POWERFILL®

POWERFILL® Product Name and Description

POWERFILL® is a PDLLA-based injectable filler designed specifically for penis enlargement and long-lasting volume restoration. This product utilizes Poly-D, L-Lactic Acid (PDLLA) technology to stimulate collagen production and provide natural-feeling results over an extended period.

• Formulation: Biodegradable and bioresorbable PDLLA microparticle polymer.
• Packaging: One vial per box.
• Manufacturer: REGEN Biotech, Inc.

POWERFILL® Key Features and Benefits

POWERFILL® is a next-generation filler offering unique benefits for non-invasive penile augmentation.

• Long-Lasting Results: Provides effects lasting 2–3 years due to natural collagen regeneration.
• Collagen Stimulation: Promotes new tissue growth for natural volume enhancement.
• Safe and Biocompatible: PDLLA is biodegradable and approved by both the U.S. FDA and KFDA.
• Minimally Invasive: Requires no incisions, stitches, or hospital stay.
• Quick Procedure: The entire treatment takes only 10 minutes under local anesthesia.

POWERFILL® Composition

The filler leverages PDLLA microparticle technology to enhance tissue structure and safety.

• Main Component: Poly-D, L-Lactic Acid (PDLLA).
• Safety Approvals:
  • PDLLA registered under FDA GRAS since 1984.
  • Proven biocompatibility and biodegradability.

POWERFILL® Intended Purpose / Indications

POWERFILL® is indicated for male patients seeking safe and effective penile augmentation.

• Enhances penis size and volume.
• Suitable for men with micropenis conditions or cosmetic preferences.
• Provides natural results without migration to other tissues.

POWERFILL® Mechanism of Action

POWERFILL® stimulates tissue regeneration and collagen production to create long-lasting volume.

• Collagen Stimulation:
  • Cells migrate into porous PDLLA microparticles within 2 weeks.
  • Collagen production increases significantly between 12–20 weeks post-injection.
• Microparticle Design:
  • Porous structure ensures effective tissue integration.
  • Cells fill empty spaces between particles, promoting volume stability.

POWERFILL® Procedure and Preparation

The procedure involves reconstitution and a straightforward injection protocol.

1. Reconstitution:
   • Mix 8 mL of Sterile Water for Injection (SWFI) and 2 mL of 2% lidocaine with one vial of POWERFILL.
   • Allow the suspension to hydrate for 10–30 minutes before injection.
2. Injection:
   • Administer the prepared suspension with local anesthesia.
   • Treatment requires 10 mL of suspension per session.

POWERFILL® Treatment Frequency

The treatment typically involves one or two sessions for optimal results.

• Initial injection can be followed by a second session after evaluating patient satisfaction.
• Long-lasting effects reduce the need for frequent repeat treatments.

POWERFILL® Safety and Biocompatibility

POWERFILL® prioritizes safety through its biocompatible and biodegradable design.

• Biodegradability:
  • PDLLA is hydrolyzed into lactic acid, glycogen, and eventually broken down into carbon dioxide and water, excreted naturally.
• Non-Migratory:
  • Filler particles remain localized to the injection site, maintaining volume and safety.
• Histological Confirmation:
  • Studies confirm cell integration and collagen production without adverse tissue reactions.

POWERFILL® Post-Treatment Care

Post-treatment care ensures optimal results and patient comfort.

• Patients can resume daily activities immediately after the procedure.
• Avoid physical strain or pressure on the treated area for a few days post-injection.

POWERFILL® Side Effects and Adverse Reactions

Side effects are minimal due to the biocompatible nature of the filler.

• Common Side Effects:
  • Temporary swelling, redness, or mild discomfort at the injection site.
• Severe Reactions:
  • Rare and limited to improper administration or technique.

POWERFILL® Patient Eligibility

This product is ideal for adult men seeking non-invasive penile augmentation.

• Suitable for individuals with no underlying autoimmune or severe health conditions.
• Not recommended for patients with active infections or hypersensitivity to PDLLA.

POWERFILL® Follow-Up and Maintenance

Follow-up sessions may be scheduled to monitor results and determine the need for additional injections.

• Treatment Maintenance:
  • Effects last over 24 months, reducing the need for frequent procedures.

POWERFILL® Manufacturer and Regulatory Information

POWERFILL® is manufactured to the highest standards by REGEN Biotech, Inc., a leader in advanced injectable solutions.

• Regulatory Approvals:
  • Certified by KFDA.
  • PDLLA raw material approved by the U.S. FDA for safety and biodegradability.
• Website: www.regenbioglobal.com