BioXcell Receives CE Mark For Device That Allows Conception And Embryo Development To Take Place Inside The Woman's Body

Beverly, MA - BioXcell, 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."

SOURCE: BioXcell