1. What is Integreat™? The Integreat™ Physician Base Preparation Kit is an inert toothpaste-based delivery system designed for use by physicians and compounding pharmacies to deliver precise, daily food protein exposure. Each kit is flexible and customizable, containing an inert base toothpaste (mint or berry flavor), enabling clinicians and compounding pharmacies to prepare patient-specific, protein-containing regimens directly in their clinics or pharmacies.

Many patients undergoing daily oral food protein exposure struggle with the need to consume a particular food each day, often experiencing “food fatigue” or sensory aversions to its taste or texture. This system may help address these barriers by integrating food protein exposure into the existing daily routine of toothbrushing, supporting long-term adherence.

Integreat™ is an inert toothpaste-based delivery system, not a drug, and therefore has no pharmacological mechanism of action, nor does it have any therapeutic effect on its own. It acts as a vehicle for delivering precise, daily food protein exposure through the existing habit of toothbrushing. The base toothpaste is inert and protein-free.

The kit creates a flexible solution for patients with unique needs, particularly:

· Food fatigue patients tired of the daily requirement of eating specific foods

· Sensory sensitivities in individuals with aversions to the taste or texture of the food itself

· Transitional life stage patients such as teenagers or young adults requiring a portable, discreet option

· Hesitant patients such as those previously unwilling to commit to other forms of oral administration

· Busy patients who want to simplify their daily tasks

No, the base toothpaste does not contain any food allergens. The toothpaste is an inert, protein-free base formulated to stabilize food proteins upon mixing. It provides no therapeutic benefit on its own and requires reconstitution by a qualified physician or compounding pharmacy prior to dispensation. Furthermore, the choice of protein and the final reconstituted preparation must be determined by the clinician and should only be administered under medical supervision.

Each kit includes:

· Inert, fluoride and protein-free toothpaste base available in either mint or berry flavors (fluoride can be added per physician instruction)

· Mixing accessories including mixing and unguator jars for professional preparation

· A metered-dose actuator pump for consistent patient dosing with a patient label

The base kit has a two-year shelf life from date of manufacture, and the expiry date is indicated on each box. The base paste formulation contains glycerin which is specifically designed to maintain protein integrity. Additional glycerin is also added during the mixing process to yield a compounded product that is stable for the intended 12 weeks of daily use by a patient. Preliminary studies with Integreat™ base toothpaste mixed with peanut protein have demonstrated protein stability for 6 – 12 months (internal data – available upon request). It is recommended that mixed pumps be refrigerated if there is any delay in patient use. Once in active use, refrigeration is not required.

The product is contraindicated for patients with known sensitivities (allergy/intolerance) to any of the ingredients in the base toothpaste. The base paste ingredients are listed on the Integreat™ box, the unguator jar, and on the pump that is distributed to the patient.

Patient use recommendations are provided as part of the Integreat™ Mixing Instructions available online in the Product Support section of the Integreat™ ordering website at www.order.intrommune.com. Please note, it is recommended that the first actuation of the final prepared toothpaste be administered in clinic under medical supervision.

Patients at risk of increased food protein absorption should refrain from using mixed toothpaste until the risk has been resolved.

Yes, fluoride can be added to Integreat™ if ordered by the physician. Detailed instructions are provided in Integreat™ Mixing Instructions found in the Product Support section of the Integreat™ ordering website at www.order.intrommune.com. Please note that fluoride is not included in the Integreat™ kit.

No. While OIT typically requires the ingestion of allergenic proteins, this system delivers measured daily food protein exposure to the oral mucosa without requiring ingestion. Unlike approved therapies, the base toothpaste provides no therapeutic benefit on its own.

No. This product has not been evaluated by the FDA and is not intended to diagnose, treat, cure, or prevent any disease. It is an inert toothpaste-based delivery system designed for in-clinic or compounding pharmacy customization.

Please refer to Integreat™ Mixing Instructions.

The base toothpaste is designed for patient-specific preparation and compatible with food protein powder.

Please refer to Integreat™ Mixing Instructions.

To maintain optimal toothpaste texture and mouthfeel of the final, mixed formulation, it is recommended to use no more than 7 grams of food powder.scription

Yes. To maintain optimal toothpaste texture and mouthfeel of the final, mixed formulation, it is recommended to use no more than 7 grams total of food powder. 19. Does Intrommune

Intrommune does not currently offer food protein powders or extracts. However, they are available from multiple sources listed in the Integreat™ Mixing Instructions.

For your practice to mix Integreat™, the following pharmaceutical grade compounding equipment is required:

· Scales & Calibration Weights

· Weigh Boats, Weigh Paper, Forceps, Spoons & Spatulas

· Sodium Fluoride USP (if ordered by the doctor)

· 50% glycerin (sterile)

· 10ml Syringes with 18-Gauge Needles

· Optional: Compounding Jar Homogenizer

For more details, please refer to Integreat™ Mixing Instructions or contact us at info@intrommune.com.

How do I order Integreat™? Once registered, kits can be ordered directly through our website www.order.intrommune.com.

Please contact info@intrommune.com for Integreat™ pricing information.

How many weeks of treatment are provided by a single Integreat™ kit? A single IntegreatTM kit is designed to last at least 12 weeks, depending on the specific dosing volume prescribed by the clinician. The kit includes a metered-dose actuator pump to ensure precise, consistent dispensing. Patients using Integreat™ consistently will require approximately 4 kits per year.

Integreat™ product support tools are available online in the Product Support section of the Integreat™ ordering website at www.order.intrommune.com. Support includes FAQs, detailed mixing instructions, and compounding support if needed.

No. Integreat™ is intended to be provided to patients by their physician after it is properly prepared by trained professionals. Integreat™ is not available for direct purchase by patients.

Please contact Intrommune directly at info@intrommune.com