Legal

These Disclaimers and Limitation of Liability Terms (“Terms”) apply to all testing, treatment, 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”).

By participating in the BATWatch™ Program, you acknowledge and agree to the following disclaimers, limitations of liability, and acknowledgments:

1. General Disclaimers for the BATWatch™ Program:

a) Innovative, Research-Based Program: BATWatch is an innovative cognitive health program that leverages biomarker testing, genetic risk assessments, and evidence-based interventions to support Alzheimer’s prevention and cognitive health management. The program is grounded in evolving clinical research and may include experimental and off-label treatment methodologies.

b) Not a Guarantee of Results: Participation in BATWatch is not a guarantee of any specific health outcomes, including the prevention of Alzheimer’s disease or other cognitive disorders. Individual responses to testing and treatments may vary based on personal medical history, genetics, and adherence to treatment protocols.

c) Educational Purpose Only: Information provided through BATWatch, including reports, assessments, or educational materials, is for informational and educational purposes only. It is not intended as medical advice or a substitute for consultation with your healthcare provider.

d) Program Evolution: BATWatch incorporates new research and advancements, which may result in changes to protocols, eligibility criteria, or services over time. BATWatch reserves the right to update or modify program components based on emerging evidence or regulatory guidance.

e) Eligibility Changes: You acknowledge that changes to program eligibility, protocols, or research standards may affect your continued participation, and BATWatch reserves the right to discontinue or modify your participation accordingly.

2. BAT Pill Protocol (BPP) Disclaimers:

a) Off-Label Use of Sirolimus (Rapamycin): The BAT Pill Protocol (“BPP”) is an off-label, evidence-based treatment designed to reduce beta-amyloid (“BAT”) levels and lower the risk of tau-driven neurodegeneration. The protocol uses Sirolimus (Rapamycin), an FDA-approved medication for other conditions, administered in pulsed cycles. Off-label prescribing is a common, legally permissible practice when supported by credible scientific evidence.

b) Off-Label Use Disclosure: Off-label use of Sirolimus is consistent with ethical medical practices and is frequently employed in fields such as oncology, cardiology, and longevity medicine. The decision to use Sirolimus off-label is based on peer-reviewed research and established clinical experience.

c) Research-Based Protocol: The BPP is founded on decades of research, including studies demonstrating Rapamycin’s role in autophagy activation, neuroprotection, and reduction of beta-amyloid accumulation. Despite this scientific foundation, BATWatch cannot guarantee specific results or health improvements.

d) Not a Cure for Alzheimer’s Disease: The BAT Pill Protocol is intended to lower biomarkers associated with Alzheimer’s risk but is not a cure for Alzheimer’s disease or any other condition. It is not a guaranteed preventive measure, and the progression of neurodegenerative diseases can be influenced by many factors beyond the program’s scope.

e) Risk of Side Effects: The BPP involves the use of Sirolimus, which carries potential side effects, including but not limited to mouth ulcers, increased cholesterol levels, gastrointestinal issues, and, in rare cases, lung toxicity or skin sensitivity. Detailed risks are outlined in the BPP Terms of Service.

For a complete description of side effects, contraindications, and management strategies, refer to the BAT Pill Protocol (BPP) Terms of Service.

3. BAT Testing Protocol Disclaimers:

a) Diagnostic and Risk Assessment Purpose: BAT Testing is a diagnostic and risk assessment tool designed to measure biomarkers such as beta-amyloid (BA), tau (T), and genetic risk factors. Test results are indicators of cognitive health risk but are not diagnostic of Alzheimer’s disease or any specific medical condition.

b) Test Accuracy and Limitations: BAT Testing is based on current scientific methodologies and validated biomarker assays. However, no test is 100% accurate, and false positives or negatives may occur. Results should be interpreted within the broader context of your medical history and clinical evaluation.

c) Testing Technology: BAT Testing may utilize third-party laboratories for sample analysis. BATWatch ensures that partner labs meet quality standards but is not responsible for errors or delays caused by third-party providers.

d) Not a Substitute for Neurological Evaluation: BAT Testing is a preventive screening tool and should not replace comprehensive neurological evaluations, brain imaging, or other diagnostic tools if cognitive symptoms are present.

4. Telehealth Services Disclaimers:

a) Scope of Telehealth Services: Telehealth services provided under the BATWatch Program include virtual consultations for test interpretation, treatment planning, and ongoing monitoring. Telehealth is a supplement to, not a replacement for, in-person medical care.

b) Technology Limitations: Telehealth services rely on internet and digital platforms. Service interruptions, connectivity issues, or technical failures may affect the quality or availability of consultations. BATWatch is not liable for such interruptions.

c) Medical Records and Privacy: Telehealth consultations are documented and become part of your medical record with BATWatch. All records are maintained in accordance with HIPAA regulations.

d) Data Security Limitations: While BATWatch follows HIPAA standards, you acknowledge that telehealth services use third-party platforms that may have their own privacy policies, and no system is entirely immune to cybersecurity breaches.

e) Telehealth Medical Limitations: Telehealth assessments have inherent limitations compared to in-person evaluations, including reduced ability to conduct physical exams.

5. BATWatch Study Data Disclaimers:

The BATWatch Protocol is an ongoing, rolling observational study tracking Beta-Amyloid (BA) 42/40 ratios and phosphorylated Tau (pTau 181) levels in patients undergoing the BAT Pill Protocol. As of the most recent update with 600 patients, results have demonstrated:

a) Up to 87% measurable reductions in Beta-Amyloid (BA) 42/40 ratios after at least one treatment cycle.

b) Up to 74% measurable reductions in pTau 181 levels, with response varying based on baseline tau burden.

c) BA 42/40 ratio reductions ranged from 10% to 30% per cycle, with some patients requiring multiple cycles to reach the threshold of ≥0.150.

d) pTau 181 reductions varied based on baseline pathology:

• Lower baseline levels: 60-74% reduction per cycle
• Moderate baseline levels: 5-20% reduction per cycle
• Higher baseline levels: Limited response observed

f) Important Considerations:

i) The BATWatch Protocol is not a treatment for Alzheimer’s disease but rather a preventive approach targeting modifiable risk factors.

ii) The study is ongoing, and data will be continuously updated as additional patients undergo treatment and long-term follow-ups are conducted.

iii) Individual responses to treatment may vary, and reductions in BA 42/40 or pTau 181 levels do not guarantee prevention of cognitive decline or Alzheimer’s disease.

iv) The information presented here is based on internal observational data and published research referenced in our Research References.

v) This study is not FDA-approved as a clinical trial, and the data provided should be interpreted as part of ongoing research into Alzheimer’s prevention strategies. Always consult with a healthcare provider before making any medical decisions.

vi) While we continue our longitudinal monitoring to refine and expand our insights, the early results confirm the potential this approach may have to make a meaningful impact on Alzheimer’s prevention. 

6. General Risk Acknowledgments:

a) Voluntary Participation: Participation in the BATWatch Program, including the BPP, BAT Testing, and Telehealth services, is entirely voluntary. You acknowledge that you have reviewed the program terms, understand the potential benefits and risks, and have provided informed consent.

b) No Guarantee of Insurance Coverage: Participation in the BATWatch Program does not guarantee that services, including testing or treatments, will be covered by your health insurance. You are responsible for any out-of-pocket expenses as outlined in the Patient Financial Terms.

c) Program Limitations: BATWatch is a specialized program focusing on cognitive health risk identification and intervention. It does not replace comprehensive primary care or specialty care for other medical conditions.

d) No Medical Emergency Services: BATWatch is not an emergency medical service. In the event of a medical emergency, you should call 911 or visit the nearest emergency room.

7. General Medical Risk and Research Acknowledgment:

a) Evolving Science: You understand that the BATWatch Program is based on evolving scientific research and that recommendations may change as new evidence emerges.

b) No Guaranteed Risk Reduction: Participation in the program, including the BAT Pill Protocol and BAT Testing, may lower Alzheimer’s risk markers but cannot guarantee risk elimination.

c) Research Participation (if applicable): If you participate in research studies within BATWatch, you acknowledge that research involves uncertainty, and outcomes cannot be predicted.

d) Use of De-Identified Data: You consent to the use of your de-identified health data for internal research, program improvements, and potential publication of aggregate findings, in accordance with the HIPAA Notice of Privacy Practices.

8. Limitation of Liability:

To the fullest extent permitted by law:

a) No Warranty: BATWatch provides the BATWatch Program, including BPP and BAT Testing, on an “as-is” and “as-available” basis without warranties of any kind, express or implied.

b) No Liability for Indirect Damages: BATWatch is not liable for any indirect, incidental, special, consequential, or punitive damages, including loss of profits, data, or goodwill, arising from your participation in the BATWatch Program.

c) Cap on Liability: BATWatch’s total liability for any claim arising out of or related to the BATWatch Program will not exceed the total amount paid by you for participation in the program during the twelve (12) months preceding the claim.

d) No Liability for Third-Party Actions: BATWatch is not responsible for actions or omissions of third-party laboratories, telehealth platforms, or service providers involved in delivering components of the BATWatch Program.

e) Force Majeure: BATWatch is not responsible for delays or failure to perform services due to events beyond its reasonable control, including but not limited to natural disasters, pandemics, labor strikes, power outages, or acts of governmental authorities.

f) No Liability for Non-Medical Outcomes: BATWatch is not responsible for non-medical consequences of participation, including but not limited to emotional distress, employment issues, or impacts on insurability.

g) No Liability for External Delays: BATWatch is not responsible for delays or disruptions in services due to actions by third-party providers, regulatory authorities, or laboratory processing issues.

9. Acknowledgment of Understanding:

By participating in BATWatch, you acknowledge that BATWatch represents an innovative approach to Alzheimer’s prevention and cognitive health management, grounded in evolving clinical research. As a participant, you understand that: a) The BATWatch utilizes an off-label, evidence-based treatment program referred to as the BAT Pill Protocol (“BPP”) designed to reduce BAT Levels and lower the risk of tau-driven neurodegeneration. BPP uses Sirolimus (Rapamycin), an FDA-approved medication for other conditions, administered in pulsed cycles. b) Off-Label Use Disclosure: BPP utilizes Sirolimus off-label, which is a standard and legally permissible medical practice when supported by scientific evidence. Off-label prescribing is common in fields such as oncology, cardiology, and pediatrics, and it is recognized as ethical when it prioritizes patient safety and transparency. c) Research-Based Protocol: BPP is based on peer-reviewed studies, extensive clinical experience, and established principles in neuroprotection and autophagy activation. However, while the treatment aims to reduce BAT Levels and associated risks, BATWatch cannot guarantee specific health outcomes. d) Not a Cure for Alzheimer’s Disease: BPP is designed to lower biomarkers associated with Alzheimer’s risk. It is not a cure or guaranteed preventative measure against Alzheimer’s or any other disease. You also acknowledge that you have read, understood, and agreed to all related terms, including the following separate documents, which together form the complete agreement governing your participation:

BATWatch Terms of Service (General program terms and indemnification)

BAT Testing Terms of Service (Diagnostic and biomarker protocols)

BAT Pill Protocol (BPP) Terms of Service (Treatment protocols and off-label disclosures)

Telehealth Services Terms of Service (Virtual care and communication standards)

Dispute Resolution and Arbitration Terms (Procedures for resolving disputes)

HIPAA Notice of Privacy Practices (How your health information is used and protected)

Patient Financial Terms (Fee schedules, insurance, and out-of-pocket costs)

10. Release of Liability Specific to the BATWatch Program

This release includes, but is not limited to, any claims arising from: a) Individual Variability: Differences in treatment responses, outcomes, or unexpected reactions. b) Diagnosis Specifics: The impact of pre-existing conditions, comorbidities, or undiagnosed conditions. c) Treatment History: Prior therapies, medical conditions, or medications that may influence outcomes. d) Adherence to Therapy: Variations in results due to your compliance with prescribed protocols. e) Complex Needs: Outcomes affected by unique health complexities or rare conditions. f) Pre-existing Conditions: Aggravation or interaction with existing medical conditions. g) Unpredictable Incidents: Unexpected medical events not foreseeable at the time of treatment. h) Emotional Stress and Distress: Including anxiety, frustration, or psychological discomfort related to treatment outcomes or experiences. i) Medication Reactions: Adverse or allergic reactions to prescribed medications, including but not limited to, Rapamycin. j) Adjustment Period: Side effects or discomfort during the initial phases of treatment. k) Interpersonal Dynamics: Impacts on relationships or emotional well-being resulting from treatment experiences. l) Unintended Consequences: Any other unexpected or unintended outcomes arising from participation in BATWatch. You further agree that this Release of Liability applies regardless of any allegations of ordinary negligence or other fault by BATWatch or its representatives, except where prohibited by applicable law.

11. Indemnification

Indemnification terms for your participation in the BATWatch Program are outlined in the BATWatch Terms of Service, which you agree to by participating in this program. Please refer to the Indemnification Section of the BATWatch Terms for complete details.

12. Governing Law and Dispute Resolution

Disputes arising from your participation in the BATWatch Program, including any services under the BAT Pill Protocol (BPP), BAT Testing, or Telehealth Services, are subject to the dispute resolution and arbitration provisions outlined in the Dispute Resolution and Arbitration Terms.

Reference to Arbitration Terms: By participating in the BATWatch Program, you acknowledge and agree that all disputes will be resolved according to the procedures specified in the Dispute Resolution and Arbitration Terms, including any binding arbitration provisions.

Priority of Terms: In the event of a conflict between this document and the Dispute Resolution and Arbitration Terms, the terms outlined in the Dispute Resolution and Arbitration Terms will govern for all dispute-related matters

13. Severability

If any provision of this document is found to be unenforceable by a court of law, the remaining provisions will remain in full force and effect.

14. No Waiver

Failure by BATWatch to enforce any provision of this document does not constitute a waiver of that provision or any other provision.

15. Affirmative Consent to Disclaimers and Limitation of Liability:

By enrolling in the BATWatch Program, you affirmatively agree to all disclaimers, acknowledgments, limitations of liability, and risk disclosures outlined in this document. You further understand that these disclaimers form a material part of your agreement with BATWatch. Additionally, you confirm that you have had the opportunity to ask questions, consult with your healthcare provider, and receive satisfactory answers before participating.