AARHUS, Denmark, July 7 /PRNewswire/ -- Unisense FertiliTech A/S (
http://www.fertilitech.com) announces that the EmbryoScope(TM) Embryo Monitoring
System and EmbryoSlide(TM) tray have received CE approval as class IIa medical
devices for use in IVF. Unisense Fertilitech A/S also received the DS/EN
ISO13485:2003 and AC:2007 quality system certificate for production,
installation and servicing of IVF incubators and related accessories

(Photo: http://www.newscom.com/cgi-bin/prnh/20090706/353010 )

Francesca Bahr, sales manager at Unisense FertiliTech A/S says the CE mark will
allow us to market the instrument to Assisted Reproduction clinics across
Europe, with the goal of improving embryo assessment and to facilitate the goal
of elective single embryo transfer.

During IVF treatment, multiple oocytes are removed from the patient and
fertilized in-vitro. The resulting fertilized eggs are cultured for a period of
2 to 5 days, before the embryologist must select the best potential embryo or
embryos to transfer to the patient. Ideally, a single embryo resulting in a
single pregnancy is optimal as multiple pregnancies present risks to maternal
and fetal health.

A major challenge for the embryologist is determining which embryos have the
best potential to create a single healthy baby.

The EmbryoScope(TM) Monitoring System allows uninterrupted observation of embryo
development in a stable environment. Embryo quality parameters can be assessed
and reviewed without the potentially damaging effects of removing the embryo
from a controlled incubation environment. Retrospective analysis of development
will allow embryologists to identify potentially new parameters for embryo

Mette Munch, Director of regulatory affairs at Unisense FertiliTech A/S says she
will now set her goal on FDA 510K clearance in order to facilitate marketing to
clinics in the United States.

The Announcement of the CE mark coincided with the successful sales launch of
the EmbryoScope(TM) Embryo Monitoring System at the European society of Human
reproduction and Embryology in Amsterdam, June 29.July 1 2009

Unisense Fertilitech A/S is a Danish company which was founded in 2003, as a
daughter company of Unisense A/S. The company develops and manufactures
instruments and analysis solutions to facilitate in-vitro Fertilization. The
company is currently involved in various international research projects
involving embryo selection and analysis, embryo respiration and stem cell

Website URL http://www.fertilitech.com

SOURCE: Unisense Fertilitech A/S

Contact Person: Francesca Bahr, Sales and Marketing Manager, Unisense
FertiliTech A/S, Mobile Phone: +45-40255538, Email Address fab@fertilitech.com