Polynucleotide-based biorevitalizing gel for vulvo-vaginal area
Certifications
Class III CE0373 medical device for intradermal infiltration of the vulvo Vaginal area, as indicated in manufacturer and clinical documentation.
Manufactured in Italy by Mastelli S.r.l., a company specialising in PN HPT® Based medical devices and operating under European medical device regulatory frameworks.
Part of Mastelli’s Aesthetic Medicine & Dermocosmetics line, which follows quality management systems consistent with ISO 13485 for medical devices (as stated in corporate and product literature).
Class III CE0373 medical device for intradermal infiltration of the vulvo Vaginal area, as indicated in manufacturer and clinical documentation.
Manufactured in Italy by Mastelli S.r.l., a company specialising in PN HPT® Based medical devices and operating under European medical device regulatory frameworks.
Part of Mastelli’s Aesthetic Medicine & Dermocosmetics line, which follows quality management systems consistent with ISO 13485 for medical devices (as stated in corporate and product literature).
Subject to post Market surveillance, risk management and traceability requirements applicable to Class III medical devices in the EU and other markets recognising CE certification.
Description
NewGyn® is a Class III CE0373 viscoelastic intradermal gel developed by Mastelli for the regeneration and revitalization of the female intimate area. The formulation combines highly purified polynucleotides (PN-HPT®) at 10 mg/ml with non-cross-linked hyaluronic acid at 10 mg/ml and mannitol as an antioxidant stabiliser. Supplied in a 2 ml pre-filled sterile syringe with two 30G ½ needles, NewGyn is designed to treat symptoms related to vulvo-vaginal atrophy such as vaginal dryness, itchiness, vulvar pain, dyspareunia and loss of elasticity. By stimulating fibroblast activity, enhancing extracellular matrix synthesis, and improving hydration and microcirculation, it supports bio-regeneration, improved tissue tone and increased comfort in the vulvo-vaginal area.
Bnefits
Addresses key symptoms of vulvo-vaginal atrophy including dryness, itchiness, soreness, vulvar pain, dyspareunia and loss of elasticity.
Enhances turgor and trophism of the skin layers and genital mucosa, improving tone and firmness of the vulvo-vaginal tissues.
PN-HPT® polynucleotides promote fibroblast activation, collagen and extracellular matrix synthesis, and cellular regeneration.
Non-cross-linked hyaluronic acid provides deep hydration, improving moisture balance and comfort in the intimate area.
Mannitol helps protect hyaluronic acid from enzymatic and oxidative degradation, prolonging its hydrating effect.
Improves overall tissue quality, radiance and freshness, supporting vulvar and labial rejuvenation.
Non-surgical, minimally invasive injectable protocol that can be performed in an outpatient setting with little or no downtime.
Class III CE-marked medical device from an established Italian manufacturer with long-standing expertise in PN-HPT® technology.
Indications
Vaginal dryness associated with hormonal changes, menopause, postpartum status or other causes of vulvo-vaginal atrophy.
Itchiness, irritation and discomfort in the vulvar and vestibular areas.
Vulvar pain and soreness related to atrophic changes in the labia and surrounding tissues.
Dyspareunia (pain during sexual intercourse) where symptoms are associated with vulvo-vaginal atrophy and dryness.
Subject to post Market surveillance, risk management and traceability requirements applicable to Class III medical devices in the EU and other markets recognising CE certification.
Polynucleotide-based biorevitalizing gel for vulvo-vaginal area
Loss of elasticity, tone and trophism of the vulvar and labial tissues.
General vulvo-vaginal and labia majora rejuvenation, including cosmetic and functional improvement of intimate skin and mucosae.
Supportive bio-regenerative treatment after gynaecological procedures, childbirth or age-related changes, at the clinician’s discretion.
Composition
Polynucleotides HPT® (PN-HPT®) 10 mg/ml – highly purified, fish-derived polynucleotides obtained with Mastelli’s High Purification Technology.
Non-cross-linked hyaluronic acid 10 mg/ml (HA 1000–1500 kDa range reported in clinical literature).
Mannitol (approx. 220 mM as reported in clinical publications) acting as an antioxidant and inhibitor of HA enzymatic and oxidative degradation.
Isotonic, viscoelastic aqueous gel excipients suitable for intradermal infiltration.
Sterile, apyrogenic gel in a pre-filled 2 ml single-use syringe.
Formulation
Isotonic, viscoelastic intradermal gel combining PN-HPT®, non-cross-linked hyaluronic acid and mannitol.
Sterile, single-use, apyrogenic 2 ml pre-filled syringe designed for intradermal injections in the female genital area.
Class III CE0373 medical device intended for bio-revitalizing intradermal infiltration of the vulvo-vaginal region.
Colourless to slightly opalescent gel with rheological properties suitable for microdroplet and linear intradermal techniques.
Packaging
Box containing 1 x 2 ml pre-filled sterile syringe of NewGyn®.
Includes 2 x 30G ½ (13 mm) needles for intradermal injection (luer lock).
Primary packaging labelled with product name, batch number, expiry date, CE0373 marking and Mastelli manufacturer details.
Supplied as a Class III medical device for professional use only, often within the broader Mastelli PN-HPT® aesthetic gynaecology portfolio.
Usage
For intradermal use only by appropriately trained and authorised healthcare professionals experienced in intimate aesthetic and gynaecological injections.
Indicated treatment area is the female genital region (e.g., vulva, labia majora and vestibular area) as defined in the clinical protocol.
Prepare the treatment area using appropriate cleansing and antiseptic measures in accordance with local infection-control guidelines.
Attach one of the supplied 30G ½ needles securely to the pre-filled syringe, ensuring a firm luer lock connection.
Injection depth: intradermal, targeting the superficial tissue layers of the vulvo-vaginal area.
Injection techniques: microdroplet, linear threading or fan technique, according to the manufacturer’s guidance and clinician’s experience.
Protocol: administer every 14–21 days for a course of 3 to 4 treatment sessions; some clinical studies have used 5-session protocols at 15-day intervals, with maintenance sessions determined by clinical judgement.
Monitor the patient for tolerance and immediate adverse reactions during and after injection; adjust injection volume and distribution based on anatomy and symptom severity.
After treatment, provide post-procedure advice, including avoiding sexual intercourse, intense friction, hot baths, swimming pools, or saunas for a period recommended by the clinician, and monitoring for any signs of infection or unusual discomfort.
Do not mix NewGyn® in the same syringe with other products or drugs; do not inject intravascularly, into mucous membranes, or into areas with active infection or lesions.
Always refer to the official instructions for use (IFU) supplied with the product and adhere to local regulations and professional guidelines.
Contraindications
Known hypersensitivity or allergy to polynucleotides (including fish-derived components), hyaluronic acid, mannitol or any excipients in the formulation.
Active local infection, inflammation, dermatologic disease or ulceration in the intended treatment area (e.g., vulvovaginal infections, herpes lesions, dermatoses).
Current or recent sexually transmitted infections or untreated genitourinary conditions where injections could exacerbate disease or spread infection.
Pregnancy and breastfeeding, due to lack of adequate safety data in these populations.
History of severe allergic reactions, anaphylaxis or multiple drug hypersensitivities where the risk of injectable medical devices is considered unacceptable by the clinician.
Presence of malignancy or premalignant lesions in the genital area, or ongoing oncologic treatments in the region, unless explicitly cleared by the responsible specialist.
Use in patients for whom intimate injectable procedures are contraindicated according to local guidelines or the treating physician’s risk assessment (e.g., significant bleeding disorders or uncontrolled systemic disease).
Adverse Effects
Transient local reactions at injection sites such as redness (erythema), swelling, mild pain or burning, tenderness, itching, warmth or pressure sensation.
Small ecchymoses (bruising), haematoma, or local oedema in the treated areas, usually resolving spontaneously within days.
Palpable nodules, induration or mild irregularities that generally diminish as the product integrates into the tissues; persistent issues may require clinical assessment.
Less common events may include prolonged swelling, inflammatory reactions or hypersensitivity responses, which should be evaluated and managed by the treating clinician.
As with any intradermal injection, there is a risk of infection, abscess formation or delayed wound healing if aseptic technique is not strictly observed.
Very rare but possible complications related to intimate injectable procedures, such as vascular compromise or neuropathic pain, although these are not specifically reported as common with NewGyn®.
Any unexpected or severe adverse event should be documented and reported in line with local pharmacovigilance and medical device reporting requirements.
Storage Conditions
Store in accordance with the conditions stated on the product packaging, typically at controlled room temperature in a cool, dry place.
Protect from direct sunlight, excessive heat and moisture; avoid temperature extremes during transport and storage.
Do not freeze the product and do not expose it to temperatures outside the recommended range for prolonged periods.
Keep the syringe in its original blister and outer carton until use to maintain sterility and protect from physical damage.
Do not use after the expiry date printed on the packaging or if the packaging, blister or syringe appears damaged or compromised.
Keep out of reach of children and unauthorised users; product is intended for professional use only.
Duration
The recommended initial regimen is a course of 3 to 4 intradermal sessions performed every 14\u201321 days. Clinical studies using the same PN-HPT\u00ae / HA / mannitol formulation for vulvar rejuvenation have employed 5-session cycles at 15-day intervals with benefits observed over several months. Long-term maintenance (e.g., periodic booster sessions) is determined individually by the treating clinician based on symptom recurrence and tissue response.
Onset
Patients may experience early improvements in hydration, comfort and lubrication within the first treatment sessions, with progressive enhancement of tissue elasticity, tone and pain relief over the course of the protocol as fibroblast activation and extracellular matrix remodelling occur. Full benefits are generally evaluated in the weeks following completion of the treatment cycle.
