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Regenyal BIOREGEN (3 x 1ml)

Regenyal BIOREGEN (3 x 1ml)

Regenyal

Dermal filler
  • 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.
  • Produced in accordance with applicable European medical device legislation and Good Manufacturing Practice (GMP) guidelines for medical devices.
Hyaluronic acid bio-inductive skin booster

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
  • 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.

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