INVO Receives 510(k) FDA Clearance for Expanded Use of the INVOcell Device

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Jun 27, 2023, 09:00 ET

INVOcell now cleared for 5-day incubation period

Supporting data reflects improved patient outcomes, similar to IVF

SARASOTA, Fla., June 27, 2023 /PRNewswire/ -- INVO Bioscience, Inc. (Nasdaq: INVO) ("INVO" or the "Company"), 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 it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to expand the labeling on the INVOcell device and its indication for use to provide for a 5-day incubation period. The data supporting the expanded 5-day incubation clearance demonstrated improved patient outcomes.

"This is a momentous day for INVO as the FDA has provided clearance for us to expand our labeling to cover a 5-day incubation period for INVOcell," commented Steve Shum, CEO of INVO. "This has been a multi-year effort to demonstrate INVOcell's ability to improve patient outcomes using a longer incubation period, similar to conventional IVF results. We believe our ability to now communicate the improved success rates using INVOcell to patients and physicians will have a positive effect on the overall confidence and adoption of the technology going forward."

	INVO Cycles	INVO Cycles	Conventional IVF
Summary Data	Day 5*	Day 3	Day 5*
	*(INSEM & ICSI)*	*(INSEM & ICSI)*	*(INSEM & ICSI)*
Total Cycle Starts	321	450	Not Avail
Total Transfers	240	421	685
Clinical Pregnancies % / Per cycle Start	42.7 %	32.4 %	Not Avail
Birth Rate % / Per cycle Start	34.9 %	23.8 %	Not Avail
Clinical Pregnancies % / Per Transfer	57.1 %	34.7 %	51.8 %
Birth Rate % / Per Transfer	46.8 %	25.4 %	44.5 %

*Retrospective (real-world data) collected from four separate clinics (2017-2019). Not all conventional IVF was collected from the four clinics. See updated Indication for Use (IFU) for additional details.

"INVOcell originally received De Novo clearance from the FDA for a day 3 incubation period," continued Shum. "Over time, industry trends for conventional IVF have moved more towards a day 5 incubation period which has generally improved pregnancy success rates. INVOcell was often being used off-label for 5-day, which similarly showed improved outcomes, and which afforded the opportunity to use real market usage data to support our 510k submission. Today's 510(k) clearance by the FDA for INVOcell use with 5-day incubation is a major accomplishment and now allows us to better showcase what INVOcell and the IVC procedure can deliver to patients in need of an affordable fertility solution. We sincerely appreciate the significant effort by our team and the clinics that contributed their real-world data."

The global fertility services market is a substantial, multi-billion-dollar industry and growing, with a significant underserved patient population. INVO's commercial strategy remains focused on helping to expand affordable care to the underserved patients in need. The Company's market approach includes the opening of dedicated "INVO Centers" offering INVOcell® and IVC procedure (three centers in North America now operational), the acquisition of existing profitable IVF clinics (signed binding agreements to acquire Wisconsin Fertility Institute), and the continued global distribution and sale of the INVOcell technology solution into existing fertility clinics.

"We believe the recent 510(k) clearance will help further support our overall commercial activities," concluded Shum.

The updated Indication for Use (IFU) is available upon request.

About INVO Bioscience and INVOcell

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), the acquisition of existing, profitable IVF clinics and the continued distribution and sale of our technology solution into existing fertility clinics. For more information, please visit invobio.com and invocell.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.