OCON Healthcare Develops New Women’s Health Devices

OCON Healthcare Develops New Women’s Health Devices

JBN recently got to take a tour of their facilities.

OCON Healthcare, an Israeli FemTech startup, manufactures and commercializes innovative 3D intrauterine devices (IUD) 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, but specifically for women. And there are a lot of medical issues which apply solely to women. Unfortunately, until now, the medtech developers and medical specialists who have worked in the field of women’s medicine have mostly been men. OCON wants to change that.

Contraception is central to women’s issues. An IUD is a device that gets implanted into a woman’s body. And it can be removed if the user wishes to conceive. 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 is OCON’s CEO. She has over 20 years’ experience in the medical device and pharmaceutical industries, specializing in the management of innovative start-ups, strategy, commercialization, BD and financing. She holds an MBA from Clark University.

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 Keren 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 these devices because only a small percentage of women have problems with them. While the devices may have been upgraded somewhat over the years, made from softer materials and so forth, there were no major changes. So many women still suffer from complications.

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 evident that the device is the cause of these problems. Malposition occurs in over 16% of women, leading to either pain or bleeding in 75% of malpositioned IUDs.

So how is OCON’s device different from all of the others? Well IUDs are T shaped. But OCON’s Ballerine is spherical, 3D shaped, smaller in size 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). OCONN explains that 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 Healthcare is developing a hormonal version of the Ballerine 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 company is currently conducting trials for the new product and so far they have gotten some very promising results. They have been so good, in fact, that Keren was actually 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.

This is why Keren Leshem saw much potential with OCON, even at a time when the company was in jeopardy. She told its investors as much.

“So I said to them, ‘you guys would be crazy to close down 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.

Like with everyone, there was considerable adversity in continuing the company’s development during the Covid crisis. Offices were closed everywhere and people needed to communicate through tele-conferencing.

“I was on Zoom 23 hours a day every day,” said Leshem. And this was not easy 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. Over all 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 a 4 PM, go home and take care of the kids and then comeback at 8 PM to finish work.”

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

Women working in a firm developing medical products for use by women to fill a need that may women have all over the world. What a novel idea. 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.

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 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 in the near future. 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 coms,” she explained. “So even if the market is over heated it won’t change the fact that our product is something that is not just in demand, it’s a necessity for women.”

Shani Eliahu is OCON’s chief technological officer. She is responsible for overseeing the actual day to day development and production of its products. Shani is also optimistic. “I believe there is a huge potential in device solutions for women, to provide women with quality of life and have 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 of the drawbacks 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 as well as OCON seems to be doing so far, look for it to make headlines in the near future.

Read more about: FemTech, MedTech, OCON