Legal

Last Updated: Jan 20th, 2025

1. Who’s Who in Your BATWATCH™ Care

These BAT PILL™ Protocol Terms apply to all BAT PILL™ Protocol services offered through the BATWATCH™ platform.

BATWatch refers collectively to a network of affiliated legal entities and coordination systems, including:

BATWatch Medical Group, LLC – A national management services organization (MSO) that provides infrastructure, coordination protocols, digital tools, and operational oversight to support early brain health monitoring and intervention.

Affiliated Professional Corporations (PCs) – State-licensed entities operating under the BATWATCH™ name (e.g., BATWatch of California, PC) responsible for delivering clinical services and telehealth care, where licensed.

BATWATCH™ Provider Network – Licensed, independent providers who engage in testing, biological review, or care coordination under the BATWATCH™ protocol.

BATWatch, Inc. – The parent company and intellectual property owner that created and licenses the BATWATCH™ platform, scoring systems, and drift-tracking frameworks. BATWatch does not deliver clinical services or act as a healthcare provider.

Unless otherwise noted, references to “BATWatch” in this document refer collectively to the ecosystem above, functioning within each entity’s defined legal and operational scope.

2. Key Definition
• BAT TEST™: A proprietary, provider-guided clinical protocol offered exclusively through BATWATCH™, which integrates commercially available blood-based laboratory assays for Beta-Amyloid and Tau into a structured process for brain health assessment and management of biological drift. The BAT TEST™ combines advanced biomarker analysis, clinical interpretation, and protocol-driven follow-up to support early intervention and prevention.
• BAT TESTING™: The structured, multi-step clinical process within the BATWATCH™ protocol that utilizes standard blood-based assays for Beta-Amyloid and Tau, enhanced by unique provider oversight, interpretation, and actionable follow-up plans. BAT TESTING™ is exclusive to the BATWATCH™ platform and represents the integration of third-party lab technology into a proprietary protocol for brain health monitoring.
• BAT LEVELS™: A proprietary clinical measurement protocol developed by BATWATCH™ that integrates blood-based biomarkers—specifically Beta-Amyloid and Tau (BA + Tau)—to quantify early brain health disruption before the onset of clinical symptoms. BAT LEVELS™ are determined and interpreted exclusively through the BATWatch™ provider-guided protocol.
• BAT SCORE™: A proprietary 0–100 scale, created and used exclusively by BATWATCH™, to measure and track the biological burden of BAT LEVELS™ and related brain health factors. A BAT SCORE™ of 100 is optimal, while scores below 100 indicate measurable biological drift. The BAT SCORE™ is calculated using a unique algorithm and clinical interpretation protocol available only within the BATWATCH™ platform.
• BAT PILL™ Protocol™: A proprietary, short-cycle intervention protocol developed by BATWATCH™ that integrates the off-label, clinician-supervised use of Sirolimus to stimulate autophagy and reduce BAT LEVELS™. The BAT PILL™ Protocol is delivered exclusively through the BATWATCH™ platform as part of a coordinated, provider-guided approach to brain health management. BAT PILL™ refers to the protocol and regimen—not to a specific manufactured pill or commercial product.
• CLEARANCE CHECK™ Panel: The final test sequence after the BAT PILL™ Protocol to confirm clearance and detect any rebound.
• FACTOR MAPPING (FM): The pre-test screening that stratifies patients based on lifestyle, inflammation, and other known contributors to brain drift.
• MECHANISM MAPPING™ (MM Panel): A deep lab panel that analyzes inflammation, glymphatic clearance, mitochondrial function, and hormone/metabolic dysfunction.
• Referring Provider: Any external clinician referring a patient for BAT TESTING™. They may receive summaries but are not required to manage treatment.
• Patient: Any individual who registers for or completes BAT TESTING™.

3. Treatment Overview: BAT PILL™ Protocol

The BAT PILL™ Protocol is a structured, evidence-based treatment designed to reduce elevated BAT LEVELS™, specifically beta-amyloid and tau proteins associated with Alzheimer’s disease risk. This protocol involves a short-term, pulsed dosing regimen of Sirolimus (Rapamycin), an FDA-approved medication used off-label within this context.

a) Treatment Objectives
Reduce BAT LEVELS™: Lower the concentration of beta-amyloid and tau proteins in the bloodstream.

Enhance Cognitive Resilience: Support mechanisms that protect against neurodegeneration.
Monitor and Adjust: Continuously assess treatment efficacy and make necessary adjustments.

b) Eligibility Criteria

Patients may be considered for the BAT PILL™ Protocol if they meet the following conditions:
Elevated BAT LEVELS™: Confirmed through proprietary testing methods.
Clinical Assessment: Determined suitable by a licensed BATWATCH™ provider.
Informed Consent: Understanding and agreement to the treatment plan and its off-label use of Sirolimus.

c) Treatment Administration

Dosage: Sirolimus is administered in a pulsed dosing schedule over a defined period.
Monitoring: Regular assessments to track BAT LEVELS™ and overall health.
Support: Ongoing communication with the BATWatch care team for guidance and assistance.

d) Potential Risks and Side Effects

While many patients tolerate the BAT PILL™ Protocol well, potential side effects may include:
Common: Mouth ulcers, gastrointestinal discomfort, fatigue.
Less Common: Elevated cholesterol levels, increased susceptibility to infections.
Rare: Lung toxicity, skin rashes.
Patients are encouraged to report any adverse effects promptly to their BATWATCH™ provider.

e) Post-Treatment Evaluation

Upon completion of the protocol:
Reassessment: BAT LEVELS™ are re-evaluated to determine treatment efficacy.
Follow-Up Plan: Based on results, a personalized plan is developed, which may include additional monitoring or interventions.

4. Why Address Elevated BAT LEVELS™
Elevated BAT LEVELS™ reflect an early biological signal that the brain’s self-cleaning systems, specifically those responsible for clearing beta-amyloid and tau proteins, may be falling behind. This buildup doesn’t happen overnight. It can silently accumulate for years, even decades, before any outward signs appear.

The BAT PILL™ Protocol was developed to:

Act before damage occurs – by intervening while cleanup systems are still modifiable
Target early biological drift, rather than waiting for cognitive symptoms
Support long-term brain function – through cellular processes like autophagy and proteostasis

This strategy reflects a shift in thinking: instead of reacting to decline, we focus on identifying early buildup and taking measurable, science-backed steps to reduce it. While many conditions linked to brain aging are complex, elevated BAT LEVELS™ are a modifiable signal… one that may offer a path toward maintaining brain health over time.

5. Mechanism of Action – How the BAT PILL™ Protocol Works
The BAT PILL™ Protocol works by triggering the body’s natural cleanup process, autophagy… to reduce the accumulation of harmful biological waste in the brain, particularly Beta-Amyloid and Tau.

These proteins build up quietly, often for decades, before any symptoms appear. By activating autophagy early, we aim to intervene before damage sets in.

a) Autophagy Activation

The BAT PILL™ (low-dose Sirolimus) stimulates autophagy, a cellular process that recycles and clears damaged proteins and waste materials. When functioning properly, autophagy prevents buildup that can interfere with brain signaling, metabolic stability, and immune regulation.

In healthy aging, autophagy keeps beta-amyloid and tau in check.

In early biological drift, these proteins start to accumulate, but the damage is still reversible.

b) Why Timing Matters

The BAT PILL™ Protocol is designed to be used before symptoms appear, when BAT LEVELS™ start to drift upward, but before neurodegeneration becomes entrenched. This window is critical.

If beta-amyloid is elevated but tau is not, the BAT PILL™ is used to reverse accumulation before tau forms.

If tau is present, the protocol may still reduce progression, but outcomes vary based on baseline pathology.

c) Not a Daily Pill. Not a Lifetime Regimen.

Unlike traditional treatments, this protocol is short-term and targeted.

Most patients complete 1 cycle (4–8 weeks) based on biomarker thresholds.

Post-treatment testing determines whether additional cycles are needed.

The goal is not suppression… it’s clearance.

d) Measurable, Trackable, Adaptive

Every cycle of the BAT PILL™ Protocol is followed by:

Mechanism Mapping Panels to evaluate immune, metabolic, and mitochondrial support systems.

ClearCheck™ Panels to confirm biomarker reduction and assess for reaccumulation.

This isn’t guesswork. It’s guided by labs, tracked over time, and designed to adapt based on your biology… not generic population guidelines.

6. About Rapamycin (Sirolimus)

a) What Is It?

The core therapeutic agent used in the BAT PILL™ Protocol is Sirolimus (commonly known as Rapamycin), an FDA-approved medication with a decades-long track record for other indications. It is used off-label in the BPP under medical supervision and in accordance with applicable regulatory guidelines.

Rapamycin is a potent mTOR inhibitor known for its role in longevity, cellular repair, and autophagy regulation. Preclinical studies suggest potential benefits in reducing beta-amyloid accumulation and supporting brain health, though the drug is not approved for Alzheimer’s treatment.

b) Why Rapamycin Was Chosen
• Enhances Autophagy: Supports clearance of accumulated amyloid before tau formation can occur.
• Reduces Inflammatory Signals: May dampen cytokines and immune pathways linked to neurodegeneration.
• Improves Neuronal Resilience: Supports metabolic health and aging processes within the brain.

c) Dosing Strategy
The BAT PILL™ Protocol is delivered in pulsed cycles designed to balance efficacy with tolerability.
• Initial cycle: 8 weeks of supervised intervention.
• Post-cycle reassessment: Follow-up testing evaluates BAT LEVELS™ response and informs next steps.

Dosing schedules may vary depending on updated clinical guidance or individual response to prior cycles, always under provider supervision. Treatment may be repeated based on individualized results and patient-provider discussion. All prescribing decisions are made by licensed medical professionals.

7. No Formulation Changes or Substitutions
The BAT PILL™ Protocol is a clinically guided treatment plan. It is not a standalone drug, nor a generalized supplement. It combines timing, dosage, patient monitoring, and post-treatment follow-up, all delivered under medical supervision by BATWATCH™-affiliated providers.

Patients may not substitute, alter, or self-administer alternative formulations of the protocol without prior approval from their prescribing provider.

This is not simply a “pill you can Google.” Even though Rapamycin is available generically, its use within the BAT PILL™ Protocol follows a specific cycle, dosing rhythm, and monitoring framework designed for brain health.

Changing the formulation, sourcing from unapproved channels, or modifying the schedule may invalidate clinical oversight, reduce effectiveness, and compromise patient safety.

All patients must agree to follow the protocol as prescribed in order to continue treatment under the BATWATCH™ program.

8. Side Effects and Safety Monitoring
All prescription medications carry potential side effects. The BAT PILL™ Protocol is no exception. While our approach uses low-dose, pulsed Rapamycin to minimize risks, patients should be aware of the following possibilities:

a) Common Side Effects
Some patients may experience mild, temporary side effects during or after treatment. These may include:
• Lowered potassium levels
• Anemia or mild reductions in blood cell counts
• Elevated blood pressure or triglyceride levels
• Temporary changes in kidney function
• Constipation, diarrhea, or abdominal discomfort
• Joint or muscle pain
• Dizziness or headaches
• Fever or fatigue
• Mouth sores or nausea

These effects are typically mild and monitored closely by the care team during each treatment cycle.

b) More Serious Side Effects
Though rare, more serious risks may include:
• Lung toxicity (pneumonitis)
• Increased susceptibility to infections
• Heightened sensitivity to sunlight or UV exposure
• Potential increased risk of skin cancer without proper sun protection

Most of these risks have been observed in higher-dose, chronic use settings, such as in transplant medicine. The BAT PILL™ Protocol uses intermittent dosing and active clinical monitoring to reduce these risks.

Patients are encouraged to discuss all potential side effects and personal risk factors with their licensed healthcare provider prior to starting treatment.

9. Exclusion Criteria
Not every patient is a candidate for the BAT PILL™ Protocol. The following medical factors may exclude a patient from receiving treatment to ensure safety and the highest standard of care. In some cases, eligibility may be reassessed after further clinical evaluation or follow-up testing.

a) Immunosuppression & Infection Risk
• Active or Recent Infections: Includes tuberculosis, hepatitis B or C, HIV, or any known opportunistic infection.
• Frequent or Severe Infections: Recurrent respiratory, urinary tract, or skin infections may disqualify a patient.
• Immunocompromised Status: Includes patients post-transplant, undergoing chemotherapy, or on chronic immunosuppressants such as corticosteroids or biologics.
• Live Vaccines: Patients requiring live vaccinations during the protocol period may be excluded.

b) Active or Recent Cancer
• Ongoing Cancer Treatment: Patients actively receiving chemotherapy, immunotherapy, or radiation.
• Cancer Diagnosed Within the Last 5 Years: Excludes all except successfully treated non-melanoma skin cancers (e.g., basal cell carcinoma).
• Unresolved Skin Lesions: Suspicious or untreated lesions must be evaluated and cleared by a dermatologist.

c) Metabolic & Organ Function
• Uncontrolled Hyperlipidemia: LDL >190 mg/dL or triglycerides >500 mg/dL.
• Liver Dysfunction: Cirrhosis, active hepatitis, or liver enzymes (ALT/AST) >3× upper normal limit.
• Kidney Dysfunction: Chronic kidney disease Stage 4 or higher (eGFR <30 mL/min).
• Proteinuria: Urine protein excretion >300 mg/day.

d) Hematological Concerns
• Low Platelets or WBC: Platelet count <100,000/μL or WBC <3,000/μL.
• Anemia: Hemoglobin <10 g/dL. e) Wound Healing & Surgery
• Recent Major Surgery: Within the past 4 weeks.
• Chronic Wounds: Includes diabetic ulcers, pressure sores, or other non-healing wounds. f) Pulmonary Risk
• History of Lung Disease: Includes interstitial lung disease or pulmonary fibrosis.
• Unexplained Shortness of Breath: Must be fully evaluated before treatment. g) Medication Conflicts
• Strong CYP3A4 Inhibitors: Concurrent use of ketoconazole, clarithromycin, ritonavir, or similar medications.
• Other mTOR Inhibitors: Concurrent use of sirolimus, everolimus, or comparable drugs. h) Cardiovascular Risk
• Recent Cardiac Events: Unstable angina or myocardial infarction within the last 6 months.
• Severe Heart Failure: NYHA Class III or IV, or other forms of decompensated cardiac disease. i) Neurological or Cognitive Barriers
• Advanced Dementia: Severe cognitive impairment that would prevent adherence to monitoring.
• Seizure History: Particularly if seizures are uncontrolled or medication-resistant. j) UV Sensitivity & Skin Cancer Risk
• History of Melanoma: Personal or strong family history.
• Photosensitive Conditions: Such as lupus, porphyria, or similar autoimmune skin disorders. k) Pregnancy & Fertility
• Pregnant or Breastfeeding: Not eligible due to limited safety data.
• Women of Childbearing Age Without Contraception: Effective contraception is required during treatment. l) Psychological Considerations
• Severe Psychiatric Conditions: Includes psychosis, active suicidal ideation, or uncontrolled depression.
• Non-Adherence History: Patients with a known history of failing to follow medical guidance may be excluded. m) Case-by-Case Review Criteria Some conditions do not lead to automatic exclusion but require additional review:
• Mildly Elevated Lipids or Liver Enzymes: Patients may proceed under closer monitoring.
• History of Cancer >5 Years Ago: May proceed if fully in remission and treatment-free.
• Older Adults with Comorbidities: May be considered if overall health is stable and risks are manageable.
Patients falling under these special considerations will be reviewed by a BATWATCH™ -affiliated provider to determine eligibility and appropriate monitoring strategy.

10. Release of Liability Specific to the BAT PILL™ Protocol
By participating in the BAT PILL™ Protocol, you voluntarily assume responsibility for potential risks, and you agree to release BATWatch and its affiliated entities from liability for claims arising from, but not limited to:
a) Individual Variability: Differences in how your body responds to treatment or unexpected results.
b) Medical Complexity: The presence of other diagnosed or undiagnosed conditions.
c) Past Treatments: The influence of other medications or historical therapies.
d) Adherence: Results affected by your level of compliance with the prescribed treatment plan.
e) Comorbidities: Outcomes complicated by rare, complex, or unmanaged conditions.
f) Aggravation of Pre-Existing Conditions: Including conditions not previously identified.
g) Unforeseeable Events: Medical incidents that could not be predicted.
h) Emotional or Psychological Impact: Anxiety, distress, or other emotional responses tied to the treatment experience.
i) Drug Reactions: Allergic or adverse responses to Rapamycin or any related compounds.
j) Adjustment Period: Side effects or discomfort during initial or transition phases.
k) Relationship Effects: Strain or emotional impact on family or interpersonal relationships.
l) Other Unintended Consequences: Any outcome not anticipated by BATWatch or your provider.

You further agree that this Release of Liability applies regardless of any claims of negligence or error by BATWatch or its representatives, except where prohibited by law.

11. Assumption of Risk
By participating in the BAT PILL™ Protocol, you affirm that:
a) Voluntary Participation: You are enrolling willingly and understand the purpose, structure, and nature of the treatment.
b) Informed Consent: You have discussed the risks, benefits, and alternatives with your provider and had the opportunity to ask questions.
c) Risk Acceptance: You acknowledge that no outcomes are guaranteed, and results may vary based on individual biology, medical history, and treatment adherence.

12. Indemnification Acknowledgment
Your participation in the BAT PILL™ Protocol is subject to the indemnification provisions outlined in the broader BATWATCH™ Terms of Service. By continuing treatment, you agree to indemnify and hold harmless BATWatch and all associated entities from any claims, losses, or liabilities related to your participation, as described in those terms.

13. Contact and Emergency Procedures
If you experience side effects or have medical concerns during your treatment:
a) Mild Side Effects: Contact your assigned BATWATCH™ provider through your patient portal or use the designated contact number provided at enrollment.
b) Emergency Situations: If you experience severe symptoms, dial 911 or visit the nearest emergency facility immediately.
c) Support Line: For urgent, non-emergency issues, call the BATWATCH™ Support Line at 202-681-1274, available Monday–Friday, 9am to 5pm PST.
d) Patient Safety Commitment: BATWatch encourages prompt reporting of all side effects or concerns so we can ensure proper follow-up and support.

14. Right to Discontinue or Terminate Treatment
BATWatch reserves the right to discontinue or pause your participation in the BAT Pill Protocol™ under the following conditions:
a) Medical Safety Concerns: Your provider determines that continuation poses a health risk.
b) Non-Compliance: Failure to attend follow-ups, complete required labs, or adhere to dosing protocols.
c) Emerging Clinical Evidence: New scientific findings suggest that the protocol is no longer appropriate for your profile.

You may also choose to discontinue at any time. However, we strongly recommend that you consult with your provider before stopping treatment to ensure a safe and informed transition.

15. 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.

16. Acceptance of Terms
Participation in the BAT PILL™ Protocol is subject to the BATWATCH™ Disclaimers and Limitations of Liability, which include full details regarding off-label medication use, research-related uncertainties, and limitation of liability. By participating, you confirm you’ve reviewed and accepted those legal terms in addition to this protocol summary.

These Terms may be updated periodically. The latest version will always be available at batlevels.com/legal. Continued participation in BAT PILL™ Protocol services constitutes ongoing agreement with any updates made.