First Baby Born in Malaysia Utilizing Innovative INVOcell Assisted Reproductive Technology

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Nov 30, 2022, 09:30 ET

Patient was part of a prospective peer reviewed study of INVOcell compared to conventional IVF (cIVF) in Malaysia
INVOcell provides an advanced, effective and affordable infertility treatment option to help increase access to care.
The multi-billion-dollar global fertility market is predicted to reach approximately US$47.9 billion by 2030 yet remains severely underserved with many patients unable to access affordable treatment.

SARASOTA, Fla., Nov. 30, 2022 /PRNewswire/ -- INVO Bioscience, Inc. (NASDAQ: INVO), a commercial-stage fertility company focused on expanding access to advanced treatment worldwide with its INVOcell ^® medical device and the intravaginal culture ("IVC") procedure it enables, today announced the birth of the first baby in Malaysia utilizing the INVOcell solution. The healthy baby boy weighed 3.53 kg and was born on November 11, 2022 at Tuanku Mizan Military Hospital in Kuala Lumpur. Physicians at Advanced Reproductive Centre (ARC), at Hospital Canselor Tuanku Muhriz (HCTM), at the National University of Malaysia conducted the IVC procedure.

"We couldn't be more pleased to have been a part of this family's journey towards parenthood," commented Steve Shum, CEO of INVO Bioscience. "The INVOcell solution is playing a key role in providing families across the world an alternative method to parenthood by leveraging its innovative medical device to allow fertilization and early embryo development to take place in vivo within the woman's body; an approach that provides for affordable, high-quality, patient-centered fertility care."

The patient was part of a prospective peer reviewed study of INVOcell compared to conventional IVF ("cIVF") that took place at ARC at HCTM. The study, titled "Comparison of Treatment Outcomes among Sibling Oocytes Using Different Culture Systems—Conventional IVF versus INVOcell Device—And Evaluation of INVOcell User Satisfaction: The INVOcIVF Study," was published in the International Journal of Environmental Research and Public Health.

Key findings of the study include:

The fertilization rate and good embryo quality were comparable (not significantly different) between INVOcell and cIVF.
Although both methods produce similar fertilization rates and good-quality embryos, the blastulation rates were better in the INVOcell group.
INVOcell can be used as an alternative method for reproductive treatment in carefully selected patients without jeopardizing outcomes.
cIVF is costly and not applicable in most rural and district areas, therefore, the INVOcell can be utilized as a cost-effective alternative to cIVF without sacrificing comfort and outcomes.

"We are pleased to see the published findings from Malaysia demonstrating the attributes of INVOcell," Shum added. "We believe Malaysia, with an approximate population of more than 32 million, represents an attractive opportunity for INVOcell. This publication follows the recent award INVOcell received as a new and innovative fertility treatment, with IVC formally being made available to patients at HTCM, one of the five university hospitals in Malaysia, and currently the highest volume fertility center in the country. We look forward to continuing our work with key partners in Malaysia to bring our innovative advanced fertility treatment to the people of Malaysia."

International Journal of Environmental Research and Public Health is an interdisciplinary, peer-reviewed, open access journal published semimonthly online by MDPI. It covers Environmental Sciences and Engineering, Public Health, Environmental Health, Occupational Hygiene, Health Economic and Global Health Research, etc.

About INVO Bioscience

We are a commercial-stage fertility company dedicated to expanding the assisted reproductive technology ("ART") marketplace by making fertility care accessible and inclusive to people around the world. Our primary mission is to implement new medical technologies aimed at increasing the availability of affordable, high-quality, patient-centered fertility care. Our flagship product is INVOcell^®, a revolutionary medical device that allows fertilization and early embryo development to take place in vivo within the woman's body. This treatment solution is the world's first intravaginal culture technique for the incubation of oocytes and sperm during fertilization and early embryo development. This technique, designated as "IVC", provides patients a more natural, intimate, and more affordable experience in comparison to other ART treatments. We believe the IVC procedure can deliver comparable results at a fraction of the cost of traditional in vitro fertilization ("IVF") and is a significantly more effective treatment than intrauterine insemination ("IUI"). Our commercialization strategy is focused on the opening of dedicated "INVO Centers" offering the INVOcell ^® and IVC procedure (with three centers in North America now operational), continuing to distribute and sell our technology solution into existing fertility clinics, & recently expanded our commercial strategy to included acquisitions of existing IVF centers where we can work with a growing number of like-minded physicians that share INVO's mission to democratize fertility care by joining forces in expanding access to treatment. We recently signed a non-binding letter for an acquisition target, have completed due diligence for this opportunity and are working to finalize definitive agreements. For more information, please visit www.invobio.com.

Safe Harbor Statement

This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at www.sec.gov. We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE INVO Bioscience, Inc.