Cell Robotics Launches International Distribution of its In Vitro Fertilization Workstation.ALBUQUERQUE, N.M.--(BW HealthWire)--Sept. 22, 1997--Cell Robotics International, Inc. (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). :CRII CRII Cooperative Research in Information Infrastructure CRII Customer Returns Improvement Initiative ) announced today that it has signed two new distributors in Korea and Brazil for their 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); (IVF IVF in vitro fertilization. IVF abbr. in vitro fertilization IVF 1 In vitro fertilization, see there 2. Intravascular fluid ) Workstation product line. These are the first in a series of distribution agreements that will be signed over the coming months in the Far East, Europe and other countries outside the United States. Shin Han Systek, Seoul, will represent Cell Robotics in Korea and Opto Eletronica S.A. in Sao Carlos will distribute the In vitro Fertilization Workstation in Brazil. The IVF Workstation is a computer-controlled micro-robotic instrument designed to offer in vitro fertilization clinics unprecedented control in the examination, measurement and manipulation of eggs and embryos. This unique instrument will provide diagnostic capabilities previously unavailable. In addition, the Workstation will introduce laser-assisted hatching, a revolutionary technique that uses a laser beam to make a small trench in the shell (or zona pellucida) of an embryo, so that it can successfully hatch and become a healthy fetus after being implanted in the uterus of the patient. In an experiment conducted in Austria, laser-assisted hatching improved IVF pregnancy rates considerably. This technique is particularly important for women in their late 30's and older because the zona is thought to become tougher as women become older. The IVF Workstation will be introduced to the European market at the Medica medica (māˑ·dē·k convention in Dusseldorf, Germany, November 19-22, 1997. Cell Robotics has received confirmation that it could begin marketing and selling the In Vitro Fertilization Workstation in the European Community. According to a notified body, the In vitro Fertilization Workstation is not classified as a medical device by the European Community and falls under general requirements as an electronic and laser device. Furthermore, the IVF Workstation will be exhibited at the American Society of Reproductive Medicine The American Society for Reproductive Medicine (ASRM) is an organization that wants to advance the "art, science, and practice of reproductive medicine" . It provides a forum for lay public, researchers, physicians and affiliated health workers through education, publications, and Meeting, October 18-22 in Cincinnati. In the USA, the IVF Workstation is now considered an Investigational Device by the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). Cell Robotics has received FDA approval of an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) and the company is currently conducting clinical trials at five clinical sites worldwide. In addition to two US sites, Santa Monica, California For other uses, see Santa Monica (disambiguation). Santa Monica is a coastal city in western Los Angeles County, California, USA. Situated on Santa Monica Bay of the Pacific Ocean, it is surrounded by the City of Los Angeles — Pacific Palisades and Brentwood on the north, and Atlanta, Georgia, there are three international sites: Assuta Hospital in Tel Aviv, Israel, Centre for Reproductive Medicine in Brussels, Belgium, and Monash University Institute of Reproduction near Melbourne, Australia. Cell Robotics' study director, Dr. Jerome Conia, stated, "We are honored to work with some of the most renowned physicians and clinics in the field." Dr. Andre van Steirteghem at the Belgium Centre was involved in many new IVF developments: embryo freezing, genetic diagnosis and in 1992 achieved the first birth using the technique of injecting a sperm into the egg. Dr. Alan Trounson in Australia recorded the first baby ever from the following: a frozen embryo, a donor egg, and a sperm retrieval operation. Dr. Trounson stated, "Laser assisted technologies represent a very important advance in the efficiency and safety of delicate micromanipulation micromanipulation /mi·cro·ma·nip·u·la·tion/ (mi?kro-mah-nip?u-la´shun) surgery, injection, or other procedures done with a micromanipulator. mi·cro·ma·nip·u·la·tion n. methods now needed in IVF. The Workstation is a sophisticated instrument that represents a very large increment in reproductive and genetic medicine. The clinical trial involving many of the premier IVF centers of the world, is a very important scientific study..." Cell Robotics International, Inc. develops, manufactures and markets several proprietary medical and research laser devices and associated products with application niches in large markets. Products include the Lasette(tm) laser finger perforator per·fo·rate v. per·fo·rat·ed, per·fo·rat·ing, per·fo·rates v.tr. 1. To pierce, punch, or bore a hole or holes in; penetrate. 2. for sampling of blood for glucose measurements, an Erbium skin resurfacing laser, and an IVF Workstation. 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: Cell Robotics International, Inc. 505-343-1131 Ext. 100 or Craig Rogers, Vice President 719/590-1793 or Edda Brown or Sean Collins Richmont Consulting 213/658-8088 |
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