We are pleased with the results of the CosmetaLife trials. As expected, they show our product compares more favorably to Restylane for the first three months and equally to Restylane at the 12-month mark. We are eager to complete the next steps with the FDA.
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St. Paul, Minn. (Vocus) July 24, 2008
Gel-Del Technologies, a St. Paul, Minnesota based biomedical device company announced that it has concluded clinical trials of CosmetaLife, a dermal filler injection that company officials say holds potential to be a more effective alternative to currently available treatments for deep lines and wrinkles that activates a more natural skin correction.
The company began clinical trials of CosmetaLife, a gel-particle product for injection to correct wrinkles, at six U.S. sites in 2006. The company hopes to introduce the product to the rapidly growing $1 billion cosmetic augmentation market in 2009.
David B. Masters, Ph.D., Gel-Del Technologies founder and president, is the inventor of the technology and its related products. Masters said, "It is exciting to see the first human use of this technology over the past 19 months. Based on the results of our 12 month clinical study, CosmetaLife provides a better early performance than hyaluronic acid products, and a lasting effect expected to persist longer due to an actual dermal correction."
Masters continued, "We are pleased with the results of the CosmetaLife trials. As expected, they show our product compares more favorably to Restylane for the first three months and equally to Restylane at the 12-month mark. We are eager to complete the next steps with the FDA."
The proprietary technology used to produce CosmetaLife is covered by 9 U.S. and 26 foreign patents and patent applications. The material is also being developed for fine-line wrinkles and lips, blood vessel grafts, cardiovascular stent coatings, cellular/bone scaffolds, fillers and drug delivery with other uses planned.
"CosmetaLife is just the first in a line of many other important medical applications," said Masters. The company has already been awarded three National Institutes of Health grants to assist it in developing drug delivery devices and artificial blood vessel grafts, based on the same platform technology.
About Gel-Del Technologies
Gel-Del Technologies (http://www.gel-del.com) is a biomedical device company that makes biomaterial products that mimic the body's tissue using revolutionary and patented protein-based fabrication techniques. David Masters, Ph.D., is the Chief Technology Officer and President of Gel-Del and is the inventor of Gel-Del's technology.
Dr. Masters is internationally recognized as an expert in biomaterials and local drug delivery. Over the past 16 years he has developed several medical products, including implantable medical devices for drug delivery, neurologic, vascular and dermal applications. Dr. Masters received his B.A. in Biochemistry and Biopsychology with Scholar Distinction, a Master's Degree in Chemistry, and a Ph.D. in 1992 in Behavioral and Neural Sciences at Rutgers University, including two awards for excellence in research. He then became a fellow and Instructor at Harvard Medical School Department of Anesthesiology, then Associate Consultant at The Mayo Clinic, Rochester, Minn., and faculty at the University of Minnesota.
davide @ ewald.com
1000 Westgate Drive
St. Paul MN 55114
dmasters @ gel-del.com