OCON Therapeutics, a leading women’s health company, has successfully raised $10 million to advance its innovative drug delivery systems aimed at managing abnormal and heavy uterine bleeding. The investment round, spearheaded by RH Capital and supported by Features Capital, Astia Angels, Exerte Partners, grants from the Israeli Innovation Authority, and business angels, underscores growing confidence in OCON’s transformative technologies.
The funding will primarily bolster the development of OCON’s IUB SEAD and IUB PRIMA 3D stent drug delivery frames, specifically designed to address the challenges posed by abnormal and heavy uterine bleeding. Notably, OCON has recently completed Phase IIb clinical studies for its IUB SEAD, a spherical endometrial ablation (EA) device. The studies, including NCT04381416, focused on evaluating the device’s safety and efficacy in premenopausal women suffering from abnormal uterine bleeding. Patients underwent up to two 30-minute EA sessions using the device in a hospital outpatient setting.
Looking ahead, OCON is gearing up to initiate a pivotal study in the United States and will commence discussions with the US Food and Drug Administration (FDA) through an investigational new drug (IND) submission. This strategic move aims to advance regulatory approvals and expand the availability of effective treatment options for women affected by these prevalent health conditions.
Abnormal and heavy uterine bleeding affects one in three women globally, necessitating alternative treatment options beyond pharmacologic therapies. EA, as facilitated by OCON’s innovative devices, offers a minimally invasive solution by utilizing energy to uniformly destroy the uterine lining, thereby providing relief from acute uterine bleeding.
OCON’s commitment to innovation extends beyond its current portfolio. The company’s lead product, IUB Ballerine, is a hormone-free contraceptive intrauterine device (IUD) employing copper for pregnancy prevention. Unlike traditional T-shaped IUDs known for invasive and painful insertion procedures, Ballerine, conceptualized by gynecologist Dr. Ilan Baram in 2008, is approximately one-third the size. It leverages OCON’s proprietary intra-uterine ball (IUB) technology, featuring a flexible spherical design that enhances comfort and usability.
Based in Modiin, Israel, OCON is preparing for a forthcoming Series A funding round aimed at expanding its product pipeline. This expansion will include advancing treatments for long-term conditions such as endometriosis with its IUB STELLA and uterine fibroids with its IUB ADIRA. CEO Keren Leshem emphasized, “We are addressing the most prevalent uterine pathologies, which are more common than diabetes or heart disease. Our focus is on delivering targeted, lower-dose treatments to minimize side effects and reduce risks associated with surgical interventions or non-compliance with oral medications.”
OCON’s pivotal role in the development of copper IUDs is underscored by its inclusion as a key player in GlobalData’s Medical Intelligence Center report. This recognition reinforces OCON’s leadership in advancing medical solutions that improve the quality of life for women globally.
