Saturday, June 17, 2017 6:00:34 AM
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
Recent INVO News
- Form 8-K - Current report • Edgar (US Regulatory) • 09/20/2024 08:05:10 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/18/2024 09:21:11 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2024 08:06:07 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 01:00:36 PM
- INVO Reports Record Second Quarter 2024 Financial Results with 481% Revenue Growth and a $1.1 Million Improvement to Adjusted EBITDA • GlobeNewswire Inc. • 08/14/2024 01:00:00 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 05/21/2024 08:39:17 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/15/2024 08:51:16 PM
- INVO Reports Record First Quarter 2024 Financial Results • GlobeNewswire Inc. • 05/15/2024 08:15:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2024 09:30:18 PM
- Micro Cap Massively Bid Up Before Opening Bell • AllPennyStocks.com • 04/17/2024 02:25:00 PM
- INVO Reports Fourth Quarter and Full Year 2023 Financial Results • GlobeNewswire Inc. • 04/16/2024 08:59:29 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/06/2024 03:24:52 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/01/2024 02:01:07 PM
- NAYA Biosciences To Acquire Clinical Stage Gene Therapy Program for Leber's Hereditary Optic Neuropathy (LHON) • GlobeNewswire Inc. • 01/23/2024 01:00:00 PM
- INVO Bioscience Files S-4 Registration and Preliminary Joint Proxy Statements in Connection with Merger with NAYA Biosciences, NAYA Announces New Board Directors • GlobeNewswire Inc. • 01/17/2024 01:00:00 PM
- Form S-4 - Registration of securities, business combinations • Edgar (US Regulatory) • 01/16/2024 10:29:59 PM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 01/10/2024 09:46:12 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/10/2024 09:05:33 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/03/2024 10:29:45 PM
- Form 424B7 - Prospectus [Rule 424(b)(7)] • Edgar (US Regulatory) • 12/28/2023 10:04:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/28/2023 10:02:41 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 12/13/2023 10:08:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/13/2023 09:53:21 PM
- NAYA Biosciences Announces Publication of New Data for its CD38-targeted Flex-NK™ Bispecific Antibody in the American Society of Hematology's Blood Journal • PR Newswire (US) • 12/11/2023 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/28/2023 10:18:38 PM
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