, 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
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.
SOURCE INVO Bioscience