Luminnova InnateSignal™ Program

Evidence-informed. Individualized. Physician-guided.

Thank you for taking the time to review the InnateSignal™ Clinical Evidence Guide.

If you would like to participate, the information below explains what the InnateSignal™ Program involves, how your treatment is individualized, and what is included in the program fee.

More Than an aVNS Device

InnateSignal™ is a physician-guided auricular vagus nerve stimulation (aVNS) treatment platform, designed to engage the body’s innate systems of Rest, Regulation and Recovery.

The program combines:

An extensive evidence-backed treatment program library
InnateSignal™ brings together stimulation approaches derived from published clinical and translational research across a wide range of health conditions and treatment objectives.

Comprehensive clinical evaluation
Your symptoms, health history and treatment priorities are assessed across multiple areas rather than considering a single symptom in isolation.

Individualized treatment selection
Your physician selects your initial program or combination of programs based on your individual presentation and the available scientific evidence.

A detailed individualized report
You receive an InnateSignal™ Comprehensive Evaluation & Initial Program, summarizing your assessment, treatment priorities and recommended initial approach.

A highly configurable InnateSignal™ PRO device
Your device is programmed with the treatment programs selected specifically for you and remains yours following completion of the program.

Structured monitoring and physician oversight
Your response is followed throughout the program using brief structured questionnaires and scheduled physician reviews.

Response-guided treatment adaptation
Your initial recommendation is a starting point. Treatment may be adjusted as we learn how you respond.

This combination is what distinguishes InnateSignal™ from simply purchasing an aVNS device with predetermined settings.

How the Program Works

1. Comprehensive Assessment

You complete a detailed InnateSignal™ questionnaire covering your symptoms, medical history, treatment priorities and relevant safety information.

2. Physician Review

Your assessment is reviewed by your physician, who considers your individual clinical picture together with the available evidence.

3. Individualized Treatment Strategy

Your recommended program or combination of programs is selected from the InnateSignal™ program library.

The process used to select and sequence treatment programs forms part of Luminnova’s proprietary clinical methodology.

4. Your Personalized Report

You receive your InnateSignal™ Comprehensive Evaluation & Initial Program, outlining the findings from your assessment, treatment priorities and initial recommendations.

Your precise treatment parameters are clearly outlined for your reference.

5. Your InnateSignal™ PRO Device

Your device is configured with your recommended programs and you are provided with guidance on its use.

The device remains yours after completion of the program.

6. Weekly Monitoring

You complete brief structured follow-up questionnaires so that changes in symptoms, tolerability and response can be tracked over time.

7. Physician Review & Treatment Adaptation

Your progress is reviewed at scheduled intervals.

Depending on your response, your physician may recommend continuing the existing approach, modifying treatment, introducing an alternative program or shifting emphasis toward another treatment priority.

For example, if one of your original priorities improves substantially during the first several weeks, treatment can increasingly focus on another identified area.

8. Progress Evaluation

Your progress is formally evaluated during the program and again at completion, with recommendations for ongoing use.

Why 12 Weeks?

The 12-week Comprehensive Program is our recommended approach.

Response to aVNS may develop over time, and different treatment objectives may respond at different rates. Twelve weeks provides time to establish an initial treatment strategy, assess response, make adjustments where appropriate and determine whether improvements are sustained.

It also allows treatment priorities to evolve.

Improvement in one area does not necessarily mean that treatment has finished. If an initial priority is responding well, greater emphasis can be placed on another area identified during your original assessment.

InnateSignal™ 12-Week Comprehensive Program

$1,895

Your program includes:

• Comprehensive initial clinical assessment

• Physician evaluation

• Individualized treatment strategy

• InnateSignal™ Comprehensive Evaluation & Initial Program report

• InnateSignal™ PRO device

• Individualized device programming

• Device and treatment guidance

• Weekly structured symptom monitoring

• Scheduled physician clinical reviews

• Response-guided treatment adjustments when appropriate

• Progress evaluation

• Comprehensive 12-week review

• Recommendations for longer-term use

Support Between Scheduled Reviews

Your program fee includes your scheduled monitoring, physician reviews and treatment adjustments arising from those reviews.

We understand that questions may occasionally arise between scheduled reviews. Brief questions relating to use of your device or clarification of your existing treatment instructions are included as part of the program.

If you would like additional individualized medical advice, a detailed review of new symptoms, or a physician consultation outside your scheduled InnateSignal™ reviews, ad hoc physician support is available for an additional fee.

This distinction allows us to provide appropriate support when needed while keeping the overall InnateSignal™ Program accessible and ensuring that additional physician time is available to patients who require it.

Prefer to Start With One Month?

We recognize that some patients may prefer a shorter initial commitment.

Flexible Monthly Enrollment

First month — $1,195

The first month includes your comprehensive evaluation, individualized report and treatment recommendations, InnateSignal™ PRO device, programming, guidance, monitoring and first-month physician oversight.

If you would like to continue:

Additional months — $550 per month

The recommended 12-week Comprehensive Program is therefore the best-value option for patients who are comfortable committing to the full treatment period, while monthly enrollment provides the flexibility to begin with a shorter commitment.

After Your 12-Week Program

At completion, you retain your InnateSignal™ PRO device and can continue using established programs independently where appropriate.

For patients who would like continued structured monitoring and physician oversight, InnateSignal™ Continuing Care is available.

Continuing Care — $495 per 3 months

This provides a pathway for ongoing monitoring, periodic physician review and appropriate treatment adjustment after completion of your initial program.

If a substantially new treatment objective arises in the future, returning InnateSignal™ patients can also be reassessed and have new programs developed without purchasing another device or repeating the entire initial program.

The InnateSignal™ Difference

InnateSignal™ is not simply an aVNS device or a single stimulation protocol.

It is an evidence-informed, physician-guided treatment platform combining an extensive program library, comprehensive clinical evaluation, individualized treatment selection, advanced stimulation technology, structured outcome monitoring and treatment that can evolve according to your response.

Evidence guides the starting point. Your individual response guides what happens next.