The manufacturing process starts with a simple mixture of 32 mg of high molecular weight HA (1100-1400 kDa) and 32 mg of low molecular weight HA (80-100 kDa). The mixture is then stabilized by the above-mentioned thermal process, which does not use crosslinking agents and consists of an initial high-temperature step followed by a low-temperature step.
The result is a product that promotes both tissue remodeling and repair processes, even when scars have already formed. It also improves skin sagging on the face, neck and body.
PROFHILO® is suitable for the treatment of the face and body, especially for the treatment of the malar-zygomatic and submalar areas. An initial cycle of two treatments 30 days apart is recommended, followed, if necessary, by maintenance treatments every 2 months. However, it is recommended to evaluate the specific PROFHILO® protocol according to the patient's aging level.
The product exhibits unique properties such as high HA concentration (64 mg/2 ml), ideal manageability, optimal tissue diffusion and low viscosity, with fluidity predominating over elasticity (tan delta > 1).
In addition, HyCoCos have a high biocompatibility profile due to several features. First, HyCoCos are prepared by biosynthesis of a natural substrate without further chemical modification; second, their thermally stabilized natural HA has a duration similar to that of a weakly crosslinked gel.
Compared to other native HA formulations, HyCoCos exhibit the potential for more effective global bioremodeling, and the simultaneous presence of high and low molecular weight hyaluronan makes them a medical device that can be used in both aesthetic and regenerative medicine.
As the research shows, the hybrid complex formed from H-HA and L-HA promotes wound healing of human keratinocytes in vitro better than HA alone.
In addition, this particular combination increases the expression levels of type I and type III collagens and elastin.
Finally, HyCoCos have been shown to promote adipogenic differentiation and proliferation of adipose-derived stem cells (ASCs), which could be used to heal local tissue ischemia and scar formation and enhance adipose tissue renewal.
Over the past three years, these in vitro data have been validated and integrated with clinical studies that have confirmed both the efficacy and tolerability of the investigated medical product.
The in vitro and clinical studies have confirmed the innovative properties of the product. Therefore, after three years of marketing, the manufacturer has reviewed the post-marketing safety data to provide a complete and comprehensive description of the product profile.