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



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.


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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#GDPR compliance: Manetu to the rescue?



On 11 March, Swedish regulators slapped Google with a $7.6 million fine for failing to adequately respond to customers’ requests to have their personal information removed from the search engine’s listings. The penalty was the ninth-highest since the EU’s watershed General Data Protection Regulation (GDPR) kicked into force in May 2018--yet it paled in comparison to the €50 million fine French data protection authorities hit Google with in January 2019.

To make matters worse, less than a week after the Swedish decision, one of Google’s smaller rivals filed a GDPR complaint with Irish regulators. The rival firm, open-source web browser Brave, alleges that the tech giant has failed to collect specific consent for sharing consumers’ data across its various services, and that its privacy policies are “hopelessly vague”. The latest complaint means that Google’s data collection practices are currently facing three open investigations by Irish privacy authorities.

Nor is Google the only company to face increased scrutiny over the management of its customers’ data. While the GDPR has netted some €114 million in fines so far, regulators across the European Union are itching to enforce the sweeping privacy regulations more thoroughly. Companies, for their part, simply aren’t prepared. Nearly two years after the GDPR entered into force, some 30% of European firms are still out of lockstep with the regulation, while surveys of European and North American executives have identified privacy risk monitoring as one of the most serious issues affecting their firms.

Despite spending billions of euro on lawyers and data protection consultants, many companies which process and retain consumer data—in practice, nearly all businesses— have not have developed a clear plan to ensure they are fully compliant with cutting-edge privacy legislation like the GDPR. Even the majority of companies which have been certified compliant are concerned that they will be unable to maintain their compliance long-term.

Among the particularly thorny issues firms are grappling with are how to pull together all the data they hold on any given consumer—and how to modify or remove that data following a customer request under the GDPR or similar legislation, such as California’s Consumer Privacy Act (CCPA).

A variety of start-ups, however, are springing up to offer innovative solutions to ease the burden of complying with increasingly strict privacy legislation. The latest, Manetu, is set to roll out its Consumer Privacy Management (CPM) software in April. The software uses machine learning and correlation algorithms to pull together any personally identifiable information which businesses are holding onto—including some data which they may not even be aware of. Consumers can then access the system to manage the permissions they’ve granted for their data, including at a highly granular level.

At the core of Manetu’s approach is the notion that giving consumers greater control over their data—a pillar of legislation like the GDPR—is good both for customers and for businesses. As CEO Moiz Kohari explained, “Putting consumers in control isn’t just the right thing to do. Ultimately, it’s good business. Treat your customers well is an old mantra, and it’s still a great one. But in today’s world, we also need to treat their data right. Do that, and you’ll earn a bond of trust that will pay dividends for a long time.”

In addition to earning customers’ trust, a more consumer-centred method of managing data can help companies optimise time and resources—both while processing data and when proving compliance with GDPR or other privacy legislation. Automating consumer requests to access, modify or delete their data drastically reduces the costs companies are currently incurring by manually addressing these requests.

In a similar way to how blockchain technology makes markets more transparent by recording all transactions in a permanent ledger, Manetu’s platform combines automation with an immutable log of exactly what permissions consumers have granted and when, and how, they have changed those permissions.

This documentation can be invaluable to companies needing to demonstrate to regulators that they are compliant with privacy regulations like the GDPR. EU rules establish, among other things, a “right to be forgotten.” Manetu’s log allows firms to both comply with “forget me” requests and prove that they’ve done so—without retaining access to information that the consumer has asked them to forget. Firms will be able to point to a comprehensive register of all the permissions users had granted or withdrawn.

The twin blows against Google—the GDPR fine imposed by Swedish authorities and the fresh investigation by Irish privacy regulators—confirm that data privacy will be one of the biggest challenges facing firms operating in Europe for the foreseeable future. It will be increasingly imperative for companies to streamline their data management processes to enable them to have the level of oversight which both regulators and consumers now expect.

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#ConsumerProtection: EU-wide rules for those sold a defective product



MEPs approved a single set of rules to ensure consumers buying online or face-to-face in a local shop obtain the remedies they are entitled to if they purchase a faulty product.

The draft law on the sale of tangible goods aims to break down barriers arising from differences in national contract laws, which hinder cross-border trade. It harmonizes certain contractual rights, such as the remedies available to consumers if a product does not perform well or is defective and the ways to use those remedies.

The proposed rules would apply to both online and offline (face-to-face) sales of goods, e.g., whether a consumer buys a household appliance, a toy or a computer via the Internet or over the counter in his/her local store.

What to do if something goes wrong

MEPs want to ensure a high level of consumer protection throughout the EU and to create legal certainty for businesses wishing to sell their products in other member states.

The draft directive includes rules on, inter alia, remedies available to consumers, the burden of proof, and the trader’s obligations.

MEPs want to guarantee that:

  • When a product is defective, the consumer would have free choice between having it repaired or replaced, free of charge;
  • the consumer would be entitled to an immediate price reduction or termination of the contract and to get his/her money back in certain cases, e.g. if a problem still appears despite the trader’s attempt to fix it, or if it is not done within one month and without any significant inconvenience to the consumer;
  • in order to ensure a higher level of consumer protection, member states may maintain or introduce in their national laws provisions on remedies for “hidden defects” and on a short-term right to reject (terminate the contract);
  • for up to one year following the purchase, the buyer would not need to prove that the good was faulty at the time of delivery (the burden of proof is reversed in favour of the consumer). For instance, currently, if a consumer discovers that a product he/she purchased more than six months ago is defective and asks the trader to repair or replace it, he/she may be asked to prove that this defect existed at the time of delivery. Under the proposed rules, throughout a one-year period, the consumer would be able to ask for a remedy without having to prove that the defect existed at the time of delivery, and;
  • the trader would be liable if the defect appears within two years from the time the consumer received the product (member states may, however, maintain a longer guarantee period in their national laws, in order to preserve the level of consumer protection already granted in some countries).

Pascal Arimont (EPP, BE), who is steering this legislation through Parliament, said: “Wherever in Europe a consumer is buying his product, they should be entitled to the same rights. And with this draft piece of legislation, we are not only ensuring a high level of consumer protection, we are also taking it to the next level.”“However, harmonized consumer sales law rules do not only imply more consumer protection. They also ensure a level-playing field for businesses, by giving them more legal certainty and confidence to engage in cross-border sales. By tearing down legal barriers, we support our very small companies in particular, allowing them to get their fair share of e-commerce next to giants such as Amazon”, he added.

Next steps

 The mandate to start negotiations with the Council of the EU was approved by the Internal Market and Consumer Protection Committee with 30 votes in favour, five against and one abstention. The Council (member states) has yet to agree on its position.


The initial proposal on contracts for goods sold online was presented in December 2015. On 31 October 2017, the European Commission presented an amended proposal to extend its scope to cover also sales of goods offline.

This proposal goes together with a proposal on contracts for the supply of digital content, voted in the committee last November (negotiations with Council are ongoing on this file).

According to a Commission survey, one of the main concerns that consumers have with regard to cross-border e-commerce is the uncertainty about their key contractual rights.

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#Endocrine disruptors: adoption of scientific criteria for #biocides



Following the endorsement by Member States, on 4 July, of the scientific criteria to identify endocrine disruptors in the field of pesticides or plant protection products  the European Commission adopted today  the scientific criteria for biocides. This will allow to fully align the criteria in both legislations, as the objective is to have the same criteria applicable in both sectors.

The adopted text will be sent to the Parliament and the Council for a scrutiny period of two-months. As for the criteria for pesticides, the criteria adopted today also specify that the identification of an endocrine disruptor should be carried out by taking into account all relevant scientific evidence including animal, in-vitro or in-silico studies, and by using a 'weight of evidence'-based approach.

It is important to note that the criteria in the area of pesticides and biocides will apply also to substances for which assessment or re-evaluations are already ongoing. For more information see here.

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