Description
Plenhyage XL Medium 1 × 2 ml
Clinical description
Plenhyage XL Medium is a CE-marked, Class-III injectable biorevitaliser from Bioformula s.r.l. formulated from high-molecular-weight polynucleotides (PDRN, salmon-derived DNA) at 2.0% (≈20 mg/ml). The product is indicated to support tissue regeneration by stimulating fibroblast activity, encouraging extracellular-matrix repair and improving dermal hydration and elasticity. It is intended for clinical use where skin quality improvement is required—reducing fine lines, improving texture and supporting recovery of photodamaged or atrophic skin—rather than for volumetric correction. The formulation is sterile, biocompatible and resorbable; manufacturer documentation emphasises its role in improving skin density, tone and turgor through regenerative (biostimulatory) mechanisms.
What Plenhyage XL Medium is similar to
Plenhyage XL Medium sits in the polynucleotide (PDRN) biostimulator / polynucleotide category alongside other PN products and combination formulations (e.g., certain Jalupro® variants which combine amino acids with DNA fragments). Mechanistically, Plenhyage XL Medium acts via polynucleotide-driven fibroblast stimulation and extracellular matrix support; this contrasts with hyaluronic-acid (HA) fillers (e.g., Juvederm®/Restylane®) that primarily provide immediate volumetric augmentation via hydrophilic gels. Compared with lighter Plenhyage XL “Thin” or more concentrated “Strong” formulas in the same product family, the Medium formulation (2.0%) is positioned for moderate skin-quality concerns — stronger than Thin for structural support but less concentrated than Strong for advanced regenerative indications. For orientation, Profhilo® (an ultra-pure HA bioremodeling product) also targets skin quality rather than volume, but uses HA rather than PDRN; clinical choice depends on desired mechanism (biostimulation vs HA-mediated hydration).
This comparison is provided for clinical orientation only and does not imply interchangeability.
Treatment areas / indications
Manufacturer-stated suggested treatment areas: face, neck and décolletage. Manufacturer product page also notes applicability to other body zones requiring regenerative support (e.g., hands, areas of mild atrophy) depending on clinical assessment. If a specific area is required, verify on the product pack/IFU.
Usage / Administration (IFU-only section)
Note: the following items reproduce only parameters that are present in the manufacturer’s public product documentation. Where the IFU or manufacturer page does not specify a parameter, this is stated explicitly.
-
Injection depth: not provided by manufacturer.
-
Volume per point / injection site: not provided by manufacturer.
-
Needle gauge: not provided by manufacturer. Manufacturer packaging statement: syringe supplied with 2 disposable needles (pack contents), but needle gauge is not specified on the publicly available product page.
-
Frequency / number of sessions: Manufacturer states “multiple sessions are usually required; the aesthetic doctor will develop a personalised treatment plan.” No precise session count/interval is given in the public IFU.
-
Professional-use disclaimer: Intended for professional medical use only; to be administered by qualified medical professionals under aseptic conditions.
Non-IFU professional practice note (not part of the official IFU): some clinicians report common practice of a course of 2–4 sessions with 2- to 4-week intervals and maintenance treatments thereafter; this protocol is reported by distributors and practitioner forums, but is not specified in the manufacturer IFU and should be used only where clinically justified.
Ingredient list
-
Active: Polynucleotides (PDRN) — high molecular weight, 2.0% (approx. 20 mg/ml).
-
Excipients: sterile water and buffering components as per manufacturer formulation (detailed excipient list in full IFU/fact sheet available to registered professionals).
-
Lidocaine: not provided by manufacturer. (Manufacturer product page does not list lidocaine content.)
-
Hyaluronic acid: some supplier pages reference PN-HA combination products, but for Plenhyage XL Medium the manufacturer declares polynucleotides (2.0%) as the key active; HA is not presented as a primary active on the official product page. If HA content is critical for clinical choice, verify on the IFU/pack.
Presentation & longevity
-
Presentation / pack: 1 glass syringe of 2 ml supplied with 2 disposable needles (single-patient sterile pack).
-
Shelf life / storage: not provided by manufacturer on the public product page; consult the product carton/IFU for shelf-life and storage temperature.
-
Duration of effect: Manufacturer: “duration varies depending on individual needs; multiple sessions usually required.” Distributor/clinic reports commonly cite modest improvements that can be sustained with maintenance treatments (numerous sellers report typical effect windows in the order of months), but manufacturer does not provide a fixed longevity figure.
Safety notes / contraindications
(Manufacturer-aligned summary; always refer to full IFU before treatment)
-
Use is contraindicated in patients with known hypersensitivity to any component.
-
Do not inject into or adjacent to areas of active skin infection, inflammation or open wounds.
-
Caution or avoid use in pregnancy and breastfeeding unless local regulations and clinician judgement allow (manufacturer documentation advises professional assessment).
-
Administer only by trained healthcare professionals; improper injection technique may increase risk of adverse events.
Regulatory status
-
CE-marked: Class III medical device, CE 0373 (manufacturer documentation).
-
UKCA / FDA: UKCA marking and FDA clearance are not specified on the public manufacturer page; verify regulatory status on the product carton, local distributor records or via regulatory databases before use in non-EU/UK markets.
FAQ
Q1 — How does Plenhyage XL Medium work?
A1 — Plenhyage XL Medium delivers purified polynucleotides (PDRN) into the dermis where they act as biostimulatory molecules: studies and manufacturer data indicate PDRN can promote fibroblast activity, support collagen and extracellular matrix repair, and improve dermal hydration and tissue resilience. These mechanisms lead to gradual improvement in skin texture and elasticity rather than immediate volumetric filling.
Q2 — Is treatment safe and what side effects occur?
A2 — According to the manufacturer, Plenhyage XL Medium is well tolerated when used by trained clinicians; common transient reactions include redness, swelling, mild bruising or local sensitivity at injection sites. Serious adverse events are rare when used according to professional standards. Proper screening and aseptic technique reduce risks. Refer to the full IFU for detailed safety information.
Q3 — What is the recommended treatment schedule?
A3 — The manufacturer specifies that multiple sessions are usually required and that clinicians should personalise the protocol. The public IFU does not give a fixed session count or interval; therefore clinicians often plan an initial series (clinically reported at 2–4 sessions in some practices) with individualised maintenance. Always follow the official IFU and local clinical guidance.
Q4 — How long do results last?
A4 — Manufacturer guidance states that duration varies by individual and treated area; no fixed longevity is published on the public product page. Clinical reports from distributor sources commonly indicate improvements lasting months with maintenance—actual duration depends on skin condition, patient factors and treatment plan.
Q5 — Can Plenhyage XL Medium replace hyaluronic-acid fillers?
A5 — No direct interchange: Plenhyage XL Medium is a PDRN biostimulator intended to improve skin quality and promote tissue regeneration, whereas HA fillers primarily provide immediate volume and structural support. Choice should be indication-led: use PN products for dermal quality and HA for volumetric restoration or contouring. In many protocols both modalities are complementary.
