Invo Bioscience Inc (OTCMKTS:IVOB) is the kind of runner we love to report on here making a spectacular run over the past 2 years from sub pennies to recent highs of $1.49 a share reached after the Company announced the FDA has granted the Company’s de novo request for the INVOcell™
The problem with IVOB is the Company has not filed a 10Q since November 2011 and as a result has been slapped with Pink/Limited Information designation from Otcmarkets. This represents a massive red flag.
Invo Bioscience Inc (OTCMKTS:IVOB) bills itself as a medical device company, headquartered in Medford, Massachusetts, focused on creating simplified, lower cost treatment options for patients diagnosed with infertility. IVOB 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.
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. In clinical studies, the INVOcell procedure produced pregnancy rates equivalent to traditional IVF treatments.
The big advantage to the INVOcell is that is can be performed in a Drs. Office and provides huge cost savings over a laboratory. According to IVOB corporate website (a really weird outdated flash format style website located at invobioscience.com) INVO Bioscience’s INVOcell will revolutionize the treatment of infertility. The INVOcell replaces the IVF laboratory and allows conception to take place naturally inside the woman’s body.
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On November 3 IVOB announced the FDA has granted the Company’s de novo request for the INVOcell™. As a result, INVOcell is the first intravaginal culture system granted marketing clearance in the United States, providing millions of infertile couples across the country access to this revolutionary infertility treatment.
CEO Katie Karloff commented “INVOcell has the ability to significantly transform the way in which fertility clinics across the United States assist infertile patients to achieve their desired outcomes in a simpler, more natural and cost effective manner. It has been a long process to de novo clearance and we are so pleased to have this approval from the FDA to begin marketing and selling in the United States. With this critical approval, we look forward to developing the partnerships necessary to bring this device to millions of patients across the United States.”
According to IVOB INVOcell has gained national attention over the last year from the infertility community as a safe, effective, and low cost fertility treatment option. During the 2015 American Society of Reproduction Medicine (ASRM) conferences, Dr. Kevin Doody of Bedford, Texas presented results of a randomized 40 patient comparative study demonstrating the INVOcell procedure performed equivalent to that of IVF, with INVOcell producing a 65% pregnancy rate. This presentation also focused on the relative cost reductions that the INVOcell procedure can allow for compared to traditional IVF treatment. As a result of the safety, equivalence of pregnancy rates, and lower overall cost of procedure, ASRM endorsed INVOcell as a viable process for treating infertile patients.
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Currently trading at a $68 million market valuation IVOB has not filed a 10Q since November 2011 and has been slapped with Pink/Limited Information designation from Otcmarkets. Certainly the INVOcell looks like an exciting product that has started to garner some big attention however Investors should be warned that IVOB innability to put out any filings represents a massive red flag and could end very badly for Investors. We will be updating IVOB as events unfold so make sure you are subscribed to Microcapdaily so you know what is going on with IVOB.
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Disclosure: we hold no position in IVOB either long or short and we have not been compensated for this article.