Nithya Collagen 1x vial

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.

This page covers the single vial 1×70 mg. The product is also available as the 3×70 mg pack (full treatment cycle) — choose it when planning a complete 3-session series for one patient.

• 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 accounting for approximately 80–90% of the dry weight of the dermis and a fundamental component of the extracellular matrix (ECM). The product is classified as a Class I Medical Device under Regulation (EU) 2017/745, confirmed by Eurofins Regulatory & Consultancy Services Italy Srl (Report ABO55120, December 2024).

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.

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 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 haemostatic action promoting platelet activation and growth factors, supports fibroblast proliferation and granulation tissue formation, activates fibronectin, fibroblasts and monocytes, and stimulates angiogenesis. After regeneration 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).

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,
• Wrinkle depth (WSRS): reduction of 33.3% — 90% of patients improved by at least 1 grade,
• Crow's feet (Glogau scale): reduction of 32.3% — 94% of patients improved by at least 1 grade,
• Profilometry (skin replicas): Ra roughness reduction of 21.7% (p<0.01), Rt reduction of 22.9% (p<0.05), Rv reduction of 17.5%,
• 3D facial volume analysis: cheek volume gain of +0.812 cc at 2 months, rising to +0.939 cc at 6 months (+15.6%) — long-lasting bio-revolumetric effect confirmed.

Treatment tolerance was rated good/excellent by investigators. No unexpected adverse reaction related to the tested product occurred during the trial.

Patient assessment at 6 months – satisfaction

• 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

• 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,
• 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

• Dissolve 70 mg of collagen powder from one vial in 5 ml of sterile physiological saline — 5–6 ml of ready-to-inject suspension is obtained.
• Prepare immediately before the procedure — each vial is for single use only.
• Store in the refrigerator after opening; use within 2 weeks.
• Injection layer: deep in the dermis or at the dermo-hypodermal junction.
• Recommended techniques: serial puncture (picotage) using a 30G needle at 45°, 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: 3 sessions at 2-week intervals. Repeat cycle 3 months after completion. Preventive use from around age 25; treatment of visible 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
• Sterilisation: terminal sterilisation by gamma radiation (dose 25 kGy)
• Does not contain: products of human origin, medicinal products or drugs
• Package contents: 1 × vial of 70 mg collagen powder; 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.

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 by Eurofins Regulatory & Consultancy Services Italy Srl (Report ABO55120, December 2024), the mechanism of action of NITHYA Type I Collagen is exclusively mechanical. The product therefore 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 dedicated cooperation terms:

• Individual wholesale pricing — volume-based discounts, negotiated individually.
• Nithya Partner Practice Programme — access to marketing materials and manufacturer treatment protocols.
• Full clinical documentation — original clinical studies and Eurofins PMI Screening reports.
• Expert support — protocol selection advice and complementary Nithya product guidance.
• Priority 24h delivery and Fast Order via WhatsApp: +48 697 197 052.

Contact: sklep@puremed.com.pl or +48 697 197 052 (WhatsApp).

FAQ – questions and answers

Is one vial enough for a full facial treatment?
Yes — from one 70 mg vial, after reconstitution in 5 ml of saline, 5–6 ml of suspension is obtained, which covers the recommended dose for the face (2–3 ml) or face + neck + décolletage combined. For a full 3-session cycle, 3 vials are needed — available in the 3×70 mg pack.

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. NITHYA's equine collagen is extracted from horse tendons and is free from this risk. Sterilised by gamma radiation (25 kGy).

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. 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 — a predictive allergy test must be performed 2 weeks before the first collagen injection. This is standard safety procedure for collagen-based products.

Can NITHYA be combined with other treatments?
Yes — it combines well with HA skinboosters, PLLA and PCL stimulators, and chemical peels. Appropriate time intervals should be maintained and expert consultation is 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.