Israeli femtech startup OCON Healthcare has developed a revolutionary intrauterine platform that prevents pregnancy and can also be used to treat abnormal uterine bleeding.
The IUB Ballerine is a hormone-free contraceptive solution that could represent the next generation of intra-uterine devices (IUDs). Unlike standard, T-shaped IUDs, the Ballerine is ball-shaped and forms a three-dimensional sphere once inserted into the uterus.
It is also roughly 30-50% smaller than traditional IUDs and is already being used by 100,000 women in 30 countries.
“It just suits our anatomy much better,” Keren Leshem, CEO of OCON Healthcare, told The Media Line during a recent tour of the company’s headquarters in the central Israeli city of Modi’in.
It just suits our anatomy much better
“Finally, [there’s] something that doesn’t malposition or perforate,” she said. “This is a ball, [it’s] very flexible, very pliable, and because it’s so small, it really caters to an increased safety profile.”
The IUB Ballerine is over 99% effective in preventing pregnancies for a period of five years and can easily be removed at any time, the firm says.
Dr. Ilan Baram, a senior Israeli gynecologist who is the founder and medical director of OCON Healthcare, invented the device after noticing quality-of-life problems and discomfort that came with rigid, T-shaped IUDs.
Notes Leshem: “I myself started using it six months ago.”
Unlike standard T-shaped copper IUDs, OCON’s IUB Ballerine (right) is smaller and made out of a flexible alloy. (Courtesy)
Comfort issues aside, the Ballerine also comes with fewer side effects. It is made out of nitinol, a super-elastic metal alloy that can be programmed to retain a given shape.
“We provide a spherical shape to the device, which opens up in the uterus, and on that frame we place the active ingredients,” Dr. Shani Eliyahu-Gross, CTO at OCON Healthcare, explained to The Media Line.
We provide a spherical shape to the device, which opens up in the uterus, and on that frame we place the active ingredients
OCON’s platform can be used for more than just birth control. In fact, its latest invention is a disposable device that can treat abnormal uterine bleeding (AUB), a medical condition that affects one in four women of reproductive age worldwide.
Known as the SEAD, the device could help women avert hospital stays as well as the painfully invasive procedures that are sometimes used to treat AUB. According to Eliyahu-Gross, SEAD, which is not yet available on the market, relies on a silver compound to ablate the uterine lining.
“We are conducting [research and development] experiments and we are already in Phase II of clinical trials,” she said.
As for the IUB Ballerine, for the past five years it has been available in Europe, Israel and South Africa. Once OCON receives FDA clearance, it will also be distributed in the United States.
The IUB Ballerine is currently assembled manually, with technicians adding one copper ball at a time. Photo taken November 8. (Raymond Crystal/The Media Line)
One Israeli doctor says that so far, his patients have been satisfied with the results.
“Actually, I’ve had a very good experience [with the Ballerine] because it’s very easy to insert,” Dr. Yeshaya Arie, who heads the Israeli Society of Contraception and Sexual Health, told The Media Line.
Arie is a senior gynecologist at Rabin Medical Center in Petah Tikva and has already administered the Ballerine to some 100 women.
“It’s even easier to insert than other IUDs,” he said.
Last year, the global IUD market raked in $4 billion and is projected to reach $5 billion by 2025, according to the latest report by IMARC Group, a market research firm.
Despite how lucrative such solutions are, for some reason, their basic shape has not evolved much in decades.
“There hasn’t been innovation forever,” Prof. Sergio Haimovich, chief medical officer at OCON, told The Media Line. “Since the T-shape started 40-50 years ago, it’s stayed the same.”
Haimovich is a world-renowned gynecological expert who has also served as the president of the World Congress of Hysteroscopy. He calls the Ballerine “completely revolutionary” in the field of contraception, saying it marks a “huge difference” in terms of safety because it has resulted in “90% fewer cases of ectopic pregnancy compared to the T-shape.”
Ahead of national “Thanks, Birth Control Day” across America on November 18, Leshem echoes these sentiments.
“This product illustrates how we need to look at the female body specifically and in more depth, and I think we’ll see a lot more technologies geared toward women in the next decade,” she said.