Cell Robotics Announces First Baby Using IVF Technology
CRII's Laser Assisted Hatching technology nearly doubles In Vitro Fertilization (IVF) pregnancy success rate to 52% in German clinic
ALBUQUERQUE, N.M.--(BW HealthWire)--May 5, 1999-- Cell Robotics International Inc. (OTC: CRII - news)
Wednesday announced the birth of the first babies from pregnancies initiated with its IVF Workstation and Laser Assisted Hatching process.
The first birth was a boy in the US, followed by the birth of twins -a boy and a girl- in Australia. Pregnancy rates from the use of Laser Assisted Hatching with the IVF Workstation have been greater than anticipated, with one fertility clinic reporting twice the rate of successful pregnancies versus older methods.
The first baby born in the United States, as part of the on-going clinical trial of Cell Robotics' Laser Assisted Hatching process using the IVF Workstation, weighed in at a hearty eight pounds and one ounce boy.
The parents had previously experienced several infertility problems, including painful and life-threatening tubular pregnancies with the resulting miscarriages, as well as several unsuccessful attempts at standard In Vitro Fertilization. The mother became pregnant on the first attempt using Cell Robotics' IVF Workstation on her embryos.
''The emotional rollercoaster we rode for two years is our unique experience with being 'fertility challenged,'' said the mother, who prefers to remain anonymous. ''We feel very fortunate to have our son and feel the technology used to help deliver him to us is heaven sent. Without question, we believe laser assisted hatching played a part in our successful pregnancy.''
Cell Robotics IVF Workstation is cleared for marketing and sales in Europe and all other countries that use the European Community regulatory standards.
This includes approximately 100 countries. In the U.S., the Food and Drug Administration (FDA) has not yet cleared the technology, although the FDA did recently allow a reduction in the sample size of the clinical study as stated in the Company's press release dated April 1, 1999.
Women in the U.S. who wish to become pregnant and who are 39 years of age or older may participate in the CRII's clinical trial by contacting either Michel Schiewe, Ph.D., California Fertility Associates, 1245 16th St., Suite 105, Santa Monica, CA, 90404, Fax. 310-828-3310, or David Hill, MD, Century City Hospital, Center for Reproductive Medicine,
2070 Century Park East, Los Angeles, CA, 90067, Fax 310-201-6657. Other clinical sites or other sites may be added in the future to www.cellrobotics.com.
David Peet, MD, who runs a highly respected fertility clinic in Berlin, Germany, purchased the first Cell Robotics laser system in Europe. Dr. Peet stated, ''After extensive research, we came to the conclusion that Cell Robotics' IVF Workstation represented the high-tech tool which offers a perfect measuring and imaging system for scientific evaluation.
''We have been using this IVF Workstation since December 1998 without initiating a single change regarding our staff, stimulation protocols, media, catheters or otherwise.''
''Our pregnancy rates without using the laser ranged between 25-30 % per ''fresh'' embryo transfer cycles and about 15-20 % in frozen embryo cycles. These results were very much in the upper German average (due to strict German regulations).'' After using the IVF Workstation...''Assessing change in pregnancy rates in late January in about 45 patients, we noted a soaring 52 %! ... Application of the Cell Robotics workstation offers a valuable advantage regarding pregnancy rates and should therefore be offered to all couples seeking our help.''
Dr. Peet achieved a 52% pregnancy rate using Laser Assisted Hatching of the embryo and 45% of the pregnancies were multiple pregnancies.
Because of the multiple pregnancies, Dr. Peet decided to start only transferring two embryos for patients under age 36 and in 190 patients, pregnancy success rates still persist at around 37 to 42%, consequently reducing percentage of multiples (twins) to 35 percent of the pregnancies.
In roughly 45 frozen embryo cycles, Dr. Peet's clinic simultaneously achieved a pregnancy rate of 35 percent per transfer compared to previous rates of 20%. Also, the rate of miscarriages has not changed significantly.
In the table below, the first three data columns summarize Dr. Peet's results and the last column shows results from the U.S. Control and Disease Center (CDC) 1996 Assisted Reproductive Technology Success Rates(a).
Before Laser Laser Laser USA IVF
(3 Embryos /cycle)(3 Embryos/cycle)(2 Embryos/cycle) Ave.1996(a)
Pregnancy
Rate 25-30% 52% 37-42% 25.9%
Multiple
Preg.
Rate 20% 45% 35%
Sample
Size Large 45 190
U.S. and international patients of any age seeking to be treated for their fertility problems may contact Dr. Peet's clinic in Berlin, Germany at IVF Praxis by Fax at 011-49-30-306-98018.
Ronald K. Lohrding, Ph.D., president and chief executive officer of Cell Robotics, commented, ''We believed the Laser Assisted Hatching process would improve the pregnancy rates in IVF applications, but almost doubling the success rate as seen in Dr. Peet's practice, has greatly exceeded our expectations.
''We are pleased that we will be showing his results and exhibiting the IVF Workstation and other fertility technology at the '11th World Congress on In Vitro Fertilization and Human Reproduction Genetics Conference' in Sydney Australia, May 9-14, 1999 and at ESHRE in Tours, France on June 27-30.''
In addition to the In Vitro Fertilization (IVF) Workstation, Cell Robotics International, Inc. manufactures, markets, and distributes the Lasette, a laser finger perforator, designed to allow diabetics to painlessly draw blood to test their glucose levels, and the Cell Robotics Workstation, a research instrument that incorporates the LaserTweezers® 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. |
