INVO Bioscience Receives CE Mark for INVOcell Device Allowing the Company to Commercially Distribute Product in Europe
European market size estimated to reach $4.4 billion by 2022
SARASOTA, Fla., Oct. 24, 2019 /PRNewswire/ — INVO Bioscience, Inc. (OTCQB: IVOB), a medical device company focused on creating alternative treatments for patients diagnosed with infertility and developers of INVOcell®, the world’s only in vivo Intravaginal Culture System, today announced the receipt of a CE Mark for its INVOcell culture and retention device. The receipt of the CE Mark is the final requirement for INVO Bioscience to begin commercially distributing the revolutionary alternative to traditional IVF through the entire European Union.
Steve Shum, CEO of INVO Bioscience, commented, “We are extremely pleased to receive this very important product certification, the CE Mark, which permits us to commercially distribute the world’s only in vivo fertilization treatment to the millions of patients throughout the countries of the EU. The European countries represent a large potential market for INVOcell, with an estimated $3 to $4 billion currently spent on IVF treatments. Importantly, INVOcell is a simple and more natural solution with the potential to expand the overall addressable market for treatment due to its ability to lower costs compared to IVF while also demonstrating comparable rates of effectiveness.”
Shum continued, “We are currently in the middle of active discussions with several distribution partners around the world, including within the European market, and look forward to providing updates on our international efforts in the near future.”
INVOcell is currently FDA-approved and being distributed in the U.S. under a separate agreement with Ferring Pharmaceuticals. The Company had entered an agreement in January 2019 in which it received an upfront payment of $5 million with the ability to receive an additional $3 million upon obtaining a label enhancement from the U.S. Food and Drug Administration. Previously, INVOcell had received a CE Mark from 2008 to 2012, however as commercialization efforts shifted to the U.S., resources prohibited the continuation of the certification until today.
Worldwide, the fertility treatment market is severely underserved. Currently, only 1% to 2% of the 150 million infertile couples worldwide are treated, or approximately 1.5 million IVF cycles annually, with the primary prohibiting factor being cost and access to treatment. The INVOcell solution, which is approximately half the cost of traditional IVF treatment and has shown comparable pregnancy rates, has the ability to significantly increase patient access. Further, INVOcell can be administered without the need for costly overhead of IVF centers and allows fertilization to occur within the women’s own body (in vivo). This in vivo fertilization is a powerful motivator for many patients and the only acceptable option available to some patients for religious and cultural reasons.
1 Based on market research of IVF market by Allied Market Research.
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 availability of care. For more information, please visit https://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.
For more information, please contact:
Steve Shum, CEO
Lytham Partners, LLC