OCON Healthcare, a women’s health company which develops, manufactures and commercializes innovative 3D intrauterine drug delivery devices based on its patented IUB (Intra-Uterine Ball) platform, announced new positive world-wide data exploring the efficacy and safety of IUB Ballerine, the company’s smart 3D hormone-free intrauterine contraceptive.
The real-world data, collected carefully from 101,583 women by OCON Healthcare’s partners in 24 countries where the IUB Ballerine is marketed commercially, shows Ballerine’s significant safety benefits over traditional T shaped IUDs.
The real-world data, compared to data on IUDs derived from the literature, demonstrates that the IUB Ballerine has a significantly higher safety profile compared to Traditional IUDs, with 90% less risk for ectopic pregnancies (IUB: 0.01%; IUD: 0.26%) and 40% less perforation risk (IUB: 0.06%; IUD: 0.13%) due to its built in safety mechanism which allows it to deploy away from the uterine walls. Moreover, the expulsion rate stands at 3.5% with the IUB™ Ballerine, compared to that of 5% with a traditional T-shaped IUD.
“More women are looking today for smart, hormone-free, long-term contraceptives with a better fit to their anatomy”, OCON’s Chief Medical Officer, Prof. Sergio Haimovich commented. “OCON’s Post Market Surveillance data, collected from over 100,000 women who have been using it, emphasizes just how effective the innovative Ballerine really is in preventing pregnancies, while showing noteworthy safety advantages over T-shaped intrauterine devices, thus protecting women’s health and improving their quality of life”.
OCON developed the IUB™, a spherical non-invasive intrauterine drug-delivery platform aimed at treating uterine related medical conditions. The company’s flagship product, the tiny and flexible IUB Ballerine contraceptive is now commercially available in 30 countries. The IUB Ballerine excels in safety compared to the traditional T-shaped contraceptives, where a copper wire is wrapped on a stiff T-shaped plastic frame. As far as the company is aware, the global contraception devices market is estimated to reach $32 billion by 2025.
OCON has 3 more IUB pipeline products in different stages of development, including the IUB SEAD, a disruptive treatment for AUB (Abnormal Uterine Bleeding), which is in phase II clinical studies in Europe as an alternative to aggressive ablation procedures including hysterectomies already showing encouraging results . As far as the company is aware, the global AUB surgery market is expected to reach $1.3 billion by 2024.
OCON Healthcare had recently announced the successful completion of its 2020 USA-focused investment round led by US-based fund Rhia Ventures, to bring its IUB Ballerine contraceptive to the U.S. market, and to expand its Phase II clinical trials for the IUB SEAD, its game-changing point of care treatment for Abnormal Uterine Bleeding (AUB). The round included new and existing investors such as Pontifax VC and U.S. based Astia Angels, as well as grants from the Israeli Innovation Authority. OCON expects another funding round in 2021.