OCON Healthcare, a women’s health company that develops, manufactures, and commercializes an innovative 3D intrauterine drug delivery technology based on its patented IUBTM (Intra Uterine Ball) platform, today announced it had completed enrollment of its Phase IIa clinical study evaluating its intrauterine drug delivery platform IUB™ SEAD™, non-invasive treatment for abnormal uterine bleeding (AUB).
The trial assesses the safety and efficacy of the IUB™ SEAD™, a disruptive treatment for AUB. In this study, 50% of the participating patients have reached the End of the Study point, demonstrating a significant reduction in bleeding, avoiding the need to undergo invasive uterine ablation procedures or even a hysterectomy.
AUB is a medical condition affecting nearly 1 out of 4 women in the reproductive age range (18-50), causing heavy irregular bleeding from the uterus resulting in a significant decrease in their quality of life and even risk of death.
OCON’s IUB™ SEAD™ is a disruptive non-invasive treatment for AUB, designed as an alternative to the traditional hormonal medication and/or aggressive and irreversible ablation procedures that are non-reversible and remove the women’s chances for later pregnancy, or hysterectomy procedures.
In this clinical study, held in 3 medical centers in Europe, 8 out of the participating 16 patients have reached the End of the Study point and demonstrated a significant reduction in bleeding. No safety issues were reported to date and all patients were discharged with no complaints. A follow-up duration of 12 months is made for each patient post-procedure.
“More women and doctors are looking today for innovative and simple solutions to treat AUB,” said Prof. Sergio Haimovich, Chief Medical Officer at OCON Healthcare.
“The IUB™ SEAD™ solves this medical condition, which negatively impacts the health and the quality of life of 25% of all women in their reproductive years, with no need for irreversible ablation techniques or hysterectomies. This groundbreaking technology already made a positive impact on women’s lives and we are certain we will see more of it during our clinical studies in the near future.”
As far as the OCON is aware, the global AUB surgery market is expected to reach $1.3 billion by 2024, with 1.4 million women per year who report AUB.