Instructions of use

exosmart™: Clinical Protocol for Point-of-Care Use

This document provides the official step-by-step instructions for the preparation of the exosmart™ Autologous Exosome Concentrate. The entire procedure should be performed under sterile conditions. The protocol takes approximately 30 minutes to complete.

Required Materials

  • 1 x exosmart™ sterile, single-use kit
  • A commercially available system or method for preparing PRP/PPP
  • 2 x 20 mL sterile Luer-lock syringes
  • 1 x 10 mL sterile Luer-lock syringe
  • Standard materials for aseptic blood draw

Step-by-Step Procedure

Stage I: Plasma Preparation (Time: Approx. 20-25 minutes)

  1. Objective: The first step is to prepare 25-30 mL of total plasma. This required volume is typically obtained from an initial whole blood draw of approximately 60 mL.
  2. Plasma Composition: It is critical that the prepared plasma includes both the Platelet-Rich Plasma (PRP) and the Platelet-Poor Plasma (PPP) layers. The exosmart™ system is designed to process this total plasma to ensure all regenerative components are captured.
  3. Preparation Method: The required 25-30 mL of total plasma can be achieved using various methods, such as a double-spin centrifuge protocol, multiple collection tubes, or any commercially available PRP preparation kit.
    • Note: Clinicians must select a preparation method that reliably yields the required 25-30 mL of total plasma. The efficiency of your chosen PRP system should be taken into consideration.
  4. Final Plasma Collection: Once prepared, carefully aspirate the 25-30 mL of total plasma into two separate 20 mL sterile syringes.

Stage II: exosmart™ Concentration (Time: Approx. 3-5 minutes)

  1. Device Connection: Unpack the sterile exosmart™ kit. Securely connect the two 20 mL syringes containing the total plasma to the input ports of the exosmart™ device.
  2. Processing: Gently and steadily push the plungers of both syringes simultaneously. The plasma will move through the ultrafiltration system. You will see the waste bag fill with clear fluid (filtrate). Continue applying steady pressure until both syringes are empty.
    • Clinical Note: The goal is a steady flow. Do not apply excessive, sudden force.

Stage III: Final Product Aspiration (Time: Approx. 1 minute)

  1. Product Recovery: Once processing is complete, open the air filter cap on the device. Connect a sterile 10 mL syringe to the output port.
  2. Aspiration: Gently pull back the plunger of the 10 mL syringe. This will aspirate the final concentrated product from within the device’s filter housing.
  3. Final Volume: You will obtain approximately 6-7 mL of the final exosmart™ Autologous Exosome Concentrate. This product is now ready for immediate clinical application.

Instructional Video - Processing Protocol:

Important Clinical Notes

  • For Single Use Only: The exosmart™ kit and all syringes are sterile and intended for a single patient procedure. Do not reuse.
  • Aseptic Technique: Strict adherence to sterile technique throughout the entire process is mandatory to ensure patient safety.
  • No Anticoagulant Needed in Final Product: The final 6-7 mL concentrate is ready for immediate use and does not require the addition of any further anticoagulant.
  • Disposal: Dispose of all used components, including the device and syringes, according to your facility’s biohazard waste disposal guidelines.

Useful tips: