Ballerine® – an innovative non-hormonal intrauterine device
Women all over the world need to compromise on therapeutic solutions that are not adapted to their body – for different needs and medical problems. In the field of contraception, for example, there are solutions such as a T-shaped intrauterine devices made of plastic, which are inserted and placed in the uterus for 5-10 years, or oral hormones taken in the form of pills, injections, intrauterine or vaginal devices that elute hormones as well.
After over 50 years of lack of innovation in this space, OCON Healthcare has developed the IUB Ballerine®, an intrauterine device made of flexible, small nitinol designed in a D3 spherical shape adapted to the uterus. The device is inserted through the thinnest tube available and it coils to it’s 3D shape inside the uterus.
Almost 1/3 in size and flexible
Unlike outdated and traditional T-shaped devices that are made of plastic, the development of OCON is similar to a stent known for use in cardiology with no sharp edges that can injure the lining of the uterus. In addition, it is almost 1/3 in size and is flexible so that when the uterus moves and contracts it does not elicit pain or extra bleeding.
OCON’s Ballerine is currently marketed in 30 countries around the world, with over 110,000 women using it so far. Its spherical, flexible and unique shape significantly reduces the risk of irritation and perforation of the uterine wall, which increases during installation and use of traditional T-shaped devices. The Ballerine manages to prevent pregnancy in 99% of cases and unlike the old device, it enjoys satisfaction of more than 85% Of the women who use it.
Treats the problem of 25% of the women in the world
Already market-validated in over 110,000 women, OCON further demonstrates its leadership in innovation by extending the use of their 3D delivery platform beyond the existing use of the copper device. The company has already developed its next product – the IUB SEAD, which is based on the same spherical platform, and is currently in the midst of clinical research here in Israel, to test its treatment for abnormal uterine bleeding. This problem affects about 1 in 4 women and has a market potential of over $1 billion.
Using the IUB SEAD, endometrial ablation procedure (a kind of peeling of the uterus lining) can be performed in a local clinic, in the community, without the need for anesthesia and an invasive and painful process that usually involves hospitalization.
Reduce the costs to healthcare systems
The device is already in Phase IIb of clinical trials and so far, the results are very encouraging, showing a dramatic reduction in bleeding and already helping women refrain from hysterectomies (Uterus removal).
The process is aimed to be performed once every few years, it will significantly reduce the costs to healthcare systems and patients, allow simple and painless insertion at the clinic and avoid more complex, painful and dangerous processes involving anesthesia that may end in hysterectomy if failed. The IUB SEAD will enable millions of women around the world to enjoy a carefree and fearless routine.
By 2024, the company expects to receive FDA approval for its two flagship products, The IUB Ballerine® and the IUB SEAD. This is a significant milestone that will allow the company to step into the US market and provide an innovative and unique solution for millions of women.
The company is already working on additional developments based on its revolutionary 3D platform – all to benefit women’s medical needs. The market potential is estimated at billions of dollars. In the future the IUB will also have a hormonal version for contraception, endometriosis and abnormal uterine bleeding and it’s already in advanced prototype stages before pre-clinical trials. Hormonal intrauterine devices are a product in huge demand amongst women and the hormonal IUB will allow the company additional exposure to a $ 2.5 billion market.
Protected by 3 patent families
OCON will continue to develop local treatments in the uterus for endometriosis, fibroids, menopausal-related problems and more. These are markets worth tens of billions of dollars and the goal is for the device to be able to carry drugs, chemicals, pharmaceuticals and hormones that are currently taken orally today which carry vast systemic side effects
The OCON platform is protected by 3 patent families some of which have already been granted worldwide and some are pending approval. The company’s developments are protected at least until 2034 from competition based on its patent portfolio.
The company has large and experienced investors in the field who have invested and continue to invest in OCON, including: the Israeli Pontifax VC, the American VCs RHIA VENTURES and ASTIA ANGELS.
- An approved CE product that demonstrated market validation on over 110,000 women worldwide.
- The company is changing the paradigm in women’s health treatments, and enables the use of its patented platform for a variety of needs.
- In 2024 the company is expected to receive FDA approvals for 2 of its flagship products.
- The company operates in huge markets and manages to meet the diverse health needs of millions of women globally.
- The company has large and experienced investors who have invested and continue to invest in OCON.
- OCON enables solutions in the community, thus making innovative therapies accessible and making medical processes cheaper, safer and fitting the women’s anatomy.
- The company is focused on women and is also managed by women who understand best the needs of their clients.
- The company has a number of patents that have already been granted and prevent direct competition by others.
- The use of the company’s product is simple and friendly to both doctors and patients, it’s smaller and less invasive and is therefore likely to become a preferred treatment.
- The company solves a variety of health conditions for every stage of a woman’s life.