OCON Healthcare Develops New Women’s Health Devices

IMGBallerine OCON

OCON Healthcare, an Israeli FemTech startup, manufactures and commercializes innovative 3D intrauterine devices (IUD) for women who wish to conceive based on its patented IUB (Intra-Uterine Ball) platform.

The company has a woman as its chair, Dr. Anula Jayasuriya.

FemTech is a form of Medtech. Until now, the Femtech developers and medical specialists who have worked in women’s medicine have mostly been men. OCON wants to change that.

Contraception is central to women’s issues. The IUD is a device implanted into the body and can be removed anytime. This gives women a higher level of freedom and control over their own bodies.

OCON’s offices are located in a technological park outside of the city of Modiin. These kinds of office parks, new high tech hubs, have been built up all over Israel in the past 30 years. Anywhere there is available space, you will find one. Right next to the airport is one simply called Airport City. Older areas, places which once had factories, have been transformed into officer parks too.

Modiin is conveniently located about halfway down the road from Jerusalem on the way to Tel Aviv. It’s on what was once a windy back road, but which has been transformed into one of Israel’s major arteries. Just to the west is the airport and after that the greater Tel Aviv area.

A number of OCON employees who work at these offices, which they only moved into this past January, leave in nearby cities like Rehovot and Kfar Sabba.

It makes sense that OCON would be based in a new area like this. Its medtech is new and groundbreaking. Their offices are on the ground floor of the building with a separate entrance.

Here they have the usual break room that you would find at any high tech startup, including a pod coffee machine. The walls are covered with various slogans like “GOOD Coffee, Good MOOD, GOOD Day,” “Don’t wait for opportunity, create it!” and “Of course you will make mistakes, but the biggest one will be not to try.”

Keren Leshem OCON’s CEO has over 20 years of experience in the medical device and pharmaceutical industries.

Keren is a straight talker who likes to get right to the point. Once in her office, she spoke all about OCON’s signature products with the focus and determination of a sales rep. She joined the company about 18 months ago and saw its great potential.

Leshem says that she understood something that its team at the time did not. It was a precarious time for OCON and it may have closed. But Leshem was determined to not let that happen and explained to the investors why the company had such great potential. She recently sat with Jewish Business News for an interview.

Speaking with full faith and passion in her company and product, Keren discussed how the traditional IUD market is worth billions of dollars a year. The industry has little incentive to innovate since only a small percentage of women have complications, but that still leaves a lot of people in need of an alternative. Businesses usually see it as most cost effective to simply replace a device with new one, as log as there is nothing life threatening involved.

While the devices may have been upgraded somewhat over the years, made from softer materials and so forth, there were no major changes. Women still suffer from complications.

Keren Leshem CEO (Courtesy OCON)

The first is malposition. This is when the IUD moves out of place and can cause a variety of problems including pain and bleeding. And it is not always clear that the device causes these problems. Malposition occurs in over 16% of women, leading to either pain or bleeding in 75% of malposition IUDs.

So how is OCON’s device different from all the others? While IUDs are T-shaped, OCON’s Ballerine is spherical, 3D shaped, smaller, and has a flexible frame.

It fully adapts to the shape and contractions of the uterine cavity, causing less irritation to the endometrium (the lining of the Uterus). OCON explains a ball will always be a ball no matter which way it turns. So it will not have the same problems as with traditional IUDs that can shift and turn inside the uterus.

But this is just the beginning. OCON is developing a hormonal version to be used for contraception but also to treat Menstrual Disorders.

The company is currently in Phase2 Clinical Trials with its IUB™ SEAD™ – an intrauterine drug delivery technology for women with abnormal uterine bleeding and/or heavy menstrual bleeding.

Current global ablation technologies in use require expensive capital equipment, extensive physician training, general anesthesia, and hospitalization and cause high indirect costs and usually pain to women. OCON hopes to change this.

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The trials for the new product are so far have gotten some very promising results. They have been so good, in fact, that Keren was grateful to see at least one participant show no improvement at all. This is because there are always outliers and if a study shows only positive results, then there must be something wrong with its procedures.

Therefore Keren Leshem saw much potential with OCON, even when the company was in jeopardy. “So I said to the investors, ‘you guys would be crazy to close this company! This is a unicorn you have here!’” she explained.

And they listened to her. A unicorn is a new company worth more than $1 billion. Considering that OCON sees a potential of billions in annual revenue once their solution gets full FDA approval, it may very well be one.

Covid-19 crisis, like many others, put them in considerable adversity in continuing the company’s development. Offices were closed everywhere and people needed to communicate through teleconferencing.

“I was on Zoom 23 hours a day every day,” said Leshem. And this was difficult for a startup trying to raise the funds needed to keep its doors open. “I’d never raised money through zoom before. They don’t really see you, so it’s not like you have really met. You don’t get the chance to do the schmoozing and things like that. It’s crazy!” she added.

“OCON is not just a company making a product for women. It is a company run by women.” Keren Leshem

“I believe in diversity. We are 85% women. Overall of the departments, no exclusivity,” Leshem told JBN. “It’s not fair, but you really have to let women do the work when you’re talking about a product made for women alone.”

And as women, they have to have more flexible schedules, especially if they have families. “A lot of us take a break at 4 PM, go home and take care of the kids, and then come back at 8 PM to finish work.”

“I want to build OCON as a women’s health hub,” she said.

Women working in firms developing medical products for use by women, fill the need many women have all over the world.

Believe it or not, most clinical studies for new medications as well as devices are not done using a cross-sample of the population at large. In fact, they are not even done with a 50-50 split of male and female subjects. Most subjects in medical studies are almost always male. But obviously, this cannot be the case when testing new products for women’s health issues.

IUB™ SEAD™ OCON

As with all startups, this one’s investors hope to make a profit from an exit, either through an initial public offering, or a direct sale to another company. And if the recent history of Israeli IPOs and startups getting bought out continues, then OCON’s investors have reason to be optimistic.

The stock markets are booming right now and a few Israeli startups have had multi-billion IPOs since the start of the year. But some analysts see a bubble and expect a market correction soon. This, however, does not concern Keren Leshem.

“I think that in Medtech you have less of a chance of a bubble-like what happened with the dot com’s,” she explained. “So even if the market is overheated it won’t change the fact that our product is something that is not just in demand, it’s a necessity for women.”

Dr. Shani Eliyahu-Gross CTO OCON at work (JBN)

Dr. Shani Eliyahu-Gross is OCON’s chief technological officer. She oversees the actual day-to-day development and production of its products. Shani is also optimistic. “I believe there is a huge potential in drug delivery solutions for women, to provide women with quality of life and make decisions while having control over their own bodies,” she told JBN.

For now, OCON’s devices are handmade, as everything is still in the developmental stage. They cut the materials into smaller pieces and then build the device.

OCON is still just a baby in the world of scientific/high-tech startups. It will take time for it to get final approval for the new devices. This is one drawback in Medtech: whatever the product may be trials must be performed and regulative bodies like the FDA must give their approval before a new product can be marketed. This is not the case for businesses developing new software or computer devices.

But if all goes well as OCON seems to do so far, look for it to make headlines soon.