INVO Bioscience Inc (INVO)

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INVO Bioscience (IVOB): Disrupting the Infertility Market
Equities Research Follow | Tuesday, 13 June 2017 14:53 (EST)
According to the Centers for Disease Control, about 12% of women in the US between the ages of 15 and 44 have difficulty conceiving. That's about 7.4 million women, based on 2010 census numbers, and worldwide estimates place the number of infertile women at 150 million. Approximately $3 billion is spent annually in the US on in-vitro fertilization (IVF) and intrauterine insemination (IUI) cycles, and Allied Market Research projects the global IVF market alone to exceed $21 billion by 2020.

The vast majority - 98% - of infertile patients go untreated, with cost and proximity to treatment centers as the greatest hindrance. We've been following a company called INVO Bioscience (OTC: IVOB) that has developed the first new device and treatment for infertility in more than 30 years that produces results comparable to IVF at half the cost.

INVOcell device

The company's INVOcell device was approved by the FDA in 2015 as a De Novo Class II device, enabling egg fertilization and early embryo development in the woman’s body. The device achieves pregnancy rates comparable to IVF while saving about $8,000 per pregnancy. The company has now signed up 50 clinics in 11 states to begin offering or referring the INVOcell device and procedure.

Source: INVO Bioscience Corporate Presentation, June 2017



INVOcell enables fertilization to occur within the women’s own body (in vivo), a powerful motivator for many patients and the only acceptable option available to some patients for religious and cultural reasons. Results have been comparable with IVF but requiring fewer visits to the fertility specialist saving time and expense for patients. The device will enable broader access to IVF treatment from a geographical perspective as currently the approximately 500 IVF centers in US are exclusively located in large urban centers. With a requirement for significantly less capital equipment costs and leasehold space to start an INVOcell equipped center, more cities and areas with lower population can support a fertility center.

OTC Pink - But Now Fully Reporting and Caught Up with the SEC

The company's stock trades on the Pink Open Market segment of the OTC market, but with its Super 10-K filing in March 2017 and subsequent regular 10-K and 10-Q filings in April and May, respectively, INVO Bioscience is now fully caught up with the SEC. CEO Katie Karloff, in the company's Q1 press release, stated the company has "made great progress in attracting physicians to offer the INVOcell device and procedure, with 27 new clinics coming on board since the beginning of the year. We anticipate that as physician training occurs in the coming months, we will see increased utilization with successful pregnancy rates which will continue to drive further adoption in the future. Importantly, we are seeing the adoption of clinics exclusively providing the INVOcell treatment, creating a model that we believe will ultimately become the key driver of growth for the Company – INVO Clinics owned by INVO Bioscience."

Issues to Consider

There are the usual liquidity risks associated with thinly traded OTC stocks, and the company does have balance sheet concerns of which investors should be aware. As of March 31st, there was less than $40,000 in cash, $675,000 in accounts payable (which the company says is all being managed pending increased revenue) and $3.6 million in back salary, expenses and notes owed to members of management and board.



INVO Bioscience has a commercially viable product that is addressing a very large market opportunity, and we're encouraged by the company's success in getting the INVOcell device adopted by treatment clinics and its attention to getting current with regulatory filings. We'll be following this company to see if it can continue to gain traction by clinics and physicians, and shore up its balance sheet in the process.



https://www.equities.com/news/invo-bioscience-ivob-disrupting-the-infertility-market