FemTech startup OCON Healthcare announces FDA acceptance of IND Application for its flagship product IUB™ Ballerine® and distribution agreements for Canada and Mexico boosting sales by $9.3 million

The new agreements bring the Ballerine®’s number of commercially signed countries to 48 with distribution agreements value of more than $45 million dollars to date.
Keren Leshem

OCON Healthcare, a women’s health company which develops, manufactures and commercializes innovative 3D intrauterine drug delivery technology based on its patented IUBTM (Intra-Uterine Ball) platform, announced that it has signed exclusive and binding distribution agreements with Global contraception giant, DKT, for an additional ten territories in the Mexico and northern LATAM region, as well as women’s health specialist, Searchlight Pharma, for the Canadian market, totaling $9.3 million. The continued growth of the IUB Ballerine® is followed by the announcement that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for the non-hormonal IUB Ballerine®, its flagship long acting reversible contraceptive (LARC). The active IND allows initiation of the company’s U.S. pivotal study planned to initiate in 2023.

These new agreements will cover Canada, Mexico, Costa Rica, Guatemala, Dominican Republic, Panama, Venezuela, El Salvador, Honduras, Nicaragua and Belize. The agreements join previous agreements signed by the company in the past year in Brazil, Argentina, Bolivia, Chile, Colombia, Ecuador, Paraguay, Peru and Uruguay, with a total value of over $15 million. OCON currently holds distribution agreements in the aggregate amount of $45 million for the IUB Ballerine globally. The company is currently commercially active with Ballerine sales in 25 countries, while over 120,000 women have already chosen to wear the contraceptive sphere in their bodies.

“We are thrilled by these strategic distribution agreements with DKT and Searchlight Pharma that will allow us to expand to eleven new territories, where the demand for modern long-term, hormone-free, safe contraception is steadily rising,” said Keren Leshem, CEO of OCON Healthcare. “Meanwhile, we are advancing our entry strategy to China and the USA, with the acceptance of our IND submission to the US FDA being an important milestone in our journey, allowing us to initiate a pivotal study for the IUB Ballerine 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 in search of innovative and unique specialty healthcare products that improve life-long human health and wellness,” said Robert Vinson, Chief Innovation Officer at Searchlight Pharma. “OCON’s IUB Ballerine meets exactly this need. With the technology’s unique 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 are looking forward to the company’s pipeline of products in the future.”

OCON’s management anticipates that sales from these agreements will begin still this year in 2022 as well as in 2023.

OCON developed the IUB™, a spherical non-invasive intrauterine drug-delivery platform adressing multibillion dollar markets in women’s health. The company’s flagship product, the small and flexible IUB™ Ballerine® contraceptive is equally effective as traditional shaped IUDs, but excels in safety compared to these contraceptives, where a copper wire is wrapped on a stiff T-shaped plastic frame. As far as the company is aware, the global contraception market is estimated to reach over $30 billion by 2025.

OCON has 2 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 Israel and Europe as an alternative to aggressive ablation procedures including hysterectomies already showing encouraging results as well as the IUB™ PRIMA™, a therapeutic-delivery to target therapy 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 excited about our collaboration with OCON Healthcare,” said Mario E Flores Alvarez, CEO of DKT Mexico & LATAM North. “As leaders in the contraception field, we believe bringing this next-generation technology designed to fit the female anatomy to our markets will offer women in our territory safer and higher quality-of-life options.”

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