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Title Third-round FDA Marketing Clearance of its ZILOS-tk? Zona Laser Drill by Hamilton Thorne Biosciences
Name Admin Date 07-08-06 15:04
May 15, 2007 ( Beverly , MA ) Hamilton Thorne Biosciences reported today that it has received third-round FDA marketing clearance for additional clinical applications for its ZILOS-tk? zona laser drill. The ZILOS-tk? is now the only non-contact laser device to be awarded marketing clearance for zona-pellucida drilling for blastomere biopsy and trophectoderm biopsy of human embryos in clinical applications. The ZILOS-tk was the first laser granted clearance for laser-assisted hatching of human embryos.

Both blastomere biopsy and trophectoderm biopsy are used in the practice of preimplantation genetic diagnosis (PGD), which determines the genetic composition of the embryo and ascertains whether it carries any disease-producing mutations. One or more embryos free of conditions that would cause serious disease may then be implanted in a woman's uterus.

“We are very pleased to offer IVF clinics the first laser system granted clearance for these two methods of clinical embryo biopsy,” said Meg Hamilton, CEO of Hamilton Thorne Biosciences, Inc. “Research has shown the ZILOS-tk? to be beneficial to the IVF clinic in terms of embryo safety, procedure speed, and simplification of the embryo biopsy process. We anticipate wide acceptance of the ZILOS-tk? as a standard technique for blastomere biopsy and trophectoderm biopsy throughout U.S. clinics.”

Laser-assisted biopsy with the ZILOS-tk? uses a highly focused laser beam to remove the zona pellucida in very precise increments. Prior to this, only mechanical or chemical methods could be used. Laser-assisted biopsy requires less handling of the embryo than these other biopsy methods. Also, laser-assisted biopsy is faster than the other methods and, therefore, the embryo spends less time outside the incubator.

The clearance of the ZILOS-tk ? provides the clinical embryologist with a welcome alternative for performing embryo biopsy. “The ZILOS-tk? Laser, as shown in our studies, both improves speed and consistency of operator technique during the embryo biopsy procedure, and improves clinical outcomes in terms of better embryo development post-biopsy and ultimately has improved implantation rates,” remarked Michael Tucker, Ph.D., Scientific Director, Georgia Reproductive Specialists ( www.ivf.com ) and IVF Lab Director, Shady Grove Fertility RCS, Rockville, MD ( www.shadygrovefertility.com ). Dr. Tucker has received world-wide recognition for his pioneering work in the IVF technologies that have helped to revolutionize the treatment of infertility. In 1992, he helped to advance the ICSI technique and was responsible for the first “ICSI baby” born in the US . In 1997, he led the team that was successful in achieving the first pregnancy and birth using cryopreserved eggs.

Hamilton Thorne Biosciences ( www.hamiltonthorne.com ) is a private, Beverly, Mass.-based technology company that supplies computer-based solutions to the infertility, drug discovery, and animal production markets.