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ADDING and REPLACING INVO Bioscience Announces Clinical Results of Initial INVO Procedures in Latin America
Wednesday October 28, 2009 - 16:00 PM EDT Released By INVO Bioscience, Inc.
Add to first sentence of release: (OTC BB: IVOB). The corrected release reads: INVO BIOSCIENCE ANNOUNCES CLINICAL RESULTS OF INITIAL INVO PROCEDURES IN LATIN AMERICA INVO Bioscience (OTC BB: IVOB) announced that CECOLFES (http://cecolfes.com/), Colombia Fertility Center, Bogota, Colombia, the first center in Latin America to introduce the INVOcell device and the INVO procedure for treatment of infertility, made known today the results of the first 28 cycles of the INVO procedure. Of the 28 patients treated, 27 patients had embryos transferred and 10 patients became pregnant with only one patient having a multiple pregnancy. This results in a 36% ongoing pregnancy rate per cycle. The average patient age was 34 years old with an average number of 6 oocytes (eggs) retrieved per patient. “We are very happy with these initial results and the patients love being involved in the process. The procedure is easy to perform and we are happy to be pioneering the INVO procedure,” said Dr. Elkin Lucena, who owns and runs the CECOLFES fertility center. He continued “We have many more patients being treated with INVO. These results validate the efficacy of the INVO procedure and we expect to perform INVO in replacement of conventional IVF,” said Lucena. CECOLFES has also opened several INVO clinics within the region. “This initial data is what the company expected since the original 800 cases performed by Dr. Ranoux using our prototype device demonstrated pregnancy rates in the range of traditional IVF. This is an exciting time for INVO Bioscience,” stated Kathleen Karloff, INVO Bioscience’s CEO. About the INVO Procedure The INVOcell and INVO Procedure combine a natural or mild (mild medication) stimulation infertility treatment cycle, using lower amounts of fertility hormones than used in traditional IVF (in vitro fertilization), with intra-vaginal incubation (IVC) of sperm and eggs. Following standard egg retrieval, the woman’s eggs (oocytes) are combined with sperm in the INVOcell, a small device, which is then sealed and placed in the woman’s vaginal cavity to incubate for three days. When the INVOcell is removed, the anticipated one to two developing embryos are transferred directly into the woman's uterine cavity, where implantation and continued pregnancy can take place. The company has received European CE Mark approval for the INVOcell in 2008 and launched the product in select countries outside the U.S. The company is also pursuing U.S. Food and Drug Administration 510(k) clearance for the INVOcell. About INVO Bioscience INVO Bioscience (IVOB) is a medical device company, headquartered in Beverly, Massachusetts, focused on creating simplified, lower cost treatment options for patients diagnosed with infertility. The company’s lead product, the INVOcell, is a novel medical device used in infertility treatment that enables egg fertilization and early embryo development in the woman’s vaginal cavity. The company was founded by Claude Ranoux, MD, a noted expert in the field of reproductive health, infertility and embryology. For more information, please visit www.invobioscience.com. This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at www.sec.gov. We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events or otherwise.
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