Cell Robotics submits IDE to FDA for In Vitro Fertilization Workstation and receives NIH/SBIR grant for product development.ALBUQUERQUE, N.M.--(BW HealthWire)--Feb. 7, 1997--Cell Robotics International Inc. (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). : CRII) announced it submitted 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) application to the 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. for a clinical trial of its 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); Workstation. If the IDE is approved by the FDA, CRII will conduct a clinical trial of the Workstation. The IVF IVF in vitro fertilization. IVF abbr. in vitro fertilization IVF 1 In vitro fertilization, see there 2. Intravascular fluid Workstation functions as a diagnostic tool with a standardized method for embryo examination and documentation. The In Vitro Fertilization Workstation will also offer laser-assisted hatching of embryos before implantation into the mother. In Austria, a member of the Cell Robotics Board of Technical Advisors has shown considerable improvement in pregnancy rates after laser-assisted hatching. Cell Robotics' clinical study is planned for five prominent IVF sites, three in the United States, one in Belgium and one in Israel. The novel sperm injection technique (ICSI ICSI - International Computer Science Institute at Berkeley, CA. ) was developed at the clinic in Belgium. In addition, Cell Robotics has been awarded a Small Business Innovative Research (SBIR) Grant of approximately $100,000 from the National Institute of Health (NIH) National Center for Research Resources The National Center for Research Resources or NCRR, is a United States government agency. NCRR provides funding to laboratory scientists and researchers for facilities and tools in the goal of curing and treating diseases. . This grant will allow CRII to develop an integrated laser module, and to research various effects of laser light on biological samples such as determining non-damaging shock wave and thermal gradient parameters. The grant also covers the development of a specialized objective lens for laser-assisted hatching. Dr. Jerome Conia, product manager for the IVF Workstation, is the author of both the SBIR and the IDE submittal. "Dr. Conia has been an invaluable asset to the company in the development of both the basic science and product development of the IVF Workstation. His scientific knowledge and experience have transformed this project from idea to reality," said Dr. Ronald Lohrding, CRII president and chief executive officer. Cell Robotics International Inc. develops, manufactures and markets several proprietary medical and research laser devices and associated products with application niches in large markets. 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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