#FemTech – Millions of women could benefit from new non-invasive treatment for pelvic floor dysfunctions

| July 23, 2019

Dr. Elan Ziv has developed a device that could transform the lives of women living with pelvic organ prolapse (POP). Visiting Brussels, we took the opportunity to interview him and find out more about a completely novel non-surgical and disposable management option for women with POP.  ConTIPI develops non-invasive and disposable vaginal devices for various pelvic floor dysfunctions in women. The first device, for stress urinary incontinence in women, was acquired by Kimberly Clark Worldwide and is already on shelves in North America. The second device for POP is ready for the market, and has a CE Mark for marketing in Europe and a 510(k) clearance from FDA for marketing in the US. 

Can you tell me more about your latest invention?

We have developed a device for pelvic organ prolapse in women. This device intended for the non-surgical and disposable management of pelvic organ prolapse in women, that means a non-surgical device, which will be the solution for most women.

Around 80% of the women around the world do not need any surgical treatment, but just nonsurgical management. And we have provided a new device for them.

What is POP? How would you describe it?

Well, it’s very common. It’s a very common condition in women that they feel that something is bulging out of the vagina. The main cause of this is childbirth, constipation and also old age and lack of estrogen. It’s very common, it happens to around 50% of the women around the world all over.
Women are very much bothered by that. But most women, estimated at around 93% are reluctant to come forward and say, I’ve got a problem. Only about six to seven percent of the women come forward, to say: “I’ve got a problem, please help me, or at least advise me what to do and how to deal with this problem.”

And is that because they are embarrassed, or is it that they are afraid of the treatment, especially if you’re you’re saying it could involve a surgical intervention? 
Well, mainly embarrassment, I think, it is still a bit of a taboo. One of the remaining taboos for women and you don’t talk about it, because it goes with the body image. It goes with anything like getting older, you might have heard that your grandmother suffered from it. This is part of it, but the other part is the fact that the treatment we have today is not very useful. The surgery is not good enough and the other means of treatment are also inadequate.
Can you give us an idea of how many people that might benefit within Europe? Or a percentage?
In Europe, we estimate that it is about 28% of the women in Europe with but with some form of problems.  Over 50% of the women worldwide have at least one of the 3 disorders. In the case of pelvic organ prolapse, it estimated that there are around 135 million women globally with this condition, around 28% in Europe. The number of affected women is huge, surgery is only partially satisfactory due to high rate of adverse effects, and the current non-invasive mode of management is by using a pessary – a reusable only rubber/silicone body which is inserted in most cases by a doctor into the vagina for 3 months, then taken out, cleaned and reinserted for another 3 months  – and so for many years. This is accompanied by pain/discomfort/discharge/infections and an inability to have intercourse.
Are you at a stage where this product will be available? Is it known about it within the gynecological profession among general practitioners?
We’ve just completed developing the device. We are a company which develops general devices, which are intended for the non-surgical and disposable management of such pelvic floor dysfunction. So one of them is the pelvic organ prolapse, which we have just completed developing. And the device is ready for the market. It’s got a CE mark, which means the ability to market within the European community. And we just received the FDA (US Federal Drug Administration) clearance. Now we are moving forward towards commercializing the device.
Since it is a common condition why hasn’t something like this been developed earlier? Or is this a question of research into women’s conditions being neglected and overlooked?
Absolutely, yes. Just like that. It’s amazing to say, but the last non-surgical innovation in this arena, came into the market about 23 years ago. And to your question, yes, the authorities are not very much aware of the women’s need and this is why there’s a new movement now actually developing itself trying to push forward the idea of FEM tech developed for women. And we are part of this movement.
What is your product like?
Our devices come within a sealed package like this one, just open the package and takes out the device. This is our devices as you can see very much like a tampon and it is inserted by the woman herself into the vagina whenever she wants. It doesn’t matter where she is she might be on vacation, no doctor is needed. The device remains in the vagina for up to seven days until the time that she wants to take it out and then you just pull the string the device shrinks back and just slides out of the vagina for disposal. There are two main concepts here. One is the shift of control. Firstly, a shift in the control of the medical condition into the hands of the woman. And the second is the freedom to decide. That means a woman may decide when she wants to insert the device when she wants to take it out. This is absolutely up to her.

Background

Dr Elan Ziv, MD, OBGYN, FPMRS, CEO & Medical Director
Dr Ziv graduated from the Sackler School of Medicine at the Tel-Aviv University in Israel and received his MD degree in 1979. He spent 5 years’ service as a doctor in the Israeli Defense Forces and then had residency in Obstetrics and Gynecology (OBGYN) at the Rabin Medical Center (campus Beilinson), which he graduated in 1990. During that time he also had a fellowship in FPMRS (Urogynecology), as a clinical research fellow at St Georges Hospital, in London, UK, under Prof Stuart Stanton (1987-88).
Until 2014 Dr. Ziv served as the director of the institute of urogynecology at Assuta Medical Centers in Tel Aviv, Israel.
As a urogynecologist, Dr. Ziv has a long-standing interest in the non-invasive treatments of urinary incontinence and of pelvic organ prolapse in women. He is an active participant and presenter in many international professional meetings, participated as a Principal Investigator in many clinical studies, and holds 19 patents with over 100 patent applications.
Following the invention of various vaginal devices, he founded ConTIPI Ltd, in 2002. The first flagship product – the Impressa Device for Stress Urinary Incontinence in women, was sold to Kimberly-Clark Worldwide Inc. and is now on the shelves as an OTC product.
CE Marking – CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.

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