Vitrolife receives FDA marketing approval of new products for the fastest growing market segments in ART (Assisted Repro

The American Food and Drug Administration (FDA) has given Vitrolife market clearance, 510(k), for G-FreezeKit Blast™, G-ThawKit Blast™, G-PGD™, and G-OOCYTE™. Cryopreservation of blastocysts and preimplantation genetic diagnosis (PGD) are both rapidly increasing infertility treatment procedures with high market potential and clear patient benefits. G-FreezeKit Blast™ and G-ThawKit Blast™ are used for cryopreservation of human blastocysts, which could save women from multiple ovarian stimulation procedures and provide better pregnancy opportunities. Furthermore, cryopreservation of embryos using the GIII Series™ makes consecutive single embryo transfers possible thereby avoiding the risks associated with multiple pregnancies while maintaining good pregnancy rates. G-PGD™ is developed to facilitate embryo biopsies. G-OOCYTE™ is used for handling of human eggs during intracytoplasmic sperm injection (ICSI). Both have new physiological compositions minimizing embryo stress from the environment. The new products were developed in close collaboration with Dr. David K. Gardner and his research team at the Colorado Center for Reproductive Medicine. “These new products represent a breakthrough as they help minimize embryo stress during ART procedures and we are happy to be able to offer these products to the clinics and patients in the USA”, says Dr. Magnus Nilsson, President of Vitrolife. “As there is an imminent need to reduce multiple pregnancies after IVF while maintaining effective infertility therapy, our new products address this need and offer real benefits to the patients”, says Mr. Tony Winslöf, Marketing Director of Vitrolife. New date for the six months report The report previously announced for the 27th of August, 2004 will now be announced on the 17th of August, 2004. Gothenburg, June 8, 2004. Vitrolife AB (publ) For further information, please contact; CEO: Dr. Magnus Nilsson Tel: +46 31 721 80 00 Mobile +46 708 22 80 61 mnilsson@vitrolife.com Acting Marketing Director Tony Winslöf Tel: +46 31 721 80 00 Mobile +46 708 22 80 15 twinslof@vitrolife.com

About Us

Vitrolife is an international medical device Group. The Fertility product area develops, produces and markets medical devices for assisted reproduction. Work is also carried out to enable the use and handling of stem cells for therapeutic purposes. Vitrolife has approximately 330 employees and the company’s products are sold in about 110 markets. The company is headquartered in Gothenburg, Sweden, and there are also offices in USA, Australia, France, Italy, United Kingdom, China, Japan, Hungary and Denmark. The Vitrolife share is listed on NASDAQ OMX Stockholm, Mid Cap.

Subscribe

Documents & Links