PROFHILO® (1 x 2 mL) | IBSA Derma (Italy)

Short Description

The global gold standard in hyaluronic acid bioremodeling, formulated with 3.2% (32 mg/mL) ultrapure Hyaluronic Acid (Total 64 mg / 2 mL) utilizing patented NAHYCO® Thermal Hybrid Technology. By combining 32 mg of High-Molecular-Weight HA with 32 mg of Low-Molecular-Weight HA without synthetic chemical cross-linking agents (100% BDDE-free), PROFHILO® diffuses across interstitial tissue planes via the standardized 5-Point BAP (Bio Aesthetic Points) Technique to trigger multi-level neocollagenesis (Types I, III, IV, and VII) and elastogenesis—counteracting cutaneous laxity, restoring hydration, and improving dermal elasticity for 6 to 9 months.

Detailed Description

PROFHILO® is an advanced, sterile, non-pyrogenic physiological injectable manufactured in Italy by IBSA Farmaceutici / IBSA Derma. Classified as a dermal bioremodeler rather than a traditional volumizing filler or superficial skin booster, Profhilo introduced the concept of bioremodeling—the direct cellular remodeling of lax cutaneous tissue through the biological signaling of hybrid hyaluronic complexes.

The core innovation relies on IBSA’s patented NAHYCO® Hybrid Technology:

• Thermal Hybridization (100% BDDE-Free): Equal parts of High-Molecular-Weight Hyaluronic Acid (H-HA: 1,100–1,400 kDa) and Low-Molecular-Weight Hyaluronic Acid (L-HA: 80–100 kDa) are thermally joined through a proprietary heating and cooling process without chemical cross-linking agents like BDDE or DVS.

• Stable Cooperative Hybrid Complexes (HCC): Thermal processing forms cooperative hydrogen-bonded hybrid complexes, achieving a concentration of 32 mg/mL (64 mg per 2.0 mL pre-filled syringe) while maintaining low dynamic viscosity and high fluid spreadability.

The Multi-Level Bioremodeling Cascade

Upon intradermal deposition, Profhilo provides dual biological action:

1. L-HA Component (Biorevitalizing Action): Slowly dissociates from the hybrid complex to bind cell-surface CD44 receptors on keratinocytes and dermal fibroblasts, stimulating the endogenous production of native hyaluronic acid and restoring deep hydration.

2. H-HA Component (Biostructuring Framework): Forms a stable extracellular hydration scaffold that provides immediate mechanical support to the dermal tissue bed, protecting against rapid enzymatic hyaluronidase degradation.

3. Multi-Type Neocollagenesis & Elastogenesis: In vitro and in vivo studies demonstrate that Profhilo upregulates the synthesis of Type I and Type III collagen in dermal fibroblasts, stimulates Type IV and Type VII collagen within the dermal-epidermal basement membrane, and drives the de novo synthesis of elastin fibers, restoring cutaneous tensile strength without altering natural facial architecture.

Treatment Areas & Indications

• Facial Skin Laxity & Chronological Aging:

  • Mild-to-moderate cutaneous sagging, tissue crepeyness, and reduced skin firmness

  • Loss of dermal elasticity, turgor, and skin bounce in the malar and submalar zones

  • Superficial fine wrinkles, accordion smile lines, and diffuse dermal atrophy

  • Chronically dehydrated, dull, or sun-damaged skin (Glogau Phototypes II–IV)

• Cervical & Submental Rejuvenation (Neck):

  • Horizontal neck rings (“necklace bands”) and generalized platysmal skin crepeyness

  • Dermal thinning and micro-sagging beneath the mandibular line

• Body Skin Laxity & Crepey Areas:

  • Décolletage solar elastosis and sleep-induced cleavage creases

  • Dorsal hand thinning, loss of volume, and dehydration

  • Localized laxity of the inner upper arms (brachia), knees, and periumbilical abdomen

Key Clinical Advantages

• High Total HA Load (64 mg / 2 mL): Delivers 32 mg/mL of pure HA, making it one of the highest-concentration hyaluronic acid injectables available globally.

• 100% Free of Chemical Cross-Linkers (BDDE-Free): Purely physical thermal bonding eliminates synthetic chemical residues, reducing the risk of late-onset immune granulomas, sterile inflammation, or chronic nodules.

• The Standardized 5-Point BAP Technique: Administered through only 5 anatomical points per facial half, minimizing treatment discomfort, bruising, and procedural duration.

• High Interstitial Spreadability: Low dynamic viscosity allows the product to diffuse evenly across anatomical compartments and tissue planes without manual pressure or post-treatment lumping.

• Natural Tissue Remodeling (Zero “Pillow-Face”): Avoids the artificial water-retentive bloating or unnatural volume projection common to traditional cross-linked fillers.

• Short Clinical Downtime: Micro-wheals formed at the BAP points typically absorb and flatten within 12 to 24 hours.

Clinical Administration: The Facial BAP (Bio Aesthetic Points) Technique

The BAP Technique was engineered to maximize product diffusion throughout the malar and submalar areas while avoiding major neurovascular bundles:

BAP Point	Anatomical Landmark	Injection Plane	Delivered Volume	Clinical Action
Point 1	Zygomatic Protrusion: At least 2 cm lateral to the outer canthus of the eye	Deep dermis / Subdermal	0.2 mL	Diffuses over the upper zygomatic arch; supports upper malar skin
Point 2	Nasal Base: Intersection of a line drawn from the nasal ala and the tragus	Deep dermis / Subdermal	0.2 mL	Covers the anterior cheek; softens early medial nasolabial lines
Point 3	Tragus: 1 cm anterior to the inferior margin of the tragus	Deep dermis / Subdermal	0.2 mL	Tightens the lateral pre-auricular vector; smooths accordion lines
Point 4	Chin: Midpoint between the lower lip and chin apex, 1 cm lateral to midline	Deep dermis / Subdermal	0.2 mL	Rejuvenates the mental crease; supports perioral skin quality
Point 5	Mandibular Angle: 1 cm superior to the angle of the mandible (gonion)	Deep dermis / Subdermal	0.2 mL	Sharpens the mandibular border; tightens lateral jawline laxity

• Total Volume Per Session: 1.0 mL per facial side (2.0 mL total syringe).

• Recommended Needle: 29G x 13 mm thin-wall needle (supplied in the kit).

• Injection Angle: 30 to 45 degrees into the deep reticular dermis / immediate subdermal interface; aspirate prior to bolus delivery.

• Standard Treatment Protocol: 2 sessions spaced 30 days (4 weeks) apart. In severe elastosis, a third session can be added at 60 days.

• Maintenance Schedule: 1 session every 6 months to maintain collagen and elastin remodeling.

Technical Specifications

Parameter	Specification
Product Classification	Hyaluronic Acid Bioremodeling Injectable / CE Class III Medical Device
Manufacturer / Origin	IBSA Farmaceutici Italia / IBSA Derma (Lodi, Italy / Lugano, Switzerland)
Proprietary Technology	NAHYCO® Thermal Hybrid Technology
HA Concentration	3.2% (32 mg/mL)
Total HA Load per Syringe	64 mg per 2.0 mL pre-filled syringe (32 mg H-HA + 32 mg L-HA)
Molecular Weight Breakdown	H-HA: 1,100 – 1,400 kDa / L-HA: 80 – 100 kDa
Cross-Linking Status	100% BDDE-Free (Pure thermal stabilization)
Packaging Presentation	1 x 2.0 mL pre-filled sterile glass syringe
Included Needles	2 x 29G (13 mm) thin-wall disposable Terumo needles
Lidocaine Content	Lidocaine-free (compatible with pre-treatment topical numbing cream)
Target Injection Planes	Deep reticular dermis or immediate subdermal junction
Recommended Technique	5-Point BAP Technique (Face) / 10-Point BAP Technique (Neck)
Papule Resolution Time	Typically flattens and absorbs within 12 to 24 hours
Expected Clinical Longevity	6 to 9 months
Storage Instructions	Store between 2°C and 25°C (36°F to 77°F); protect from light and freezing
Regulatory Category	CE-marked Class III Medical Device (CE 0373) / Prescription Only (Rx)

Comparative Benchmark: Bioremodelers vs. Traditional Boosters

Feature	PROFHILO® (Classic)	PROFHILO® STRUCTURA	RESTYLANE® Vital (Galderma)	JALUPRO® Super Hydro
Primary Anatomical Target	Dermis (ECM redensification)	Superficial Fat (SAT lipo-lift)	Mid-to-deep dermis	Deep facial retaining ligaments
HA Technology	NAHYCO Hybrid (BDDE-free)	NAHYCO Hybrid (BDDE-free)	NASHA (BDDE cross-linked)	Linear Non-Cross-Linked Hybrid
Total HA Load	64 mg / 2 mL (32 mg/mL)	90 mg / 2 mL (45 mg/mL)	20 mg / 1 mL (20 mg/mL)	80 mg / 2.5 mL (32 mg/mL)
Additional Actives	Pure Hyaluronic Acid	Pure Hyaluronic Acid	Pure Hyaluronic Acid	7 Amino Acids + 3 Peptides
Application Method	5-Point BAP (29G needle)	Retrograde fanning (25G cannula)	Micro-papules / Meso-injector	6+1 BAP ligament boluses
Primary Clinical Outcome	Skin firmness, elasticity, glow	Adipose remodeling, contour lift	Deep hydration reserve	Retaining ligament tightening
Induction Schedule	2 sessions (4 weeks apart)	2 sessions (4 weeks apart)	3 sessions (4 weeks apart)	2 sessions (4 weeks apart)

Professional Advisory: PROFHILO® is a CE Class III medical device intended strictly for certified aesthetic physicians, dermatologists, and plastic surgeons trained in facial anatomy and deep dermal injection techniques. It must not be injected intravascularly or into deep supraperiosteal bone depots. Injection into the hyper-mobile vermilion lip body or glabella is contraindicated.