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$INVO Bioscience ‘Freed’ To Roll Out Affordable Infertility Treatment Clinics (INVO Centers) Across The US

By John F. Heerdink, Jr.
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.


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 have commenced at the Company’s first U.S.-based INVO Center in Birmingham, Alabama following its opening in August 2021.

  • The second U.S.-based INVO Center opened in Atlanta, Georgia in September 2021. The practice has begun seeing patients and will perform initial treatment cycles this week.

  • The first international INVO Center opened 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.

  • Signed a partnership agreement with Lyfe Medical, LLC to establish and operate a INVO Center in the San Francisco Bay area to offer the INVOcell.

  • Completed the acquisition of a Canadian-based entity formed to offer INVOcell in Canada.

  • Development efforts for new branding, logos and website are underway, as well as an expanded social media presence. Rollout is expected in the coming weeks.

  • International distribution and INVO Center developments continue across all continents.


The current population of Mexico in 2021 is 130,262,216. According to macrotrends, the fertility rate of Mexico fell gradually from 6.5 births per woman in 1971 to 2.072 births per woman in 2021.


Positib Fertility, an INVO Center” became the first INVO Center in Mexico on Nov. 1 and follows the recent openings of INVO Centers in Birmingham, Alabama and Atlanta, Georgia. Positib Fertility is a partnership between INVO Bioscience and experienced reproductive specialist Dr. Francisco Arredondo, MD., MPH and Dr. Ramiro Ramirez Gutierrez, MD. Dr. Arredondo was an early adopter of the INVOcell solution as he began offering IVC via the INVOcell to his patients at fertility clinics in San Antonio and Austin in 2016. In 2017, due to the success in expanding the accessibility of infertility treatment to patients utilizing INVOcell, he decided to open a center where he would exclusively offer the INVOcell solution in McAllen, Texas. Dr. Arredondo successfully sold his U.S.-based fertility clinics in 2019 and is now focused on bringing the INVOcell solution to Mexico.

Dr. Francisco Arredondo, MD., MPH

“I am incredibly excited to announce the grand opening of the first INVO Center in Mexico, ‘Positib Fertility,’ focused on the providing patients with an effective and affordable infertility solution. As an early adopter of the truly remarkable INVOcell technology while practicing in the United States, I was able witness the joy that can be brought to so many families struggling with fertility. I look forward to bringing that same joy to the people of Monterrey and the surrounding areas by the opening of this first-of-its-kind clinic in Mexico, stated Dr. Francisco Arredondo, MD., MPH.

Francisco Arredondo MD, MPH, FACOG graduated summa cum laude from the Monterrey Institute of Technology and Higher Studies School of Medicine in Mexico. In 1991, the Mexican president honored him as “one of the best medical students in the country.” Two years before that, Dr. Arredondo found his passion in fertility while collaborating with Mexico’s first successful In Vitro Fertilization team. His determination to become a fertility specialist led him to do: research at the World Health Organization’s Reproductive Biology Center in Mexico City; an internship in Kahn Mount Sinai School of Medicine in New York City; an OBGYN residency at University of TexasHealth Science Center of San Antonio, Texas; a Fertility Fellowship at Hospital of the University of Pennsylvania; and a Master’s in Public Health at Harvard University where he focused on international health and business management. He practiced as an OBGYN in rural Kentucky and later became an Assistant Professor of Reproductive Biology at Case Western Reserve University in Cleveland, Ohio. Dr. Arredondo’s 40th birthday inspired him to combine his medical, entrepreneurial, and management skills to follow a new path as a “MedikalPreneur” — a term he coined — which led him back to San Antonio to open his own fertility center. Over 13 years, he and his three-member team grew a network of fertility centers and entrepreneurial ventures with more than 80 team members. In 2018 and 2019, some of his corporations underwent two mergers and made him the Chief Medical Officer of America’s largest network of fertility centers, overseeing more than 50 fertility specialists. After achieving his professional and financial goals, Dr. Arredondo sold his interest in many of his companies and embarked on a new venture: Social Entrepreneurship to democratize fertility services. A member of the medical advisory board for various American companies, he also advises national and international private equity firms that focus on health investments. Dr. Arredondo shares his success secrets so you can become a MedikalPreneur to transform your medical practice, achieve your greatest professional fulfillment, and maximize your financial potential. Dr. Arredondo is also a member of  Medical Advisory Board of Pregyny, Inc, (NASDAQ: PGNY, mkt cap ~$5.1B) that is a leading fertility benefits management company that combines clinical and emotional guidance, science, technology and data to provide comprehensive value-based fertility solutions for self-insured employers. Progyny’s benefit plans are designed to improve outcomes, shorten time to pregnancy and reduce total fertility-related costs. Lastly Dr. Areredondo is a member of the Scenic Advisory board of INVO Bioscience (NASDAQ: INVO).

 

“For too long, advanced fertility services have been largely unattainable to a large segment of the global population due to industry capacity and cost. I look forward to the opening of Positib Fertility leveraging the INVOcell technology which solves these two critical challenges helping to achieve the goal of democratizing fertility services” stated Ramiro Ramirez, MD, of Positib Fertility.


About INVOcell

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. This transaction is set to close on November 30, 2021. 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 closed trading on November 8th at $3.31. The 52- week trading range for INVO is $2.90 – $12.30.

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.



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