Hamilton Thorne Biosciences Announces FDA Marketing Clearance of its ZILOS-tk Zona Laser Drill for Assisted Hatching of Embryos

BEVERLY, Mass.--()--Nov. 9, 2004--Hamilton Thorne Biosciences reported today that it has received FDA marketing clearance for its ZILOS-tk(R) zona laser drill. The ZILOS-tk(R) is the first non-contact laser device to be awarded marketing clearance for laser-assisted hatching of human embryos in clinical applications.

Assisted hatching is used to help the embryo hatch from its protective outer shell, the zona pellucida, and promote implantation in the uterine wall after embryo transfer. Laser-assisted hatching with the ZILOS-tk(R) 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 for assisted hatching of human embryos in clinical settings. Laser-assisted hatching requires less handling of the embryo than these other assisted hatching methods. Also, laser-assisted hatching is faster than the other methods and, therefore, the embryo spends less time outside the incubator.

"We are very pleased to offer IVF clinics the first laser system granted clearance for clinical laser-assisted hatching," said Meg D. Hamilton, CEO of Hamilton Thorne Biosciences, Inc. "Research has shown the ZILOS-tk(R) to be beneficial to the IVF clinic in terms of embryo safety, procedure speed, and simplification of the assisted hatching process. We anticipate wide acceptance of the ZILOS-tk(R) as a standard technique for assisted hatching throughout U.S. clinics."

The clearance of the ZILOS-tk(R) provides the clinical embryologist with a welcome alternative for performing assisted hatching. "The ZILOS-tk(R) system has proven itself to me and my colleagues time and again as the easiest and most effective tool for breaching the zona pellucida. Long-term experience within our labs has shown clearly that it is not only fast and user-friendly, but also "embryo-friendly," 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). Recognized in his field as one of the world's top ten scientists in early human reproduction, Dr. Tucker is widely known and respected for his breakthrough achievements in assisted reproductive technology. Dr. Tucker co-authored 4 research abstracts featuring the ZILOS-tk(R), which were recently presented at the American Association of Reproductive Medicine Annual Meeting in Philadelphia, PA.

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

Contacts

Hamilton Thorne Biosciences, Inc.
Meg D. Hamilton, 800-323-0503
CEO
www.hamiltonthorne.com

Contacts

Hamilton Thorne Biosciences, Inc.
Meg D. Hamilton, 800-323-0503
CEO
www.hamiltonthorne.com