By Chloe Kent 16 Jun 2021                     (Last Updated June 16th, 2021 13:06)
IUB Ballerine is reinventing the non-hormonal intrauterine device for the 21st century. Credit: Shutterstock
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Finding a suitable contraceptive isn’t always a straightforward process. The number of options available can often seem overwhelming, and each comes with a catalogue of potential side effects and different levels of efficacy, all of which needs to carefully considered before a decision is made. Hormonal forms of contraception, such as the pill or the implant, tend to work by stopping the body from ovulating using synthetic versions of the hormones that people already naturally produce. However, they have been linked to a wide range of side effects, including acne, mood swings and even rare cases of blood clots , which many patients find off-putting. For those who prefer a non-hormonal option, the copper intrauterine device (IUD) is an increasingly popular choice and is known to be 99% effective in preventing pregnancy. The small, T-shaped piece of plastic and copper doesn’t prevent ovulation but is inserted into the uterus for five to ten years, and acts as a spermicide. The increased copper ions within the cervical mucus damage sperm and disrupt their motility, making it difficult for them to fertilise an egg. It is also thought that should an egg still become fertilised, the copper IUD may prevent the fertilised egg from implanting into the uterine wall. However, this mechanism of action is contested and there has been no concrete evidence that IUD users experience higher levels of embryonic loss compared to those not using contraception. The non-hormonal IUD may leave the body’s natural hormonal balance unaffected, but it can still lead to complications. The most common side effect is heavier and more painful menstrual periods, which occurs in 20% to 50% of users. Rarer, more serious complications can arise as well. IUDs have been known to expel themselves from the uterus, a complication thought to arise in 2.2% to 11.4% of cases, as well as perforate the uterine lining – something which only happens 0.3% to 2.6% of the time but can be very serious when it does. The copper IUD can also become malpositioned within the uterus, with one study finding that 11% of IUDs became malpositioned . This is typically associated with significant pain and excess bleeding, although some people will find it doesn’t cause them any problems. Additionally, on the rare occasions a pregnancy does occur in an IUD user, it’s more likely to be ectopic, implanting outside of the womb. These pregnancies are not viable and usually need to be removed either medically or surgically. Now, the team at OCON Medical say they’ve come up with a solution to these complications. Meet the IUB Ballerine
OCON’s intrauterine ball (IUB Ballerine) first launched in Austria in 2014, works along the same principle as the T-shaped copper coil, preventing pregnancy by releasing copper ions into the uterus. Like some copper IUDs, it can be left in place for five years and is also 99% effective in preventing pregnancy. But where the traditional IUD is rigid and sharp, potentially leading to discomfort or pain, the IUB is made up of 17 small copper beads strung along a flexible string made of a metal called nitinol. Nitinol, an alloy used extensively in medical implants such as coronary stents, can be programmed to retain a certain shape, and here is designed to curl up into a ball. During insertion, the string is stretched out to allow it to pass through the cervical opening and into the uterus, but it springs back into a ball shape when the procedure is complete. The IUB Ballerine is also a fraction of the size of a standard IUD, measuring 15mm in diameter compared to up to 32mm in diameter for T-shaped devices. OCON Medical CEO Keren Leshem says: “It may sound obvious, but the uterus is not two-dimensional. It’s a three-dimensional cavity with constant contractions which present issues when 2D intrauterine carriers are located within. “Due to the IUB Ballerine’s spherical 3D shape, smaller size and its flexible frame, it fully adapts to the shape and contractions of the uterine cavity, causing less irritation to the lining of the uterus. Having a ball-shape means it cannot malposition – a ball will always be a ball no matter which way it turns.”
In theory, the IUB should work more ergonomically with the body than the IUD, leading to fewer unpleasant side effects while retaining the same efficacy. As well as reducing the risk of malpositioning, the risk of perforation should be reduced too – the IUB lacks any sharp edges that could pierce the uterine wall. Leshem says: “The Ballerine has built-in safety mechanisms turning it 180° away from the upper uterine wall upon release inside the cavity, leading to less perforation risk. “Additionally, there is a tremendous safety advantage when looking at ectopic pregnancies. The small ball inside the cavity does not block the entrance of the fallopian tubes like the T-IUD does, resulting in a 90% reduction in the risk of a pregnancy developing outside the uterine cavity. Almost 50% of pregnancies that occur with traditional IUDs are ectopic.”
OCON estimates that of the over 100,000 IUB Ballerine insertions to date, expulsion rates are around 3.5%, perforation 0.07% and ectopic pregnancy only 0.01%. What is next for OCON Medical? OCON says that the basic design of IUB Ballerine can be repurposed for a number of indications and that it is currently researching and developing several treatment options for uterine health issues. These include abnormal uterine bleeding, heavy menstrual bleeding, uterine fibroids and cancers, endometriosis and hormonal replacement therapy. The company is also looking into developing a hormonal contraceptive version of the IUB Ballerine, to give users additional options. It is currently undergoing Phase II clinical trials into the IUB Spherical Endometrial Ablation Device (SEAD), an intrauterine drug delivery system for people with abnormal uterine bleeding or heavy menstrual being. “The IUB SEAD is a market game-changer through simplicity, cost-effectiveness and new and innovative yet gentle ‘substance-derived ablation’ technology,” says Leshem. “The current standard of care, global endometrial ablation, is considered invasive, burdensome, debilitating, costly and may result in uterine wall adhesions and even a hysterectomy. Current global ablation technologies currently in use require expensive capital equipment, extensive physician training, general anaesthesia and hospitalisation and cause high indirect costs and usually pain to women.”
OCON is also looking to roll out the IUB Ballerine into more territories. It is currently available in numerous European territories, as well as Israel, Kenya, Uganda and South Africa, and OCON is planning to expand to South America, Russia and the Commonwealth of Independent States, Ukraine, Japan and Turkey. While the Ballerine was supposed to become available on the UK NHS last year, the rollout was delayed as a result of the Covid-19 pandemic. It is however available privately. Leshem says: “OCON will continue to lead with excellence in the FemTech space. We see OCON becoming a hub for women’s health by building pillars of therapies all directed to conditions currently treated systemically, using pills with side effects. “Now women will be able to treat conditions such as abnormal uterine bleeding, endometriosis, myomas, cancers and other indications directly at the target tissue with safe and effective technology that fit their anatomy.”
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IUB Ballerine: an ergonomic approach to non-hormonal contraception

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A report published by the UN revealed that 63.6% of women with a partner rely on some form of birth control. Whether you’ve been on birth control for six months, six years or longer the process of finding the right method for you can be a journey and the onus to change methods is often on the patient. Being clued up on the different types of birth control, their effectiveness and side effects can be a lot to take in. However, the Ballerine IUB device is one of the newer forms of birth control on offer and it could work for you if you’d rather steer clear of hormonal birth control. After years of fighting, the pill became widely available over 50 years ago. Over half a decade later and it continues to be the most popular form of prescribed contraceptive in England, reports the Guardian. The publication notes that nine in 10 people are prescribed the pill but experts have raised concerns people are not given options. The IUB Ballerine is a newer form of birth control. Its website details that it requires no hormones and is over 99% effective at pregnancy prevention for up to five years. It works in a similar way to other coils in that the contraceptive properties come from copper. Daniela Schardinger from OCON Medical helped to develop the new method. She told Refinery29 that, unlike other T-shaped coils, the Ballerine was designed to be spherical so when your uterus contracts it doesn’t shift around. “It has a built-in safety mechanism to minimize the risk of perforating the uterine wall, and it’s also flexible,” she said, “This means it adjusts to your contractions and is just a better fit to what we know of the uterus today." According to Ocon Medical, the Ballerine releases small amounts of copper to provide protection against pregnancy. It’s inserted through a small tube and can be inserted at any point in your cycle so long as you’re sure you’re not pregnant. It’s likely that the Ballerine IUB is like no contraceptive you’ve seen before. It’s made up of 17 copper balls and is half the size of the usual IUDs. It’s covered in polyethylene terephthalate and is designed to fit snugly in your uterus. Before you make the decision to change your contraception it’s always best to speak to a medical professional. VeryWell Health outlines that when you’re looking at your birth control options you should consider whether the method fits your lifestyle, if you plan to get pregnant and when, whether it’ll protect you from sexually transmitted infections and how effective each method is. MORE FOR YOU
“My first question is always, ‘What’s most important to you?’” Ob-Gyn Ashley Brant, DO told Cleveland Clinic, “For one person, the answer is fewer side effects. For another, it’s a less painful period. Those preferences, plus the woman’s medical history, can help guide the decision.”
The Ballerine IUB website details that after it’s inserted you may experience heavier, longer periods and spotting between periods. However, they write that this should stop after two to three months. It also may fall out of your uterus. This is called expulsion and it’s more common in people who have never been pregnant before. If you want to try the Ballerine IUB you’ll need to book a consultation with your doctor and they’ll be able to tell you whether it’s a suitable option for you. While studies suggest that the responsibility to find the right contraceptive option still largely falls on the patient, it’s great that there’s more research being conducted into reproductive and sexual health. The more information there is out there and options there are on the market, the more likely you are to be able to feel empowered and in control of your birth control choices.

The Newest Hormone-Free Contraceptive You Need To Know About

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Global Intrauterine Devices Market Demand 2019 – HLL Lifecare, Medisafe Distribution, HRA Pharma, OCON Medical

Summary
OCON Medical Ltd OCON Medical is a manufacturer of women 's health products. The company provides leverages intrauterine technology to develop contraceptive intrauterine devices for women. It develops IUB SCu300, an advanced intrauterine device that is compatible with the uterine cavity. OCON Medical's device helps to reduce side effects such as menorrhagia or any discomfort. The company's product is a three dimensional device that also functions as drug eluting platform where its technology is based on shape memory alloy. It partners with other pharmaceutical companies for its research and development activities. OCON Medical is headquartered in Modiin, Israel. This report is a source for data, analysis, and actionable intelligence on the company's portfolio of pipeline products. The report provides key information about the company, its major products and brands. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. Scope:
The report reviews detailed company profile with information on business description, key company facts, major products and services, key competitors, key employees, locations and subsidiaries and recent developments
The report analyzes all pipeline products in development for the company OCON Medical Ltd
The report provides pipeline analysis on all pipeline products of the company by equipment type, by indication, by development stage, and by trial status
The report covers detailed information on each pipeline product with information on pipeline territory, stage of development, device class, regulatory path, indications, applications and estimated launch date
The report provides detailed description of products in development, technical specification and functions
The report also covers ongoing clinical trials wherever applicable with information on trial name, trial objective, sponsor, trial design , trial status and phase, estimated start and end date. Reasons to Buy:
Develop business strategies by understanding the trends and developments driving the medical devices pipeline and technology landscape
Design and develop your product development, marketing and sales strategies by understanding the competitor portfolio
To formulate effective Research  Development strategies
Develop marketentry and market expansion strategies
Exploit inlicensing and outlicensing opportunities by identifying products, most likely to ensure a robust return
Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline
Identify emerging players with potentially strong product portfolio and create effective counterstrategies to gain competitive advantage
Develop competition strategies by identifying the status and likely launch of the competitors' pipeline products through review of the clinical trials, stage and of development, etc
Identify, understand and capitalize the next highvalue products that your competitor would add in its portfolio
Note: Some sections may be missing if data is unavailable for the company
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OCON Medical Ltd  Product Pipeline Analysis 2018 Update Report Updated 06122018 Prices from USD $750

Chemo Group invests in OCON Medical
The Israeli company has developed the IUB, a proprietary intrauterine platform made of a super-elastic alloy. Global healthcare giant Chemo Group has made a significant strategic investment in Israeli women's health company OCON Medical . No financial details were disclosed. RELATED ARTICLES
Based in Modiin, OCON Medical has developed the IUB intrauterine platform. The Chemo Group, through its Exeltis Women’s Health Business, has been OCON’s commercial partner since 2016 and is marketing the IUB Ballerine, a spherical copper intrauterine device based on OCON’s IUB propriety technology platform, in several European countries, including Spain and Italy. This investment accelerates OCON’s continued rapid growth and expansion in both marketed products as well as further development of their IUB (IntraUterine Ball) technology platform applications. Among others this includes the Sphera, a hormonal contraception based on the spherical frame, as well as other therapeutic gynecological applications. The IUB Ballerine, with over 50,000 units sold, consistently gains market share wherever it has been launched, succeeding across very different markets, thus proving the concept of the IUB technology platform’s attractiveness to gynecological prescribers globally. OCON is currently implementing their planned market launches of the IUB Ballerine product and initiating the clinical phase of their current assets, starting in 2017, which thus maintains their ambitious growth trajectory. OCON CEO Ariel Weinstein said, “I am proud to welcome Chemo as OCON’s strategic shareholder after having experienced a fruitful collaboration on many markets. This new money will allow us to accelerate marketing roll out of the IUB Ballerine in numerous countries, R&D with the goal to start first in woman for two new products in Q4, 2017 and Q3, 2018, focus on US entry and increase manufacturing capacity." Chemo Group chairman Leandro Sigman, who has joined OCON's board, said, “I am excited by OCON's innovative IUB technology. It is being really well received by gynaecologists and women seeking long acting hormone free contraception. Our Exeltis Women's Health Business will accelerate the uptake of the IUB, while as a shareholder Chemo Group can really support OCON’s growth strategy”. OCON Medical was established in 2011 and is the developer of the IUB, a proprietary intrauterine platform made of a super-elastic alloy which is an ideal carrier for multiple substances and indications. OCON’s products have been sold in many European countries since 2014 and the company is actively developing pipeline products for additional indications. Published by Globes [online], Israel business news - www.globes-online.com - on October 19, 2017
© Copyright of Globes Publisher Itonut (1983) Ltd. 2017

Chemo Group invests in OCON Medical

Insud Pharma facilitates access to pharmacological treatments and carries out research to create improved solutions.

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The Chemo Group , through its Exeltis Women 's Health Business , has been OCON Medical 's commercial partner since 2016 and is marketing the IUB ™ Ballerine ™ , a spherical copper intrauterine device based on OCON Medical 's IUB ™ propriety technology platform , in several European countries , including Spain and Italy .

OCON Medical announces its new successful round of financing & arrival of Chemo Group as shareholder, News, Media Center, RMI Partners

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OCON Healthcare develops, manufactures, and commercializes cutting-edge women’s health products based on its patented IUB (Intra Uterine Ball) proprietary platform. The IUB, made from a super-elastic alloy Nitinol, is an ideal carrier for multiple drugs to the uterus to treat a variety of conditions.

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