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NEWEST 2ml 2% (10mg) PN HPT (Plenyhage Medium)

NEWEST 2ml 2% (10mg) PN HPT (Plenyhage Medium)

NEWEST

Injectable skin booster
  • Class III CE Marked medical device for intradermal infiltrations, as listed in Mastelli’s aesthetic medicine portfolio.
  • Manufactured by Mastelli S.r.l. under quality management systems compliant with European medical device regulations (including ISO 13485 for medical devices).
  • Based on PN HPT® technology with documented clinical evaluations and consensus guidance for aesthetic medicine use.
  • Subject to post Market surveillance, risk management and vigilance requirements for high Risk medical devices in markets recognising CE certification.
Polynucleotide and hyaluronic acid biorevitalizing gel

Description

NEWEST 2ml 2% (10mg) PN-HPT (Plenyhage Medium) is a Class III CE-marked intradermal biorevitalizing gel from Mastelli that combines 10 mg/ml Polynucleotides HPT (PN-HPT®) with 10 mg/ml non-cross-linked hyaluronic acid and mannitol. Supplied in a 2 ml pre-filled syringe with two 30G ½ needles, it is designed for injection in the face, neck and décolletage. The formulation targets acne scarring, advanced photo- and chrono-ageing, dehydration and loss of elasticity, particularly in mature and dehydrated skin. Clinical data show significant improvements in elasticity, brightness and reduction of wrinkles and roughness, while PN-HPT® supports dermal bio-regeneration and hyaluronic acid provides deep, long-lasting hydration.

Bnefits

  • Combined PN-HPT® (10 mg/ml) and non-cross-linked hyaluronic acid (10 mg/ml) with mannitol for synergistic regenerative and hydrating effects.
  • Clinically documented improvements in skin parameters: approximately +39.6% elasticity, +51.1% brightness, and −17.1% wrinkles and roughness after treatment protocols.
  • Effective for acne scars, scarring and more significant levels of skin damage and ageing in the face, neck and décolletage.
  • Deeply hydrates and improves turgor and elasticity of mature and dehydrated skin.
  • PN-HPT® supports fibroblast activation, extracellular matrix renewal and collagen and elastin synthesis, promoting true bio-regeneration.
  • Mannitol provides antioxidant protection and helps slow enzymatic and oxidative degradation of hyaluronic acid, prolonging the hydrating effect.
  • Improves overall skin quality, texture, tone and radiance without adding bulk like traditional fillers.
  • Non-surgical, minimally invasive injectable treatment with structured protocols for younger and advanced-age patients.

Indications

  • Biorevitalisation and rejuvenation of the skin of the face, neck and décolletage.
  • Acne scarring and other atrophic or textural scars in the indication areas.
  • More significant levels of skin damage and ageing, including photo- and chrono-ageing.
  • Fine lines and wrinkles associated with dehydration and loss of elasticity.
  • Mature and dehydrated skin requiring improved elasticity, turgor and radiance.
  • General improvement of skin tone, brightness and texture in the treated regions, as assessed by a qualified practitioner.

Composition

  • Polynucleotides HPT (PN-HPT®) 10 mg/ml (highly purified polynucleotides obtained with High Purification Technology).
  • Non-cross-linked hyaluronic acid 10 mg/ml.
  • Mannitol approximately 200 mM/L as an antioxidant and HA-stabilising agent.
  • Physiological buffer and excipients in a sterile, apyrogenic, isotonic gel suitable for intradermal injection.
  • 2 ml total gel volume in a pre-filled syringe.

Formulation

  • Isotonic, viscoelastic intradermal gel containing PN-HPT®, non-cross-linked hyaluronic acid and mannitol.
  • Class III medical device (CE-marked) for intradermal infiltrations of the face, neck and décolletage.
  • Colourless to slightly opalescent gel formulated for microinjections in the dermis with fine needles.
  • 2 ml pre-filled syringe presentation for single-patient, single-use application.

Packaging

  • Box containing 1 x 2 ml pre-filled sterile syringe of NEWEST 2ml 2% (10mg) PN-HPT.
  • Includes 2 x 30G ½ (13 mm) needles for intradermal injection.
  • Packaging labelled with product name, PN-HPT®, hyaluronic acid and mannitol content, volume, batch/lot number and expiry date.
  • Displays CE marking and Class III MD status along with Mastelli manufacturer details.
  • Supplied with instructions for use (IFU); intended strictly for professional use.

Usage

  • For intradermal use only by appropriately trained and authorised healthcare professionals (e.g., aesthetic physicians, dermatologists) familiar with PN-HPT® injectables.
  • Perform a full medical history and skin assessment, confirming indications such as acne scarring, photoageing or dehydration and ruling out contraindications; obtain informed consent.
  • Cleanse and disinfect the treatment areas (face, neck, décolletage) using appropriate antiseptic techniques.
  • Attach one of the supplied 30G ½ needles securely to the pre-filled syringe, ensuring a firm luer-lock connection.
  • Injection depth: intradermal (superficial to mid-dermis), as indicated by the IFU and clinical protocols.
  • Injection techniques: serial puncture, microdroplet, linear threading, or fan technique depending on anatomical area, skin thickness and treatment objectives.
  • Suggested protocol for younger patients: one session every 14–21 days for a total of 3 sessions.
  • Suggested protocol for advanced skin ageing: one session every 14–21 days for a total of 4 sessions.
  • Adjust treatment volume and pattern according to lesion type (e.g., acne scars, diffuse photoageing) and clinical judgement.
  • After injecting, lightly massage the area if needed to optimise distribution, avoiding excessive pressure on fragile skin.
  • Provide post-treatment advice including avoidance of intense heat, sun exposure, aggressive skincare and strenuous exercise for a short period, and emphasise regular photoprotection.
  • Do not mix NEWEST with other products in the same syringe or inject into blood vessels; avoid use in areas with active infection or skin disease. Follow the official IFU and local guidelines at all times.

Contraindications

  • Known hypersensitivity or allergy to polynucleotides (including fish-derived components), hyaluronic acid, mannitol or any other excipients in the formulation.
  • Active or recent skin infections, inflammation, dermatitis or herpetic lesions in the intended treatment area.
  • History of severe allergic reactions or anaphylaxis where injectable medical devices may pose increased risk.
  • Uncontrolled systemic diseases, significant autoimmune conditions or immunosuppression where intradermal biorevitalisation is considered inappropriate by the treating physician.
  • Bleeding disorders or current significant anticoagulant therapy that may increase the risk of bruising or bleeding at injection sites, unless carefully assessed by the clinician.
  • Pregnancy and breastfeeding, due to the absence of adequate safety data.
  • Presence of malignant or premalignant lesions in the treatment area unless explicitly cleared by the responsible specialist.
  • Any other contraindications listed in the official NEWEST instructions for use or in relevant local clinical guidelines.

Adverse Effects

  • Common transient injection-site reactions such as redness (erythema), swelling, mild pain or tenderness, itching, warmth and a feeling of tightness.
  • Small bruises (ecchymoses), haematoma and temporary oedema at injection sites, usually resolving spontaneously within a few days.
  • Palpable papules or small lumps immediately after intradermal injections, typically subsiding as the product integrates into the dermis.
  • Occasional prolonged erythema, increased sensitivity or local inflammatory response requiring clinical evaluation and symptomatic management.
  • Rare hypersensitivity or allergic reactions to one of the components, which may require medical treatment.
  • As with any intradermal injection, there is a risk of infection, abscess formation or delayed wound healing if aseptic technique is not correctly followed.
  • Very rare but potential complications associated with injectable procedures, such as vascular compromise or tissue ischaemia if inadvertently injected intravascularly or too deeply.
  • Practitioners should follow the safety information and adverse event guidance within the IFU and report serious incidents according to local medical device vigilance requirements.

Storage Conditions

  • Store according to the temperature conditions indicated on the packaging (typically controlled room temperature; do not freeze).
  • Protect from extremes of heat and cold and from direct sunlight; avoid temperature fluctuations during transport and storage.
  • Keep the syringe in its original blister and outer carton until use to maintain sterility and protect from physical damage and light.
  • Do not use after the expiry date or if the packaging, blister or syringe appears damaged or compromised.
  • Store out of reach of children and unauthorised persons; for professional use only.

Duration

Typical initial treatment courses consist of 3 sessions (younger patients) or 4 sessions (advanced skin ageing) performed every 14\u201321 days. Clinical and real-world experience suggests that improvements can persist for several months after the treatment cycle, with maintenance sessions scheduled according to the patient\u2019s age, skin condition and response.

Onset

Early improvements in hydration, brightness and skin comfort are often noticeable within weeks of starting treatment, with more pronounced gains in elasticity, texture and reduction in wrinkles and scarring emerging progressively over the full course of 3\u20134 sessions and the following weeks as dermal remodelling occurs.

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