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GOURI Liquid PCL (1x1ml)

GOURI Liquid PCL (1x1ml)

GOURI

Collagen biostimulator – injectable implant
  • CE Marked injectable medical device under the European medical device directive/regulation.
  • Manufactured in facilities fulfilling relevant quality standards for medical devices (e.g. ISO 13485), per manufacturer information.
  • Subject to regulatory requirements for distribution and use restricted to qualified medical professionals as per CE Mark classification.
Fully liquid polycaprolactone (PCL) facial biostimulator, 1 mL pre-filled syringe

Description

GOURI Liquid PCL is a pioneering injectable collagen stimulator using a fully solubilized polycaprolactone (PCL) solution at 210 mg/mL (21%). Developed by DEXLEVO Inc. using CESABP technology, the product is intended for aesthetic facial rejuvenation by stimulating natural collagen synthesis without immediate volumising effect. The liquid PCL spreads homogeneously in the dermal tissue after injection, gradually improving skin firmness, elasticity and texture while reducing wrinkles and fine lines.

Bnefits

  • First fully liquid, particle-free PCL injectable biostimulator on the aesthetic market.
  • High-concentration liquid PCL (210 mg/mL) designed for deep dermal diffusion and even distribution for global facial rejuvenation.
  • Stimulates collagen production naturally, improving skin firmness, elasticity and dermal density over time.
  • Smooths moderate-to-deep wrinkles and improves overall skin quality without creating an artificial ‘filler’ look.
  • Versatile application, suitable for pan-facial treatment or targeted areas like around the eyes.
  • Results are gradual and natural-looking, avoiding abrupt volumetric changes associated with traditional fillers.
  • Reported duration of effect lasts up to 18–24 months depending on patient factors and maintenance protocol.
  • Reduced risk of nodules or irregularities due to absence of particulate matter in formulation.

Indications

  • Facial rejuvenation in adults showing signs of ageing such as skin laxity, fine to moderate wrinkles and loss of dermal elasticity.
  • Pan-facial skin-quality improvement, including tightening, smoothing and improved texture.
  • Targeted treatment for delicate zones, including periorbital area (around eyes) when appropriate and performed by trained practitioners.
  • Suitable for patients seeking gradual, natural skin rejuvenation rather than immediate volume enhancement.
  • Use in aesthetic medical practice by qualified practitioners experienced in injectable biostimulators.

Composition

  • Active: Polycaprolactone (PCL), fully solubilized, at 210 mg/mL (21% w/v).
  • Vehicle: aqueous solution forming a homogeneous, clear liquid implant (full excipient profile as per manufacturer’s CESABP technology; detailed excipients not publicly disclosed).

Formulation

  • Fully solubilized liquid PCL injectable – no microparticles, suspensions or particulate fillers.
  • Clear, homogeneous liquid suitable for injection into dermal or subdermal tissue, designed for collagen biostimulation rather than volumization.
  • Biocompatible and biodegradable polymer that gradually degrades while stimulating endogenous collagen synthesis.
  • CE-marked injectable medical device under European regulatory framework.

Packaging

  • Single-use 1 mL pre-filled sterile syringe containing the liquid PCL implant.
  • Luer-lock connection to allow secure attachment of sterile needles or cannulas (typically selected by the practitioner).
  • Syringe is protected in sterile blister or barrier packaging within a labelled outer carton including product name, volume, lot/batch number, expiry date and CE mark.
  • Intended strictly for single-patient use; any unused portion must be discarded according to medical waste protocols.

Usage

  • GOURI must be administered only by licensed aesthetic physicians or qualified medical professionals trained in injectable biostimulators.
  • Before injection, inspect the vial and packaging; do not use if integrity is compromised or syringe is expired.
  • Cleanse and prepare the skin aseptically; select suitable sterile needle or cannula based on planned injection depth and area.
  • Inject into the deep dermal/subdermal plane following the manufacturer’s injection protocol; minimal bolus points are required due to high spreadability.
  • Use gentle, even injection technique to allow homogeneous diffusion of the liquid PCL throughout the tissue.
  • Record batch number and injection details in patient records for traceability and follow-up.
  • Advise the patient on post-procedure care including avoiding excessive pressure, heat, or strenuous activity for a specified period, and monitoring for any adverse signs.
  • Dispose of used syringe and any residual product as per clinical waste regulations; do not re-use.

Contraindications

  • Known allergy or hypersensitivity to polycaprolactone (PCL) or any component of the implant.
  • Active infection, inflammation, skin disease or compromised skin integrity at intended injection sites.
  • History of severe allergic reactions to injectable biostimulators or implants.
  • Autoimmune disease, immunosuppression or conditions that impair wound healing, unless evaluated and cleared by a specialist.
  • Pregnancy or breastfeeding, unless permitted by local regulatory and clinical guidance.
  • Patients with unrealistic expectations or psychological conditions (e.g. body dysmorphic disorder) for whom aesthetic interventions are deemed inappropriate.
  • Injection into or near blood vessels, or in high-risk anatomical zones without appropriate expertise and precautions.

Adverse Effects

  • Transient injection-site reactions such as redness, swelling, tenderness, itching or bruising are common and usually resolve within days.
  • Temporary tightness or firmness in treated areas as collagen remodeling begins.
  • Rarely, localised nodules, papules or unevenness may occur if distribution is not uniform or in individuals with heightened tissue sensitivity.
  • Delayed inflammatory reactions, including swelling or induration, possibly occurring weeks to months post-treatment in rare cases.
  • Hypersensitivity reactions ranging from mild local irritation to more significant allergic-type responses, though severe reactions are uncommon.
  • Infection at the injection site if aseptic technique or post-procedure care is inadequate.
  • Potential vascular complications if improperly injected (e.g., intravascular injection or vascular compression) although the liquid, non-particulate nature of GOURI may reduce but does not eliminate such risks.
  • Pigment changes, scarring or tissue irregularities in areas affected by significant reaction, inflammation or improper technique.

Storage Conditions

  • Store the pre-filled syringe in its original box in a clean, dry place protected from direct sunlight.
  • Maintain storage temperature as specified by the manufacturer (typically controlled room temperature; avoid freezing and excessive heat).
  • Do not use if the sterile blister or syringe integrity is compromised or if product is beyond expiry date.
  • Keep out of reach of children and unauthorised persons.
  • Transport under conditions that protect from physical shock and extreme temperature fluctuations.

Duration

Improvement develops gradually over weeks to months, with effects reportedly lasting up to 18\u201324 months depending on patient\u2019s metabolism, skin condition and maintenance protocol.

Onset

Unlike traditional fillers, GOURI does not produce immediate volume; early improvements in skin quality may appear within weeks as collagen production is stimulated, with full rejuvenation effects emerging progressively over several months.

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