May 29, 2008 14:57 ET
BioXcell's New INVOcell Receives CE Mark "Declaration of Conformity;" Allows Conception and Embryo Development to Take Place Inside the Woman's Body
BEVERLY, MA--(Marketwire - May 29, 2008) - BioXcell (http://www.bioxcell.com), a medical
device company with a proven and patented technology to revolutionize the
treatment of infertility, announces it has received the CE Mark
"Declaration of Conformity." Requirements for the CE marking are created
by the European Union (EU), but the markings are required throughout
European Economic Area (EEA). In the EEA, the CE Marking is equivalent to
approval by the Food and Drug Administration (FDA) in the U.S.
According to Claude Ranoux, M.D., President and Chief Scientist of
BioXcell, "INVOcell allows conception and embryo development to take place
inside the woman's body, making having a baby simpler and less expensive,
while promoting more involvement by the woman. Our device, the INVOcell,
and the INVO procedure, are less expensive and simpler to perform than
conventional in vitro fertilization."
Dr. Ranoux added, "The INVO procedure uses a lower stimulation approach to
produce eggs for fertilization. Eggs are combined with sperm in the
INVOcell device and placed in the woman's vaginal cavity where it remains
for 3 days. This step eliminates the need for a complex IVF laboratory and
allows the woman's body to provide the nurturing environment in which
conception and early embryo development take place."
Rusty Warren, Ph.D., BioXcell Chief Executive Officer, said, "The INVOcell
device and procedure were developed by Dr. Claude Ranoux. Over 800 cases
using prototype devices have been published in the scientific literature.
The INVOcell is a precisely designed device, manufactured in the U.S. by an
ISO-13485 certified company."
About BioXcell, A Simpler Way To Life
BioXcell's INVOcell will revolutionize the treatment of infertility. The
INVOcell replaces the IVF laboratory and allows conception to take place
naturally inside the woman's body. INVO offers a new fertility treatment
that can be performed successfully in the office of an infertility
specialist. INVO is simple and more effective that IUI and at a lower cost
per pregnancy compared to IVF. Previous worldwide studies (over 800
clinical cases) published in peer-reviewed journals have demonstrated an
efficacy of this procedure to be comparable to conventional IVF. BioXcell
has 5 current patents on the INVOcell device and procedure. The company is
actively pursuing distribution in Europe, Latin America and Asia. BioXcell
products are expected to be available in the United States in 2009 after
FDA approval. Please visit www.bioxcell.com for more information.