INVO Bioscience, Inc. (NASDAQ: INVO) is a medical device and fertility clinic development company focused on creating simplified, affordable 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.” The INVOcell® enables the first intra-vaginal culture (IVC) procedure in the world and is used for the natural, in-vivo incubation of eggs and sperm during fertilization and early embryo development. The INVOcell offers 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 and increase the availability of care. For more information, please visit invobioscience.com.
On Thursday, INVO Bioscience, Inc. (NASDAQ: INVO) announced the Company has entered into an expanded agreement with Ovoclinic, a group of clinics specialized in assisted reproductive treatments with four locations across Spain (Madrid, Marbella, Málaga, Ceuta) and collaborating centers around Europe, to accelerate adoption of INVOcell within their markets. The agreement includes the expanded adoption of INVOcell within Ovoclinic locations as well as establishing an INVO Center of Excellence for future training for the European Market. Cristina Gonzalez, embryologist and Quality Manager of Ovoclinic laboratories stated, “After several successful trials implementing the exciting INVOcell fertility treatment, Ovoclinic aims to provide its patients with this effective alternative to the processes used so far in Spain in the field of reproductive medicine. We consider INVOcell to be an effective method of natural reproduction that involves the future mother at the very first moment of the process. We are confident that this innovative treatment will help many patients to choose this new alternative solution to achieve their dream of forming a family by actively participating in the reproductive process.” According to the World Bank, Spain, with total population of approximately 47 million people, has one of the lowest fertility rates in Europe, affecting approximately 15% of the population, or one in seven couples of reproductive ages. According to reports, in 2010, there were approximately one million couples requesting assisted reproductive treatment, however only 22% received one or more assisted reproductive treatment cycles. The average waiting time for an IUI or IVF cycle in a public health facility was 339 days. Ovoclinic reports that they maintain the best technical and human resources to deal with all kinds of infertility problems along with the simplest and most natural treatments to the most complex and advanced techniques pioneered in Spain. Ovoclinic also works in partnership with Ovobank, the first European Donor Egg Bank in Europe.
Steve Shum, CEO of INVO Bioscience (NASDAQ: INVO)
“Since our initial relationship began earlier this year, the teams at INVO and Ovoclinic have worked closely together to train their medical team and introduce the INVOcell solution to patients in need of advanced fertility treatment. We are thrilled to be expanding our relationship with Ovoclinic through this agreement, which reflects their enthusiasm and belief in the INVOcell treatment option and desire to not only expand the technology in their own clinics, but also utilize their strong reputation and current operations in Spain to become a center of excellence to help promote INVOcell to other fertility clinics in the EU. We look forward to working closely with Ovoclinic to help expand adoption and achieve our goal of advancing assisted reproductive treatment throughout Spain to the many individuals that need care,” stated Steve Shum, CEO of INVO Bioscience.
PREVIOUSLY REPORTED PROGRESS
After the market closed on Monday Nov. 8, INVO Bioscience, Inc. (NASDAQ: INVO) announced that it will regain full U.S. commercialization rights for its patented INVOcell® device due to Ferring International Center S.A.’s termination for convenience of that certain Distribution Agreement dated November 12, 2018 with INVO, which termination will officially take effect on January 31, 2022. Additional information regarding the timing and transfer of the INVOcell U.S. commercialization rights can be found in the Company’s Form 8-K filed with the Securities and Exchange Commission and available at www.sec.gov. Mike Campbell, COO and VP business development of INVO stated, “We thank Ferring for their valuable partnership and contributions toward the advancement of the INVOcell technology over the past three years. We are excited, and INVO is fully prepared to support and execute on the opportunities across our expanding customer base in the U.S.”
Over the past three years, INVO has been executing on a multi-faceted commercialization strategy, which includes partnering to open dedicated “INVO Centers” focused on INVOcell and the IVC procedure, and establishing agreements with distributors in key markets. The terms of the U.S. Distribution Agreement had limited the number of INVO Centers that they were allowed to operate. INVO can now further support U.S. fertility clinicians directly as the exclusive provider of INVOcell® in pursuit of their mission to bring advanced fertility care to the millions of people that are without access to infertility treatment.
Steve Shum, CEO of INVO Bioscience (NASDAQ: INVO)
“The patients are at the core of our strategy, and we believe that our partnerships and multi-channel business approach can most effectively deliver treatment where it is needed. We believe that direct access to the U.S. market enables us to aggressively pursue our mission to address and improve capacity constraints in the market, and to provide quality fertility care to the patients who need it. We have assembled a strong team of industry leaders who are highly experienced in commercializing advanced reproductive technologies. With the capital we have raised, we are well positioned to leverage their expertise and our infrastructure to accelerate adoption of INVOcell throughout all channels in the U.S. market. In our opinion, the clinical and commercial validation of INVOcell has grown tremendously over the past few years and we believe this provides a solid foundation for our strategy. Direct control of the U.S. market should now enable us to sell directly into the existing IVF clinics, expand the number of INVO Centers free of any limitations, and to aggressively pursue our market expansion to increase access to care,” stated Steve Shum, CEO of INVO Bioscience (NASDAQ: INVO).
An Update on Recent Commercialization Milestones
Initial treatment cycles commenced at the Company’s first U.S.-based INVO Center in Birmingham, Alabama following its opening in August 2021.
Opened the second U.S.-based INVO Center in Atlanta, Georgia, in September 2021. The practice began seeing patients and performed its initial treatment cycles last week.
Opened the first international INVO Center, and third overall in Monterrey, Mexico, on November 1, 2021. The Monterrey INVO Center has begun seeing patients, with the first cycles scheduled to occur later this year.
Completed its acquisition of a Canadian-based entity, originally formed to offer INVOcell®, to advance its distribution in Canada.
Signed a partnership agreement with Lyfe Medical, LLC to establish and operate an INVO Center in the San Francisco Bay area to offer the INVOcell®.
Four poster abstracts discussing INVOcell® were presented at the 77th Scientific Congress & Expo of the American Society for Reproductive Medicine (“ASRM”) held in Baltimore, Maryland in October 2021.
The INVOcell procedure is the first in-vivo culture (IVC) system in the world used for the incubation of eggs and sperm during fertilization and early embryo development within the body, as an alternative to conventional In Vitro Fertilization (IVF) and Intrauterine Insemination (IUI). Through its in vivo approach, INVOcell offers patients a more natural and intimate experience with comparable results at a lower cost.
INVO Bioscience (NASDAQ: INVO) WAS RECENTLY FUNDED BY WALL STREET
On Oct. 1, INVO announced that it had entered into definitive agreements with institutional and accredited investors and members of INVO Bioscience’s management team to purchase 1,240,763 shares of its common stock at a purchase price of $3.26 per share, in a registered direct offering priced at-the-market under Nasdaq rules, for gross proceeds of approximately $4.0 million. The registered direct offering was expected to close on or about October 5, 2021, subject to the satisfaction of customary closing conditions. The group of investors includes members of INVO Bioscience’s management team, including Steve Shum, CEO, and Andrea Goren, CFO. Paulson Investment Company, LLC is acting as the exclusive placement agent for the offering. The gross proceeds from the offering are expected to be approximately $4.0 million, before deducting placement agent’s fees and other offering expenses. INVO Bioscience currently intends to use the net proceeds from this registered direct offering for general corporate and working capital purposes.
Also, on Oct. 1, INVO entered into a separate Stock Purchase Agreement with Paradigm Opportunities Fund, LP an accredited institutional investor, pursuant to which we will issue to such investor 600,703 shares of their common stock, par value $0.0001 per share for a purchase price of $3.329 per share for an aggregate purchase price of $1,999,740.29. The Shares will be issued under the exemption from registration under Section 4(a)(2) and/or Rule 506 of the Securities Act of 1933, as amended. The Purchase Agreement contains a $250,000 break-up fee whereby if either party fails to close, it will be required to pay the non-breaching party a fee of $250,000. The investor under the Purchase Agreement also agreed to a 1-year lock up period with respect to the Shares.
TRADING INVO’S STOCK
INVO Bioscience’s stock is currently trading at $3.76 on the NASDAQ and has traded into positive territory for 8-consectuiive days (see the 14-day chart above.) The 52- week trading range for INVO is $2.90 – $12.30. INVO Bioscience currently has ~11.73M shares issued and outstanding. Colliers Securities recently published and updated reported with a BUY Rating and a $6 Target Price.
INVO’S BOARD OF DIRECTORS
Barbara Ryan is an INVO Bioscience Board Member
INVO has also transformed their board of directors adding a couple of powerful global thought leaders including Barbara Ryan, a Corporate (Public) Board Member with expertise in Healthcare and Life Science Capital Markets – Audit -Strategic Counselor to CEO/C-Suite within Biopharma & Med-Tech with 31 Years of experience working on Wall Street as Pharmaceutical Analyst and Managing Director and a frequent guest expert on CNBC. INVO also recently added Rebecca Messina. Messina has broad international experience in leading marketing for elite brands and businesses including Uber Technologies (UBER), Beam Suntory and The Coca-Cola Company (KO). She is currently a Senior Advisor at McKinsey & Company focused on advising internal teams and firm clients in the areas of marketing as a growth lever, including data driven marketing, brand building, and strategically shaping and transforming marketing agendas.
Rebecca Messina is an INVO Bioscience Board Member
“Democratizing Infertility – A Severely Underserved Global Market”
On April 13, INVO’s CEO Steve Shum delivered his presentation is titled “Democratizing Infertility – A Severely Underserved Global Market.” You may view the video of the event which has now been viewed over 20k now at this link: https://youtu.be/w4yQIc7eO5k.
ADVANCING THE USE OF INVOcell® WITHIN THE OB/GYN COMMUNITY
In yet another progressive move, INVO Bioscience, Inc. (NASDAQ: INVO), a medical device company focused on commercializing the world’s only in vivo Culture System (IVC), INVOcell® announced on June 14th that they had the appointed Barbara Levy, M.D., FACOG, FACS as the Company’s Senior VP, Global Clinical Integration. Dr. Levy is considered one of the most influential clinical executives in the world, recently serving as Vice President, Health Policy at the American College of Obstetricians and Gynecologists (ACOG) and chair of the American Medical Association/Specialty Society Relative Value Scale Update Committee. She joins INVO Bioscience to help further develop and accelerate the Company’s global OB/GYN channel strategy. Dr. Levy has been a vocal advocate for women’s health and health equity with appearances on The Oprah Winfrey Show and multiple other media outlets. Her research interests span from outcomes research in minimally invasive gynecologic surgery to optimizing care for women with chronic pelvic pain. Her clinical work focused on evidence-based, equitable, comprehensive care for women throughout their life course. She has published and co-authored over 85 studies.
Barbara Levy, M.D., FACOG, FACS as the Company’s Senior VP, Global Clinical Integration at INVO Bioscience
“Women’s healthcare has been a life-long passion for me and a critical component of improving women’s health and wellbeing is treatment for infertility. There is a large unmet need for efficient and scalable advanced treatment options, that are also accessible and affordable, to help bring equity to the large underserved patient population suffering from infertility. I believe IVC and the INVOcell technology provides a unique market solution and am excited to be joining the INVO Bioscience team to focus on quality and outcomes for patients and to support fertility practice healthcare professionals,” stated Barbara Levy, M.D., FACOG, FACS as the Company’s Senior VP, Global Clinical Integration at INVO Bioscience.
Dr. Levy is an advocate for advancing the quality of women’s health. Dr. Levy was in private practice in comprehensive holistic women’s health for over 30 years and served as a Medical Director for Women’s and Children’s Services for the Franciscan Health System in Washington State. She has served as a reviewer and editor for several medical journals, including Obstetrics & Gynecology, American Journal of Obstetrics and Gynecology, JAMA, JMIG, Fertility and Sterility.
In 2012 Dr. Levy joined the American College of Obstetricians and Gynecologists (ACOG) as Vice President for Health Policy, directing the expansion of the Advocacy Division to support implementation of best practices in women’s health. She built a team dedicated to improvement in health equity and outcomes in maternity care, primary women’s healthcare, and surgical interventions.
Dr. Levy graduated magna cum laude from Princeton University. She obtained her medical degree from the University of California, San Diego, followed by an internship and residency at the Oregon Health Sciences University.