To: Joe Copia who wrote (13999 ) 4/1/1999 9:42:00 AM From: Due Diligence Respond to of 25711
CRII: good news. DD (PR Wires) DJ: FDA Grants Reduction in the Size of Cell Robotics' IVF C DJ: FDA Grants Reduction in the Size of Cell Robotics' IVF Clinical Trial FDA approves a significant reduction in sample size of the Clinical Trial for Laser Assisted Hatching for In Vitro Fertilization applications ALBUQUERQUE, N.M., April 1 /PRNewswire/ -- Cell Robotics International, Inc. (OTC Bulletin Board: CRII), the developer of the In Vitro Fertilization (IVF) Workstation, has been notified by the Food and Drug Administration (FDA) that it has approved Cell Robotics' request for modifications to the Laser Assisted Hatching clinical trial. These changes reduce the number of patients required and simplify other aspects of the study. "The IVF pregnancy success rate using Laser Assisted Hatching has exceeded our expectations and we are pleased that the FDA has approved our request to significantly reduce our sample size for the clinical trial. Obviously, this will accelerate the clinical trial process and we eagerly anticipate that our workstation will be available for couples in the U.S. sooner than originally anticipated when the trials began," said Ronald K. Lohrding, Ph.D., Cell Robotics' President and CEO. The IVF Workstation is currently approved for sale in Europe and much of the rest of the world. The first European system was delivered to a German physician in December of 1998 and he has been achieving excellent pregnancy success rates using the Laser Assisted Hatching techniques on all of his IVF patients. This success has led to several additional systems being delivered outside the U.S. One of the reasons that couples have trouble having children is that the shell or zona pellucida around the woman's egg is too tough and the embryo is unable to break out and become a healthy fetus. During the IVF process, Laser Assisted Hatching creates a small trench or crack in the shell so that when the embryo is ready to hatch, it can break out of the shell. As women age the shell is thought to become tougher. As part of the aggressive worldwide marketing and sales campaign the IVF Workstation will be available at the following conferences: -- the British Fertility Society (Newcastle, UK), April 1999 -- the World Congress on In Vitro Fertilization and Human Reproduction Genetics (Sydney, Australia), May 1999 -- the European Society for Human Reproduction and Embryology (Tours, France), June 1999 -- the American Society for Reproductive Medicine (Toronto, Canada), September 1999 In addition to the In Vitro Fertilization (IVF) Workstation, Cell Robotics International, Inc. is the developer of the Lasette(TM), a laser finger perforator that allows diabetics to sample their blood for glucose measurements in a nearly painless manner. It also manufactures, markets, and sells the Cell Robotics Workstation, a research instrument that incorporates the LaserTweezers(R) and LaserScissors(TM) for manipulating and cutting cells and chromosomes. Additional information is available on the Cell Robotics Web Site at cellrobotics.com , by e-mail at crii@cellrobotics.com, or by telephone at (505) 343-1131. As a cautionary note to investors, although the FDA has approved the Cell Robotics request for reducing the size of its clinical trial, this action does not imply that this investigation will develop sufficient safety and effectiveness data for FDA clearance of this device. Also, certain matters discussed in this press release may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such matters involve risks and uncertainties that may cause actual results to differ materially, including the following: changes in economic conditions; general competitive factors; the Company's ability to execute its service and product sales plans; and the risks described from time to time in the Company's Securities and Exchange Commission filings. /CONTACT: Craig Rogers, Vice President - Investor Relations of Cell Robotics, Inc., 719-590-1793; or Retail: Jim Estrada or Brett Maas, or Analysts/Institutional: Joe Dorame, or Media: Jeff Stanlis, all of RCG Capital Markets Group, Inc., 602-675-0400/ 08:00 EST *** end of story ***