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Plenhyage XL Range

Plenhyage XL Range

Plenhyage XL

Bio-remodelling injectable
  • Class III injectable medical device based on polynucleotides, manufactured by Bioformula s.r.l. in Italy.
  • CE Marked device (CE 0373) within the Plenhyage XL polynucleotide range, intended for professional medical use only.
  • Produced in accordance with applicable European medical device regulations and quality standards for injectable dermal products.
Polynucleotide skinbooster / biorevitaliser

Description

Plenhyage XL Thin (1 x 2ml) is a Class III injectable medical device based on 0.75% high molecular weight polynucleotides (PDRN) designed to revitalise thin, delicate and early-ageing skin without adding volume. Developed by Bioformula s.r.l., it acts as a biorevitaliser/skinbooster for fragile areas such as the periorbital region, neck and décolletage, improving skin quality, elasticity, hydration and structure through fibroblast stimulation and extracellular matrix regeneration.

Bnefits

  • Contains 0.75% high molecular weight polynucleotides to revitalise delicate or early-ageing skin without bulk or volumisation.
  • Acts as a biorevitaliser/skinbooster to improve skin quality, elasticity and structure in thin and fragile areas of the face and neck.
  • Supports fibroblast activity, collagen and extracellular matrix regeneration for gradual improvement in firmness and texture.
  • Provides deep hydration and antioxidant action, helping restore optimal skin condition and radiance.
  • Formulated specifically for sensitive zones such as the periorbital area, neck and décolletage where stronger formulations may be too aggressive.
  • Light, low-viscosity gel designed for subtle skin quality transformation rather than deep volumetric filling.
  • Supplied in a ready-to-use 2 ml pre-filled glass syringe with two 30G 1/2" needles for precise, minimally invasive application.
  • Made from highly purified, biocompatible and resorbable polynucleotides derived from salmon sperm DNA, with a high safety profile.

Indications

  • Revitalisation of delicate, thin or early-ageing skin.
  • Improvement of skin quality and elasticity in fragile zones such as periorbital area, neck and décolletage.
  • Treatment of fine lines and superficial wrinkles in thin skin.
  • Bio-restructuring and hydration of photo-aged or mildly lax skin without adding volume.
  • Patients who require gentle regeneration and hydration rather than intensive volumetric correction.

Composition

  • High molecular weight polynucleotides (PDRN) 0.75% (7.5 mg/ml) in a 2 ml pre-filled syringe.
  • Highly purified, biocompatible and resorbable polymerised DNA fragments derived from salmon sperm DNA.
  • Aqueous injectable gel vehicle (exact excipients not fully specified in publicly available sources).

Formulation

  • Sterile, apyrogenic, injectable gel based on high molecular weight polynucleotides (PDRN).
  • Concentration of active polymerised polynucleotides: 0.75% (7.5 mg/ml).
  • Class III polynucleotide-based biorevitaliser/skinbooster for professional use only.
  • Non-volumising formulation designed for thin and delicate skin areas.

Packaging

  • 1 x 2 ml pre-filled glass syringe of Plenhyage XL Thin.
  • 2 x 30G 1/2" disposable sterile needles included in each pack.
  • Supplied as a single-use, ready-to-inject medical device for professional use.

Usage

  • For use only by appropriately trained healthcare professionals experienced in injectable aesthetic treatments.
  • Use according to the manufacturer’s and local distributor’s reconstitution/handling and injection protocol for Plenhyage XL Thin.
  • Inject into the indicated dermal or superficial subdermal plane in thin and delicate skin areas (e.g. periorbital region, neck, décolletage), following recommended injection techniques (micro-injections, nappage, or other appropriate patterns) while carefully avoiding intravascular injection.
  • Treatments are typically performed as a course of sessions spaced several weeks apart; the exact number of sessions and interval should be determined by the clinician based on the patient’s skin condition and desired outcome.
  • After injection, gently massage the treated area if recommended by protocol to ensure even product distribution.
  • Advise the patient on standard post-procedure care such as avoiding makeup on treated areas immediately post-treatment, minimising sun/heat exposure, and following clinic-specific aftercare instructions.
  • Dispose of the syringe, needles and any unused product in accordance with local regulations for clinical sharps and pharmaceutical waste; do not reuse or resterilise.

Contraindications

  • Known hypersensitivity or allergy to polynucleotides or any component of the formulation.
  • Active skin infections, inflammation or dermatological conditions at or near the intended injection site.
  • Severe systemic illness, uncontrolled autoimmune disease or conditions where injectable aesthetic procedures are contraindicated, unless the risk–benefit has been carefully evaluated.
  • History of severe hypertrophic scarring or keloid formation in the planned treatment area.
  • Pregnancy or breastfeeding, and patients under 18 years of age, due to lack of adequate safety data.
  • Use by non-medical personnel or for self-administration.

Adverse Effects

  • Typical injection-related reactions such as transient redness, swelling, tenderness, bruising or mild pain at the injection site.
  • Temporary papules or small bumps at injection points, which usually resolve spontaneously over a few days.
  • Rarely, local inflammatory reactions, prolonged oedema or nodules may occur and may require medical management.
  • As with any injectable procedure, there is a risk (albeit low with correct technique) of vascular compromise, tissue ischemia or necrosis if injected intravascularly.
  • Potential allergic or hypersensitivity reactions in susceptible individuals.
  • Risk of infection at the injection site if aseptic technique is not strictly observed.

Storage Conditions

  • Store in a cool, dry place away from direct sunlight, within the temperature range specified on the product packaging (typically controlled room temperature).
  • Do not freeze and protect from excessive heat or sudden temperature changes.
  • Keep the syringe in its original packaging until use to maintain sterility and protect from light and contamination.
  • Do not use after the expiry date or if the packaging or syringe is damaged.

Duration

Clinical sources describe results from Plenhyage XL Thin as typically lasting around 4\u20136 months after a course of treatments, with maintenance sessions recommended to sustain skin quality improvements. Exact duration varies by patient, indication and treatment protocol.

Onset

Some improvement in hydration and skin smoothness may be visible within days, with progressive enhancement of texture, elasticity and fine lines over the following weeks as fibroblast activity and extracellular matrix regeneration occur. Full benefits generally develop gradually over several weeks and may continue to improve with subsequent sessions.

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