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INVO Receives 510(k) FDA Clearance for Expanded Use of the INVOcell Device
INVOcell now cleared for 5-day incubation period Supporting data reflects improved patient outcomes, similar to IVF SARASOTA, Fla., June 27, 2023 /PRNewswire/
About this update from Invo Fertility, Inc.
[{"type":"text","content":"INVOcell now cleared for 5-day incubation period\nSupporting data reflects improved patient outcomes, similar to IVF\nSARASOTA, 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.\n\n \n \n \n \n \n \n\n \n\"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.\"\nINVO Cycles\nINVO Cycles\nConventional IVF\n Summary Data\nDay 5*\nDay 3\nDay 5*\n (INSEM & ICSI)\n (INSEM & ICSI)\n (INSEM & ICSI)\nTotal Cycle Starts\n321\n450\nNot Avail\nTotal Transfers\n240\n421\n685\nClinical Pregnancies % / Per cycle Start\n42.7 %\n32.4 %\nNot Avail\nBirth Rate % / Per cycle Start\n34.9 %\n23.8 %\nNot Avail\nClinical Pregnancies % / Per Transfer\n57.1 %\n34.7 %\n51.8 %\nBirth Rate % / Per Transfer\n46.8 %\n25.4 %\n44.5 %\n*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.\n\"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 opportunit...