Cell Robotics can begin marketing In Vitro Fertilization Workstation to European Community.ALBUQUERQUE, N.M.--(BW HealthWire)--Feb. 26, 1997--Cell Robotics International Inc. (OTC:CRII CRII - Cooperative Research in Information Infrastructure) announced it has received confirmation that it can begin marketing its In Vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro (  n v Fertilization external fertilization union of the gametes outside the bodies of the originating organisms, as in most fish. internal fertilization union of the gametes inside the body of the female, the sperm having been transferred from the body of the male by an accessory sex organ or other means. Workstation in the European Community European Community: see European Union.. According to a Notified Body, the In Vitro Fertilization in vitro fertilization (vē`trō, vĭ`trō), technique for conception of a human embryo outside the mother's body. Several ova, or eggs, are removed from the mother's body and placed in special laboratory culture dishes (Petri dishes); sperm from the father are then added, or in many cases a sperm is injected directly into Workstation developed by CRII will not be classified as a medical device by the European Community. The Workstation will fall under general requirements as an electronic and laser device. This classification will allow the company to begin marketing the product in the European Community more quickly than previously anticipated. The Workstation is a computer-controlled instrument designed to offer in vitro fertilization clinics unprecedented control in the examination and manipulation of embryos. The In Vitro Fertilization Workstation will provide diagnostic capabilities previously unavailable for embryo evaluation and manipulation. In addition to providing the capability to inject sperm into the egg (ICSI ICSI - I Can't Stand It ICSI - Imperfect Channel State Information ICSI - Institut Canadien de la Santé Infantile (Canadian Institute of Child Health) ICSI - Institute for Clinical Systems Improvement ICSI - Institute for Clinical Systems Integration ICSI - Institute of Company Secretaries of India ICSI - Integrated Circuit Solution Incorporation ICSI - Interdepartmental Committee on Security and Intelligence (Canada)), the Workstation will also introduce laser-assisted hatching, a revolutionary technique used to improve pregnancy rates. In Austria, Dr. Wilfried Feichtinger, a member of CRI's board of technical advisors, applied laser-assisted hatching of an embryo's outer shell that resulted in a success rate almost three times greater than that achieved with other conventional techniques. "Currently there are quite varied success rates among in vitro fertilization clinics. I believe that the In Vitro Fertilization Workstation provides technology that will result in better and more uniform success rates. Our instrument will offer ease-of-use and time savings to the physician. Any unsuccessful IVF attempt is devastating to the couple. It is our hope that by introducing precise technology, we will reduce both the emotional and financial costs to couples," said Dr. Ronald Lohrding, president and chief executive officer of Cell Robotics. The In Vitro Fertilization Workstation is currently under review by the FDA for an investigational device exception (IDE). If the IDE application is approved, the company will begin a clinical trial of the device at five in vitro fertilization clinics (one in Europe, one in Israel and three in the United States). The clinical trial will be a major step in bringing the complete product to market in the United States. Cell Robotics International Inc. develops, manufactures and markets several proprietary medical and research laser devices and associated products with application niches in large markets. These devices include the Lasette that uses a laser to sample blood for glucose measurements and an Erbium skin resurfacing laser. Additional information is available on the Cell Robotics Web Site at http://www.cellrobotics.com/cell, by e-mail at crii@cellrobotics.com, or by telephone at 505/343-1131. CONTACT: Craig Rogers, 719/590-1793 |
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