It would not be an exaggeration to say that until fairly recently, female health was not prioritized in the medical technology industry. 

“The women’s health technologies that are available today are 60 years old, from T-shaped IUDs to ultrasound,” Daniela Schardinger, VP Marketing & Medical Affairs at OCON Therapeutics, tells ISRAEL21c.

Intrauterine platform

Israel-founded OCON Therapeutics develops, manufactures and commercializes women’s health products based on its patented, spherical, non-invasive, intrauterine drug delivery technology. 

It is designed to adapt to the uterus, while being large enough not to pass through the cervix opening that leads to the uterus. 

“It’s a three dimensional stent, very similar to the stent they put in the heart. Only ours looks like a little ball, with little titanium balls all around it,” says Keren Leshem, the CEO of OCON Therapeutics.

Its structure is ideal to carry multiple drugs to the uterus for treating a variety of conditions.

“On these little balls we load different medicines, chemicals, hormones, therapeutics, to treat the most prevalent diseases in women’s health related to the uterus,” she explains.

“The unique point about our technology is not only that the device itself turns into a ball once inside the uterus, but also the therapeutics on it know how to adapt themselves.” 

The device could remain in the body “for half an hour or for half a decade,” depending on the purpose. 

Birth control method

The company’s current flagship product is a non-hormonal copper contraceptive, IUB Ballerine, based on the same novel technology.

“Today the only thing that can be placed in the uterus is an IUD [intrauterine device] or an IUS [intrauterine system] that also takes care of heavy menstrual bleeding. Other than that, it’s all done orally through pills, which have systemic side effects,” Leshem says. 

The OCON treatment device is on the verge of receiving regulatory marketing approval by the Food and Drug Administration (FDA) in the United States, where OCON is currently conducting a vital study for IUB Ballerine. 

The startup also holds distribution agreements for IUB Ballerine worth a total of $45 million, including with Canada and Mexico. 

In the pipeline 

OCON is currently developing two other pipeline products utilizing the IUB frame to treat symptoms such as abnormal uterine bleeding and heavy menstrual bleeding, myomas (non cancerous tumors also known as uterine fibroids) and endometriosis.

“One out of 10 women suffer from endometriosis; seven out of 10 women will have a fibroid by the age of 57; one out of three women suffer from heavy menstrual bleeding. These are huge markets, bigger than diabetes or cancer,” says Leshem.

In order to bring the two products to market, OCON is set to open its series A funding round toward the end of 2024. 

“I think that each project needs anywhere between $10 million and $30 million to complete; these are all drugs, so they take time and money and a lot of work to get through clinical studies,” adds Leshem. 

Since its founding in 2012, OCON has raised over $30 million. 

Pioneer

OCON is one of a few med-tech companies in the World Economic Forum, having been named a Technology Pioneer by the organization in 2022. 

“That means that we can help shape and create policy around women’s health worldwide,” adds Leshem. 

But, being an industry pioneer in the sphere of female health is not an easy task.

“When I first joined OCON was when I saw how hard it was to get funding, to get attention, to really put women’s health at the forefront, because you’ll always get the question, ‘Well, what about the men?’” notes Leshem.

Schardinger adds that the field lacks not only funding, but also research. 

“Women have been excluded from clinical studies by pharmaceutical companies or research organizations until not too long ago. Women were considered a high risk because of the menstrual cycle or the possibility of getting pregnant during a clinical study,” she explains. 

“Not only we don’t know a lot about female anatomy, but even the most basic medication we take, like aspirin, we don’t know how it really affects women.”

Leshem says that the lack of women in high-power positions in investment firms and medical regulatory authorities has also played a role in the female health being neglected. 

“Look at the field of OB-GYN. I think in the US, 80 percent of OB-GYN residents used to be men. Now it’s 75% female. So it takes time for that shift to take place,” Leshem notes.  

Woman’s world

OCON was founded by Israeli physician Dr. Ilan Baram, who is only involved with the company now as a shareholder.

Leshem, who joined OCON in 2014, is an Israeli med-tech veteran. Schardinger used to run a women’s health distribution company in Austria and Switzerland.

“I actually was a distributor of IUB Ballerine in Europe, and I just loved the technology; it was so innovative because there hasn’t really been much innovation in that field, so I decided to join OCON in a bigger capacity in 2018,” explains Schardinger.

Additionally, at least 85% of the company’s 20-strong workforce are women. 

“Our team is really top notch; each one is very, very good at what they do. I think we have the best recipe to succeed, it’s just a matter of getting funding,” concludes Leshem.

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