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.
INVO Bioscience, Inc. is a medical device company focused on commercializing the world’s only in vivo Intravaginal Culture System (IVC), INVOcell®, an effective and affordable treatment for patients diagnosed with infertility. (PRNewsfoto/INVO Bioscience, Inc.)
“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.”
