The revolution for diagnostics

A good treatment starts with an excellent diagnosis, which is precisely the mission of GYNTOOLS.

GYNTOOLS’ universe

GYNTOOLS was founded in 2016 in Jerusalem by Prof’ Ahinoam Lev Sagie, MD, Meny Lev Sagie and Nimrod Lev and offers an automated device dedicated to providing excellent diagnostics for both infectious and non-infectious potential conditions of vaginitis. Most women suffer at least once in their lifetime from vaginitis. Unfortunately, Vaginitis is misdiagnosed in 50% of first clinic visits - an acute problem that directly costs payers more than $3B in redundant expenses each year, causing continuous suffering among patients and costing tens of billions in repeated visits, loss of productivity and health complications.

GYNTOOLS offers a simple, accurate, but above all, fast diagnostic system called Gyni™. It only takes a few minutes for the device to make a diagnosis, for both infectious and non-infectious conditions, from a single swab, with more than 90% accuracy, which can only be gratifying.

GYNTOOLS has started commercializing its devices in Israel and Switzerland. They have a commercial pilot in Israel, and they are going to start another pilot with another Israeli HMO. They already have permission to start a third pilot with the Israeli Defence Forces (IDF). In Israel, it is mandatory for women to serve in the army. When they suffer from vaginal problems, it takes much time for them to see a military gynecologist who can examine them, with no better diagnosis than with the general population. This third pilot allows a self-sample collection by female soldiers who suffer from vaginitis, rapid testing in Gyni™ at their base and remote treatment prescribed by a physician, according to Gyni’s results. In Switzerland, the GYNTOOLS representative is Expirion GmbH.

GYNTOOLS’ primary mission is to provide better health to women. With the American FDA they identified what kind of evidence they will look for FDA clearance and are working on a clinical trial that will start in 2022. GYNTOOLS will start its FDA related trial in Switzerland at the University Medicine of Geneva. They have many strings that connect them to Switzerland, and Tech4Eva is one of them.

An industry facing many challenges

One of the biggest challenges for start-ups is fundraising. But GYNTOOLS also sees several other challenges, such as reimbursement, which can appear complicated. Indeed, depending on the continent and the country, reimbursement guidelines may change. In Switzerland, reimbursement procedures even depend on the cantons (local regions). Another barrier is the device's registration to be recognized by peers and users. Indeed, bringing a new product to the market is not necessarily easy, and users need to identify the product and understand the benefits of this device.

Since GYNTOOLS is working with solid local dealers and representatives, the team is not developing the market from scratch. They are joining and partnering with local forces that know the environment of clinics, gynecologists, reimbursement processes, and commercial environments. This saves time to go to market, as they do not need to reach each clinic individually.

Since the onset of the coronavirus crisis, GYNTOOLS has noticed that investors are becoming more and more interested in both remote medical technologies and diagnostics. Remote diagnostics, as the coronavirus pandemic showed, is a must-have. Therefore, creating diagnostic tools to solve a medical issue is again in the trending markets.

In the past year, there has been an increase in attention to women's health. Whether from VCs, who traditionally didn't put much effort or attention into it or from scientific manufacturers. Increasingly, people realize that men and women do not react the same to treatments or doses. It seems that there is a growing awareness about trials and research having been done mainly on male subjects, and that more and more people are focusing on research related to women's health issues.

The future of GYNTOOLS

For the moment, GYNTOOLS focuses mainly on the Swiss and Israeli markets, but the start-up does not intend to stop there. They are working hard to establish themselves in other European locations and hope to enter the American market by 2023.

GYNTOOLS will remain in the women's diagnosis area, which is an area they specialize in and are well connected with experts worldwide. They are thriving to take this know-how forward and make Gyni™ the standard for first-line vaginitis diagnostics, for the benefit of all women, who deserve a better service, but for now, the first step is to bring Gyni™ to the market and launch it.

For more information, visit: www.gyntools.com