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Keren Leshem, CEO, OCON Healthcare

The female body is responsible for additional natural responsibilities like childbirth, maintaining menstrual cycles, and hormonal changes over the years, which places a heavy burden on their health. The healthcare industry needs to adopt newly developed products and treatments to deliver better health assistance to women.

OCON Healthcare develops innovative and reliable medical solutions inspired by women’s bodies and anatomy to better women’s lives worldwide. The company has developed next-generation products like IUB™ Ballerine®, IUB™ SEAD™, and IUB™ PRIMA™ to serve women’s health safely and effectively. Its objective is to bring in an innovative, high-quality intrauterine drug-delivery technology to enhance and impact women’s health and quality of life.

During an interview with Insights Care, Keren Leshem, CEO, and Anula Jayasuriya, Chairwoman of the Board, shared insights about their modern healthcare company that is supporting women’s health requirements by utilizing advanced solutions.

Please brief our audience about your company, its USPs, and how it is currently positioned as a reliable name in the healthcare space.
OCON Healthcare develops innovative and safe medical solutions inspired by women’s bodies and anatomy to allow more therapeutic choices and better the lives of women everywhere. An Israeli FemHealth revolution — OCON is led by women for women, with an 85% female team working on the future of drug delivery to the uterus.

OCON Healthcare’s novel platform technology, namely IUB™ (IntraUterine Ball), is made from a super-elastic spherical high-tech frame that can retain its shape and is an ideal drug-delivery platform to the uterus to treat various health conditions such as endometriosis (one in ten women), myomas/fibroids (seven in ten women), cancers, heavy and abnormal uterine bleeding (one in three or four women), and also allows additional options for contraception that are safe and effective.

Chronic conditions more often burden women disproportionately: Abnormal Uterine Bleeding, Endometriosis, and Myomas/Fibroids are a few examples. Heavy menstrual bleeding is a global problem that affects one-third of women globally, according to the ACOG. More than 40% of women suffer from depression due to heavy periods. More than 70% of women have uterine fibroids by age 50, with women of color being at higher risk.

In addition, women still carry the burden of side effects: More than 20% of women discontinue their birth control solutions due to side effects. Women have a 1.7-fold greater risk of developing adverse reactions to treatments. Sadly, large health inequities among women remain. Current outdated technologies impact the health economics of entire societies, marital qualities of partnerships, family planning, and productivity in the workforce. OCON is here to change that!

OCON’s mission is to improve women ‘s health and quality of life globally.

Tell us more about your organization’s offerings and what aspects make it stand out in the healthcare industry.

Today, traditional contraception and therapies for endometriosis, myomas, heavy/abnormal menstrual bleeding, and contraception are mainly hormonal and often oral, causing long-term systemic side effects. Second-line procedures or techniques are often invasive (can lead to up to 25% Hysterectomies), costly, and not applicable and/or not accessible to all women, especially in Low to Mid Income Countries (LMIC) since they require a hospital setting and expensive capital equipment.

The time is right to introduce new technologies that would allow essentially all women in need to get a solution that fits their anatomy, moving away from systemic side effects, and have procedures performed in a more targeted, faster, and uncomplicated way in their community with their trusted OBGYN or midwife.

OCON’s 3D “smart” drug-delivery platform is the ideal carrier for any drug or substance to be introduced directly to the target tissue to treat various women’s health conditions away from systemic side effects. Here is a taste of our platform products in different stages of availability:

IUB™ Ballerine®

OCON’s flagship product is the IUB™ Ballerine®, a hormone-free, small, 3D, flexible birth control LARC (long-acting reversible contraception) device. The IUB Ballerine® is commercial in the EU, Middle East, parts of Africa, S. America, and will soon be so in Japan, Russia, China, and the USA.

Understanding the drawbacks and the myriad of issues women face with traditional T-shaped IUDs, leading them to discontinue their use, led OCON to create the IUB™ Ballerine® to be spherical and small (only 15 mm in diameter) designed to effortlessly adapt and position itself in line with the uterus’s contractions and movements.

This ‘smart’ personalization minimizes the typical risks of damage and irritation in the uterus associated with conventional T-shaped devices, demonstrates an improved safety profile leading to fewer perforations (40% less), malposition, and ectopic pregnancies (over 90% less).

The IUB™ Ballerine® has already been adopted globally in over 110,000 diverse women in 30 markets, demonstrating a significant validation of its platform and future products to continue to create high customer fulfillment levels emphasizing the success of OCON’s innovation for the femtech space.  

IUB™ SEAD™

OCON’s most revolutionary and game-changing drug product is the IUB™ SEAD™ (Spherical Endometrial Ablation Device), non-hormonal once-and-done treatment for women suffering from heavy menstrual bleeding and/or abnormal uterine bleeding.

With its non-invasive simplicity and cost-effectiveness, the IUB SEAD™ will be a game-changer. With a gentle ablation to the bleeding endometrium free from harmful hormones and targeted to be safer than the current standard of care for global endometrial ablation, which is invasive. It requires hospitalization and general anesthesia and is very painful and expensive due to capital equipment needs and could cause uterine wall adhesions and/or result in hysterectomies in up to 25% of women – this treatment always leaves the woman infertile afterward and is limited or not available in LMIC.

OCON’s product is currently in Phase IIb clinical studies demonstrating highly encouraging results with over 80% average reduction in bleeding within the first month, with no to very mild pain scores reported, and 95% Quality of Life Satisfaction reported.

IUB™ PRIMA

Through OCON’s therapeutic-delivery IUB™ PRIMA, the company is working on additional pipeline products to target therapy areas such as endometriosis and myomas as well as heavy menstrual bleeding and other hormonal solutions delivered directly through the uterus moving away from systemic side effects. The IUB PRIMA’s first drug will be Levonorgestrel.

What would be your advice to budding entrepreneurs who aspire to venture into the healthcare industry?

Focus on education first, and your customers will be able to make better and more informed decisions. It will also help emerging entrepreneurs build a community around their products. The community can then turn into paying customers, and word-of-mouth is priceless.

Network is essential to build your brand and to have support and advice on anything you wish to build or create. Your network can also help you quickly find the right key opinion leaders, help you fundraise and help you focus!

Being mentored as well as acting as a mentor is most important to shaping your leadership and outlook.  

How do you envision scaling your company’s operations and offerings in 2022 and beyond?

In 2022, OCON will continue developing the 3D Ball pipeline, making sure we can initiate our pivotal study in the USA, continue to grow our markets to allow women more choices for their reproductive health, and advance our clinical assets even further!

OCON will further focus on shaping its pipeline offering through its innovative platform technology by researching and developing solutions for women’s pain points that have been overlooked for decades, such as endometriosis, for example.

OCON aims to accompany women throughout their different life stages with solutions and therapies that are specifically designed for the female anatomy.

The Coherent Leadership

Keren Leshem, OCON’s CEO, is a seasoned executive with 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 was recently dubbed as one of the three women shaping the future of women’s health by Forbes Magazine.

Before leading OCON Healthcare, Ms Leshem held various global CEO, board, and management positions within the pharmaceutical and medical industries, both in Israel and abroad.

Ms Leshem currently sits on FemTech Lab’s admissions and advisory boards as well as LSX’s advisory board and is a mentor through the 8400 Healthtech Network.

When Ms Leshem joined OCON, she quickly re-designed the strategy and products and diversified OCON’s team and board to be women-led and teamed up with Anula Jayasuriya, MD, PhD, MBA, to become Chairwoman of OCON’s board.

Anula Jayasuriya is an inspiring and successful private equity executive and venture capitalist whose background combines deep business, scientific, and medical knowledge with broad clinical, industry, entrepreneurial, and investment experience.

She serves on the boards of several biotechnology companies and also serves on non-profit boards. Ms Jayasuriya holds a BA (summa cum laude) from Harvard, an MD and PhD from Harvard Medical School, as well as an MBA with distinction from Harvard Business School and an M. Phil. in pharmacology from the University of Cambridge, in England. She is the Founder and Managing Director of EXXclaim Capital and Co-founder of Evolvence India Life Science Fund.