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

28th June, 2023

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.

INVOcell now cleared for 5-day incubation period

Supporting data reflects improved patient outcomes, similar to IVF

"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.