Gouri (1 Syringe x 1ml Per Pack)
GOURI
Collagen biostimulator – injectable implantFully liquid polycaprolactone (PCL) collagen stimulator, 1 mL pre-filled syringe
Certifications
- CE Marked injectable medical device based on fully solubilised polycaprolactone (PCL) for aesthetic use in relevant markets.
- Manufactured under medical device quality Management systems consistent with international standards such as ISO 13485.
- Developed using CESABP (Collagen Enabled Solubilized Active and Biodegradable Polymer) technology to provide a homogeneous, particle Free liquid implant meeting safety and performance requirements for dermal injection.
- Distributed in compliance with regulations restricting supply and use to suitably qualified medical professionals.
- CE Marked injectable medical device based on fully solubilised polycaprolactone (PCL) for aesthetic use in relevant markets.
- Manufactured under medical device quality Management systems consistent with international standards such as ISO 13485.
- Developed using CESABP (Collagen Enabled Solubilized Active and Biodegradable Polymer) technology to provide a homogeneous, particle Free liquid implant meeting safety and performance requirements for dermal injection.
- Distributed in compliance with regulations restricting supply and use to suitably qualified medical professionals.
Fully liquid polycaprolactone (PCL) collagen stimulator, 1 mL pre-filled syringe
Description
Gouri (1 Syringe x 1ml Per Pack) is a next-generation collagen stimulator and the first fully liquid type polycaprolactone (PCL) injectable developed by DEXLEVO Inc. Using patented CESABP (Collagen Enabled Solubilized Active and Biodegradable Polymer) technology, Gouri contains fully solubilised liquid PCL that spreads naturally throughout the face after injection. It restores the collagen synthesis rate that has declined with age, providing deep, pan-facial skin rejuvenation, improved elasticity and dermal density without acting as a traditional volumising hyaluronic acid filler. The homogeneous, particle-free formulation offers smooth extrusion and predictable results, with long-lasting cosmetic performance.
Bnefits
- First fully liquid type polycaprolactone (PCL) injectable collagen stimulator on the market.
- Increases and restores collagen synthesis that has decreased due to skin ageing.
- Naturally distributes from injection points across the entire face, enabling comprehensive rejuvenation with relatively few injection sites.
- Provides deep skin rejuvenation and helps prevent visible signs of ageing through long-lasting collagen stimulation.
- Delivers natural-looking improvement in skin quality, elasticity and firmness rather than a pronounced volumising or “overfilled” appearance.
- Homogeneously solubilised in water, resulting in a smooth, acceptable extrusion force and easy handling for practitioners.
- Particle-free liquid PCL (no microparticles) helps reduce the risk of nodules and irregularities associated with particulate biostimulators.
- Demonstrates longer cosmetic performance compared to typical hyaluronic acid fillers, with sustained biostimulatory effects.
Indications
- Stimulation of collagen production for global facial rejuvenation in adults with age-related decline in skin quality.
- Improvement of skin firmness, elasticity and dermal density through endogenous collagen regeneration.
- Softening of mild to moderate facial wrinkles and skin laxity as part of regenerative aesthetic treatment plans.
- Pan-facial anti-ageing treatments where natural, gradual skin-quality improvement is preferred over immediate volumisation.
- Adjunctive therapy in patients seeking preventive or maintenance collagen stimulation to slow visible skin ageing.
Composition
- Active ingredient: Polycaprolactone (PCL), fully solubilised biodegradable polymer at a concentration of 210 mg/mL (21% w/v) per 1 mL syringe.
- Vehicle: Aqueous solution forming a homogeneous, transparent liquid implant (buffered water with proprietary excipients per DEXLEVO’s CESABP technology).
- No hyaluronic acid: Gouri is PCL-based and does not contain hyaluronic acid.
- No lidocaine: Local anaesthetic is not included in the standard formulation.
- No additional active ingredients or microparticles: The biostimulatory effect relies exclusively on fully liquid PCL.
Formulation
- Fully solubilised, homogeneous liquid polycaprolactone (PCL) implant produced using CESABP (Collagen Enabled Solubilized Active and Biodegradable Polymer) technology.
- Particle-free liquid formulation (no suspended microspheres), designed to spread evenly through dermal and subdermal tissues.
- Biocompatible and biodegradable polymer that gradually degrades while stimulating neocollagenesis in the deep dermis.
- Non-volumising collagen stimulator: provides gradual structural and textural improvement via collagen regeneration rather than immediate bulk volume.
- Clear, low-viscosity injectable solution intended for deep dermal or subdermal administration by trained medical professionals.
Packaging
- One single-use, pre-filled sterile syringe containing 1 mL of liquid PCL (Gouri) per pack.
- Syringe equipped with a Luer-lock connection for secure attachment of a compatible sterile needle or cannula (usually supplied separately).
- Each syringe is sealed in a sterile blister or equivalent barrier and placed within an outer printed carton.
- Outer packaging includes product name, volume (1 mL), batch/lot number, expiry date, manufacturer (DEXLEVO Inc.), device classification and regulatory markings.
- Intended strictly for single-patient, single-session use; any unused product must be discarded in accordance with clinical waste regulations.
Usage
- Gouri must only be administered by licensed healthcare professionals trained in injectable collagen biostimulators and complication management.
- Before use, clinicians should read and follow the official Instructions for Use (IFU), including full indications, contraindications, injection techniques and recommended treatment protocols.
- Inspect the outer carton, blister and syringe for integrity and verify the expiry date; do not use if packaging is damaged or the product is out of date.
- Prepare the patient’s skin using appropriate cleansing and antiseptic measures and maintain strict aseptic technique throughout the procedure.
- Attach an appropriate sterile needle or cannula to the Luer-lock syringe; injection is typically performed into the deep dermis or subdermal plane at defined points across the face, following the manufacturer’s protocol.
- Inject slowly and evenly, allowing the fully liquid PCL to spread naturally; avoid intravascular injection by using correct depth, angle and aspiration according to best practice.
- Document batch/lot number, injection sites, volume administered and treatment date within the patient’s medical record for traceability.
- Provide post-treatment instructions, including avoiding excessive manipulation of treated areas, intense heat or cold exposure, and strenuous exercise for a recommended period, and advise the patient on expected transient reactions and red-flag symptoms.
- Dispose of the used syringe, needle/cannula and any remaining product immediately after the procedure as clinical waste; never reuse the syringe or share between patients.
Contraindications
- Known hypersensitivity or allergy to polycaprolactone (PCL) or any other component of the product.
- Active infection, inflammation or dermatologic disease at or near the intended injection sites (e.g., bacterial infection, herpes, dermatitis).
- History of severe allergic reactions or anaphylaxis to injectable implants or collagen-stimulating products.
- Uncontrolled systemic illness, significant autoimmune disease or immunosuppression where elective aesthetic procedures may pose increased risk, unless carefully assessed and approved by an appropriate specialist.
- Patients with known bleeding disorders or on high-dose anticoagulant or antiplatelet therapy where injection-related bleeding risk is unacceptably high without medical management.
- 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 nodule formation) to PCL-based or similar biostimulatory injectables without specialist evaluation.
- Use in patients with unrealistic expectations, untreated body dysmorphic disorder or other psychological conditions where aesthetic intervention is clinically inappropriate.
- Intravascular injection or use in high-risk anatomical areas without appropriate expertise and strict adherence to risk-reduction techniques.
Adverse Effects
- Common transient injection-site reactions such as erythema (redness), swelling, tenderness, bruising, itching or mild pain, typically resolving within a few days.
- Temporary sensation of tightness or firmness in treated regions as tissue remodelling and collagen production progress.
- Occasional palpable irregularities or localised areas of firmness if product distribution is uneven or if there is a focal tissue response; these may require observation, massage or further medical assessment.
- Rare delayed inflammatory reactions, including persistent swelling, induration or erythema weeks or months after treatment.
- Hypersensitivity or allergic-type reactions, ranging from localised irritation to more significant responses in susceptible individuals.
- Infection at injection sites, including cellulitis or abscess, especially if aseptic technique or post-treatment care is inadequate.
- Potential vascular complications due to inadvertent intravascular injection or vascular compression, which may present with pain, blanching, livedo reticularis, tissue ischaemia or necrosis and require urgent intervention.
- Infrequent pigmentary changes or scarring in areas affected by significant inflammation, infection or necrosis.
- Very rare granulomatous or foreign-body reactions to PCL or its degradation products, which may necessitate specialist management.
Storage Conditions
- Store Gouri in its original outer carton 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 exposing the product to excessive heat or large temperature fluctuations, which may adversely affect stability and performance.
- 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 appears damaged, opened, leaking or contaminated.
- Transport under appropriate conditions that prevent mechanical damage and exposure to extreme temperatures.
Duration
Clinical improvements in skin quality usually develop progressively over several weeks and can last approximately 12\u201324 months, depending on the patient\u2019s age, skin condition, lifestyle, treatment area and maintenance schedule. Many protocols use an initial series of sessions followed by periodic maintenance treatments to sustain collagen levels and aesthetic outcomes.
Onset
Gouri does not provide an immediate volumising effect; instead, early improvements in skin texture and elasticity are typically observed within weeks as collagen synthesis is stimulated, with more pronounced, natural-looking rejuvenation and lifting effects evolving over subsequent months.
