A British biomedical company, InterCytex, says it is aiming to bring its anti-aging and scar repairing product Vavelta to the US market.
The product is already available from accredited clinics in the UK through an injection process, but the company says it is now well under way with the process of getting it approved by the US FDA.
But besides the FDA, the company will also have to face the challenge of convincing potential consumers that injections containing a substance derived from collagen cells from babies’ foreskin could prove a beneficial part of their beauty regime.
The foreskins are evidently donated with the approval of mother’s whose babies have just been circumsized, the basic idea being that the developing collagen derived from the skin samples can be used to encourage the growth of new collagen, rather than just replacing it.
A permanant approach
In fact, the strength of this is that instead of being a temporary treatment, the effects of the injections are permanent – an advantage that puts it well ahead of other injectable anti-aging treatments, the company claims.
It works because the formulation used in the injections relies on tiny skin cells known as fibroblasts that rejuvenate and revitalize damaged skin by repopulating areas where skin cells have been damaged.
Those fibroblasts are formulated as a suspension - what the company terms Human Dermal Fibroblasts (HDFs) - that are packaged in 1ml cell storage mediums for the injection process.
The company says that the injection process is carried out using a fine gauge needle and is minimally invasive.
Like Botox, the treatment is targeted as the injections are concentrated in areas where the most damage has occurred: around the eyes, forehead and mouth in the case of photoaging damage, and anywhere on the face or body in the case of scar or burn damage.
But one of the drawbacks for this treatment is the limited availability of this type of HDFs, which invariably pushes the price of the treatment up significantly. It is approximately double the cost of a similar Botox injection treatment.
However, the company says that the treatment is not likely to be made available in the US any time soon, as the US FDA validation process could take up to four years to be finalized.