CE Marked injectable medical device: Pluryal Biosculpture syringes are CE 0373 (MD Skin Solutions) and supplied with CE 0123 needles (Sterimedix LTD), indicating conformity with applicable EU medical device directives/regulations.
Manufactured in Europe under an ISO 13485 Certified quality management system for medical devices.
Industrial bioprocess and environmental management aligned with ISO 14001 standards as stated by the manufacturer.
CE Marked injectable medical device: Pluryal Biosculpture syringes are CE 0373 (MD Skin Solutions) and supplied with CE 0123 needles (Sterimedix LTD), indicating conformity with applicable EU medical device directives/regulations.
Manufactured in Europe under an ISO 13485 Certified quality management system for medical devices.
Industrial bioprocess and environmental management aligned with ISO 14001 standards as stated by the manufacturer.
MATRICYAL 3D Technology formulation with residual BDDE content ≤ 0.1 ppm, significantly below commonly accepted regulatory limits for HA fillers.
Description
Pluryal Biosculpture 2 x 1.1ml is an injectable hyaluronic acid dermal filler and skin densifier from the Pluryal Densifiers range, designed for the bioremodelling of sagging skin. Based on MATRICYAL 3D Technology, it combines cross-linked and free hyaluronic acid at a concentration of 25 mg/ml to provide volume restoration, skin tightening and deep hydration while biostimulating collagen and improving overall skin quality. Supplied as two pre-filled 1.1 ml syringes, it is a sterile, apyrogenic, physiological and resorbable gel implant intended for injection into the deep dermis or superficial hypodermis to treat skin laxity, mid-to-deep wrinkles, mild volume loss, contour defects and signs of fatigue on the face and back of the hands.
Bnefits
Restructures and restores facial volumes in areas affected by sagging and mild to moderate volume loss
Tightens sagging skin and attenuates cutaneous flaccidity through bioremodelling of dermal and hypodermal tissues
Smooths medium to deep wrinkles and folds, improving overall facial contour
Hydrates the skin deeply by restoring the natural osmolarity of soft tissues and boosting hyaluronic acid levels
Improves skin texture, elasticity and firmness for a fresher, less tired appearance
Acts as a densifier sitting between a skin booster and classic filler, combining hydration, support and biostimulatory effects
Provides natural-looking results thanks to small HA particle size and excellent tissue integration, minimising the risk of a ‘string effect’
Uses MATRICYAL 3D Technology to blend cross-linked and free HA with very low residual BDDE (<0.1 ppm) for safety and biocompatibility
CE-marked injectable medical device manufactured in Europe under ISO 13485 and ISO 14001 quality and environmental standards
Results are long-lasting, with clinical experience and distributor information indicating effect duration typically around 6–12 months, depending on patient and treatment plan
Indications
Bioremodelling and densification of sagging skin with mild to moderate laxity
Restructuring of facial volumes and attenuation of flaccidity
Correction of medium to deep facial wrinkles and folds (e.g. nasolabial folds, perioral lines, marionette lines, frown lines)
MATRICYAL 3D Technology formulation with residual BDDE content ≤ 0.1 ppm, significantly below commonly accepted regulatory limits for HA fillers.
Part of the Pluryal Densifiers range of certified biostimulators and densifiers, produced by MD Skin Solutions, Luxembourg.
Part of the Pluryal Densifiers range of certified biostimulators and densifiers, produced by MD Skin Solutions, Luxembourg.
Hyaluronic acid dermal filler / skin densifier
Treatment of skin laxity and small volume loss in the cheeks, perizygomatic area, chin and jawline
Improvement of fatigued, devitalised facial appearance and irregular skin texture
Volume restoration and skin quality improvement on the back of the hands
Adjunctive treatment for certain textural imperfections and some scar corrections where a HA densifier is appropriate
Suitable for adult patients, typically starting from around 35 years of age, seeking non-surgical rejuvenation with natural results
Composition
Cross-linked hyaluronic acid 25 mg/ml (2.5% HA) derived from biofermentation of Streptococcus equi subsp. zooepidermicus, highly purified
MATRICYAL 3D Technology active matrix: blend of cross-linked HA with two molecular weights: 2 million Da (approx. 60%) and 1 million Da (approx. 30%)
Embedded free hyaluronic acid layer: approximately 10% native HA with molecular weight around 500 kDa incorporated into the 3D matrix
Residual BDDE (1,4-Butanediol Diglycidyl Ether) ≤ 0.1 ppm following dialysis purification during manufacturing
Physiological saline buffer and excipients suitable for sterile, apyrogenic, resorbable HA gel implants (exact excipient list not fully detailed in public brochure)
Formulation
Sterile, apyrogenic, physiological and resorbable HA gel implant acting as a skin densifier
Single-phase, non-calibrated 3D matrix gel based on MATRICYAL 3D Technology, combining cross-linked and free HA
Concentration: 25 mg/ml hyaluronic acid (including approximately 10% free HA embedded in the matrix)
Low residual BDDE (<0.1 ppm) due to long crosslinking time at low temperature and subsequent purification
Intended for injection in the deep dermis or superficial hypodermis using needles or cannula according to recommended techniques
Packaging
Box containing 2 x 1.1 ml pre-filled glass syringes of Pluryal Biosculpture gel (total 2.2 ml)
Each pack typically includes 2 x 27G needles and 2 x 30G needles (Sterimedix LTD, CE 0123), as per manufacturer brochure
Syringes CE 0373, MD Skin Solutions (medical device)
Tamper-evident, recyclable carton packaging with product name, batch number and expiry date
Usage
Pluryal Biosculpture is a professional-use-only injectable medical device and must be administered by appropriately trained and qualified healthcare or aesthetic practitioners in accordance with local regulations.
Before treatment, perform a full medical history, assess indications, rule out contraindications and obtain informed consent. Examine the treatment areas (face, jawline, chin, cheekbones, nasolabial folds, perioral region, back of hands, etc.) and plan injection points and volumes.
Cleanse and disinfect the treatment area thoroughly. If desired and appropriate, apply a topical anaesthetic according to clinic protocol and manufacturer recommendations.
Pluryal Biosculpture is supplied ready to use in pre-filled syringes; do not mix with other products in the same syringe. Attach the recommended sterile needle or cannula (e.g. 27G or 30G) under aseptic conditions and expel any air bubbles prior to injection.
The recommended injection level is the deep dermis or superficial hypodermis, depending on the target area and desired effect. Use appropriate injection techniques such as linear threading (anterograde or retrograde), fanning, microdroplet/subdermal papules or cannula-based techniques according to the Pluryal protocol.
Example techniques from the manufacturer include: Double7Lift Technique with cannula in a fan pattern from single entry points; microdroplet technique (subdermal papules) with small boluses (not more than about 0.02 ml per point separated by roughly 5 mm); 5-Points Technique around the malar bone for skin laxity; and fan pattern injections for larger-volume deficiencies.
Avoid intravascular injection by aspirating carefully where appropriate and injecting slowly with minimal pressure. Constantly monitor patient comfort, colour, capillary refill and any pain or blanching during injection; stop immediately and follow emergency protocol if vascular compromise is suspected.
After injection, gently massage the treated areas if recommended, to ensure even distribution of the gel and to shape the result. Do not over-massage or apply excessive pressure.
Typical initial treatment protocol (per Pluryal brochure and distributor guidance): 1 session per month for 2–3 months, depending on skin laxity and volume loss. Adjust the number of syringes and treated areas according to individual needs and tolerance.
Maintenance treatment is commonly recommended approximately every 5–6 months, or as clinically indicated, to sustain skin densification and volume.
Advise patients on aftercare: avoid makeup on treated areas for several hours; avoid intense heat or cold exposure, vigorous exercise, alcohol, and massaging the area for at least 24 hours; avoid sunbeds and direct sun exposure for a short period; follow specific clinic instructions.
Document the procedure thoroughly, including lot numbers, injection sites, total volume used and any immediate reactions. Provide the patient with information about expected results, possible adverse effects and when to seek medical advice.
Refer to the official Pluryal Biosculpture Instructions for Use (IFU) and Brochure PRO for full, up-to-date guidance on indications, techniques, precautions, contraindications and management of complications.
Contraindications
Hypersensitivity or allergy to hyaluronic acid or any component of the formulation (including residual BDDE or excipients).
History of severe allergic reactions or anaphylaxis, particularly to injectable HA fillers.
Presence of active infection, inflammation, dermatitis or skin disease at or near the intended injection sites (e.g. active herpes simplex, bacterial or fungal infections).
Autoimmune diseases or immune system disorders where injectable HA may be inadvisable, unless a specialist has assessed and approved treatment.
Tendency to keloid formation or hypertrophic scarring in the planned treatment areas.
Known bleeding disorders or current use of anticoagulant/antiplatelet therapy that significantly increases bleeding risk, unless evaluated and cleared by a prescribing clinician.
Pregnancy and breastfeeding (commonly listed as contraindications or strong precautions for aesthetic fillers).
Previous permanent fillers or implants in the same area where interactions or irregularities could occur, unless assessed by an experienced injector.
Any other contraindications, warnings or precautions specified in the official Pluryal Biosculpture IFU and local regulatory guidelines.
Adverse Effects
Typical transient injection-site reactions such as redness (erythema), swelling, tenderness, pain, warmth, itching, bruising or slight bleeding.
Temporary lumps, papules or nodules at injection points, which usually resolve as the product integrates and oedema subsides.
Asymmetry or irregular contour if placement or volume distribution is suboptimal, generally manageable with massage or further correction once swelling subsides.
Hypersensitivity reactions, including local inflammatory responses; very rare cases of more persistent inflammatory nodules or granulomas may occur with HA fillers.
Infection at injection sites if inadequate aseptic technique is used; requires prompt medical management.
Rare but serious vascular complications (e.g. intravascular injection leading to ischaemia, tissue necrosis, visual disturbance or blindness) as with all injectable fillers; these are medical emergencies requiring immediate specialist treatment according to established filler complication protocols.
Any other adverse events described in the official IFU, which practitioners must familiarise themselves with before use.
Storage Conditions
Store in a clean, dry place at controlled room temperature, typically between 2°C and 25°C, as indicated on the packaging.
Protect from direct sunlight and excessive heat or freezing temperatures.
Do not freeze the product; freezing may damage the HA gel and compromise safety and performance.
Keep syringes in their original blister and carton until use to maintain sterility and traceability.
Do not use after the expiry date printed on the pack or if the packaging or syringes are damaged, opened or show signs of compromised sterility.
Discard any unused product after opening a syringe; Pluryal Biosculpture is intended for single-patient, single-use only.
Duration
Manufacturer and distributor information describe a protocol of 1 treatment per month for 2\u20133 months as an initial course, followed by maintenance sessions approximately every 5\u20136 months. Clinical and commercial sources indicate that aesthetic effects typically last around 6\u201312 months, depending on the patient\u2019s age, lifestyle, skin condition, treatment area and injection technique.
Onset
A visible volumising and lifting effect is usually noticeable immediately after injection, due to the presence of cross-linked HA gel. Improvements in hydration, skin texture and laxity continue to evolve over the following weeks as the MATRICYAL 3D matrix releases free HA and stimulates dermal remodelling.
