CE Marked injectable medical device (syringe CE 0373, MD Skin Solutions; needles CE 0318, BD) compliant with relevant EU medical device regulations.
Manufactured in Europe under an ISO 13485 Certified quality management system for medical devices.
Produced in compliance with Good Manufacturing Practice (GMP) standards for sterile injectable products.
CE Marked injectable medical device (syringe CE 0373, MD Skin Solutions; needles CE 0318, BD) compliant with relevant EU medical device regulations.
Manufactured in Europe under an ISO 13485 Certified quality management system for medical devices.
Produced in compliance with Good Manufacturing Practice (GMP) standards for sterile injectable products.
Galenic form described as isotonic, viscoelastic, non Pyrogenic, sterile gel with pH approximately 7.2.
Based on patented HPN Technology using highly purified, sterilised polynucleotides and hyaluronic acid.
Description
Pluryal Densify 2ml is an injectable skin densifier and biostimulatory skin booster from the Pluryal Densifiers range by MD Skin Solutions. Based on patented HPN Technology, it combines highly purified polynucleotides, non-cross-linked hyaluronic acid and mannitol in a sterile, isotonic, viscoelastic gel for total skin regeneration. Injected into the deep dermis or superficial hypodermis, it deeply hydrates the skin, stimulates fibroblast activity and collagen synthesis, improves microcirculation, protects against free radicals and promotes tissue repair. It is designed to treat dull, tired, dehydrated and aggressed skin on the whole face (except the under-eye area), neck, décolletage and back of the hands, and can also help with sagging skin, acne scarring and preparation for other aesthetic procedures.
Bnefits
Deeply hydrates the skin from within thanks to non-cross-linked hyaluronic acid and polynucleotides.
Densifies the skin by stimulating fibroblasts to produce collagen, elastin, hyaluronic acid and extracellular matrix proteins.
Improves microcirculation and tissue oxygenation, helping skin look fresher and more radiant.
Protects against free radicals and oxidative stress via mannitol and the scavenger effect of polynucleotides.
Promotes tissue regeneration and repair, improving skin texture, colour and overall quality.
Combats signs of fatigue and dullness, restoring glow and luminosity.
Increases firmness, elasticity and turgor for smoother, less brittle and more resilient skin.
Helps to treat sagging skin and improves the appearance of acne scars and surface irregularities.
Ideal as a pre-treatment biorevitalisation phase prior to fillers, lasers, peels and other aesthetic procedures.
Clinically and scientifically documented to improve skin age parameters and provide cumulative, long-lasting rejuvenation.
Indications
Dull, tired skin with signs of fatigue and lack of radiance.
Dehydrated skin with reduced turgor and elasticity.
Loss of firmness and mild to moderate skin laxity on face, neck, décolletage and hands.
Aggressed or recently treated skin (e.g. post-laser, post-surgery, post-fillers) after an appropriate waiting period.
Uneven skin tone and texture, including fine surface irregularities and some types of acne scarring.
Preparation and bio-revitalisation of the skin prior to other aesthetic treatments such as fillers, lasers and peels.
Whole-face rejuvenation (except under-eye area): improvement of colour, texture and overall skin quality.
Back of the hands, neck and décolletage rejuvenation for improved firmness, hydration and glow.
Composition
Polynucleotides 20 mg per 2 ml syringe (10 mg/ml): highly purified, pharmaceutical-grade, natural DNA fragments extracted from salmon milt, biocompatible and fully absorbable; provide tissue regeneration and trophic stimulation.
Hyaluronic acid 20 mg per 2 ml syringe (10 mg/ml): natural, non-cross-linked, highly purified HA produced by bio-fermentation of Streptococcus equi; provides deep moisturisation, turgor and support to the dermal extracellular matrix.
Mannitol 80 mg per 2 ml syringe (40 mg/ml): sugar alcohol with antioxidant properties that scavenges free radicals and prolongs the action of hyaluronic acid by protecting it from degradation.
Isotonic buffer solution and excipients suitable for sterile, non-pyrogenic injectable gels (pH approximately 7.2).
Formulation
Isotonic, viscoelastic, non-pyrogenic, sterile gel for intradermal injection.
Non-cross-linked hyaluronic acid combined with highly purified polynucleotides and mannitol using HPN Technology.
Hyaluronic acid of natural, bacterial origin (bio-fermentation), highly purified and non cross-linked.
Polynucleotides (PDRN-like) with molecular weights typically between ~80 and 2000 kDa, highly purified to remove protein traces and reduce immunogenicity.
Mannitol added at 40 mg/ml to provide antioxidant protection and slow HA degradation, enhancing duration of effect.
Intended injection level: deep dermis and/or superficial hypodermis depending on technique and treatment area.
Packaging
Box containing 1 x 2 ml pre-filled glass syringe of Pluryal Densify gel.
2 x 30G 1/2" needles for injection.
Instructions for Use (IFU) leaflet.
2 traceability labels for patient and clinic records.
Labelled as a CE-marked injectable medical device manufactured by MD Skin Solutions in Europe.
Usage
Pluryal Densify is an injectable medical device intended only for trained and qualified healthcare or aesthetic professionals experienced in intradermal injection techniques.
Perform a full medical history and skin assessment, identify indications (e.g. dull, tired, dehydrated, aggressed skin), exclude contraindications and obtain informed consent prior to treatment.
Cleanse and disinfect the treatment area thoroughly. Topical anaesthetic can be used according to clinic protocol if needed.
Attach a sterile 30G 1/2" needle (or appropriate cannula) to the pre-filled 2 ml syringe using aseptic technique and expel any air bubbles before injection.
Recommended injection level (per manufacturer): deep dermis or superficial hypodermis, adapted to the area and technique chosen.
Common techniques include microdroplet (subdermal papules) with small boluses (approx. 0.05 ml) spaced about 1 cm apart, or cannula-based techniques such as the Double7Lift fan technique and linear threading/fanning along the skin.
Target areas listed by the manufacturer include: whole face (except under-eye area), neck, décolletage and back of the hands; adapt volume and pattern to individual skin condition and aesthetic goals.
Initial treatment protocol (manufacturer guidance): three sessions with 3-week intervals between each injection for skin repair and densification.
Maintenance protocol: for younger skin, one injection every 3 months; for tired or more damaged skin, one injection every other month, adjusted to clinical response and patient needs.
For preparation before aesthetic procedures (bio-revitalisation phase), a series of four injections at 1-week intervals may be used in the month preceding treatments such as fillers, lasers or peels.
For recently aggressed skin (e.g. post-laser, surgery or other procedures), wait approximately 3 weeks before starting a Pluryal Densify course, following manufacturer guidance and clinical judgement.
Inject slowly, with minimal pressure and careful aspiration where appropriate, monitoring for pain, blanching or other signs of vascular compromise; discontinue immediately and follow complication protocols if adverse signs occur.
After injection, gently massage the area only if needed to distribute product evenly; avoid excessive pressure that might displace the gel.
Provide aftercare instructions: avoid makeup for several hours, avoid intense heat/cold, saunas, vigorous exercise and alcohol for 24 hours, and protect treated areas from strong sun and UV exposure for several days.
Refer to the official Pluryal Densify professional brochure and Instructions for Use for full details on indications, techniques, precautions and management of adverse events.
Contraindications
Hypersensitivity or allergy to polynucleotides, hyaluronic acid, mannitol or any component of the formulation.
History of severe allergic reactions or anaphylaxis to injectable biostimulators or similar products.
Active skin infection, inflammation or disease at or near the intended injection sites (e.g. bacterial infection, viral lesions such as herpes, dermatitis).
Autoimmune diseases or immunodeficiency disorders where injectable biostimulatory treatments may be inadvisable, unless carefully assessed and approved by a specialist.
Known tendency to keloid or hypertrophic scar formation in the proposed treatment area.
Bleeding disorders or current significant anticoagulant/antiplatelet therapy with increased risk of bleeding, unless evaluated and cleared by a prescribing clinician.
Pregnancy and breastfeeding (commonly contraindicated or strongly discouraged for elective aesthetic injectables).
History of severe systemic disease or uncontrolled medical conditions where elective aesthetic procedures are not appropriate.
Any other contraindications or warnings listed in the official Pluryal Densify Instructions for Use and local regulatory or professional guidelines.
Adverse Effects
Typical, usually transient injection-site reactions such as redness (erythema), swelling, tenderness, pain, warmth, itching, minor bruising or slight bleeding.
Transient papules, small nodules or irregularities at injection points, generally resolving as oedema subsides and the product integrates into tissue.
Temporary asymmetry or overcorrection immediately after treatment, which often improves as swelling reduces; may occasionally require adjustment in subsequent sessions.
Local inflammatory or hypersensitivity reactions such as prolonged redness, swelling or induration, which should be evaluated and managed by a clinician.
Risk of infection at injection sites if aseptic technique is not strictly followed; may require antimicrobial treatment and medical follow-up.
As with all injectable intradermal treatments, very rare but serious complications related to inadvertent intravascular injection or vascular compromise are possible, including ischaemia or tissue necrosis; urgent recognition and management according to established filler/biostimulator complication protocols are required.
Any additional adverse effects mentioned in the official Pluryal Densify Instructions for Use, which treating practitioners must review before use.
Storage Conditions
Store in a clean, dry place at controlled room temperature as indicated on the packaging, typically between 2°C and 25°C.
Protect from direct sunlight and sources of heat or cold; do not freeze the product.
Keep the pre-filled syringe in its original blister and outer carton until use to maintain sterility and traceability.
Do not use if the packaging, blister or syringe is damaged or if sterility is compromised.
Do not use after the expiry date printed on the packaging.
Discard any unused product after opening; Pluryal Densify is intended for single-patient, single-use only.
Duration
Manufacturer protocols recommend an initial course of 3 injections at 3-week intervals, followed by maintenance injections every 3 months for young skin or every other month for more tired skin. Clinical and commercial sources describe cumulative, long-lasting effects with treatment cycles typically maintained over many months; exact duration varies with patient age, skin condition, lifestyle and treatment plan rather than a fixed single-session longevity.
Onset
Patients usually notice increased hydration, radiance and improved skin texture within weeks of starting treatment, with progressive improvements in firmness, elasticity and skin quality over the course of the initial 3-session protocol and subsequent maintenance.
