CE Marked injectable medical device based on fully solubilised polycaprolactone (PCL) for aesthetic use in appropriate markets.
Manufactured under medical device quality Management systems consistent with international standards such as ISO 13485.
Developed using CESABP technology to provide a homogeneous, particle Free liquid implant that meets safety and performance requirements for dermal injection.
CE Marked injectable medical device based on fully solubilised polycaprolactone (PCL) for aesthetic use in appropriate markets.
Manufactured under medical device quality Management systems consistent with international standards such as ISO 13485.
Developed using CESABP technology to provide a homogeneous, particle Free liquid implant that meets safety and performance requirements for dermal injection.
Supplied to and intended for use only by qualified medical professionals, in accordance with local regulations governing injectable medical devices.
Description
Gouri Skin Booster 1 x 1ml is a liquid polycaprolactone (PCL) collagen stimulator developed by DEXLEVO Inc. using its patented CESABP (Collagen Enabled Solubilized Active and Biodegradable Polymer) technology. Positioned as the first fully liquid type PCL injectable, Gouri restores the collagen synthesis rate that has declined with age by stimulating natural collagen regeneration throughout the face. The particle-free liquid formulation spreads naturally from a limited number of injection points, providing pan-facial skin rejuvenation, improved elasticity and texture, and a more youthful appearance without acting as a traditional volumising dermal filler.
Bnefits
First fully liquid type polycaprolactone (PCL) injectable skin booster designed specifically as a collagen stimulator.
Increases and restores collagen synthesis rate that has decreased due to skin ageing.
Naturally spreads from injection points to the entire face, enabling uniform, pan-facial rejuvenation.
Based on CESABP technology, which activates natural skin collagen regeneration without the use of microparticles.
Improves skin elasticity, firmness and texture, contributing to smoother, more youthful-looking skin.
Provides holistic, natural-looking rejuvenation rather than a localised volumising or “filled” effect.
Particle-free liquid formulation reduces the risk of nodules associated with particulate biostimulators.
Can be used as a premium regenerative skin booster in combination with other aesthetic treatments, in appropriately selected patients.
Indications
Anti-ageing facial treatment in adults with reduced collagen and visible signs of skin ageing.
Collagen stimulation to improve overall skin quality, including elasticity, density and texture.
Skin rejuvenation for patients seeking natural, gradual improvement rather than immediate volumisation.
Treatment of mild to moderate facial wrinkles and skin laxity as part of a regenerative aesthetic protocol.
Pan-facial skin booster therapy, with optional targeted treatment of specific areas such as the periorbital region where clinically appropriate.
Polycaprolactone (PCL) 210 mg/mL (21% w/v) – fully solubilised biodegradable polymer acting as the active collagen-inducing component.
Aqueous vehicle – water-based solution forming a homogeneous, transparent liquid implant (full list of excipients supplied in the manufacturer’s Instructions for Use).
No hyaluronic acid – Gouri is PCL-based and does not rely on HA for its effect.
No lidocaine – local anaesthetic is not included in the standard Gouri formulation.
No added microparticles or additional active ingredients – the collagen-stimulating effect is derived solely from liquid PCL.
Formulation
Fully solubilised liquid polycaprolactone (PCL) injectable produced using CESABP technology.
Homogeneous, particle-free liquid implant designed to spread evenly through dermal tissues after injection.
Biocompatible and biodegradable polymer that gradually degrades while promoting neocollagenesis in the deep dermis.
Non-volumising collagen stimulator – does not attract water like hyaluronic acid; instead, it induces endogenous collagen production for gradual structural improvement.
Supplied as a clear, low-viscosity injectable solution intended for deep dermal or subdermal application by trained professionals.
Packaging
Single-use, pre-filled sterile syringe containing 1 mL of liquid PCL (Gouri Skin Booster 1 x 1ml).
Luer-lock syringe connection for secure attachment of appropriate sterile needles or cannulas (typically provided separately by the clinic in line with regulatory requirements).
Syringe supplied in a sterile blister or protective barrier system within an outer carton.
Outer carton and syringe labelling include product name, volume (1 mL), batch/lot number, expiry date, manufacturer details (DEXLEVO Inc.) and device classification/markings.
Intended for professional use only and single-patient, single-session application; any unused product must be discarded after treatment.
Usage
Gouri Skin Booster must only be administered by licensed, trained aesthetic practitioners (e.g., doctors, nurses or other regulated professionals) familiar with injectable collagen biostimulators and complication management.
Before treatment, review the official GOURI Instructions for Use (IFU) from the manufacturer and follow all recommendations on indications, contraindications, injection planes, and maximum volume per session.
Inspect the syringe and packaging for integrity and expiry date; do not use if the sterile barrier is compromised or the product is out of date.
Prepare the treatment area by cleansing and disinfecting the skin according to clinic aseptic protocol.
Attach an appropriate sterile needle or cannula and inject into the recommended deep dermal or subdermal plane at designated points, using a limited number of injection sites to allow natural diffusion across the face.
Inject slowly and evenly, monitoring patient comfort and tissue response; avoid intravascular injection.
Record batch/lot number, injection sites, and total volume used in the patient’s medical record for traceability.
Provide post-procedure guidance, such as avoiding excessive manipulation of treated areas, extreme heat or cold, and strenuous exercise for a specified time, along with information on expected transient reactions and when to seek urgent review.
Dispose of used syringe, needle/cannula and any residual 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 infection, inflammation or dermatological disease at or near the planned injection sites.
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 treatments may pose increased risk, unless carefully evaluated and approved by a specialist.
Patients with known bleeding disorders or those receiving high-dose anticoagulant or antiplatelet therapy, unless the risk has been assessed and managed by the treating physician.
Pregnancy and breastfeeding, as safety of liquid PCL collagen stimulators has not been established in these populations.
Previous serious adverse reaction (e.g., granulomas, chronic nodules) to PCL-based or similar biostimulatory injectables without appropriate specialist review.
Use in patients with unrealistic expectations or body dysmorphic disorder for whom aesthetic procedures are clinically inappropriate.
Intended or inadvertent intravascular injection or use in high-risk anatomical areas without proper expertise and risk-mitigation strategies.
Adverse Effects
Common transient injection-site reactions such as redness, swelling, tenderness, bruising, itching or mild pain, usually resolving within a few days.
Temporary sensation of tightness or firmness in treated areas as tissue remodelling and collagen synthesis occur.
Occasional palpable irregularities or localised areas of firmness if product distribution is uneven or in individuals with heightened tissue reactivity; may require clinical assessment.
Rare delayed inflammatory reactions, including persistent swelling, induration or erythema weeks or months after treatment.
Hypersensitivity reactions ranging from mild local irritation to more significant allergic-type responses in susceptible individuals.
Injection-site infection, including cellulitis or abscess, particularly if aseptic technique or aftercare is inadequate.
Potential vascular compromise from accidental intravascular injection or vascular compression, presenting as pain, blanching, livedo reticularis, ischaemia or tissue necrosis and requiring urgent management.
Infrequent pigmentary changes or scarring in areas affected by significant inflammation, infection or necrosis.
Rare granulomatous or foreign-body reactions to PCL or degradation products that may require specialist intervention.
Storage Conditions
Store the product in its original packaging in a cool, dry place away from direct sunlight.
Maintain storage within the temperature range specified on the packaging (typically controlled room temperature); do not freeze.
Avoid exposing the syringe to excessive heat or large 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 outer carton and syringe label.
Do not use if the sterile packaging is damaged, opened, or shows any signs of leakage or contamination.
Transport under conditions that protect from physical shock and extreme temperatures.
Duration
Clinical improvements in skin quality and firmness typically develop gradually over weeks and may last approximately 12\u201324 months, depending on the patient\u2019s age, skin condition, lifestyle, treatment area and maintenance protocol.
Onset
Gouri does not produce an immediate volumising effect; early improvements in skin texture and elasticity are usually observed within several weeks as collagen production is stimulated, with progressive, natural-looking rejuvenation continuing to evolve over the following months.
