Gouri Polycaprolactone Injectable Implant (1 x 1ml)
GOURI
Collagen biostimulator – injectable implantFully liquid polycaprolactone (PCL) collagen stimulator for facial rejuvenation
Certifications
- CE Marked injectable medical device based on fully solubilised polycaprolactone (PCL) for aesthetic use.
- Manufactured under medical device quality Management systems consistent with ISO 13485 or equivalent standards.
- Uses CESABP technology (Collagen Enabled Solubilised Active and Biodegradable Polymer) to meet safety and performance requirements for homogeneous, particle Free PCL implants.
- Distributed in compliance with regulatory frameworks restricting use to qualified medical professionals.
- CE Marked injectable medical device based on fully solubilised polycaprolactone (PCL) for aesthetic use.
- Manufactured under medical device quality Management systems consistent with ISO 13485 or equivalent standards.
- Uses CESABP technology (Collagen Enabled Solubilised Active and Biodegradable Polymer) to meet safety and performance requirements for homogeneous, particle Free PCL implants.
- Distributed in compliance with regulatory frameworks restricting use to qualified medical professionals.
Fully liquid polycaprolactone (PCL) collagen stimulator for facial rejuvenation
Description
Gouri Polycaprolactone Injectable Implant (1 x 1ml) is a liquid PCL collagen stimulator developed by DEXLEVO Inc. using CESABP (Collagen Enabled Solubilised Active and Biodegradable Polymer) technology. As the first fully liquid type PCL injectable, it distributes naturally across the face after injection, restoring the collagen synthesis rate that has declined with skin ageing. By stimulating neocollagenesis in the deep dermis, Gouri provides deep skin rejuvenation, improving skin structure, elasticity and overall quality without acting as a traditional volumising filler.
Bnefits
- First liquid-type polycaprolactone (PCL) injectable designed specifically as a collagen stimulator.
- Restores and increases collagen synthesis that has decreased due to skin ageing.
- Naturally spreads from the injection points to the entire face, enabling comprehensive, uniform rejuvenation.
- Provides deep skin rejuvenation with sustainable results that help prevent further visible signs of skin ageing.
- Improves skin firmness, elasticity and texture through endogenous collagen production rather than immediate artificial volume.
- Liquid, particle-free PCL formulation reduces risk of nodules associated with particulate biostimulators.
- Suitable for treating broader facial areas with fewer injection points thanks to high spreadability.
- Delivers gradual, natural improvement in overall facial appearance with long-lasting results.
Indications
- Collagen stimulation for global facial rejuvenation in adults with age-related decline in skin quality.
- Improvement of skin laxity, dermal density and fine-to-moderate wrinkles by increasing endogenous collagen production.
- Deep skin rejuvenation for patients seeking prevention or softening of visible ageing signs rather than immediate volumisation.
- Pan-facial treatment where uniform improvement in skin quality and elasticity is desired.
Composition
- Polycaprolactone (PCL) 210 mg/mL (21% w/v) as fully solubilised biodegradable polymer.
- Aqueous vehicle forming a homogeneous, transparent liquid implant (buffered solution with excipients as specified in the official Instructions for Use).
Formulation
- Fully solubilised liquid polycaprolactone (PCL) implant with no suspended microparticles.
- Based on CESABP (Collagen Enabled Solubilised Active and Biodegradable Polymer) technology for stable, homogeneous distribution.
- Biocompatible, biodegradable polymer that is gradually broken down while stimulating neocollagenesis in the deep dermis.
- Non-volumising collagen stimulator designed to improve skin structure and elasticity rather than create immediate bulk.
- Clear, low-viscosity liquid suitable for controlled injection into dermal or subdermal planes.
Packaging
- Single-use pre-filled sterile syringe containing 1 mL of liquid PCL implant.
- Luer-lock syringe connection to allow secure attachment of sterile needles or cannulas (not included by some distributors due to regulatory requirements).
- Syringe supplied in a sterile blister or equivalent barrier within an outer carton bearing product name, volume, batch/lot number, expiry date, manufacturer details and CE mark.
- Intended for single-patient, single-session use; any remaining product must be discarded after treatment.
Usage
- For professional use only by qualified aesthetic physicians or suitably trained medical practitioners experienced in injectable treatments.
- Before use, read and follow the official Instructions for Use (IFU) supplied by the manufacturer, including recommended injection planes, patterns and volumes.
- Inspect packaging and syringe; do not use if sterile barrier is damaged, if the solution appears cloudy or contains particles, or if product is past expiry.
- Prepare the treatment area using appropriate antiseptic measures and maintain strict aseptic technique throughout the procedure.
- Inject into the recommended deep dermal or subdermal layer at defined points; allow Gouri’s liquid PCL to spread naturally to achieve full-face coverage.
- Use slow, controlled injections, monitoring tissue response and patient comfort; do not inject intravascularly.
- Document batch/lot number, injected volume and anatomical sites in the patient’s medical record for traceability.
- Provide post-treatment care instructions, including avoiding excessive manipulation of treated areas, extreme temperatures and strenuous exercise for a specified period.
- Dispose of used syringes, needles/cannulas and any remaining product as clinical waste in accordance with local regulations; never reuse the syringe.
Contraindications
- Known hypersensitivity or allergy to polycaprolactone (PCL) or any other component of the product.
- Active skin infection, inflammation or dermatologic disease at or near the planned injection site.
- History of severe allergic reactions or anaphylaxis to injectable implants or biostimulatory fillers.
- Uncontrolled systemic illness, significant autoimmune disease or immunosuppression where elective aesthetic procedures are inadvisable without specialist assessment.
- Bleeding disorders or current use of potent anticoagulant or antiplatelet therapy that significantly increases injection-related bleeding risk, unless carefully managed by a physician.
- Pregnancy and breastfeeding, as safety of liquid PCL collagen stimulators has not been established in these populations.
- Previous serious adverse reaction (e.g., granuloma, chronic nodules) to PCL-based or similar biostimulatory injectables, unless evaluated and cleared by a specialist.
- Use in patients with unrealistic expectations or body dysmorphic disorder for whom aesthetic treatment is inappropriate.
- Intravascular injection or injection in high-risk anatomical zones without appropriate expertise and use of risk-mitigation techniques.
Adverse Effects
- Transient injection-site reactions such as redness, swelling, tenderness, bruising, itching or mild pain, typically resolving within a few days.
- Temporary sensation of tightness or firmness in treated areas as tissue remodelling and collagen production occur.
- Occasional localised irregularities or palpable areas if product distribution is uneven or tissue response is focal; may require medical assessment.
- Rare delayed inflammatory reactions, including prolonged swelling or induration at treated sites.
- Hypersensitivity reactions ranging from localised erythema and pruritus to more significant allergic-type responses in susceptible individuals.
- Infection at injection sites, including cellulitis or abscess, particularly if aseptic technique or aftercare is inadequate.
- Potential vascular compromise (e.g., due to inadvertent intravascular injection or compression), which may lead to pain, blanching, livedo reticularis, ischaemia or tissue necrosis and requires urgent management.
- Risk of pigmentary changes or scarring in areas affected by significant inflammation, infection or necrosis.
- As with all injectable collagen stimulators, infrequent granulomatous or long-lasting foreign-body reactions are possible and may require specialist treatment.
Storage Conditions
- Store in the 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 large temperature fluctuations that may affect product stability.
- Keep out of 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 packaging is damaged or if the syringe shows any sign of leakage or contamination.
- Transport under appropriate conditions to prevent mechanical damage and exposure to extreme temperatures.
Duration
Clinical improvements in skin quality develop gradually over weeks and may last approximately 18\u201324 months, depending on the patient\u2019s physiology, lifestyle, treatment area and maintenance schedule.
Onset
Initial improvements in skin texture and elasticity typically emerge within weeks as collagen production is stimulated, with progressive rejuvenation and lifting effects continuing to develop over several months following treatment.
