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NEWEST® (1 x 2 ml)

NEWEST® (1 x 2 ml)

NEWEST

Injectable skin booster
  • Class III medical device with CE0373 marking for intradermal infiltrations as listed by Mastelli in its aesthetic medicine portfolio.
  • Manufactured by Mastelli S.r.l. under quality management systems consistent with European medical device regulations (including ISO 13485 for medical devices, as indicated in corporate information).
  • Part of Mastelli’s intradermal skin rejuvenators line (Polynucleotides & Hyaluronic Acid) designed for professional aesthetic medicine.
  • Subject to post Market surveillance, clinical evaluation and regulatory oversight in markets where CE Marked devices are recognised.
Polynucleotide and hyaluronic acid biorevitalizing gel

Description

NEWEST® 2 ml is a Class III CE-marked injectable biorevitalizing gel from Mastelli that combines 10 mg/ml Polynucleotides HPT (PN-HPT®) with 10 mg/ml non-cross-linked hyaluronic acid and mannitol. Designed for intradermal infiltrations of the face, neck and décolletage, it targets acne scarring, photo- and chrono-ageing, dehydration and loss of elasticity. Clinical data show significant improvements in skin elasticity, brightness, wrinkles and roughness, while the PN-HPT® technology provides antioxidant protection, fibroblast regeneration and stimulation of collagen and elastin synthesis. Each pack contains a 2 ml pre-filled syringe and two 30G ½ (13 mm) needles for professional use only.

Bnefits

  • Advanced biorevitalising injectable that combines highly purified polynucleotides (PN-HPT®) with non-cross-linked hyaluronic acid and mannitol.
  • Clinically documented improvements: approximately +39.6% skin elasticity, +51.1% brightness, and −17.1% reduction in wrinkles and skin roughness after treatment protocols.
  • Provides deep hydration and improved turgor through hyaluronic acid while PN-HPT® supports tissue regeneration at a cellular level.
  • Antioxidant protection via mannitol helps protect tissues and hyaluronic acid from oxidative stress and enzymatic degradation.
  • Improves fine lines, textural irregularities, acne scars and photo-damage on the face, neck and décolletage.
  • Enhances overall skin quality, radiance and firmness, making it suitable for mature, dehydrated and structurally damaged skin.
  • Supports inhibition of photo- and chrono-ageing processes by stimulating fibroblasts and extracellular matrix renewal.
  • Non-surgical, minimally invasive treatment with visible results after the first procedure and sustained effects when used in a protocol of sessions.

Indications

  • Bio-revitalization of the skin of the face, neck and décolletage.
  • Treatment of fine lines, superficial wrinkles and early to moderate photo-ageing.
  • Improvement of skin affected by acne scarring and other atrophic scars.
  • Management of dehydrated, thin or fragile skin with loss of elasticity and firmness.
  • Supportive treatment for skin with significant environmental or intrinsic ageing damage.
  • Antioxidant and protective treatment against oxidative stress and photo- / chrono-ageing.
  • General improvement of skin tone, brightness and texture in indication areas as assessed by a qualified practitioner.

Composition

  • Polynucleotides HPT (PN-HPT®) 10 mg/ml (highly purified polynucleotides obtained with Mastelli High Purification Technology).
  • Non-cross-linked hyaluronic acid 10 mg/ml.
  • Mannitol (antioxidant and HA-stabilising agent).
  • Physiological excipients and buffer in an isotonic viscoelastic gel suitable for intradermal injection.
  • Sterile, apyrogenic, non-animal-origin components as specified in the device instructions for use.

Formulation

  • Isotonic, viscoelastic intradermal gel containing PN-HPT®, non-cross-linked hyaluronic acid and mannitol.
  • Injectable dermal skin booster/biorevitaliser supplied in a sterile 2 ml pre-filled syringe.
  • Designed for intradermal infiltrations in the face, neck and décolletage using fine needles (30G ½).
  • Class III medical device (MD) with CE0373 marking for intradermal skin rejuvenation indications.

Packaging

  • Box containing 1 x 2 ml pre-filled sterile syringe of NEWEST®.
  • Supplied with 2 x 30G ½ (13 mm) sterile needles for intradermal injection.
  • Packaging clearly labelled with product name, composition (PN-HPT®, HA, mannitol), volume, lot number and expiry date.
  • CE0373 mark and Class III medical device classification printed on the packaging together with Mastelli manufacturer information.
  • Intended for professional use only; includes package insert / instructions for use (IFU).

Usage

  • For intradermal use only by suitably trained and authorised healthcare professionals (e.g., aesthetic doctors, dermatologists) familiar with injectable biorevitalisation techniques.
  • Perform a full patient assessment including medical history, skin condition, indications, contraindications and expectations; obtain informed consent.
  • Cleanse and disinfect the treatment areas (face, neck, décolletage) using appropriate antiseptic protocol.
  • Attach one of the supplied 30G ½ needles securely to the pre-filled syringe, ensuring proper luer-lock engagement.
  • Injection depth: dermis (superficial to mid-dermis depending on area and technique).
  • Techniques: linear threading, serial puncture/point technique, cross-hatching, fan or mixed technique according to anatomical region and clinical judgement.
  • Typical protocol (from clinical and distributor guidance): a series of around 3 sessions spaced approximately 3 weeks apart; some clinicians may adapt frequency and number of sessions depending on skin condition and treatment goals.
  • The preparation may also be delivered using adjunctive methods such as iontophoresis or electroporation where appropriate and in line with IFU and local practice.
  • After injection, gently massage the treated skin if needed to optimise product distribution, avoiding excessive pressure.
  • Provide post-treatment guidance including avoiding intense heat (sunbeds, saunas), aggressive skincare, and strenuous exercise for a short period; instruct patients to use broad-spectrum SPF and to report any unexpected reactions.
  • Do not mix NEWEST® in the same syringe with other products or inject into blood vessels; avoid areas with active infection, inflammation or lesions.
  • Always refer to and follow the latest official instructions for use (IFU) provided with the product and comply with local regulations and clinical guidelines.

Contraindications

  • Known hypersensitivity or allergy to polynucleotides (including fish-derived DNA if applicable), hyaluronic acid, mannitol or any other component of the product.
  • 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.
  • Autoimmune diseases, immunosuppression, or uncontrolled systemic illnesses where injectable biorevitalisation is considered inappropriate by the treating physician.
  • Bleeding disorders or current significant anticoagulant therapy that may increase the risk of bleeding or bruising, unless carefully evaluated and managed by the clinician.
  • Pregnancy and breastfeeding, due to lack of sufficient safety data in these populations.
  • Presence of malignancy or premalignant lesions in the treatment area, or history of skin cancer in the area unless cleared by the relevant specialist.
  • Any other contraindications or precautions specified in the official NEWEST® instructions for use or applicable local clinical guidelines.

Adverse Effects

  • Expected transient local reactions at injection sites such as redness (erythema), swelling, mild pain or tenderness, itching, warmth or a feeling of tightness.
  • Small bruises (ecchymoses), haematoma and temporary oedema in treated areas, typically resolving spontaneously within a few days.
  • Palpable small lumps or mild irregularities immediately post-injection, generally resolving as the gel integrates; persistent nodules require clinical evaluation.
  • Occasional prolonged erythema, increased sensitivity or local inflammatory reactions; management may include cooling, topical care or medical treatment based on severity.
  • Rare hypersensitivity reactions or allergic responses to one of the components, potentially requiring medical intervention.
  • 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 dermal injections, such as vascular compromise or tissue ischaemia, although these are uncommon when product is correctly injected intradermally and not intravascularly.
  • Healthcare professionals are advised to familiarise themselves with the contraindications, warnings and possible adverse events detailed in the IFU and to report any serious incidents according to local medical device vigilance requirements.

Storage Conditions

  • Store in accordance with the temperature range specified on the packaging (typically at controlled room temperature, away from excessive heat or cold).
  • Do not freeze. Avoid exposing the product to extreme temperature fluctuations during transport or storage.
  • Keep the syringe in its original blister and carton until use to maintain sterility and protect from light and physical damage.
  • Do not use the product after the expiry date printed on the pack or if the packaging, blister or syringe is damaged or shows signs of compromise.
  • Store out of the reach of children and unauthorised persons; product is for professional use only.

Duration

According to distributor and clinical information, visible improvements may be observed after the first procedure, with optimal results achieved following a series of about 3 sessions performed roughly every 3 weeks. Results can last up to approximately 6 months, depending on factors such as age, skin condition, lifestyle, sun exposure and individual metabolic response. Maintenance treatments can be scheduled at the clinician\u2019s discretion.

Onset

Early improvements in hydration and radiance can appear in the days to weeks following the first session as dermal hydration increases. Progressive enhancement of elasticity, brightness and reduction of wrinkles and roughness occurs over the treatment course and subsequent weeks as fibroblast activation and extracellular matrix remodelling take place.

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