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PROGRESS REPORT: INVO Biosciences Signs JV Agreement To Open 1st U.S. INVOcell-Exclusive Clinic

By John F. Heerdink, Jr.
The infertility population in the U.S. is large and significantly underserved. Currently, it is estimated that more than 90% of the patients who need advanced fertility treatment are unable access it. – Dr. Karen Hammond

INVO Bioscience, Inc. (NASDAQ: INVO) is a medical device company focused on creating simplified, lower-cost treatments for patients diagnosed with infertility. Their solution, the INVO® Procedure, is a revolutionary in vivo method of vaginal incubation that offers patients a more natural and intimate experience. Their 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). Their  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 the availability of care.

On Monday, INVO announced the signing of a 50/50 joint venture agreement in partnership with reproductive specialists Dr. Nicholas Cataldo, MD, MPH, Dr. Karen R. Hammond, DNP, CRNP, and Lisa Ray, MS, ELD, to open the first Joint Venture INVO-exclusive clinic in the United States. The INVO clinic will be located in Birmingham, Alabama and is expected to be operational in the second half of 2021. Together, the team of Cataldo, Hammond, and Ray has been one of the IVF industry’s leading advocates of the INVOcell solution. Since 2018, they have performed more than 700 cycles with INVOcell with patients traveling to Birmingham from more than 28 states across the country to access the procedure. Dr. Hammond and Lisa Ray are also members of the INVO Bioscience Scientific Advisory Board.

Steve Shum, CEO of INVO Bioscience (NASDAQ: INVO)

“This is an important milestone for INVO Bioscience as we plan the opening of the first Joint Venture INVOcell-exclusive clinic in the United States in partnership with leading reproductive specialists. The exclusive clinic model creates a unique opportunity for INVO and our partners to drive accelerated adoption of the INVOcell solution while increasing the capacity of the infertility industry, improving affordability, and facilitating greater access for patients. We are fortunate to partner with such high caliber partners as Drs. Cataldo, Hammond and Ray, who are extremely well-versed in the INVOcell technology and have a proven track record of successful implementation within a thriving clinical setting. We believe their expertise will be invaluable as we build a successful operating model which can be replicated for additional INVOcell-exclusive clinics.  We look forward to reporting on those additional activities in the near future,” Steve Shum, CEO of INVO Bioscience (NASDAQ: INVO)


  • Last week, INVO announced that they has agreed to an amendment of their agreement with Ferring Pharmaceuticals that provides for an increase in the number of INVO company-owned US-based clinics initially allowable under the agreement and removes certain geographical restrictions. The amendment also adjusted the remaining annual 2020 minimum contractual product purchase requirement, whereby Ferring will place a $501,000 order, which will be recognized as revenue by INVO Bioscience in the first quarter of 2021. READ STORY.
  • Recently, INVO announced the Company has received approval by COFEPRIS to import INVOcell into Mexico. In late 2020, INVO Bioscience established a joint venture focused on establishing fertility centers dedicated to offering INVOcell, with the initial center, called Positib Fertility, to be located in the city of Monterrey, Mexico. Steve Shum, CEO of INVO Bioscience, commented, “We are extremely pleased to have received approval by COFEPRIS to begin importing INVOcell into Mexico. This was a key step in the process to open our first joint venture owned clinic in the large and growing Mexico market for infertility services. Our internal team along with our JV partners have and continue to work aggressively and with a relentless focus to bring the INVOcell treatment option to the many patients in need of care within Mexico.”
  • On March 1, INVO announced that it has advanced its commercialization efforts into the European fertility market by securing initial orders of INVOcell in Madrid and Barcelona, Spain. INVOcell will initially be available at three separate existing fertility clinics which have placed orders and commenced training. Please read the story here.
  • Since January 2019, INVO Bioscience has signed commercialization agreements in the United States, India, as well as parts of Africa and Eurasia and Mexico for the INVOcell device.
  • INVO’s Management Issued a letter to shareholders earlier this year that spoke to their key developments and future initiatives that have positioned their product INVOcell® within the severely underserved fertility market. PLEASE read the story here.


  • Vista’s View

    INVO Bioscience (INVO) is an emerging company that owns the INVOcell system, an FDA cleared medical device that is one of only 3 ways today that a couple that is struggling with infertility may choose to use to try to get pregnant and that offers a more economical and natural way to proceed. Industry forecasts suggest that only 1% to 2% of the estimated 150 million infertile couples worldwide are currently being treated so they are working in a severely underserved market that has capacity constraints, access to care & cost issues which the INVOcell system seems to address.

    INVO Bioscience successfully conducted a public offering in November 2020, raising net proceeds of approximately $11.6 million at $3.20/share, while uplisting the company onto the NASDAQ market. These moves strengthened their balance sheet & their position to execute on their commercialization efforts in the US and around the world and helped improve the adoptability of investors and Wall Street alike.

    INVO has structured distribution agreements in eight countries located within Africa, Asia, Europe, and the Middle East.

    INVO has now structured additional joint venture agreements to open INVOcell-exclusive clinics in the US and Mexico where they will share not only in the sales of the INVOcell system, but also in the greater revenue of every cycle that would be . 

    Upcoming milestones include opening more distributor & joint venture agreements, opening of 1-2 INVO-only clinics in Q1/2021 with existing partners in the U.S. and abroad, making progress with existing relationships the various countries, & successfully receiving the nod from the FDA for 5-day labelling, which alone would allow INVO to achieve a milestone payment of $3 Million from their U.S. partner Ferring Pharmaceuticals.

    INVO’s stock closed trading at $5.40 during yesterday’s session, The 52-week range of $2.90- $12.30. The current 3-month average daily volume is 1.92 million shares. 

    Learn more about INVO Bioscience (NASDAQ: INVO) at our VP Watchlist page. 




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