IBSA PROFHILO BODY

The Profhilo Body kit contains the following products:

- Profhilo Body (medical device)

- Profhilo Figura (cosmetic)

- Profhilo Figura Body Patch (cosmetic)

Profhilo Body - 3ml pre-filled syringe:

Hyaluronic acid (HA) is a polysaccharide naturally present in the body whose primary function is to maintain proper tissue hydration thanks to its intrinsic ability to retain a large amount of water. Sodium hyaluronate is composed of repeating chains of N-acetylglucosamine and sodium glucuronate disaccharide units. It is an essential component of the extracellular matrix in most tissues, including the skin.

PROFHILO BODY consists of a buffered physiological solution of high molecular weight (H-HA) and low molecular weight (L-HA) hyaluronic acid. The H-HA and L-HA used in this product are obtained through bio-fermentation and have not undergone any chemical modification; this characteristic ensures excellent tolerability. Furthermore, thanks to a specific and patented treatment of the solution (NAHYCO Hybrid Technology), the H-HA chains of different molecular weights present in PROFHILO BODY interact with each other, giving PROFHILO BODY unique rheological characteristics that allow for the administration of higher H-HA concentrations without increasing the solution's viscosity. The formula in PROFHILO BODY, based on hyaluronic acid (HA) of varying molecular weights, is based on the Hydrolift Action system, an innovative approach designed to compensate for the physiological decrease in HA in the skin. It restores hydration, elasticity, and firmness by synergistically combining deep hydration with the mechanical lifting action of addressing skin depressions.

INTENDED USE:

PROFHILO BODY is indicated for adults (men and women) for the corrective/plumping action of natural and induced skin depressions.

PROFHILO BODY intervenes in the physiological process of reduced skin hydration, alteration of elastic fibers and collagen in the dermis, and loss of firmness and skin tone. This occurs, for example, in cases of excessive dehydration, weight loss, and aging, accompanied by a loss of endogenous HA. The viscoelastic and hydrating properties of hyaluronic acid (HA), combined with its ability to maintain adequate levels of HA in skin tissues, allow for tissue rehydration and create optimal conditions to prevent and promote tissue remodeling, with a restorative effect on damage related, for example, to the skin healing process. Intradermal administration of PROFHILO BODY thus restores the physiological amount of HA in the treated tissues to achieve a beneficial effect on the skin.

INDICATIONS:

PROFHILO BODY is indicated:

• for the treatment of body tissue remodeling to correct skin laxity.

• in the dermal tissue repair process, in cases of scars resulting from superficial skin trauma (acne scars).

INTENDED POPULATION AND USERS:

PROFHILO BODY is indicated for adults (men and women) and is administered by intradermal injection. PROFHILO BODY may only be injected by a qualified healthcare professional. PROFHILO BODY PRODUCT SOLD BY PRESCRIPTION ONLY.

COMPOSITION:

PROFHILO BODY consists of a pre-filled 3 ml syringe of solution, containing:

HYALURONIC ACID SODIUM SALT: 48 mg (H-HA) + 48 mg (L-HA)

SODIUM CHLORIDE: 24.000 mg

SODIUM PHOSPHATE: 0.615 mg

WATER FOR INJECTION: q.s. 3.0 ml

DOSAGE:

It is recommended to perform an initial cycle of two treatment sessions, spaced 30 days apart, possibly followed by maintenance sessions every 2 months. However, it is suggested that the specific protocol for using PROFHILO BODY be evaluated according to the patient's degree of aging.

AVAILABLE PACKAGING:

PROFHILO BODY is available in a box containing one pre-filled syringe and two 29G x ½” (0.33 x 12 mm) needles, in the following volumes:

- 3 ml pre-filled syringe (48 mg (H-HA) + 48 mg (L-HA) of sodium hyaluronate in 3 ml of buffered sodium chloride solution). The syringe contents are sterile and pyrogen-free. The pre-filled syringe is steam-sterilized.

Profhilo FIGURA - 150 ml airless bottle

Profhilo FIGURA Body Patch - 4 single-use patches