INVO Bioscience Announces Positive Results Of A Phase IV Trial Of INVOcell

Dr. Kevin Doody, sponsor-investigator and founder of Centre for Assisted Reproduction (CARE) of Bedford, TX and INVO Bioscience, a medical device company focused on treatment options for patients diagnosed with infertility, recently announced the publication of the positive results of a Phase IV trial showing the INVOcell intravaginal culture (IVC) system was equivalent to traditional In-Vitro Fertilization (IVF) incubation when comparing quality of embryos transferred and live birth rates, the primary endpoint of the trial. The results were published in the February 2016 online first issue of Journal of Assisted Reproduction and Genetics (JARG)¹.

The positive trial results were derived from a randomized, single-center, controlled trial and are the first published results to evaluate live birth rates comparing intravaginal culturing of embryos using INVOcell to traditional IVF incubation. In the trial, the quality of day 5 embryos incubated in INVOcell was compared to traditional IVF incubated embryos. INVOcell cultured embryos were shown to be equivalent to traditional IVF embryos for embryos that were transferred. This resulted in near identical live birth rates with INVOcell generating 16 live births in 11 of 20 (55%) cycles compared to traditional IVF, which created 15 live births in 12 of 20 cycles (60%). The trial demonstrated that INVOcell is equivalent to traditional IVF incubation when comparing quality of embryos transferred and live birth rates.

Dr. Kevin Doody commented, "By comparing INVOcell to traditional IVF in a randomized, controlled trial, we now have data that clearly demonstrates that INVOcell has comparable live birth rates to traditional IVF, a key factor in evaluating the cost savings benefit of the INVOcell device and procedure. The ability to have equivalent live birth rates using the INVOcell device and procedure, which uses the patients' own vaginal cavity as an incubating system, has the potential to significantly lower the costs of assisted fertility procedures compared to traditional IVF, which relies on high levels of overhead necessary for the incubating process."

Kathleen Karloff, chief executive officer of INVO Bioscience, commented, "These positive Phase IV results highlight both the safety and efficacy of INVOcell, and further support vaginal culture as an exciting new treatment option that will provide increased access for a significant number of infertile patients who cannot currently access or afford treatment. The inability to have a child affects 6.7 million women in the U.S². Our vision is to markedly expand and exclusively service a new segment of patients in the $23 billion dollar worldwide market."

Dr. Doody concluded, "The next step is to build or augment existing facilities and leverage the simplicity of vaginal culture and INVOcell to support and expand our IVF infrastructure. Once this is in place we can truly harness the power of vaginal culture using INVOcell."

About INVOcell
The INVOcell is used for the incubation of eggs and sperm during fertilization of early embryo development. Unlike conventional infertility treatments such as in vitro fertilization (IVF), where the eggs and sperm develop into embryos in a laboratory, the INVOcell utilizes the women's vagina as a natural incubator to support embryo development. The key features and benefits of the INVOcell device and procedure include: providing a more natural and stable vaginal incubation than in a conventional IVF incubator; providing psychological benefits to patients/couples and promoting greater involvement by couples; reducing the risk of incorrect embryo transfers; and reducing the cost of infertility treatments and increasing geographic accessibility.

About The Centre for Assisted Reproduction (CARE)
CARE is an independent facility providing comprehensive medical care for the treatment of infertile patients. Established in 1989, CARE has been providing state-of-the-art fertility treatment to residents of Dallas, Fort Worth, and cities throughout the state of Texas. CARE strives to make it easy for patients to receive cutting-edge treatment and maintains longstanding relationships with all major managed care organizations. CARE offers a comprehensive suite of services including IVF and egg donation. CARE centers are conveniently located in Bedford, Fort Worth and Frisco, Texas. For more information, visit www.embryo.net.

About INVO Bioscience
INVO Bioscience (IVOB) is a medical device company, headquartered in Medford, 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, visit www.invobioscience.com.

^1.  http://link.springer.com/article/10.1007/s10815-016-0661-0/fulltext.html
^2.  https://www.asrm.org/detail.aspx?id=2322