Polynucleotide and hyaluronic acid biorevitalizing gel
Certifications
Class III CE Marked medical device for intradermal infiltration of face, neck and décolletage.
Manufactured by Mastelli S.r.l. under quality management systems compliant with European medical device regulations (including ISO 13485 for medical devices, as indicated in corporate materials).
Part of Mastelli’s PN HPT® aesthetic medicine portfolio, which is subject to clinical evaluation, risk management and post Market surveillance in accordance with EU medical device legislation.
Class III CE Marked medical device for intradermal infiltration of face, neck and décolletage.
Manufactured by Mastelli S.r.l. under quality management systems compliant with European medical device regulations (including ISO 13485 for medical devices, as indicated in corporate materials).
Part of Mastelli’s PN HPT® aesthetic medicine portfolio, which is subject to clinical evaluation, risk management and post Market surveillance in accordance with EU medical device legislation.
Polynucleotide and hyaluronic acid biorevitalizing gel
Description
NEWEST 2ml 2% (10mg) PN-HPT is a Class III CE-marked intradermal biorevitalizing gel from Mastelli that combines 10 mg/ml PN-HPT® (Polynucleotides – High Purification Technology) 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 into the face, neck and décolletage. The formula targets acne, scarring and more significant levels of skin damage and ageing, with clinical data showing marked improvements in skin elasticity, brightness and reduction of wrinkles and roughness. It is especially suggested for mature and dehydrated skin, where it deeply hydrates, stimulates dermal regeneration and improves overall skin quality.
Bnefits
Advanced biorevitalising injectable combining highly purified PN-HPT® with non-cross-linked hyaluronic acid and mannitol.
Suggested for mature and dehydrated skin presenting photo- and chrono-ageing, uneven texture and loss of elasticity.
Clinical studies have shown approximately 39.6% improvement in skin elasticity, 51.1% enhancement in brightness, and 17.1% reduction in wrinkles and rough skin when used in protocolled treatment courses.
PN-HPT® supports fibroblast activation, collagen and elastin synthesis and extracellular matrix renewal, promoting true tissue bio-regeneration.
Non-cross-linked hyaluronic acid 10 mg/ml provides deep hydration, improving turgor and suppleness without adding bulk like volumising fillers.
Mannitol acts as an antioxidant, helping to protect tissues and slow enzymatic and oxidative degradation of hyaluronic acid, prolonging its effects.
Effective treatment option for acne scarring, other superficial atrophic scars and visible signs of skin damage and ageing in the face, neck and décolletage.
Improves overall tone, brightness and smoothness of the skin, leaving the complexion more radiant and refined.
Indications
Biorevitalisation and rejuvenation of the skin of the face, neck and décolletage.
Suggested application on mature and dehydrated skin showing loss of elasticity, dullness and fine-to-moderate wrinkles.
Adjunctive treatment for acne scarring and other atrophic or textural scars in the indication areas.
Management of more significant levels of skin damage and ageing (photo- and chrono-ageing).
Improvement of uneven texture, roughness and superficial lines associated with dehydration and structural decline.
General enhancement of skin brightness, tone and quality in appropriate patients, as assessed by a qualified practitioner.
Composition
PN-HPT® (Polynucleotides – High Purification Technology) 10 mg/ml.
Non-cross-linked hyaluronic acid 10 mg/ml.
Mannitol (antioxidant and hyaluronic acid stabiliser).
Isotonic buffered excipients and purified water in a sterile, apyrogenic gel suitable for intradermal injection.
Total volume: 2 ml per pre-filled syringe.
Formulation
Isotonic, viscoelastic intradermal gel combining PN-HPT®, non-cross-linked hyaluronic acid and mannitol.
Class III CE-marked medical device formulated for intradermal infiltrations of face, neck and décolletage.
Colourless to slightly opalescent gel designed for injection with fine needles using microdroplet, linear or fan techniques.
Supplied as a single-patient, single-use 2 ml pre-filled syringe.
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) sterile needles for intradermal injection.
Outer carton and syringe labelling include product name, composition (10 mg/ml PN-HPT®, 10 mg/ml non-cross-linked HA, mannitol), volume, batch/lot number and expiry date.
Displays CE mark and Class III MD status together with Mastelli manufacturer details.
Supplied with instructions for use (IFU); indicated for professional medical-aesthetic use only.
Usage
For intradermal use only by trained and appropriately licensed healthcare professionals (e.g., aesthetic physicians, dermatologists) experienced in injectable biorevitalisation.
Conduct a full medical history and skin assessment to confirm suitability (mature/dehydrated skin, acne scarring, photoageing) and to rule out contraindications; obtain informed consent.
Cleanse the treatment areas (face, neck, décolletage) thoroughly and disinfect according to clinical protocol.
Attach one of the supplied 30G ½ needles securely to the pre-filled syringe using the luer-lock connection.
Injection depth: intradermal, targeting superficial to mid-dermis depending on anatomical site and skin thickness.
Injection techniques: microdroplet, linear threading or fan technique, adjusting spacing and volume per point according to indication and desired coverage.
Suggested protocol for younger patients: one session every 14–21 days for a total of 3 sessions.
Suggested protocol for advanced skin ageing or more damaged skin: one session every 14–21 days for a total of 4 sessions.
Adjust the volume and injection pattern in areas with acne scars or more pronounced damage, taking care to avoid overcorrection or excessive trauma.
After injection, gently massage the treated areas if required to optimise product distribution, avoiding excessive pressure, especially in thin or fragile skin.
Provide post-treatment instructions including avoidance of intense heat (saunas, steam rooms), vigorous exercise, alcohol excess and direct sun/UV exposure for a short period; advise use of broad-spectrum sunscreen and gentle skincare.
Do not mix NEWEST with other products in the same syringe. Do not inject intravascularly or into areas of active infection, inflammation or disease. Always follow the official IFU and local regulations.
Contraindications
Known hypersensitivity or allergy to polynucleotides (including fish-derived components where applicable), hyaluronic acid, mannitol or any excipients in the formulation.
Active 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.
Significant coagulation or bleeding disorders and/or current use of potent anticoagulants that may increase bleeding or bruising risk, unless carefully assessed and managed by the clinician.
Pregnancy and breastfeeding, due to lack of adequate safety data in these populations.
Presence of malignancy or premalignant lesions in the treatment area unless explicitly cleared by the responsible specialist.
Any additional contraindications or warnings stated in the official NEWEST instructions for use or applicable local clinical guidelines.
Adverse Effects
Common transient injection-site reactions such as erythema (redness), swelling, mild pain or tenderness, warmth, itching or a feeling of tightness.
Small bruises (ecchymoses), haematoma or temporary oedema at injection sites, usually resolving within a few days.
Palpable papules or small lumps immediately after intradermal injections, generally subsiding as the gel integrates into the dermis.
Occasional prolonged redness, increased sensitivity or local inflammatory reactions 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 strictly followed.
Very rare but potential complications associated with injectable procedures, such as vascular compromise or tissue ischaemia if inadvertently injected intravascularly or too deeply.
Any unexpected, persistent or severe adverse event should be documented and managed according to the IFU and local medical device vigilance requirements.
Storage Conditions
Store according to the temperature range specified on the packaging (typically controlled room temperature; do not freeze).
Protect from extremes of heat and cold and from direct sunlight; avoid significant temperature fluctuations during transport and storage.
Keep the pre-filled syringe in its original blister and outer carton until use to maintain sterility and protect from light and physical damage.
Do not use after the expiry date printed on the packaging or if the blister, syringe or security seals appear damaged or compromised.
Store out of reach of children and unauthorised persons; product is intended exclusively for professional use.
Duration
Typical initial treatment courses consist of 3 sessions (younger patients) or 4 sessions (advanced skin ageing or more damaged skin) performed at intervals of approximately 14\u201321 days. Clinical benefits often persist for several months after the end of the treatment cycle, with maintenance sessions scheduled according to individual skin condition, age, lifestyle and practitioner judgement.
Onset
Early improvements in hydration, radiance and skin comfort may be noticeable within the first few weeks of treatment, with more substantial gains in elasticity, brightness and reduction of wrinkles and roughness developing progressively over the course of 3\u20134 sessions and in the weeks that follow as dermal remodelling and collagen synthesis occur.
