Hillel's Tech Corner: Solution for female urine incontinence

The women’s health technology sector, which is more popularly referred to as FemTech, has been on the rise in the past decade.

By HILLEL FULD
Solution for female urine incontinence (photo credit: Courtesy)
Solution for female urine incontinence
(photo credit: Courtesy)
Much of what I cover in this column revolves around medical breakthroughs that are along the lines of AI in MedTech, cancer treatments, and early detection of major diseases. While they are all certainly important, there is an elephant in the room that must be addressed, both in my column and in general, and that is the topic of women’s health. We’re approaching 2020, and it’s high time this important topic stops being considered a taboo to discuss.
Now that we got that out of the way, allow me to proceed.
The women’s health technology sector, which is more popularly referred to as FemTech, has been on the rise in the past decade. Although it has traditionally revolved around female health topics such as menstruation, fertility, and pregnancy, it also includes a broader range of other less represented issues.
These include topics such as uro-gynecology, which, as the name implies, is a hybrid of urology and gynecology. Vesico-vaginal fistula, for instance, is a global epidemic that is prevalent in developing countries that are limited in resources, and it causes a total loss of bladder control.
In such countries with these low-income populations, forced pregnancies of young teenagers, and prolonged labor often leads to disastrous complications during childbirth, such as uro-genital fistula. Sub Saharan Africa accounts for 32.5 million annual births. In such areas, young women are made to stay in labor for more than one day. It can sometimes even take 5-7 days. This unfortunately leads to stillborn babies, followed by the development of uro-genital fistulas.
Women who develop fistula experience continuous urine leakage, accompanied with the odor of urine, which leads to them being ostracized by their families and friends. Without treatment, the prospect of women with obstetric fistulas to function normally, especially after the trauma of losing a child, is almost non-existent. These cases are largely underreported in developing countries. According to the Fistula Foundation of the UN (UNFPA,) 1-2 million women worldwide have an unrepaired obstetric fistula and live with the fistula. The same study estimates that there are 100,000 new cases of obstetric fistula each year.
There are, thankfully, numerous aid groups organized to help these women. Surgeons often volunteer their services to operate on as many women as possible in an effort to put an end to their uncomfortable situation. While every bit does help, if you take the numbers of UNFPA on the existing 2 million fistula patients, and consider that since 2003, less than 100,000 fistula repairs have been done, you can calculate that it may take at least 150 years to repair all existing cases at this rate. Mind you, this is without factoring the 100,000 new cases each year. Unfortunately though, about one-third of these surgeries fail and call for a second operation. Half of the remaining patients continue to experience leakage, this time through their urethra, which loses its ability to contract and keep the urine from leaking.
Prof. Daniel Yachia, president and CTO of Innoventions decided to tackle this challenge head on. Upon being confronted with this problem, he decided that: “If we cannot treat all, at least we can palliate.”
THIS WAS the birth of his idea for a Fistula Occluder Device (FOD) for mechanically occluding the fistula and creating immediate dryness and hygiene for female patients. The FOD is a flat balloon with a magnetic core, which is made to be inserted into the bladder, and a magnetic device, comparable to tampons, which is made to be inserted into the vagina, up to the fistula opening. The vaginal magnet attracts the balloon, and keeps it in the vaginal side of the fistula, and occlude it. It’s a surprisingly simple solution.
The main advantage of this balloon is in its ease-of-use and its low cost. Since it is not a surgical procedure and there is no need for a physician, and it can be used in any remote village. By training local ambulatory health service providers such as nurses or even a woman from the village, the balloon can be inserted and the patient can be instructed on how to use the vaginal magnetic tampon.
Yachia is a professor of Urology and a successful serial Israeli entrepreneur. He co-founded InStent Inc. (M&A by Medtronic) as well as Allium Medical Solutions Ltd. In order to commercialize his many inventions as well as the FOD device he established “Innoventions,” a unique private technological incubator based in Or Akiva, developing his own uro-gynecology inventions. Yachia and his family invested close to $6 million so far towards the developments coming out of Innoventions. Through their OEM agreement with Blue Neem, a prominent medical device company in India, the Innoventions team is expecting to reach initial revenues in 2020, with additional developments in the works.
Yachia believes that this device will help a very large number of fistula patients who cannot access or afford surgery, and help bring hundreds of thousands of women back to a more comfortable way-of-life, all with dignity. Innoventions is in the process of donating FODs to philanthropic organizations active in Africa.
The FOD is based on the more sophisticated ContiSphere – a device aimed for developed countries, for sealing the bladder outlet with an intravesical balloon-shaped floating element, commanded by an external magnet for women who failed incontinence surgery or are not fit for surgery.
UI affects 15 million patients in Europe, over 18 million patients in the US, and 10 million patients in other developed countries. 80% of these UI patients are women.
Approximately 500,000 female UI patients worldwide undergo surgery every year, of which 30-40% fail within 3-5 years after surgery. In addition, about 5% of the total incontinent patient population is unfit for surgery or refuse surgery. The total number of female UI patients, meeting one or more of these criteria is approximately 1.8 million patients, and they are all suitable for the ContiSphere. The ContiSphere was already successfully studied in patients (with a 86.3% success rate), proving its simplicity and effectiveness. Innoventions invested close to $2 million towards the development of the device, and is in the process of commercializing through a joint venture established with BlueNeem. The ContiSphere is expected to launch in 2020 in India, and then, pending the appropriate regulatory approvals in the rest of the world.
When it comes to women’s health, we have all heard of certain cancers, pregnancy issues, and heart disease. But there is so much more to it than that, as seen here with urine incontinence, and 2020 should be the year in which we collectively, and very openly, bring awareness to these issues and their preventive measures.