FemTech Startup OCON Healthcare Announces FDA Acceptance of IND Application for Lead Product IUB™ Ballerine® and Distribution Agreements for Canada and Mexico, Boosting Sales by $9.3M
OCON Healthcare, a women’s health company that develops, manufactures and markets innovative 3D intrauterine drug delivery technology based on its patented IUBMT (Intra-Uterine Ball), announced that it has signed exclusive and binding distribution agreements with the global contraceptive giant, DKT, for ten additional territories in the Mexico and northern LATAM region, as well as with the specialist in women’s health, Searchlight Pharma, for the Canadian market, totaling $9.3 million. The continued growth of IUB Ballerine® is followed by the announcement that the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for the non-hormonal IUB Ballerine®, its contraceptive reversible long-acting headlight (LARC). The active IND enables the launch of the company’s pivotal US study, which is scheduled to launch in 2023.
These new agreements will cover Canada, Mexico, Costa Rica, Guatemala, Dominican Republic, Panama, Venezuela, El Salvador, Honduras, Nicaragua and Belize. The agreements are in addition to previous agreements signed by the company last year in Brazil, Argentina, Bolivia, Chile, Colombia, Ecuador, Paraguay, Peru and Uruguay, for a total value of more than $15 million. OCON currently has distribution deals totaling $45 million for IUB Ballerina worldwide. The company is currently commercially active with sales of Ballerina in 25 countries, while more than 120,000 women have already chosen to carry the contraceptive sphere in their body.
“We are delighted with these strategic distribution agreements with DKT and Searchlight Pharma which will allow us to expand into eleven new territories, where demand for modern, long-term, hormone-free and safe contraception is steadily increasing,” said Keren Leshem, CEO. of OCON Healthcare. “Meanwhile, we are advancing our China and US entry strategy, with the acceptance of our US FDA IND submission being an important step in our journey, enabling us to initiate a pivotal study for the Ballerina IUB for marketing approval. We anticipate that our activities to expand our existing markets, while developing our platform products for additional markets, will result in significant value for our shareholders.”
“We are always on the lookout for innovative and unique specialty healthcare products that improve human health and well-being across the lifespan,” said Robert Vinson, chief innovation officer at Searchlight Pharma. “OCON’s Ballerina IUB meets exactly this need. With the unique technology design and safety features, we strongly believe that we will be able to successfully promote the entry of this innovation into Canada for the benefit of women in this region and look forward to the product portfolio. of the company in the future.
OCON management expects sales of these deals to begin again this year in 2022 as well as 2023.
OCON has developed the IUB™, a non-invasive spherical intrauterine drug delivery platform for multi-billion dollar women’s health markets. The company’s flagship product, the small and flexible IUB™ Ballerine® contraceptive is as effective as traditionally shaped IUDs, but excels in safety compared to those contraceptives, where a copper wire is wrapped around a plastic frame rigid T-shaped. To the best of the company’s knowledge, the global contraceptive market is expected to reach over $30 billion by 2025.
OCON has 2 other IUB™ pipeline products in various stages of development, including the IUB™ SEAD™, a disruptive treatment for Abnormal Uterine Bleeding (AUB), which is in Phase II clinical studies in Israel and Europe as an alternative to aggressive ablation procedures, including hysterectomies already showing encouraging results, as well as IUB™ PRIMA™, a therapeutic treatment to target therapeutic areas such as endometriosis and myomas as well as heavy menstrual bleeding and other indications moving away from systemic side effects due to oral consumption.
“We are thrilled with our collaboration with OCON Healthcare,” said Mario E Flores Alvarez, CEO of DKT Mexico & LATAM North. “As leaders in the field of contraception, we believe that the introduction of this next-generation technology designed to adapt to female anatomy in our markets will provide women in our territory with safer and better options. quality of life.”