FDA approves trials for new anti-wrinkle surgery

By Louise Prance

- Last updated on GMT

Related tags Blood

The Food and Drug Administration (FDA) has approved potential
clinical trials on a new surgical treatment for wrinkles,
CosmetaLife, which could rival established treatments such as
Restylane and Botox.

Gel Del Technologies has created the dermal filler injection to create in-roads within the surgical anti-wrinkle market and is aiming to integrate the product fully in the US market by the end of 2008.

The company, a biomedical device company based in Minnesota, has started the clinical trials on the gel particle product at four out of six planned US sites this fall. The company has stated that it is hoping to conclude trials by 2007.

Founder and president of Gel Del Technologies, David B. Masters said "Based on our preclinical studies, it (CosmetaLife) provides a long lasting effect than any other tissue fillers and it provides actual dermal correction".

As the proprietary technology of 8 US and 17 foreign patents used to produce the product are also beneficial to blood vessel grafts, cardiovascular stent coatings and cellular/bone scaffolds, amongst others, the company has plans to diversify its product development.

The company is planning to develop drug delivery devices and artificial blood vessel grafts using the same platform technology as the anti-wrinkle treatment following the approval of three grants by the National Institutes of Health.

Masters said, "CosmetaLife is just the first in a line of many other important medical applications. We are confident that our CosmetaLife trials will be successful in comparison to Restylane. It is exciting to see the first human use of this technology."

The cosmetic augmentation market is growing at a phenomenal rate, currently valued at $1 billion, it is set to grow even further in coming years.

The company states that it is expecting the product to be more beneficial to consumers than current treatments on the market, such as Botox, which started to be used as an anti-wrinkle treatment in the US some ten years ago. Since then it has evolved in to a multi-million dollar category.

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