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
"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
"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
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SOURCE INVO Bioscience, Inc.
