Plinest Hair 1 x 2ml

Plinest

Injectable hair biostimulator

Polynucleotide hair and scalp mesotherapy

Class III CE Marked 0373 medical device within the PN HPT® polynucleotide range used in Plinest and Newest products.
Manufactured by Mastelli S.r.l. under ISO 13485 Certified medical device quality management system and in compliance with EU MDR 2017/745.
CE Marked and listed by multiple European distributors as a CE Certified, traceable injectable medical device.

Class III CE Marked 0373 medical device within the PN HPT® polynucleotide range used in Plinest and Newest products.
Manufactured by Mastelli S.r.l. under ISO 13485 Certified medical device quality management system and in compliance with EU MDR 2017/745.
CE Marked and listed by multiple European distributors as a CE Certified, traceable injectable medical device.

Polynucleotide hair and scalp mesotherapy

Description

Plinest Hair 1 x 2ml is a polynucleotide-based injectable gel (PN-HPT® – Polynucleotide High Purification Technology) specifically designed for trophic action on the hair, eyebrows and beard. It contains highly purified polymerised polynucleotides at 7.5 mg/ml in a 2 ml pre-filled syringe and is used intradermally to stimulate fibroblasts, encourage cell turnover, improve elasticity, enhance extracellular matrix synthesis and hydrate the scalp and hair-bearing skin. By regenerating hair follicles and improving scalp quality, Plinest Hair helps reduce hair loss, support new hair growth and improve hair density, strength and overall appearance in both men and women experiencing thinning or hormonally driven hair loss.

Bnefits

Polynucleotide-based injectable gel (PN-HPT® 7.5 mg/ml) for hair, eyebrows and beard trophic support.
Promotes fibroblast activation, encouraging cell turnover and dermal regeneration.
Enhances protein production and extracellular matrix (ECM) synthesis, improving skin elasticity and structure.
Helps improve hair and scalp quality, including density, strength and overall appearance.
Supports regeneration of hair follicles and can reduce hair loss in androgenic and hormonal alopecia.
Provides deep hydration to the scalp, contributing to healthier hair growth and improved comfort.
Promotes bio-regeneration with powerful wound-healing and anti-inflammatory polymers.
Non-volumising biostimulator that can be used as an alternative or adjunct to hair transplant and other hair-restoration therapies.

Indications

Trophic action on hair, eyebrows and beard.
Improvement of scalp condition and hair quality in men and women.
Supportive treatment for hair thinning, shedding and early androgenic or hormonal alopecia.
Adjunctive therapy after trichological surgery or hair transplant procedures.
Enhancement of hair density, strength and shine, and improvement of scalp elasticity and hydration.

Composition

Polynucleotides (PN-HPT®) 7.5 mg/ml (0.75%): highly purified polymerised DNA fragments of fish origin.
Aqua (water).
Sodium chloride.
Sodium phosphate.
Disodium phosphate.

Formulation

Sterile, non-pyrogenic, viscoelastic injectable gel based on highly purified polymerised polynucleotides (PN-HPT®).
Concentration: 7.5 mg/ml PN-HPT® (15 mg polynucleotides per 2 ml syringe).
Intradermal mesotherapy / biorevitalisation product for hair-bearing areas (scalp, eyebrows, beard).
Class III CE-marked polynucleotide medical device for professional use only.

Packaging

1 x 2 ml pre-filled syringe of Plinest Hair gel.
2 x 30G 1/2" (13 mm) sterile disposable needles included in each box.
Single-use sterile blister and outer carton packaging.

Usage

For intradermal use only by appropriately trained and certified healthcare professionals.
Cleanse and disinfect the treatment area (scalp, eyebrows or beard region) according to standard aseptic protocols.
Injection depth: intradermal.
Injection technique: microdroplet technique with intradermal infiltrations of approximately 0.2 ml for each droplet, or microdroplet/linear retrograde technique using the full 2 ml per session as per protocol.
Distribute the product evenly across the treatment area, avoiding intravascular injection and respecting relevant anatomical structures.
Suggested protocol: Phase I – one session every 7–14 days for 4 sessions; Phase II – one session every 21–30 days for a further 4 sessions. Total of 8 sessions, then maintenance as clinically indicated.
Plinest Hair can be used alone or combined with other hair-restoration treatments (e.g. PRP, mesotherapy, topical therapies) according to practitioner judgement.
After treatment, advise the patient to avoid harsh chemical treatments, excessive heat or sun exposure on the treated area for a short period and to follow any additional aftercare instructions provided by the clinic.
Dispose of the syringe, needles and any unused product immediately after use in approved sharps and clinical waste containers; do not reuse or resterilise.

Contraindications

Known hypersensitivity or allergy to fish-derived products, polynucleotides or any component of the formulation.
Active infection, inflammation, dermatitis or other dermatological disease at or near the intended injection site.
Severe systemic illness, uncontrolled autoimmune disease or coagulation disorders where injectable aesthetic procedures are contraindicated unless the risk–benefit has been carefully evaluated.
History of severe hypertrophic scarring or keloid formation at or near the treatment area.
Pregnancy or breastfeeding, and patients under 18 years of age, due to insufficient safety data.
Use by non-medical personnel or self-administration.

Adverse Effects

Typical injection-related reactions such as transient redness, swelling, tenderness, bruising or mild pain at injection sites.
Temporary papules or small nodules at microdroplet injection points, usually resolving spontaneously within a few days.
Occasional itching, warmth or mild discomfort in the treated area.
As with other intradermal injectables, there is a potential risk of infection or prolonged local inflammatory reaction if aseptic technique is not strictly observed.
Very rare but serious complications associated with intradermal injections, such as vascular compromise or tissue necrosis, may occur if product is inadvertently injected intravascularly or if incorrect technique is used.

Storage Conditions

Store between 2°C and 25°C in a cool, dry place.
Do not freeze.
Keep protected from direct light and excessive heat.
Store in the original packaging until use to maintain sterility and product integrity.
Do not use after the expiry date or if the packaging, syringe or sterility seal is damaged.

Duration

Clinical and distributor data indicate that results typically develop over the initial course of 8 sessions (two phases over several weeks), with visible improvement often noted after the first 4 sessions; benefits in hair density and scalp quality may last approximately 6\u201312 months, after which periodic maintenance sessions are recommended based on individual response and degree of hair loss.

Onset

Improvement in scalp hydration and comfort may be noticeable within weeks, with visible changes in hair quality, reduced shedding and early signs of regrowth generally emerging after several sessions (commonly after the initial 4-treatment phase) and continuing to progress throughout the full 8-session protocol.