Mastelli NEW Gyn
Mastelli
Aesthetic gynaecology injectablePolynucleotide and hyaluronic acid biostimulator for genital area
Certifications
- Part of the Mastelli PN HPT polynucleotide range manufactured in a pharmaceutical laboratory operating under stringent regulatory and quality standards.
- Polynucleotides HPT Based products used in this portfolio are classified as Class III CE Marked 0373 medical devices in the EU/UK regulatory framework.
- Manufactured under ISO 13485 Compliant quality management systems for medical devices.
- Part of the Mastelli PN HPT polynucleotide range manufactured in a pharmaceutical laboratory operating under stringent regulatory and quality standards.
- Polynucleotides HPT Based products used in this portfolio are classified as Class III CE Marked 0373 medical devices in the EU/UK regulatory framework.
- Manufactured under ISO 13485 Compliant quality management systems for medical devices.
Polynucleotide and hyaluronic acid biostimulator for genital area
Description
Mastelli NEW Gyn is an injectable polynucleotide-based biostimulator specifically developed for aesthetic and functional gynaecology. The product contains PN-HPT (Polynucleotides High Purification Technology) at 10 mg/ml together with non-crosslinked hyaluronic acid at 10 mg/ml and mannitol, presented as a sterile gel in a 2 ml pre-filled syringe. NEW Gyn is suggested to enhance turgor and trophism of the skin layers and genital area mucosae, improving tissue hydration, elasticity and overall quality. It is designed for intradermal application in intimate areas by trained medical professionals using microdroplet, linear or fan injection techniques, following a structured treatment protocol.
Bnefits
- Enhances turgor and trophism of genital area mucosae and surrounding skin.
- Improves tissue hydration and elasticity thanks to non-crosslinked hyaluronic acid and PN-HPT.
- Supports regenerative processes and tissue quality through polynucleotides with high purification technology.
- Mannitol contributes antioxidant and osmoprotective action, helping to stabilise hyaluronic acid and prolong hydration.
- Suitable for intimate-area biostimulation as part of aesthetic gynaecology protocols.
- Packaged with fine-gauge needles (30G ½) for precise, minimally traumatic intradermal injections.
- CE-marked Class III polynucleotide technology used across the Mastelli PN-HPT portfolio, backed by clinical experience.
Indications
- Suggested to enhance turgor and trophism of skin layers and genital area mucosae.
- Support of tissue quality and hydration in the external genital area within aesthetic gynaecology practice.
- Adjunctive regenerative treatment in intimate-area rejuvenation protocols, as determined by the treating physician.
- Patients with reduced elasticity, dryness or loss of tone in the genital skin and mucosae where a medical professional considers PN-HPT and HA biostimulation appropriate.
Composition
- PN-HPT (Polynucleotides High Purification Technology) 10 mg/ml.
- Non-crosslinked hyaluronic acid (sodium hyaluronate) 10 mg/ml.
- Mannitol.
- Sterile buffered aqueous vehicle suitable for intradermal injection.
Formulation
- Sterile, apyrogenic, visco-elastic injectable gel.
- Non-crosslinked hyaluronic acid combined with highly purified polynucleotides (PN-HPT) and mannitol.
- Intended for intradermal and mucosal-adjacent injection in genital and perigenital tissues by qualified clinicians.
- Supplied ready to use in a pre-filled 2 ml syringe.
Packaging
- One 2 ml pre-filled sterile syringe of Mastelli NEW Gyn per box.
- Supplied with two 30G ½ disposable needles.
- Tamper-evident sterile blister and outer carton with product, batch and expiry information.
- Class III medical device labelling in line with Mastelli PN-HPT range.
Usage
- For intradermal use only and exclusively by qualified medical professionals experienced in aesthetic gynaecology injections.
- Recommended injection depth: intradermal in the indicated genital area skin and mucosa-adjacent tissues.
- Injection techniques: microdroplet, linear or fan technique, according to the anatomical area and clinical judgement.
- Typical protocol: one session every 14–21 days for a total of 3 to 4 sessions.
- Assess tissue response after the initial course; maintenance sessions may be scheduled at the clinician’s discretion.
- Use aseptic technique throughout the procedure. Do not reuse syringes or needles; single use only.
- After treatment, advise the patient to avoid friction, heat (saunas, hot baths), sexual activity and intense physical exercise in the treated area for a period defined by the clinician, and to follow all post-procedure care instructions.
Contraindications
- Known hypersensitivity or allergy to hyaluronic acid, polynucleotides, mannitol or any component of the formulation.
- Active infection, inflammation, lesions or dermatological disease in the intended treatment area (including genital infections or ulcerations).
- Systemic infections or febrile illness at the time of treatment.
- Autoimmune diseases or severe immunosuppression, unless the treating physician considers treatment appropriate and safe.
- Pregnancy and breastfeeding, as a precaution in line with common practice for aesthetic injectables.
- History of severe allergic reactions or anaphylaxis to injectable biomaterials.
- Any other condition that the treating physician judges to be incompatible with intradermal polynucleotide and hyaluronic acid injection.
Adverse Effects
- Transient erythema, swelling and tenderness at injection sites in the genital area.
- Small intradermal papules or nodules immediately after injection, usually resolving within a few days.
- Bruising or haematoma at injection sites.
- Temporary discomfort or sensitivity in the treated area.
- As with any injectable procedure, there is a risk of infection, local inflammatory reaction, or delayed hypersensitivity, though reported events with PN-HPT products are generally mild and transient.
- Very rare risk of more significant complications associated with improper injection technique or failure to follow aseptic procedures.
Storage Conditions
- Store at controlled room temperature according to the temperature range stated on the packaging (commonly between 2 °C and 25 °C).
- Keep the syringe in its original packaging until use to maintain sterility and protect from light.
- Do not freeze. Avoid exposure to excessive heat or direct sunlight.
- Do not use after the expiry date or if the packaging is damaged or opened.
- Single-use device: discard any unused product and all used needles and syringes in accordance with local regulations for clinical sharps waste.
Duration
Initial treatment course generally consists of 3 to 4 sessions performed every 14\u201321 days, with further maintenance sessions scheduled according to clinical assessment and patient needs.
Onset
Improvement in tissue hydration and comfort can be noticed in the weeks following the first sessions, with more marked enhancement of turgor and trophism typically observed after completion of the 3\u20134 session protocol.
