment platform with high confidence and high predictive power.

U.S. Food & Drug Administration Market Clearance

With several U.S. and international market clearances secured by AvailDX's founder, we are confident in our ability to successfully navigate the regulatory landscape. AvailDX recognizes the value of clinical evidence, from crafting a clinical strategic plan to obtaining market clearance and acknowledges the importance of continually leveraging clinical evidence to drive increasing value. Therefore, investing in this clinical strategy is key to driving adoption and achieving commercial success.

Timeline

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