SARASOTA, Fla., Feb. 5, 2020 /PRNewswire/ -- INVO Bioscience, Inc. (OTCQB: IVOB), a medical device company focused on treating infertility with its FDA-cleared INVOcell® product, today announced receipt of Institutional Review Board (IRB) approval to commence its planned clinical trial to evaluate the modified INVOcell system for effectiveness of achieving fertilization, implantation, embryo development, clinical pregnancy, and live birth after 5-days of continuous vaginal incubation.

The objective of this study is to assess the efficacy, comfort and retention of the INVOcell with the retention device, and demonstrate superiority following 5-day vaginal incubation as compared to current 3-day vaginal incubation indication.

The pivotal trial (clinicaltrials.gov identifier: NCT04246268) is a single arm, multicenter, open label trial at three clinical centers in the United States with each center enrolling 60 patients between the ages of 18 and 37 years old. The providers at each center will conduct the processes of ovarian stimulation, egg retrieval and embryo transfer per the standard protocols for their centers. Patient recruitment at each site has begun.

Currently in the United States, 62% of fresh embryo transfers are performed on Day 5 and 30% on Day 3 (CDC Assisted Reproductive Technology report, 2016 data).

"Expansion of our label to 5-day continuous vaginal incubation is a key objective as we look to enhance the INVOcell procedure beyond its currently approved 3-day use and align with the current standards within the fertility industry," commented Steve Shum, CEO of INVO Bioscience. "Now that we have begun recruitment, we look forward to the clinical sites commencing enrollment shortly."

INVO Bioscience's U.S. distribution partner, Ferring Pharmaceuticals, is providing MENOPUR® (menotropins for injection) at no cost to clinical participants. Per terms of an existing commercialization agreement, INVO Bioscience will receive a $3 million milestone payment from Ferring, upon successful FDA-clearance for 5-day continuous vaginal incubation. 

"Conducting the pivotal clinical trial is a critical step in continuing to expand our commercialization of the INVOcell system, and, most importantly, realizing our mission of advancing the treatment of infertility," said Lori Kahler, Vice President of INVO Bioscience.  

Additional information on the clinical trial can be found at:

https://clinicaltrials.gov/ct2/show/NCT04246268

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 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.

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SOURCE INVO Bioscience, Inc.