CE Marked Class III medical device (CE marking confirmed for Regenyal Bioregen in EU/EEA markets).
Manufactured by Regenyal Laboratories Srl under ISO 9001 certified quality management system.
ISO 13485 certified quality system for medical devices.
ISO 14001 certified environmental management system for the manufacturing site.
CE Marked Class III medical device (CE marking confirmed for Regenyal Bioregen in EU/EEA markets).
Manufactured by Regenyal Laboratories Srl under ISO 9001 certified quality management system.
ISO 13485 certified quality system for medical devices.
ISO 14001 certified environmental management system for the manufacturing site.
Manufacturing and formulation developed under the Regenyal "Green Injections" safety and environmental standard.
Description
Regenyal BIOREGEN is a sterile, resorbable, injectable medical device based on ultra-pure, non-animal hyaluronic acid in a multifractional (multi–molecular weight) gel. It is designed for face and body bio-induction to correct superficial skin blemishes, light wrinkles and pigment spots by hydrating, protecting and bio-restructuring the dermal tissue, with immediate and long-lasting rejuvenation effects.
Bnefits
Provides multifractional bio-induction with five different hyaluronic acid molecular weights for immediate and long-lasting skin bio-restructuring
Intense hydration and protection of the dermis, improving skin elasticity and firmness
Reduces light wrinkles and fine lines on the face, neck, décolleté, hands and other treated areas
Helps correct superficial pigmentation spots and improves overall skin tone and radiance
Improves the appearance of acne scars and red stretch marks
Supports tissue regeneration and metabolic processes through ultra-pure, bio-compatible hyaluronic acid
Non-animal, bacterial-fermentation hyaluronic acid with reduced external chemical substances (Green Injections standard)
Results typically visible from the first treatment and can last up to approximately 6 months, depending on patient and technique
Indications
Superficial skin blemishes of the face and body
Light and fine wrinkles (forehead, glabella, periocular, perioral, cheeks)
Superficial pigmentation spots on the face, décolleté and body
Skin ageing and loss of firmness of face, neck and décolleté
Rejuvenation of the backs of the hands
Skin laxity and loss of tone above the knees
Red stretch marks
Areas with acne scars
General improvement of skin quality and brightness
Composition
Hyaluronic acid sodium salt 16 mg/ml (1.6%) in buffered physiological solution
Manufacturing and formulation developed under the Regenyal "Green Injections" safety and environmental standard.
Produced in accordance with applicable European medical device legislation and Good Manufacturing Practice (GMP) guidelines for medical devices.
Produced in accordance with applicable European medical device legislation and Good Manufacturing Practice (GMP) guidelines for medical devices.
Hyaluronic acid bio-inductive skin booster
Multifractional hyaluronic acid with five molecular weights: approximately 2 kDa, 100 kDa, 200 kDa, 500 kDa and 1 MDa
Ultra-pure, bio-compatible, non-animal origin hyaluronic acid obtained by bacterial fermentation
Phosphate-buffered saline
Water for injectable solutions
Formulation
Sterile, resorbable, non-cross-linked hyaluronic acid gel for intradermal injection
Multifractional (multi–molecular weight) hyaluronic acid for combined hydration, protection, regeneration and re-structuring
Single-phase gel with high homogeneity and thixotropic properties, designed for even spread in dermal tissue
Medical device, Class III (EU), intended for professional use only
Packaging
Box containing 3 pre-filled, single-use sterile syringes of 1 ml each (3 x 1 ml)
Each syringe contains 16 mg/g hyaluronic acid sodium salt in buffered physiological solution
3 sterile 33G x 4 mm TSK needles (CE 0123) supplied in sealed blisters
Package insert / instructions for use
Adhesive traceability labels for patient records
Sterile blister packaging for each syringe and needle
Usage
Intended exclusively for intradermal injection by trained and appropriately licensed healthcare professionals experienced with injectable medical devices.
Inject into the superficial to mid dermis using linear threading or serial micro-papular techniques, depending on the treatment area and indication.
For periocular areas, use very superficial linear injections along marked lines, releasing small amounts of product while withdrawing the needle.
For perioral wrinkles, use superficial linear or serial micro-papular injections along the visible lines, with additional linear injections in the mid-dermis parallel to the vermilion border as indicated.
For neck and décolleté, use serial micro-papular or linear injection patterns in parallel lines, potentially cross-hatched to enhance the bio-inductive effect.
For hands, perform micro-papular injections across the dorsal surface followed by gentle massage to distribute the product evenly.
For red stretch marks, apply a series of micro-injections along each stretch mark followed by light massage.
Recommended treatment protocol from the technical sheet: 1 ml every 2 weeks for 6 weeks (3 sessions) and, if needed, 1 ml monthly thereafter as maintenance, according to clinical judgment.
Avoid intravascular injection. Aspirate carefully where appropriate and inject slowly.
Do not overcorrect; avoid excessive injection volumes in a single point or session.
After injection, gently massage the treated area as needed to achieve a smooth and homogeneous distribution.
Always follow the full official instructions for use (IFU) provided in the product leaflet, including warnings, contraindications and precautions.
Contraindications
Hypersensitivity or allergy to hyaluronic acid or any of the excipients in the formulation.
Presence of active or recent skin infections, inflammatory lesions, herpes, or dermatological disease at or near the intended injection sites.
Known severe autoimmune diseases or immune system disorders, unless the treating physician judges the procedure to be appropriate after careful evaluation.
History of severe allergic reactions or anaphylaxis to injectable medical devices or dermal fillers.
Patients with known tendency to hypertrophic scars or keloids in the proposed treatment areas.
Bleeding disorders, coagulation abnormalities or current use of anticoagulant or antiplatelet medications that significantly increase bleeding risk, unless the risk–benefit has been assessed by a physician.
Pregnancy and breastfeeding (typically contraindicated or not recommended due to lack of clinical data).
Patients under 18 years of age.
Any general contraindications to hyaluronic acid dermal fillers or injectable aesthetic procedures, as determined by the treating healthcare professional.
Always consult and follow the official instructions for use (IFU) for the complete and authoritative list of contraindications before treatment.
Adverse Effects
Common, usually transient injection-site reactions such as redness (erythema), swelling (oedema), tenderness, pain, itching, warmth or mild bruising.
Small papules, lumps or nodules at or near the injection site, typically resolving with massage or over time.
Temporary irregularities of the skin surface or asymmetry in the treated area.
Local hematomas or ecchymosis due to needle puncture of small vessels.
Rare inflammatory reactions such as prolonged redness, induration, edema or sensitivity.
Delayed hypersensitivity reactions or immune-mediated responses (e.g. swelling, firmness, erythema) which may require medical management.
Infection at the injection site if aseptic technique is not strictly observed.
Very rare but serious complications associated with any injectable facial filler, such as accidental intravascular injection leading to tissue ischemia or necrosis, or ocular complications including vision disturbances or loss; these require immediate emergency management by a qualified physician.
Any unexpected, persistent or severe adverse reaction should be evaluated promptly by the treating healthcare professional; refer to the official IFU for a full and up-to-date safety profile.
Storage Conditions
Store the product in its original packaging until use to protect the syringes and needles from light and contamination.
Keep at controlled room temperature as specified in the official IFU (commonly within the 2–25 °C range for hyaluronic acid gels), avoiding extreme heat or cold.
Do not freeze.
Protect from direct sunlight and sources of heat.
Keep out of reach of children.
Do not use after the expiry date printed on the packaging.
Use only if the blister and syringe are intact and the solution appears clear and free from particles.
Single-use device: do not resterilize and do not reuse any opened or partially used syringe.
Duration
Typical initial protocol: 3 treatment sessions of 1 ml each, administered every 2 weeks over approximately 6 weeks; maintenance treatments of 1 ml about once per month may be performed based on clinical assessment. Clinical effects (hydration, skin quality and bio-restructuring) are reported to last up to approximately 6 months, varying with patient factors and injection technique.
Onset
Hydration and volume effects are generally visible immediately or soon after the first treatment session, with progressive improvement in skin texture, brightness and firmness over the following weeks as bio-inductive and bio-restructuring processes occur.
