GOURI (1x1ml)
GOURI
Collagen biostimulator – injectable implantFully solubilized liquid polycaprolactone (PCL) collagen inducer for facial rejuvenation
Certifications
- CE Marked injectable medical device based on fully solubilized polycaprolactone (PCL), classified under medical Device regulations in the EU/EEA.
- Developed using DEXLEVO’s patented CESABP (Collagen Enabled Solubilized Active Biodegradable Polymer) technology, which enables microparticle Free liquid PCL for dermal injection.
- Manufactured in facilities operating under medical Device quality management systems (e.g., ISO 13485) as reported in manufacturer and distributor documentation.
- Distributed to licensed medical professionals in compliance with local regulations governing injectable aesthetic medical devices.
- CE Marked injectable medical device based on fully solubilized polycaprolactone (PCL), classified under medical Device regulations in the EU/EEA.
- Developed using DEXLEVO’s patented CESABP (Collagen Enabled Solubilized Active Biodegradable Polymer) technology, which enables microparticle Free liquid PCL for dermal injection.
- Manufactured in facilities operating under medical Device quality management systems (e.g., ISO 13485) as reported in manufacturer and distributor documentation.
- Distributed to licensed medical professionals in compliance with local regulations governing injectable aesthetic medical devices.
Fully solubilized liquid polycaprolactone (PCL) collagen inducer for facial rejuvenation
Description
GOURI (1x1ml) is the world’s first fully solubilized liquid collagen-inducing polycaprolactone (PCL) injectable, developed by DEXLEVO Inc. using its patented CESABP (Collagen Enabled Solubilized Active Biodegradable Polymer) technology. As a fully liquid, particle-free PCL implant, GOURI spreads homogeneously in the deep dermis after injection and stimulates natural neocollagenesis to improve skin structure, elasticity and facial contours. Designed exclusively for medical aesthetic practitioners, it provides pan-facial, gradual and natural rejuvenation without the immediate bulk or “filler” look, positioning it as a premium regenerative aesthetic medicine solution.
Bnefits
- World’s first fully solubilized liquid PCL collagen inducer, offering a unique, particle-free biostimulatory approach.
- Patented CESABP technology ensures a homogeneous, stable, fluid solution that diffuses evenly through dermal tissues.
- Stimulates endogenous collagen production (neocollagenesis) to improve skin firmness, elasticity, texture and dermal density.
- Delivers natural, progressive rejuvenation without creating an artificial volumising or overfilled appearance.
- Enables comprehensive facial treatment with a reduced number of injection points due to high spreadability within the deep dermis.
- Provides long-lasting results, with collagen-induced improvements that can persist for many months after treatment.
- Liquid formulation without microparticles reduces the risk of nodule formation associated with particulate biostimulators.
- Premium positioning in regenerative aesthetic medicine, suitable for patients seeking global skin-quality enhancement rather than focal volume.
- CE-marked medical device manufactured under dedicated medical-device quality systems.
Indications
- Stimulation of collagen production for global facial rejuvenation in adults with mild to moderate skin laxity.
- Improvement of skin structure, elasticity and firmness across the face via neocollagenesis.
- Enhancement of natural facial contours and dermal density without immediate volumising filler effect.
- Preventative collagen-stimulation strategies in patients beginning to show early signs of ageing who wish to maintain skin quality.
- Adjunctive treatment within broader aesthetic plans where pan-facial skin-quality improvement and regenerative effects are desired.
Composition
- Polycaprolactone (PCL): fully solubilized biodegradable polymer, acting as the active collagen-inducing component (liquid PCL).
- Concentration of PCL: 210 mg/mL (21% w/v) according to technical listings for GOURI liquid PCL presentations.
- Vehicle: aqueous solution forming a homogeneous, transparent, fully liquid implant (full excipient profile provided in the official Instructions for Use and may include buffering and stabilising components in line with CESABP technology).
Formulation
- Fully solubilized liquid polycaprolactone (PCL) injectable implant with no suspended microparticles.
- Patented CESABP (Collagen Enabled Solubilized Active Biodegradable Polymer) technology providing a fluid, stable, homogeneous solution.
- Biocompatible, bioresorbable polymer that gradually degrades while inducing the formation of new collagen within the dermis.
- Designed to be injected into the deep dermis/subdermal planes, diffusing evenly to provide uniform biostimulation across large facial areas.
- Acts as a collagen biostimulator rather than an instant volumising filler, promoting gradual tissue regeneration and skin-quality improvement.
Packaging
- Single-use, pre-filled sterile syringe containing 1 mL of fully solubilized liquid PCL (GOURI 1x1ml).
- Luer-lock syringe connection compatible with appropriate sterile needles or cannulas selected by the practitioner.
- Syringe presented in an individual sterile blister or equivalent barrier system placed inside an outer printed carton.
- Outer packaging identifies the product (GOURI), volume (1 mL), manufacturer (DEXLEVO Inc.), CE mark, batch/lot number, expiry date and relevant medical-device symbols.
- Each syringe is intended for a single patient and single treatment session; any residual product must be discarded after use.
Usage
- GOURI is reserved strictly for aesthetic physicians and suitably qualified medical practitioners trained in injectable techniques and complication management.
- Before use, read the full Instructions for Use (IFU) supplied by DEXLEVO, including indications, contraindications, warnings, recommended injection planes and treatment protocols.
- Ensure the treatment area is clean and free from makeup; prepare the skin according to standard aseptic procedures.
- Attach an appropriate sterile needle or cannula (commonly 30–35G, according to IFU and clinical judgement) and inject into the recommended deep dermal layer at designated points, using a limited number of injection sites for pan-facial distribution.
- Inject slowly and evenly; the liquid PCL formulation will diffuse through the tissue, so only modest mechanical manipulation (if any) is typically required.
- Record batch/lot number, volume used, injection sites and treatment date in the patient’s medical record for traceability.
- Provide post-treatment care advice, such as avoiding strenuous exercise, extreme temperatures and manipulation of treated areas for a specified period, and instruct the patient on signs of possible complications requiring urgent review.
- Do not reuse the syringe; dispose of any remaining product and used materials as clinical waste in accordance with local regulations.
Contraindications
- Known hypersensitivity or allergy to polycaprolactone (PCL) or any other component of the product.
- Active infection, inflammation or skin disease at or near proposed injection sites (e.g., bacterial, viral or fungal lesions, dermatitis).
- History of severe allergies, anaphylaxis or significant hypersensitivity reactions to injectable implants or collagen stimulators.
- Patients with uncontrolled systemic diseases, significant autoimmune pathology or immunosuppression in whom elective injectable procedures may pose increased risks, unless carefully assessed by a specialist.
- Known bleeding disorders or current treatment with potent anticoagulants/antiplatelet agents where injection-related bleeding risk is unacceptably high without medical management.
- Pregnant or breastfeeding patients, as safety has not been established and treatment is generally not recommended.
- Previous history of serious adverse reactions (e.g., granulomas, persistent nodules) to PCL-based or similar biostimulatory fillers without specialist evaluation.
- Intended or inadvertent intravascular injection, or use in high-risk anatomical areas without appropriate expertise and risk-mitigation strategies.
- Use in patients with unrealistic expectations or psychological conditions (such as body dysmorphic disorder) for whom aesthetic treatment is inappropriate.
Adverse Effects
- Common, usually transient injection-site reactions such as redness, swelling, tenderness, bruising, itching or mild pain.
- Temporary sensation of tightness or firmness in treated areas as collagen stimulation and dermal remodelling occur.
- Localised nodules, papules or irregularities in rare cases, particularly if product distribution is not uniform or in individuals with heightened tissue reactivity.
- Delayed inflammatory or immune-mediated reactions presenting as swelling, induration or erythema weeks or months after treatment.
- Hypersensitivity reactions ranging from localised itching and redness to, very rarely, more severe allergic responses requiring medical management.
- Injection-site infection, including cellulitis or abscess formation, if aseptic technique or aftercare is inadequate.
- Vascular events related to inadvertent intravascular injection or vascular compression, potentially leading to pain, blanching, livedo reticularis, tissue ischaemia or necrosis; these require immediate recognition and urgent management.
- Pigmentary changes or scars can occur in areas affected by significant inflammation, infection or necrosis.
- The overall safety profile is consistent with that of other injectable collagen biostimulators when used correctly by trained professionals, but all potential adverse events must be reviewed in the IFU and current clinical guidance.
Storage Conditions
- Store in the original packaging in a clean, dry place, protected from direct sunlight.
- Maintain storage at the temperature range specified on the packaging (typically controlled room temperature); do not freeze.
- Avoid exposing the product to excessive heat or significant temperature fluctuations, which may compromise stability.
- Keep out of the reach and sight 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 is damaged, opened or shows any sign of compromised integrity.
- Transport under appropriate conditions to avoid mechanical shock and extreme temperatures.
Duration
Clinical effects develop progressively after treatment, with collagen-related improvements typically lasting several months; many protocols describe durable benefits in skin quality and firmness for approximately 6\u201312 months, after which maintenance sessions may be scheduled based on individual response and ageing.
Onset
GOURI does not create an immediate volumising effect; instead, visible rejuvenation occurs gradually as neocollagenesis is stimulated. Initial improvements in skin texture and firmness are generally observed within weeks of treatment, with further enhancement over subsequent months.
