NewGyn (1 x 2ml)
NewGyn
Intimate injectablePolynucleotide and hyaluronic acid gel for vulvo-vaginal area
Certifications
- Class III CE Marked medical device for intradermal infiltration in the vulvo Vaginal area.
- Manufactured by Mastelli S.r.l. under quality management systems compliant with European medical device regulations, including ISO 13485 for medical devices.
- Listed within Mastelli’s Aesthetic Medicine & Dermocosmetics PN HPT® portfolio as a gel containing Polynucleotides HPT, Hyaluronic Acid and Mannitol for intradermal infiltrations in a 2 ml pre Filled syringe.
- Subject to clinical evaluation, risk management and post Market surveillance in accordance with applicable EU and regional medical device legislation.
- Class III CE Marked medical device for intradermal infiltration in the vulvo Vaginal area.
- Manufactured by Mastelli S.r.l. under quality management systems compliant with European medical device regulations, including ISO 13485 for medical devices.
- Listed within Mastelli’s Aesthetic Medicine & Dermocosmetics PN HPT® portfolio as a gel containing Polynucleotides HPT, Hyaluronic Acid and Mannitol for intradermal infiltrations in a 2 ml pre Filled syringe.
- Subject to clinical evaluation, risk management and post Market surveillance in accordance with applicable EU and regional medical device legislation.
Polynucleotide and hyaluronic acid gel for vulvo-vaginal area
Description
NewGyn is a Class III CE-marked, isotonic viscoelastic gel containing PN-HPT® (highly purified polynucleotides), non-cross-linked hyaluronic acid and mannitol, supplied in a 2 ml pre-filled syringe with two 30G ½ needles. Developed by Mastelli for intimate gynaecological and aesthetic use, it is injected intradermally into the vulvo-vaginal and labial tissues to enhance turgor and trophism of the skin layers and genital area mucosae. By promoting tissue regeneration, hydration and improved elasticity, NewGyn is used to address symptoms of vulvo-vaginal atrophy such as dryness, itching, soreness, dyspareunia and loss of tone, as well as for labia and vulvar rejuvenation.
Bnefits
- Enhances turgor and trophism of vulvar and vulvo-vaginal skin and mucosa, improving tone and tissue quality.
- Improves vaginal and vulvar hydration, helping relieve dryness, irritation and soreness in the intimate area.
- Promotes tissue regeneration by stimulating fibroblast activity and supporting collagen and elastin synthesis through PN-HPT®.
- Non-cross-linked hyaluronic acid provides deep, long-lasting hydration and contributes to improved firmness and elasticity.
- Mannitol acts as an antioxidant and protects hyaluronic acid from enzymatic and oxidative degradation, prolonging its activity.
- Reduces symptoms associated with vulvo-vaginal atrophy such as itching, dyspareunia and loss of elasticity.
- Supports labia and vulvar rejuvenation, improving the aesthetic appearance and consistency of intimate tissues.
- Minimally invasive injectable procedure that can be tailored in cycles of sessions with limited downtime.
Indications
- Enhancement of turgor and trophism of skin layers and genital area mucosae in the vulvo-vaginal region.
- Vulvo-vaginal atrophy-related symptoms, including dryness, burning, irritation and discomfort.
- Vulvar pain and dyspareunia associated with atrophic, dehydrated or fragile intimate tissues.
- Itchiness and loss of elasticity in the vulvar and vestibular areas.
- Labia rejuvenation, including improved elasticity and correction of volume/tone deficits following ageing, childbirth or surgery.
- General regeneration and revitalisation of female intimate skin where improved elasticity, hydration and tissue quality are desired, as assessed by a qualified clinician.
Composition
- Polynucleotides HPT (PN-HPT®) 10 mg/ml.
- Non-cross-linked hyaluronic acid 10 mg/ml (HA, typically 1000–1500 kDa molecular weight range as described in clinical literature).
- Mannitol approximately 220 mM/L as an inhibitor of enzymatic and oxidative degradation of hyaluronic acid.
- Isotonic buffered aqueous excipient system suitable for intradermal injection.
- Sterile, apyrogenic viscoelastic gel contained in a 2 ml pre-filled syringe.
Formulation
- Isotonic, viscoelastic intradermal gel combining PN-HPT®, non-cross-linked hyaluronic acid and mannitol.
- Class III CE-marked medical device designed for intradermal infiltrations in the vulvo-vaginal and vulvar area.
- Pre-filled, single-use, sterile, apyrogenic 2 ml syringe dispensed with two 30G ½ (13 mm) needles.
- Formulated to support tissue regeneration, hydration and elasticity in intimate mucosa and skin without creating excessive bulk.
Packaging
- Box containing 1 x 2 ml pre-filled sterile syringe of NewGyn.
- Supplied with 2 x 30G ½ (13 mm) sterile needles for intradermal injection.
- Packaging labelled with 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 medical device status along with Mastelli manufacturer details.
- Includes instructions for use (IFU); intended strictly for professional medical and aesthetic gynaecology use.
Usage
- NewGyn is for intradermal use only and must be administered by qualified healthcare professionals experienced in intimate injectable treatments (e.g., gynaecologists, aesthetic doctors).
- Perform a full medical and gynaecological history and examination, and assess indications (e.g., vulvo-vaginal atrophy symptoms, labia rejuvenation) and contraindications; obtain informed consent.
- Cleanse and disinfect the vulvar and peri-vaginal treatment area in accordance with local infection-control protocols; topical anaesthetic may be used as required.
- Attach one of the supplied 30G ½ needles securely to the pre-filled syringe, ensuring a firm luer-lock connection.
- Injection depth: intradermal, targeting vulvar skin dermis and mucosal lamina propria as per protocol.
- Injection technique: microdroplet, linear or fan technique, distributing small aliquots in the labia majora, vulvar vestibule or other indicated areas according to anatomy and clinical goals.
- Standard aesthetic/gynaecology protocol from suppliers: one treatment every 14–21 days for 3 to 4 sessions; some clinical protocols for vulvar rejuvenation use 3–6 sessions spaced 2–4 weeks apart, with maintenance sessions every 2–6 months depending on symptom severity and response.
- Monitor patient comfort throughout and adjust injection points and depth based on tissue thickness and sensitivity.
- After treatment, gently apply light pressure or cooling if needed; instruct patients to avoid intercourse, intense physical activity, hot baths, swimming pools and use of irritant products in the area for a period recommended by the clinician.
- Do not mix NewGyn with other products in the same syringe and do not inject into blood vessels, active lesions or infected tissue; always follow the official IFU and local clinical guidelines.
Contraindications
- Known hypersensitivity or allergy to polynucleotides (including fish-derived DNA), hyaluronic acid, mannitol or any other component of the product.
- Active vulvo-vaginal or genital infection (bacterial, viral, fungal) or active inflammatory dermatoses in the intended treatment area.
- Untreated sexually transmitted infections or acute genitourinary conditions where injection could exacerbate disease or spread infection.
- History of severe allergic reactions or anaphylaxis where injectable medical devices may pose increased risk.
- Significant bleeding disorders or current use of anticoagulant therapy where intradermal injections may present unacceptable risk in the clinician’s judgement.
- Pregnancy and breastfeeding, due to insufficient safety data in these populations.
- Presence of malignancy or premalignant lesions in the genital area unless explicitly cleared by the responsible specialist.
- Any other contraindications or precautions stated in the official NewGyn instructions for use or relevant local clinical and gynaecological guidelines.
Adverse Effects
- Expected, transient local reactions at injection sites such as redness, swelling, tenderness, pain or burning sensation, itching, warmth and a feeling of pressure or fullness.
- Small bruises (ecchymoses), haematoma and local oedema in the treated vulvar or labial areas, typically resolving spontaneously within days.
- Temporary nodules, induration or palpable irregularities at injection points that usually diminish as the gel integrates into the tissue.
- Occasional prolonged erythema, local inflammatory reactions or heightened sensitivity that may require clinical evaluation and symptomatic management.
- Rare hypersensitivity or allergic reactions to one of the components, potentially requiring medical intervention.
- As with any intradermal injection in intimate areas, there is a risk of infection, abscess formation or delayed wound healing if aseptic technique is not strictly followed.
- Very rare but possible complications related to injections, such as vascular compromise, tissue ischaemia or neuropathic pain if the product is inadvertently deposited too deeply or near critical structures.
- Any unexpected, persistent or severe adverse event should be documented, promptly evaluated and reported 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.
- Do not freeze; protect from extremes of heat or cold and from direct sunlight.
- 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 the product after the expiry date printed on the packaging or if the blister, syringe or security seals are damaged or compromised.
- Store out of reach of children and unauthorised persons; product is intended exclusively for professional use.
Duration
A typical initial course consists of 3\u20134 intradermal sessions performed every 14\u201321 days; some clinical protocols recommend 3\u20136 treatments spaced 2\u20134 weeks apart depending on symptom severity. Clinical and distributor information suggest that results often persist for around 6\u201312 months, after which maintenance sessions can be scheduled according to the patient\u2019s symptoms, age, hormonal status and clinician\u2019s judgement.
Onset
Symptomatic relief (e.g., reduced dryness, irritation and discomfort) and improvement in tissue hydration and softness may be observed within the first few sessions, typically over several weeks. Structural changes in elasticity, turgor and labial appearance evolve progressively during the treatment cycle and in the following months as fibroblast activity, extracellular matrix remodelling and improved microcirculation take effect.
