Legal

Last Updated: March 27, 2025

In Plain English: This document explains how BAT Testing™ works, who’s responsible, how your data is used, and how we handle things like re-testing or follow-ups. It’s meant to keep you safe, informed, and supported throughout your cognitive health journey.

1. Who’s Who in the BATWatch Program

These BAT Testing™ Terms of Service (“Terms”) apply to all testing, coordination, clinical interpretation, and support services offered through the BATWatch™ platform.
The term “BATWatch” refers collectively to a network of affiliated legal entities that deliver cognitive health services under the BATWatch™ brand. This includes both:

• BATWatch Medical Entities – Licensed professional corporations (PCs) and clinical providers operating under BATWatch Medical, Inc. and its affiliated regional PCs. These entities are responsible for all medical and clinical services, including testing, diagnosis, interpretation, and treatment decisions.

• BATWatch Non-Medical Entities – Administrative and operational support entities, including BATWatch, LLC and its regional Series MSOs. These entities provide technology, coordination, patient support, and non-clinical logistics.

• BATWatch Network Providers – third-party independent healthcare providers who have joined the BATWatch provider network. These providers may assist in test ordering and collaborate with BATWatch clinical teams to ensure streamlined care.

Together, these affiliated groups are referred to in this document as “BATWatch” unless otherwise noted. All references to clinical services, test interpretation, or treatment relate specifically to licensed providers operating under BATWatch Medical entities or participating in the BATWatch Provider Network (“BATWatch Network”).

These Terms apply only to BAT Testing™ services and associated support functions, and do not cover non-testing services such as treatment protocols or platform usage, which are governed under separate agreements.

2. Definitions

For the purposes of these Terms, the following terms are defined as follows:

“BAT Testing™” – Encompasses a range of clinically validated assessments designed to evaluate biomarkers associated with cognitive health. The specific biomarkers and methodologies utilized are proprietary to BATWatch and are continually refined based on the latest clinical research and advancements.

“BATWatch” – Refers collectively to BATWatch, LLC (the non-clinical management services organization), BATWatch Medical, Inc. (and its affiliated professional corporations), and any subsidiaries or affiliated entities operating under the BATWatch brand. This unified term is used for simplicity to describe the full set of entities supporting, coordinating, and/or delivering the BAT Testing™ program.

“BATWatch Affiliates” – Includes both clinical and non-clinical entities operating as part of the BATWatch structure, including licensed professional entities providing medical services, non-clinical administrative and technology providers, and regional MSOs or professional corporations supporting geographic expansion.

“BATWatch Medical” – Refers to BATWatch Medical, Inc., its affiliated professional corporations (e.g., BATWatch Medical of [State], P.C.), and all licensed medical providers operating under the BATWatch brand. BATWatch Medical entities are responsible for clinical oversight, treatment decisions, and medical testing services under the BATWatch Protocol™.

“BATWatch Network” – A group of independent, third-party healthcare providers and organizations who have formally joined the BATWatch ecosystem and are authorized to order BAT Testing™ on behalf of their patients. These providers may assist with initial test ordering and collaboration, while all clinical interpretation and treatment planning remains centralized through BATWatch Affiliates.

“ClearCheck™ Panel” – The final follow-up testing sequence performed after completion of the BAT Pill Protocol™, used to confirm treatment efficacy, monitor for recurrence, and guide long-term care planning.

“Contributing Factor Mapping (CFM)” – A structured pre-test assessment process that evaluates non-genetic and lifestyle contributors to abnormal BAT Level™ accumulation. Used to personalize follow-up pathways and prioritize early screening in elevated-risk patients.

“Patient” or “You” – Any individual who registers for, undergoes, or is referred for BAT Testing™ services under the BATWatch program, either directly or through a participating provider.

“Referring Provider” – Any licensed clinician who refers a patient into the BATWatch system or orders testing through the BATWatch Network. These providers may or may not be directly employed by BATWatch Affiliates but are granted limited access to test results and coordination tools when applicable.

“BAT Level Index™ (BLI)” – A proprietary risk scoring framework used within the BATWatch Protocol™ to interpret test data and guide clinical decision-making. The specific formulas and decision logic are proprietary to BATWatch and not publicly disclosed.

“BAT Pill Protocol™” or “Clearance Protocol™” – A structured treatment sequence developed by BATWatch involving short-cycle pharmaceutical intervention to reduce abnormal BAT Levels™ and prevent disease progression.

“BAT Levels™” – A general term used to describe the biological presence or accumulation of beta-amyloid and tau proteins detectable through blood-based cognitive biomarker testing.

“Terms” – This document, the BAT Testing™ Terms of Service, which governs use of BAT Testing™ services through BATWatch and outlines the rights, responsibilities, and limitations for both patients and providers.

3. Your Results, Our Responsibilities

a) Data Custodian

BATWatch are the designated custodian of all patient medical records associated with BAT Testing™, including lab results, interpretation notes, and treatment recommendations. All records are maintained in compliance with HIPAA and applicable state or international data privacy laws.

b) Results Access

The BATWatch Platform provides patients secure access to their results and status updates. Authorized referring providers and participating providers in the BATWatch Network may also be granted secure access to patient results for coordination purposes, based on patient consent and data-sharing preferences.

c) Shared Access with Referring Providers

If a licensed third-party provider initiated the BAT Test™ order or is affiliated with the BATWatch Network, that provider may receive test results, risk stratification details, and care coordination summaries from BATWatch. However, treatment decisions and centralized care remain under the jurisdiction of BATWatch unless otherwise contracted.

d) Data Use for Research and Improvement

De-identified test results may be used for quality improvement, analytics, and research purposes, including registry contributions, in accordance with applicable privacy laws and BATWatch’s Privacy Policy. No personally identifiable information will be used without explicit patient consent.

e) Record Retention

BATWatch retains patient records, including testing data, risk scoring, and treatment logs, for a period required under federal and state recordkeeping regulations, or longer if required for clinical research purposes.

4. Testing Limitations Disclaimer

a) For Informational and Clinical Use Only:

BAT Testing™ results are intended to inform personalized cognitive health strategies and support medical decision-making. Results should always be interpreted by a licensed healthcare provider in the context of your overall clinical picture.

b) Not a Diagnostic Tool:

The BAT Level Index™ (BLI) and associated scoring frameworks used in the BATWatch Protocol™ are decision-support tools and do not serve as a standalone diagnosis for Alzheimer’s disease or other conditions. Diagnostic conclusions should be made through comprehensive clinical evaluation.

c) No Treatment Without Clinical Review:

All treatment decisions, including the use of the BAT Pill Protocol™ or related interventions, must be made following a telehealth or in-person consultation with a licensed provider. Self-directed interpretation or action based on results is strongly discouraged.

d) Results May Vary:

Laboratory results may be influenced by individual biological variation (e.g., acute illness, medications, lifestyle factors). The BATWatch Protocol™ incorporates sequential testing strategies to reduce the risk of false results and ensure clinical validity.

e) Proprietary Methodology Notice:

The internal logic used to generate BAT Level Index™ scores and interpret results is proprietary to BATWatch and is not disclosed in these Terms. Patients and providers receive summarized findings, clinical recommendations, and threshold-based guidance rather than access to the raw decision engine logic.

5. Appeals and Re-Testing Policy

BATWatch provides a structured framework for managing concerns related to test outcomes, insurance coverage, and eligibility for retesting.

a) Re-Testing Eligibility:

Re-testing may be approved under the following conditions:

• Borderline Findings: When results fall within threshold ranges that, per the BATWatch Protocol™, warrant confirmation prior to further testing or treatment.
• Sample Integrity Concerns: Laboratory error, sample degradation, or other quality control issues.
• New Clinical Information: A provider identifies significant new clinical evidence that warrants reassessment.

b) Re-Testing Process:

• Requests must be submitted within 30 days of receiving results.
• Re-testing follows the same protocol and sequencing logic as the original testing set.
• Results will be reviewed and delivered within the standard reporting window after retesting is completed.

c) Insurance Appeals:

• BATWatch will provide supporting documentation for medical necessity, including relevant biomarker thresholds, risk stratification, and clinical rationale.
• If a patient’s insurer denies coverage, our team can assist in preparing appeal letters, supporting lab documentation, and explanatory summaries based on the BATWatch Protocol™.

d) Multi-Test Sequencing:

• Re-tests are not automatically authorized for all patients. Only those who meet pre-established clinical criteria (as outlined in the protocol) will qualify.
• Repeat testing without appropriate clinical rationale may not be reimbursed by insurers.

6. Testing

6.1 BATWatch offers a non-invasive, lab-based testing protocol designed to detect cognitive biomarkers associated with Alzheimer’s progression before clinical symptoms emerge. This structured blood testing process provides an accessible alternative to invasive diagnostics such as spinal taps or brain imaging.

a) Multi-Stage Testing Approach

The BATWatch Protocol™ utilizes a multi-step testing protocol designed to evaluate cognitive health risk based on emerging biomarker science. Testing is conducted in stages to ensure patient affordability, insurance coverage, and clinical necessity. All panels and decision logic are proprietary to the BATWatch Protocol™ and may evolve with future advancements.

The following tests and panels are referred to by trademarked names and may include a combination of blood-based biomarkers relevant to beta-amyloid accumulation, tau-related neuronal injury, inflammation, genetic predisposition, and mitochondrial or metabolic function.

BA Test (Beta-Amyloid):

Measures 42/40 plasma ratios associated with early beta-amyloid accumulation. Serves as the foundational screening tool.

• Pre-Clearance (PC) Panel:

Includes labs that evaluate cardiovascular, metabolic, and inflammatory mechanisms known to contribute to abnormal biomarker accumulation. Results may support further testing and help determine patient eligibility for treatment protocols.

• T Test (Phosphorylated Tau):

Ordered only when indicated by BA and PC results. Measures plasma pTau181 to assess neurodegeneration severity.

b) Additional Panels in Treatment Sequences

Following treatment initiation or completion, the protocol may include additional labs as part of ongoing monitoring or post-treatment validation. These include:

• Midpoint Check (MC):

A simplified inflammation and toxicity screening, typically midway through treatment.

• ClearCheck (CC) Panel:

A comprehensive follow-up test that re-evaluates key biomarkers post-treatment. May include a repeat of BA and T testing, mechanism markers, and related labs.

• Mechanism Mapping (MM) Panel:

A specialized set of labs used to evaluate blood-brain barrier integrity, neuroinflammatory activity, mitochondrial energy deficits, and genetic transport function. This panel is typically reserved for select cases requiring deeper analysis.

c) Adaptive Testing Pathways

Not all patients will undergo every test. Eligibility is determined by a combination of test results, protocol logic, and provider recommendation. Testing sequences may be modified based on:

• Initial Risk Stratification
• Response to Treatment
• Insurance Authorization Requirements
• Clinical Justification for Deeper Investigations

d) Protocol Transparency & Proprietary Structure

The order and inclusion of tests are determined by clinical algorithms and risk stratification protocols developed by BATWatch. The full testing sequence, thresholds, and decision logic that guide each patient’s journey are proprietary to BATWatch and subject to ongoing refinement. Medical providers follow internal guidance and clinical review standards developed by BATWatch.

All clinical services related to testing—including test review, ordering, and treatment recommendations—are exclusively provided by BATWatch oversees administrative coordination, patient support, and platform operations. These may vary based on insurance status, clinical presentation, or regional availability.

e) Centralized Oversight

Regardless of where the tests are ordered or collected, all:

• Test interpretation
• Risk stratification
• Treatment eligibility decisions
• Recommendations

…are made by BATWatch or authorized clinical personnel under its oversight. This ensures consistency, quality control, and adherence to the BATWatch Protocol™.

6.2 Referral Providers

Licensed providers within the BATWatch Network may initiate testing based on protocol eligibility. These providers:

• Can order initial BA Tests
• May receive patient results and recommendation summaries (with patient consent)
• Are not required to manage treatment or follow-up testing unless formally contracted

In all cases, BATWatch assumes responsibility for delivering treatment-related services and ongoing patient management.

7. Accuracy, Validation, and Multi-Test Strategy

BAT Testing™ is structured to ensure clinical accuracy through a multi-step validation process. Unlike single-test models that may be prone to variability, BATWatch utilizes protocol-based redundancies to refine results, confirm biomarker progression, and support confident decision-making.

a) Why Multi-Test Validation Matters

Blood-based biomarkers can be influenced by temporary physiological states, such as infections, stress, or inflammation. To address this, the BATWatch Protocol™ uses sequential testing and retesting strategies to validate results when needed—particularly if early-stage biomarker levels fall into borderline zones.

This approach reduces false positives, improves test specificity, and strengthens the clinical justification required for insurance approvals.

b) Structured Protocol Enhancements

The protocol is designed to evolve over time while remaining rooted in a consistent methodology. Its architecture includes:

• Staged Panel Logic: Each testing stage builds upon previous results, ensuring that subsequent steps are only initiated when medically appropriate.
• Double Confirmation Requirements: Certain biomarkers—such as BA and T—may require retesting under protocol-specific circumstances to account for transient variations.
• Parallel Biomarker Mapping: Multiple contributing mechanisms are mapped to identify risk pathways and justify treatment strategies.

c) Statistical Integrity

BATWatch targets cumulative accuracy above 90%, achieved through:

• High-Specificity Biomarker Selection
• Redundant Panel Logic
• Conditional Escalation Protocols

These design principles support robust clinical decision-making while maintaining alignment with payer requirements for evidence-based justification.

d) Agnostic Testing Compatibility

BATWatch does not rely on any single laboratory or test kit. While Quest Diagnostics is currently the primary lab provider, the protocol is designed to work with any lab that meets quality benchmarks for the required analytes.

This ensures:

• Future-Proof Design: As new diagnostic options become available, the protocol can adapt without disruption.
• Cost Control: Competitive test sourcing prevents pricing monopolies.
• Patient Access: Wider lab compatibility increases testing accessibility across geographies.

e) Insurance Alignment

The multi-test design supports pre-authorization success by:

• Demonstrating medical necessity through clear, documented staging.
• Providing layered evidence that aligns with insurer decision-making protocols.
• Reducing audit flags by preventing unnecessary or premature testing.

8. Pre-Test Stratification and Eligibility Logic

a) Age-Based Eligibility

BAT Testing™ is available to adults aged 30 and older, regardless of symptoms, based on research showing that beta-amyloid accumulation begins decades before cognitive decline becomes apparent.

• Average-Risk Population: Routine screening is recommended starting at age 40.
• Elevated-Risk Population: Individuals in their 30s may qualify earlier based on family history, lifestyle factors (e.g., tobacco use, alcohol, recreational drug use), or other contributing factor risks.

This tiered framework ensures timely intervention aligned with biomarker progression while expanding access to at-risk populations.

b) Contribution Factor Mapping (CFM)

BATWatch uses a unique pre-test mapping process to evaluate the likelihood of abnormal biomarker development. This approach replaces outdated “risk scores” with a focus on real-world contributors:

• Family history of Alzheimer’s or dementia
• Cardiometabolic dysfunction (e.g., A1C, lipid imbalances)
• Chronic inflammation
• Mitochondrial and hormonal imbalances
• Environmental or lifestyle exposures (e.g., substance use, sleep disruption)

CFM is used to tailor the sequence of testing—not to deny testing—but to prioritize patients for appropriate follow-up and intervention. It also supports insurance justification for further testing (e.g., Mechanism Panels, T Testing).

c) Pre-Test Disclosures and Consent

Patients are informed during registration that:

• Initial testing is not diagnostic.
• BAT Testing™ sequences are used to stratify likelihood of cognitive biomarker accumulation and support early interventions.
• Additional testing may be ordered based on results, medical necessity, and insurer approval.
• The decision to proceed with treatment is always made in coordination with a licensed provider.

d) No Cost Barrier Policy

If a patient meets eligibility criteria but encounters insurance denial or financial limitations, BATWatch provides access to subsidized testing, discounted lab rates, and payment plans.

9. Pre-Clearance Testing Pathway

The Pre-Clearance process is the standardized two-step confirmation protocol used before initiating the clearance protocol (“BAT Pill Protocol™”). This testing phase provides clarity on both early accumulation and possible downstream impact, ensuring patients and providers have the necessary clinical data to move forward safely and confidently.

a) Step 1: BA Test – Beta-Amyloid 42/40 Ratio

This lab-based test identifies abnormal beta-amyloid accumulation in plasma—a leading biomarker of Alzheimer’s risk. It is the earliest signal in the progression timeline and the foundation of the BAT Testing™ Sequence.

• If the BA Test™ result is within normal range, the patient is advised to return for routine monitoring annually.
• If the BA Test™ is elevated, the Pre-Clearance (PC) Pathway is activated to investigate further.

b) Step 2: T Test – Phosphorylated Tau (pTau-181)

The T Test evaluates for signs of tau-based neurodegeneration. While beta-amyloid accumulation may be present for decades without damage, the presence of tau suggests that damage may already be occurring.

• If tau is negative, this represents a key window for prevention, and the clearance BAT Pill Protocol™ is recommended to remove beta-amyloid and avoid future tau formation.
• If tau is positive, patients are advised to proceed with the BAT Pill Protocol™ and engage in close follow-up to track reduction and assess for re-accumulation risk post-treatment.

c) Multi-Test Correlation

To account for biological variability, both tests are interpreted in context, and follow-up may be recommended when:

• Results fall near threshold ranges
• Lab inconsistencies or delays occur
• Mechanism mapping identifies risk-enhancing conditions (e.g., inflammation, cardiovascular dysfunction)

Where required, insurers are provided with supporting documentation to justify sequential testing using this validated structure.

d) Clinical Coordination

All test orders, results interpretation, and follow-up recommendations are performed by BATWatch. Results are shared with the patient’s primary care provider (PCP) if designated, and next steps are always made in collaboration with the clinical team.

10. Clearance Protocol™ (BAT Pill Treatment Cycle)

The BAT Pill Protocol™ is BATWatch’s structured 8-week treatment approach designed to reduce elevated BAT Levels™—addressing the underlying biological accumulation before irreversible damage occurs.

This intervention is coordinated by BATWatch through weekly monitoring and patient communication systems.

a) Simplicity & Science

Treatment is initiated with a short course of an FDA-approved oral medication, dubbed the BAT Pill™ (Sirolimus). This medication is already approved for other uses and is prescribed off-label within the BATWatch clinical framework.

The cycle lasts only 8 weeks, with most patients requiring just one treatment. This short protocol allows for meaningful BAT Level™ reduction while maintaining high adherence and low long-term burden.

b) Eligibility

BAT Pill Protocol™ is typically initiated under the following conditions:

• Elevated beta-amyloid with or without tau presence
• A BAT Level Index Score exceeding predefined intervention thresholds
• Clearance confirmed through the ClearCheck™ two-test sequence

Additional clinical considerations may include age, mechanism mapping findings, and individual provider discretion.

c) Monitoring & Communication

Patients enrolled in the BAT Pill Protocol™ receive:

• Weekly check-ins (via SMS or secure messaging) to support adherence and track experience
• Midpoint labs to ensure safety and effectiveness (e.g., urinalysis and lipid panel)
• Final follow-up testing to evaluate treatment impact and determine next steps

BATWatch coordinates all prescription fulfillment, refill tracking, and adverse event escalation in collaboration with the patient’s designated provider.

d) Insurance Considerations

BATWatch will assist with prior authorization, clinical justification letters, and pharmacy coordination for eligible patients. Because this is a short-cycle, low-dose intervention aimed at preventive care, most commercial insurers view it favorably when initiated through validated testing.

e) Post-Treatment Evaluation

At the conclusion of the BAT Pill Protocol™, patients undergo final biomarker testing using the ClearCheck™ Panel, a comprehensive assessment that confirms treatment efficacy and evaluates the risk of re-accumulation.

Next steps will be based on results:

• Clear: Return to annual testing with no further treatment needed
• Partial Response: Consider extended or second cycle
• Persistent Elevation: Engage in targeted follow-up and Mechanism Mapping (MM Panel)

11. ClearCheck™ Panel: Post-Treatment Confirmation Testing

Following completion of the Clearance Protocol™, patients may undergo a follow-up lab sequence known as the ClearCheck™ Panel. This panel is designed to confirm treatment efficacy and support future monitoring decisions. It is coordinated through BATWatch and may be ordered by a BATWatch Network provider or authorized third-party provider in accordance with BATWatch clinical protocol guidelines.

a) Purpose

The ClearCheck™ Panel serves as the final step in the BATWatch treatment sequence. Its purpose is to:

• Confirm whether BAT Levels™ have successfully returned to a safe range.
• Identify any lingering signs of abnormal biomarkers related to neurodegeneration or re-accumulation.
• Evaluate specific contributing factors that may influence future risk.
• Guide long-term follow-up plans based on each patient’s treatment response.

b) General Components

To protect the proprietary nature of the BATWatch Protocol™, exact test names and sequences are not disclosed in this section. However, patients and providers can expect the ClearCheck™ Panel to generally include:

• Repeat biomarker testing of prior indicators measured during the initial sequence (e.g., BA and T levels).
• Reassessment of contributing mechanisms tied to inflammation, neuroprotection, and mitochondrial health.
• Genetic profiling relevant to long-term clearance potential and recurrence risk.
The complete list of markers is maintained internally by BATWatch and is only disclosed to authorized providers. BATWatch may revise panel components over time based on emerging science and real-world treatment data.

c) Insurance & Financial Considerations

As a post-treatment efficacy panel, this testing is typically eligible for insurance coverage under medical necessity guidelines. BATWatch will coordinate the necessary documentation, prior authorization (when applicable), and direct communication with patients about any out-of-pocket costs.

Financial support and payment plans may be available for patients experiencing financial hardship, ensuring equitable access to treatment monitoring.

d) Post-Cycle Pathways

ClearCheck™ Panel results inform the next phase of care and monitoring cadence:

• Resolved – Patient has normalized results and is advised to resume annual BA Testing only.
• Inconclusive or Partially Cleared – Patient may be flagged for extended monitoring or supportive intervention.
• Potential Recurrence Indicators – Further evaluation may be needed, including optional repeat Clearance Protocol™.

In all cases, ClearCheck™ results are reviewed by the BATWatch clinical team. Summary findings may be shared with the patient’s primary care provider or ordering physician, with patient consent, to support collaborative care.

12. Intellectual Property and Proprietary Rights

All testing methodologies, panel names, sequencing logic, scoring systems (including the BAT Level Index™), and branded protocol terminology (e.g., Clearance Protocol™, BAT Pill™, ClearCheck™, Mechanism Mapping™, Contribution Factor Mapping™) are proprietary to BATWatch. These materials are protected under applicable intellectual property laws, including trademark, trade secret, and copyright protections.

No part of the BATWatch Protocol™, including test sequencing or decision logic, may be replicated, reverse-engineered, or redistributed without written authorization from BATWatch. Any unauthorized use of BATWatch’s intellectual property may result in legal action.

All materials provided through the BATWatch Platform, including visual representations, summaries, and guidance documents, are for personal and clinical use only and may not be used for commercial purposes without express written permission.

13. Acceptance of Terms

By participating in BAT Testing™ or engaging with any services provided through BATWatch or its authorized affiliates, you acknowledge that you have read, understood, and agreed to these Terms of Service.

These Terms may be updated periodically. The latest version will always be available at batlevels.com/legal (or applicable legal domain). Continued participation in BAT Testing™ services constitutes ongoing agreement with any updates made.