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GOURI 1 x 1 ml

GOURI 1 x 1 ml

GOURI

Collagen biostimulator – injectable implant
  • CE Marked medical device (CE 2764) for aesthetic use within the European market.
  • Manufactured in ISO 13485 Certified production facilities, indicating compliance with recognised medical Device quality management standards.
  • Developed using DEXLEVO’s patented CESABP technology (Collagen Enabled Solubilized Active and Biodegradable Polymer) for fully liquid PCL without microparticles.
  • Subject to conformity assessment and post Market surveillance requirements associated with CE Marked medical devices in the EU/EEA and other CE Recognising markets.
Fully liquid polycaprolactone (PCL) collagen stimulator for full-face rejuvenation

Description

GOURI 1 x 1 ml is a premium injectable collagen biostimulator from DEXLEVO Inc. and the first fully liquid polycaprolactone (PCL) injectable implant. Using patented CESABP (Collagen Enabled Solubilized Active and Biodegradable Polymer) technology, GOURI contains a homogeneous, particle-free 21% PCL solution (210 mg/mL) that spreads naturally through the injected facial tissues. Rather than acting as a traditional volumising dermal filler, it restores the collagen synthesis rate that declines with age, promoting neocollagenesis throughout the face to improve skin elasticity, firmness and texture. As a CE-marked medical device (CE 2764), GOURI is intended for professional use in the treatment of age-related skin laxity and wrinkles, delivering gradual, natural-looking rejuvenation with long-lasting results.

Bnefits

  • First fully liquid, particle-free PCL injectable, enabling smooth, even distribution in facial tissues without microparticles.
  • Acts as a collagen biostimulator rather than a classic filler, restoring collagen synthesis that has declined due to skin ageing.
  • Provides comprehensive, pan-facial rejuvenation by stimulating neocollagenesis across the entire treated area, improving skin elasticity and firmness.
  • Natural-looking results with minimal immediate bulk or artificial volume; gradual improvement in skin quality over weeks to months.
  • High spreadability reduces the need for multiple localised boluses and complex shaping after injection.
  • Long-lasting effect, with clinical results typically maintained for around 6–12 months as the PCL slowly degrades while newly formed collagen persists.
  • Fully soluble liquid PCL with no suspended particles reduces risk of nodule formation associated with particulate stimulators.
  • Biocompatible, biodegradable polymer that is gradually broken down by hydrolysis and eliminated from the body.
  • CE-marked medical device manufactured in ISO 13485-certified facilities, supporting consistent quality and regulatory compliance.

Indications

  • Injection by qualified healthcare professionals for aesthetic improvement of age-related facial skin laxity and wrinkles.
  • Pan-facial skin rejuvenation, including improvement in skin firmness, elasticity and fine-to-moderate wrinkles.
  • Supportive treatment to enhance overall skin quality and structure in patients with early to moderate signs of photoageing and chronoageing.
  • Adjunctive collagen-stimulating therapy in aesthetic treatment plans where a global skin-quality improvement is desired rather than focal volumising.
  • Use in adults (typically over 30 years of age) with clinically evident reduction in facial skin firmness and collagen density.

Composition

  • Polycaprolactone (PCL) 210 mg per 1 mL syringe (21% w/v fully solubilised liquid PCL).
  • Aqueous vehicle (water-based solution) forming a homogeneous, transparent liquid implant; detailed excipient profile is provided in the official Instructions for Use (IFU) and may include buffering and stabilising components as per Dexlevo’s CESABP technology.

Formulation

  • Fully solubilised, high-molecular-weight PCL polymer in a 21% liquid solution (210 mg/mL) without suspended microparticles.
  • Homogeneous, transparent, non-particulate injectable implant designed to spread naturally in dermal and subdermal tissues.
  • Biocompatible and biodegradable polymer that is gradually degraded by hydrolysis over approximately 6–12 months.
  • CE-marked medical device (CE 2764) manufactured under ISO 13485-compliant quality systems.
  • Formulated as a collagen biostimulator: it does not primarily create immediate bulk volume but induces gradual neocollagenesis and dermal remodelling.

Packaging

  • Single pre-filled sterile syringe containing 1 mL of liquid PCL (GOURI 1 x 1 ml).
  • Luer-lock syringe connection for secure attachment of appropriate sterile needles or cannulas (supplied separately unless included by the distributor).
  • Each syringe is packaged in an individual sterile blister or equivalent barrier inside a printed outer carton.
  • Outer carton and syringe labelling include product name, volume, batch/lot number, expiry date, manufacturer (DEXLEVO Inc.), CE mark (CE 2764) and relevant medical device symbols.
  • Intended strictly for single use; any unused product remaining after a session must be discarded according to clinical waste regulations.

Usage

  • GOURI must only be used by doctors or appropriately qualified healthcare professionals trained in injectable collagen biostimulators and complication management.
  • Before use, clinicians must read and follow the official Instructions for Use (IFU) supplied by DEXLEVO, including full indications, contraindications, warnings and injection guidance.
  • Inspect the packaging and syringe; do not use if the blister or syringe is damaged, if the solution appears discoloured or particulate, or if the product is past its expiry date.
  • Inject using aseptic technique into the indicated dermal or subdermal planes at injection points and dosing determined by the IFU and the practitioner’s clinical judgement.
  • GOURI is designed to spread through the tissue after injection; gentle massage of the treated areas may be used according to the IFU and clinic protocol.
  • Treatment plans commonly involve an initial series of sessions spaced several weeks apart, followed by maintenance treatments at intervals based on skin condition and response; exact schedules should follow manufacturer guidance and practitioner assessment.
  • Record batch/lot number, injection sites, total volume used and treatment date in the patient’s medical records for traceability.
  • Provide patients with pre- and post-treatment advice, including avoidance of extreme heat/cold, intense exercise and manipulation of treated areas for a specified period, in line with clinic and IFU guidance.
  • In the event of suspected complications (e.g., severe pain, unexpected swelling, skin discolouration or signs of infection), follow established emergency protocols and refer or escalate appropriately.

Contraindications

  • Known hypersensitivity or allergy to polycaprolactone (PCL) or any component of the product.
  • Active or recent infection, inflammation or skin disease at or near the intended injection sites (e.g., bacterial, viral or fungal lesions, dermatitis).
  • History of severe allergic reactions or anaphylaxis to injectable implants or collagen stimulators.
  • Autoimmune disease, immunosuppression or significant systemic illness where elective injectable treatments may pose increased risk, unless carefully evaluated and approved by a specialist physician.
  • Known bleeding disorders or current use of potent anticoagulant or antiplatelet therapy that significantly increases the risk of bleeding or haematoma, unless the risk–benefit is assessed and managed by a prescribing clinician.
  • Pregnancy and breastfeeding, as safety has not been established in these populations and treatment is generally not recommended.
  • Previous history of severe or recurrent adverse reactions to PCL-based or other biostimulatory fillers (e.g., granulomas, chronic nodules) without specialist review.
  • Intended injection into or very close to blood vessels, or in anatomically high-risk zones without appropriate expertise and precautions.
  • Use in patients with unrealistic expectations, body dysmorphic disorder or other psychological conditions where aesthetic interventions are contraindicated.

Adverse Effects

  • Common transient injection-site reactions such as erythema (redness), swelling, tenderness, itching, bruising or mild pain, which typically resolve within days.
  • Temporary sensation of tightness or firmness in treated areas as collagen stimulation and tissue remodelling occur.
  • Localised nodules, papules or unevenness if product distribution is irregular or if there is a focal tissue response; these may require medical evaluation and management.
  • Delayed inflammatory reactions, including swelling or induration occurring weeks or months after treatment in rare cases.
  • Hypersensitivity or allergic-type reactions, which may present as localised or more generalised swelling, redness or itching; severe reactions are rare but require prompt medical care.
  • Infection at the injection site, potentially progressing to cellulitis or abscess formation if aseptic technique or aftercare is inadequate.
  • Vascular compromise due to inadvertent intravascular injection or compression, potentially leading to pain, blanching, livedo reticularis, tissue ischaemia or necrosis; although risk is mitigated by the liquid, non-particulate nature of GOURI, it cannot be excluded and requires urgent intervention.
  • Pigmentary changes or scarring in areas affected by significant inflammation or necrosis.
  • Very rare granulomatous or long-lasting foreign-body reactions to PCL, which may necessitate specialist management.
  • As with all injectable collagen stimulators, the full adverse-event profile and management recommendations are detailed in the official IFU and current clinical guidelines.

Storage Conditions

  • Store GOURI in its original packaging in a clean, dry place, protected from direct sunlight.
  • Maintain storage within the temperature range specified on the packaging (typically controlled room temperature); do not freeze.
  • Avoid exposure to excessive heat or wide temperature fluctuations, which may affect product stability.
  • Keep out of the reach of children and unauthorised persons.
  • Do not use after the expiry date printed on the carton and syringe label.
  • Do not use if the sterile blister or syringe has been opened, damaged or shows signs of compromised integrity.
  • Transport under appropriate conditions to protect from physical shock and extreme temperatures.

Duration

PCL within GOURI typically degrades over approximately 6\u201312 months, during which collagen biostimulation occurs. Clinical improvements in skin quality and firmness can persist beyond the polymer\u2019s presence due to newly formed collagen; many protocols recommend an induction series followed by maintenance treatments roughly every 6\u201312 months, tailored to individual skin ageing and response.

Onset

GOURI does not act as an instant volumising filler; visible improvements usually begin to appear within 1\u20132 weeks as neocollagenesis is initiated, with further enhancement of skin firmness, texture and wrinkle reduction developing progressively over several weeks to months after each treatment session.

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