Nithya Collagen 3x5ml

Official and exclusive distribution in Poland

PureMED is the sole authorised distributor of the Nithya brand (Euroresearch Srl) in Poland.

No other shop or wholesaler in Poland is authorised to sell Nithya products. By purchasing from PureMED you are guaranteed product authenticity through the official distribution channel, with full batch and expiry-date traceability.

• What is NITHYA Type I Collagen?
• Mechanism of action – mechanotransduction
• Biological cascade of equine collagen
• Confirmed by clinical trial – results
• Patient assessment at 6 months
• Indications and treatment areas
• Preparation and injection technique
• Composition, sterilisation and package contents
• Contraindications
• Regulatory status – EU Medical Device
• Individual offer for clinics and practices
• FAQ – questions and answers

What is NITHYA Type I Collagen?

NITHYA Type I Collagen is a sterile equine type I collagen powder produced by the Italian laboratory Euroresearch Srl (Milan), intended for intradermal injections for dermo-bioregenerative and biorevitalising purposes. The product contains 100% pure type I collagen extracted from horse tendons — the substance that accounts for approximately 80–90% of the dry weight of the dermis and is a fundamental component of the extracellular matrix (ECM).

The product is classified as a Class I Medical Device under Regulation (EU) 2017/745, as confirmed by the analytical report of Eurofins Regulatory & Consultancy Services Italy Srl (ABO55120, December 2024). This classification unambiguously confirms that NITHYA acts through a mechanical mechanism — not pharmacological, immunological or metabolic.

Mechanism of action – mechanotransduction

Injected equine type I collagen acts via the mechanism of mechanotransduction — the process by which cells convert mechanical stimuli from their environment into biochemical signals. After intradermal injection, collagen:

• exerts traction on type VI collagen fibrils forming a network in the immediate vicinity of cell membranes,
• the resulting mechanical stress stimulates fibroblasts to produce new extracellular matrix,
• alters the physical and mechanical environment of surrounding cells, activating mechanoreceptors (integrins, focal adhesions),
• triggers signalling pathways influencing cell behaviour — migration, proliferation and differentiation essential for tissue repair,
• forms a biological scaffold that restores the correct dermal microenvironment and promotes fibroblast proliferation.

Importantly, the product's effectiveness is not mediated by chemical interaction with cellular receptors or metabolic pathways, but by the mechanical forces and structural properties it imposes on surrounding tissue: pressure, rigidity and resistance to stretching.

Biological cascade of equine collagen – what happens in the tissue

Injected equine type I collagen is gradually replaced step by step by the patient's own new collagen. In vivo studies have shown that fibroblasts exposed to equine collagen respond by up-regulating genes with a positive effect on tissue regeneration:

• Fibrillin 1 — involved in the structural integrity of tissues, binding tropoelastin during elastic fibre formation and directing growth factors (TGF-β, BMP) to the ECM,
• Fibronectin 1 — involved in cell adhesion and migratory behaviour,
• Integrin subunit alpha 5 — involved in cell adhesion, immune response, haemostasis and tissue repair.

The equine collagen matrix also induces a haemostatic action promoting platelet activation and growth factors, supports fibroblast proliferation and granulation tissue formation, activates fibronectin, fibroblasts and monocytes, and stimulates angiogenesis — the formation of new capillaries. After the regeneration process is complete, the product undergoes slow biodegradation.

Confirmed by clinical trial – results (Sparavigna et al., 2017)

The efficacy of NITHYA Type I Collagen was confirmed by a multicentre, investigator-initiated, open clinical trial conducted across 6 Italian centres on 72 healthy female patients aged 40–65, published in the Journal of Clinical & Experimental Dermatology Research (Sparavigna A. et al., 2017, DOI: 10.4172/2155-9554.1000391).

Trial protocol: 3 injections (T0, T1 at 2 weeks, T2 at 4 weeks) + follow-up to 6 months (T5). Assessed using WSRS, FVLS and Glogau scales, skin replica profilometry, and 3D facial volume analysis (VECTRA H1).

Clinical results at 2 months after the first injection (T3):

• Cheek volume loss (FVLS): improvement of 32.4% — 88% of patients showed a reduction of at least 1 grade on the clinical scale,
• Wrinkle depth (WSRS): reduction of 33.3% — 90% of patients showed improvement of at least 1 grade,
• Crow's feet (Glogau scale): reduction of 32.3% — 94% of patients showed improvement of at least 1 grade,
• Crow's feet profilometry (skin replicas): Ra roughness reduction of 21.7% (p<0.01), Rt wrinkle height reduction of 22.9% (p<0.05), Rv wrinkle depth reduction of 17.5%,
• 3D facial volume analysis: average cheek volume gain of +0.812 cc vs baseline at 2 months, rising to +0.939 cc at 6 months (+15.6% more than at 2 months) — confirming a long-lasting bio-revolumetric effect.

Treatment tolerance was rated good/excellent by investigators. No unexpected adverse reaction related to the tested product occurred during the trial. Mild to moderate bruising at injection sites resolved completely within 5–10 days.

Patient assessment at 6 months – satisfaction

At the end of the trial (6 months after the first injection), patients completed an efficacy questionnaire. Combined percentage of medium, marked and very marked improvement ratings:

• Improvement in cheek volume: 95% of patients
• Improvement in skin smoothness: 95% of patients
• Improvement in superficial wrinkles: 95% of patients
• Improvement in skin suppleness: 94% of patients
• Improvement in skin brightness: 93% of patients
• Lifting effect: 89% of patients
• Improvement in skin hydration: 89% of patients
• Reshaping of face silhouette: 88% of patients
• Improvement in deep wrinkles: 87% of patients

Indications and treatment areas

According to the official manufacturer documentation (Euroresearch Srl), NITHYA Type I Collagen is indicated for:

• biorevitalisation of the dermis and skin,
• dermis regeneration after traumatic events and post-traumatic lesions,
• treatment of imperfections and blemishes of the face, neck, décolletage and body associated with ageing,
• treatment of tissue laxity, correction of skin hypotrophy and hypotonia, reduced skin elasticity,
• modelling of genetic defects of the face and body such as skin hypotrophy, hypotonia and reduced skin elasticity,
• restoration and/or correction of signs of facial fat loss (lipoatrophy),
• restoration and/or correction of facial acne scars.

Treatment areas: face, neck, décolletage, hands. Recommended volume per session: face 2–3 ml, neck 0.5–1 ml, décolletage 0.5–1 ml, hands 0.5 ml.

Product preparation and injection technique

Preparing the suspension:

• Dissolve 70 mg of collagen powder from one vial in 5 ml of sterile physiological saline (or double-distilled water).
• Prepare the suspension immediately before the procedure — each vial is for single use only.
• Store in the refrigerator after opening; use within 2 weeks.

Injection technique:

• Injection layer: deep in the dermis or at the dermo-hypodermal junction.
• Recommended techniques: serial puncture (picotage) using a 30G needle at a 45° angle, or linear technique.
• Volume per point: 0.1–0.2 ml at 1.5–2 cm intervals, or 0.05 ml at 0.5 cm intervals.

Treatment protocol: standard cycle — 3 sessions at 2-week intervals. Repeat cycle 3 months after completion of the previous series. Preventive use from around age 25; treatment of visible signs of ageing from age 30 onwards.

Composition, sterilisation and package contents

• Active substance: Equine type I collagen, 100% purity — extracted from horse tendons
• Form: homogeneous, fine powder, ivory-white in colour with a characteristic acetic acid odour
• Sterilisation: terminal sterilisation by gamma radiation (dose 25 kGy)
• Does not contain: products of human origin (tissues or blood), medicinal products or drugs
• Primary packaging: glass vial with aluminium ferrule
• Package contents: 3 × vial of 70 mg collagen powder; each vial yields 5–6 ml of ready-to-inject suspension
• EAN: 8054953400198
• Manufacturer: Euroresearch Srl, Corso Venezia 5, 20121 Milan, Italy

Contraindications

• pregnancy and breastfeeding,
• active inflammation or infection at the injection site,
• autoimmune diseases,
• hypersensitivity or allergy to collagen or product components (allergy test required 2 weeks before the first injection),
• tendency to keloid scarring,
• significant systemic diseases (diabetes, endocrine, hepatic, renal, cardiac, oncological disorders),
• blood clotting disorders or anticoagulant medication (medical consultation required),
• pharmacological treatments that may influence results (NSAIDs, antihistamines, corticosteroids, immunosuppressants).

Important: A predictive allergy test must be performed 2 weeks before the first injection without exception.

Regulatory status – Medical Device compliant with Regulation (EU) 2017/745

Based on the analysis conducted by Eurofins Regulatory & Consultancy Services Italy Srl (Report ABO55120, December 2024), it was demonstrated that the mechanism of action of NITHYA Type I Collagen is exclusively mechanical — through the structural and biomechanical properties of collagen — and not pharmacological, immunological or metabolic. On this basis, the product qualifies as a Medical Device under Regulation (EU) 2017/745, Article 2, and MDCG 2022-5 guidelines. The product is sterile, single-use and non-active.

Individual offer for clinics and practices – exclusive Nithya distributor in Poland

As the sole authorised Nithya distributor in Poland, we offer clinics and aesthetic medicine practices dedicated cooperation terms:

• Individual wholesale pricing — volume-based discounts, negotiated individually for each practice.
• Nithya Partner Practice Programme — access to marketing materials, educational support and manufacturer treatment protocols.
• Full clinical documentation — we supply practices with original clinical studies and regulatory reports (Eurofins PMI Screening) for patient and regulatory authority reference.
• Expert support — protocol selection advice and guidance on complementary Nithya products.
• Priority 24h delivery — partner practice orders fulfilled first.
• Fast Order — quick orders via WhatsApp without logging in: +48 697 197 052.

For individual pricing or further information on the partner programme: sklep@puremed.com.pl or +48 697 197 052 (WhatsApp).

FAQ – questions and answers

How does equine type I collagen differ from bovine or ovine collagen?
Bovine and ovine collagen are excluded from injectable applications due to the risk of prion transmission (spongiform encephalopathy, Creutzfeldt-Jakob disease). NITHYA's equine collagen is extracted from horse tendons and is free from this risk. It is sterilised by gamma radiation (25 kGy), guaranteeing full microbiological safety.

What is mechanotransduction in the context of NITHYA?
Injected collagen acts as a biological scaffold within the dermis. Cells (primarily fibroblasts) sense mechanical changes in their environment through receptors (integrins) and convert these stimuli into biochemical signals, triggering repair processes and production of new extracellular matrix. This is why NITHYA is classified as a medical device rather than a drug — it acts through physical properties, not chemical ones.

When are the results of NITHYA treatment visible?
The clinical trial showed statistically significant improvement already 2 weeks after the first injection, with marked results (33% wrinkle reduction, 32% improvement in cheek volume) at 2 months from treatment start. The bio-revolumetric effect continued to increase at 6 months, reaching a cheek volume gain of +0.939 cc.

Is an allergy test required?
Yes — the NITHYA clinical protocol requires a predictive allergy test to be performed 2 weeks before the first collagen injection. This is the standard safety procedure for collagen-based products.

How many vials are needed for a full treatment cycle?
The standard cycle consists of 3 sessions at 2-week intervals. The 3×70 mg package contains vials for 3 sessions for one patient (face: 2–3 ml from one vial suspended in 5 ml of physiological saline).

Can NITHYA be combined with other treatments?
Yes — the product combines well with HA skinboosters, PLLA and PCL stimulators, and cleansing treatments (chemical peels). Appropriate time intervals should be maintained. The clinical trial excluded patients who had HA injections, radiofrequency or botulinum toxin within 6 months before enrolment — expert consultation is therefore recommended when planning combination therapy.

This product may only be used by doctors and cosmetologists trained in aesthetic medicine. By purchasing this product, you confirm that you hold the required professional qualifications in accordance with applicable regulations.