Swiss startup wants to save women from unnecessary pain


Many women experience “significant pain” when inserting or removing the IUD. © Keystone / Christian Beutler

Inserting an IUD can be very painful, which prevents many women from using this method of contraception. A Swiss start-up has developed a new instrument for this procedure that represents new hope.

This content was posted on August 04, 2020 – 17:24

“I remember that pain very well and it hurts me physically when I think about it. It was like the physical version of what it felt like to hear nails creaking on a blackboard. When I want to get it out, I’ll have to be anesthetized,” says a woman who recently had an IUD, or intrauterine device (IUD), installed.

It is hard to believe that over the last century, the design of the main instruments used for routine gynecological examinations and procedures has changed little. To insert and remove the IUD through the cervix, doctors must grasp it and often puncture it with a type of long forceps called a tenaculum. In some patients, it can cause bleeding or trauma to the cervix.

Doctors at the Center hospitalier universitaire vaudois (CHUV) in Lausanne are currently testing an alternative to the tenaculum of a claw. Based on suction, this new instrument was developed by a local company, Aspivix.

Inserted in the uterus, the IUD is one of the most effective forms of contraception. More than one in five Swiss women in their thirties use it. But pain or fear of pain is a well-known barrier to its use.

‘Strong pain’

And it is a fact, many women experience “severe pain” during the insertion or removal of the IUD. According to one of the most cited studies, this is the case for 17% of women who have never given birth and 11% of those who have.

In Lausanne, the trial is led by the head physician of the CHUV department of gynecology, Professor Patrice Mathevet. “It’s a recognized problem,” he said. In the second part of the study, we will compare how patients assess pain with the two different methods.”

The traditional tenaculum is still a good instrument, he says, however. “He looks really aggressive when you see him, but he’s been perfected over time.” He himself applies a local anesthetic to the cervix before using it. The tenaculum is also used for embryo transfer in assisted reproduction or for other procedures.

Several measures to combat pain during IUD insertion, however, do not bring the expected results, according to a study carried out in 2015external link. And other doctors prefer approaches based on their own experience.

The three founders of Aspivix – Julien Finci, David Finci and Mathieu Horras – are proud of the softer instrument they designed to replace the tenaculum. They note, however, that it has been difficult to convince investors, particularly men, to take an interest in a health issue that only affects women.

“In German, the tenaculum is called Kugelzange, or pliers to extract the balls. It is derived from a medical instrument used in times of war”, indicates Julien Finci, technical manager at Aspivix.

chance

The project to commercialize an alternative instrument results from the career choices of the Finci brothers. A medical engineer, Julien was designing medical instruments for a company active in the life sciences sector when David, a gynecologist, told him about the problems that tenaculum pain caused him in his work. Julien then began to think about the possibility of reinventing this instrument through suction.

In 2013, he took a course on startups at the Venturelab of his alma mater, EPFL, and then realized that he would have to ally himself with someone with a business acumen. Mathieu Horras, marketing manager at the company where he worked and with whom he ran during his lunch break, was soon convinced of the project’s potential.


Julien Finci and Mathieu Horras ©Zuzanna Adamczewska-Bolle

“Six months after David and I came up with this idea, we partnered with Mathieu, who became CEO of the company,” says Julien Finci. Mathieu Horras now has the zeal of a new convert. “The tenaculum was developed with little regard for the well-being of the patient. I had no idea what the problem was when Julien started talking to me about it and I was quite skeptical.

The potential market is huge. Aspivix conducted its own survey of around 100 doctors and midwives. 98% of respondents said they were not satisfied with the tenaculum.

“Pain and fear of pain are a significant barrier for women who may benefit from an IUD. But it remains the most effective reversible contraceptive method”, says Mathieu Horras. A systematic studyexternal link published in 2015 by Cochrane confirms the deterrent role played by this fear.

Male investors!

That hasn’t stopped Mathieu Horras from facing investor skepticism during funding rounds. “We had difficulties in establishing contact with investors, who are mostly men. Drone stories would immediately make them dream. In contrast, health benefits for women are rarely an easy topic. This isn’t the kind of question you discuss over dinner, whether you’re a doctor or a patient.

Step by step, the creators of Aspivix, however, managed to raise enough funds since 2015 to advance their idea. The company was selected by the Swiss Innovation Agency Innosuisse and is now participating in a coaching and scaling program that will continue until 2022.

Aspivix’s new generation of surgical instruments is also expected to receive approval from European health and safety authorities this year. The small company and its nine employees are therefore at a decisive stage. The next challenge will be to guarantee the production and distribution of the instruments. Although a clinical trial is not mandatory for this type of product, the company will integrate the recommendations resulting from the study carried out at CHUV.


Aspivix’s instrument (right) next to a tenaculum. ©Zuzanna Adamczewska-Bolle

next steps

Currently, there is only one analog device in the world. Developed by New Orleans-based company Bioceptive, it received FDA approval in 2015 but has yet to be commercialized. Bioceptive did not respond to questions about its device, which “uses gentle suction to grasp the cervix, opening access to a variety of instruments and procedures,” according to press reports at the time.

Mathieu Horras emphasizes that a good idea is not enough. “It has to be practical and usable. We had to reduce the number of components in our single-use device to make its production more flexible.”

Aspivix wants its products to be made in Switzerland and has identified several suppliers of plastic instruments. Unlike the traditional tenaculum, it is a single-use utensil that is then thrown away.

Aspivix is ​​also looking for distribution partners. “Companies that have everything to gain if this instrument is imposed. In our case, IUD producers seem to be the most obvious solution.”

Whether women have to wait a long time or not, the Aspivix solution will never be the panacea and some women will always suffer from uterine cramping. But the fact that less aggressive instruments are in the works is a good sign in this neglected field of medicine.

According to JTI standards

According to JTI standards

More: SWI swissinfo.ch certified by the Journalism Trust Initiative

Leave a Comment