INVO Bioscience Obtains Regulatory Approval to Import INVOcell Into Mexico

SARASOTA, Fla., March 1, 2021 /PRNewswire/ -- INVO Bioscience, Inc. (NASDAQ: INVO), a medical device company focused on commercializing the world's only in vivo Intravaginal Culture System (IVC), INVOcell^®, an effective and affordable treatment for patients diagnosed with infertility, today announced the Company has received approval by COFEPRIS to import INVOcell into Mexico. In late 2020, INVO Bioscience established a joint venture focused on establishing fertility centers dedicated to offering INVOcell, with the initial center, called Positib Fertility, to be located in the city of Monterrey, Mexico. 

COFEPRIS or the Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios) is the department within the Mexican Secretariat of Health that deals with the importation of medical devices and issues advertising permits for these products.

Steve Shum, CEO of INVO Bioscience, commented, "We are extremely pleased to have received approval by COFEPRIS to begin importing INVOcell into Mexico. This was a key step in the process to open our first joint venture owned clinic in the large and growing Mexico market for infertility services.  Our internal team along with our JV partners have and continue to work aggressively and with a relentless focus to bring the INVOcell treatment option to the many patients in need of care within Mexico."

Francisco Arredondo, MD., MPH, INVO Bioscience's JV partner in Mexico, and an early adopter of the INVOcell solution, commented, "As the first infertility clinic physician to open a dedicated INVOcell center in 2017 in McAllen, Texas, a boarder city between the U.S. and Mexico, I discovered first hand the positive impact that the INVOcell solution can provide to families struggling with fertility. The ability to bring this affordable and effective technology to the citizens of Mexico is extremely gratifying on a personal level and brings us closer to the goal of democratizing the fertility industry."

Dr. Arredondo was an early adopter of the INVOcell solution as he began offering IVC via the INVOcell to his patients at fertility clinics in San Antonio and Austin in 2016. In 2017, due to the success in expanding the accessibility of infertility treatment to patients utilizing INVOcell, he decided to open a center where he would exclusively offer the INVOcell solution in McAllen, Texas. Dr. Arredondo successfully sold his U.S.-based fertility clinics in 2019 and is now focused on bringing the INVOcell solution to Mexico.

Ramiro Ramirez, MD, of Positib Fertility, S.A. de C.V., added, "We have finalized our site selection in Monterrey, Mexico, and with the importation approval now complete, we look forward to launching Positib Fertility as quickly as possible."

About INVO Bioscience

We are a medical device company focused on creating simplified, lower-cost treatments for patients diagnosed with infertility. Our solution, the INVO^® Procedure, is a revolutionary in vivo method of vaginal incubation that offers patients a more natural and intimate experience. Our lead product, the INVOcell^®, is a patented medical device used in infertility treatment and is considered an Assisted Reproductive Technology (ART). The INVOcell^® is the first Intravaginal Culture (IVC) system in the world used for the natural in vivo incubation of eggs and sperm during fertilization and early embryo development, as an alternative to traditional In Vitro Fertilization (IVF) and Intrauterine Insemination (IUI). Our mission is to increase access to care and expand fertility treatment across the globe with a goal to lower the cost of care and increase the availability of care. For more information, please visit http://invobioscience.com/

Safe Harbor Statement

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. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. 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, Inc.