INVO Bioscience Commences Registration Process for INVOCell Fertility Device in China
8/10/2010 9:21:16 AM
BEVERLY, Mass., Aug. 10 /PRNewswire-FirstCall/ -- INVO Bioscience, Inc. (OTC Bulletin Board: IVOB), a medical device company focused on treatment options for patients diagnosed with infertility, today announced that it has commenced the registration process for its INVOCell fertility device with the State Food and Drug Administration (SFDA) of the Peoples Republic of China (PRC). The Company's exclusive distribution partner in the PRC, the Progressive Group, has determined after meetings with the SFDA that the regulatory agency may confer a Class II medical device classification on INVOCell, thereby exempting INVO Bioscience from conducting clinical trials to complete the approval process.
Document submission to the SFDA has begun and needed translations are being performed. Upon approval and addressing appropriate manufacturing requirements, the Progressive Group will be able to distribute INVOCell to Mainland China, Hong Kong and Taiwan.
INVOCell is CE Mark approved in Europe and Canada and conforms with all consumer health and safety requirements. INVOCell is currently marketed and sold in , Austria, , Canada, Cameroon, Columbia, Dominican Republic, Guatemala, Nicaragua, Pakistan, Panama, Peru, Spain, Togo, Turkey, and Venezuela.
Dr. Claude Ranoux, founder, president and chief scientist at INVO Bioscience, said, "We are pleased to commence the regulatory approval process in the Peoples Republic of China. INVO Bioscience has leading-edge technology that can provide great benefits to couples looking to address infertility issues in a manner that is cost effective and minimizes the potential for multiple births. We look to our future in China with great anticipation."
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.
Forward Looking Statements
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SOURCE INVO Bioscience