Femtech’s fight to shake up the French conventional medical system

Last year, Emmanuel Macron announced a 7 billion euro financing plan – €2 billion of which would move towards startups — make France the European leader in healthcare innovation by 2030.

Now freshly re-elected and with a lot of work to do, how is Macron’s health tech revolution going – and how is femtech doing in particular?

Investment strategies

In 2021, health technology startups in France raised 2.3 billion eurosmarking a 50% increase over the previous year.

But said Julien Payen, CEO and co-founder of biomedical startup Lattice Medical, investors aren’t as keen everything types of health technologies.

“It’s a little harder to fund projects that develop hardware like we do – implantable medical devices – than projects that are more digital.”

medical mesh builds custom 3D-printed implants for women undergoing mastectomy after breast cancer. The implant, called MATISSE, dissolves and is absorbed by body tissues in 12 to 18 months — leaving only natural tissue regenerated from the patient’s own fat cells. So far, it has raised seed money and run a successful crowdfunding campaign to pursue its clinical development.

For Léocadie Raymond, co-founder of TEOLAB and Luneale, which manufactures ergonomic and environmentally friendly menstrual cups, the difficulties began not with investors, but with doctors.

When Raymond introduced gynecologists to Luneale in 2015, she was met with skepticism. Even though Luneale’s menstrual cup was designed with expert advice from midwives and an ergonomist, the three male gynecologists she first approached weren’t interested.

Léocadie Raymond founds Luneale

“They told me that periods and menstruation were not part of their job,” Raymond told Sifted. “Talking about periods was still taboo.”

In the field of women’s health, male expertise persists in France. If women today represent 51% of gynecological practitioners in France, 74% of the Board of Directors of the National College of French Obstetricians and Gynecologists are men.

“We still have a rather masculine medical profession. But it is changing because the new generation is above all women, ”says Sifted Dr. Léa Delbos, gynecologist in Angers.

By bringing period products to the public market, femtech startups like Luneale are changing the conversation.

Now gynecologists are approaching Luneale after hearing about their patients’ menstrual cups.

“We were able to capitalize on our own customers. We have a lot of success through word of mouth,” says Raymond. “Things are starting to change.

Conflicts of interest

Some femtech innovations, such as diagnostic tests and surgical implants, require navigating clinical trials and the French network of research hospitals. Despite the prevalence of publicly funded research in France, these projects are often slow to move forward.

France “goes slower than the rest of the world” in terms of scientific research, Frédérique Sachwald, director of the OSTFrench public interest group for research and innovation, Told The world in September 2021. It also produces fewer scientific publications than other leading countries, going from sixth place in 2009 to ninth in 2019.

Some startups hope to accelerate innovation in women’s health through private funding. But others worry that private funding creates too many conflicts of interest.

“I believe in public research. There are fewer vested interests,” Sonia Bisch, spokesperson for StopVOG, a French charity that fights to end gynecological and obstetrical violence, told Sifted.

Matisse Implant
Lattice Medical Mattisse Implant

Others believe that private innovation from startups is essential to counter the slow pace of public research. Delbos, the gynecologist, says privately supported research is more complicated due to potential conflicts of interest, but public research does not prioritize areas of women’s health like endometriosis.

“It’s a recurring dilemma in medicine,” she tells Sifted. “Sometimes you have to work with the industry and bring in people who are trained differently and can progress faster.”

Delbos is helping lead a trial for a saliva test created by French startup Ziwig to detect endometriosis. One in 10 women have the condition – where tissues similar to the lining of the uterus develop in other parts of the body. Ziwig did not receive public funding for the project but partnered with fifteen medical centers in France for its trials.

“For the moment, we have not received any public aid. Partnerships with hospitals are through mutual agreements,” says Yahya El Mir, CEO and co-founder.

Currently, it takes on average seven to ten years for women to be diagnosed with endometriosis. The pain can be debilitating and lead to fertility issues. If Ziwig is successful, the time to diagnosis could be reduced to a few weeks.

“We go from 10 years to 10 days,” explains El Mir.

Questions around trust

"Health Check Up Grand Prizes"
El Mir at the “Grands Prix Check Up Santé” ceremony with Marie Agnès Caderby and Fabien Guez.

Although the saliva test is promising, questions have been raised by activists and researchers over whether or not it is as accurate as Ziwig claims – a thorny debate for privately funded lawsuits, especially in the wake of the Theranos scandal in the United States.

Anna Stevenson, president of the French association for endometriosis research AAERS, calls for caution.

“Ziwig has put in a heavy press effort that tends to exaggerate search results,” she says.

The initial study involved 200 patients with suspected endometriosis, which is a much smaller sample size than traditional clinical trials. The study has not been validated using a randomized controlled trial, i.e. a group of disease-free patients.

El Mir dismisses the criticism, noting that because the test uses artificial intelligence, the algorithm learns from an initial data set – a number of patients with and without endometriosis in this case – and can thus detect the “diagnostic signature” of the disease without the need for a trial of thousands of patients.

Ziwig's endometriosis tests accompanied by an award the company won for its product
Ziwig’s endometriosis tests have won awards

“From a statistical point of view, evaluating 2,600 biomarkers for 200 individuals is only possible thanks to an AI that is far superior to conventional statistical tools. The level of precision per individual is extreme and explains the number of subjects to explain the reproducibility of the signature,” explains El Mir.

A recent study published in Nature found similar results, he notes. To further validate the test, Ziwig has an ongoing trial in 1,000 patients at five medical centers across France.

To improve public trust and work with the French model of public research, some femtech startups partner with research hospitals. To develop its breast reconstruction implant, Lattice Medical signed a six-year public-private research contract with the University of Lille. Most hospital doctors with a university function in France, the partnership was a natural way to develop their research, Payen told Sifted.

“We set up the project with two doctors and a surgeon from the Lille University Hospital. In general, hospitals are very receptive to this innovation,” he says.

Payen expects clinical trials of the implant to begin between July and October this year, and to be on the market by 2025.

Costs of innovation for patients

Within France’s national healthcare system, most drugs and procedures are affordable, but femtech startups still have to go through lengthy bureaucratic procedures and clinical trials to get their innovations eligible for healthcare coverage. Without these reimbursements, it may be unaffordable for many patients.

Ziwig’s Endotest, for example, costs hundreds of dollars. He is in negotiations with the French Haute Autorité de Santé, the body that regulates the French health insurance system, to have his test covered by insurance. However, it will likely take more data from trials to convince them. “We knew very well that from a psychological point of view, we need more credible data to reassure us, just like the health authorities before committing to reimburse the test,” El Mir said.

Breast reconstruction surgery after a mastectomy is covered by most European health systems, including France, so Lattice implants should receive approval and be completely free for patients once they have it. summer. However, as an innovative technology, it could take seven to ten years to be registered by the European Medical Device Regulation (EU MDR), a process that Lattice has already started.

In France, menstrual cups are not reimbursed by Social Security, but some mutuals, including those offered to students, support them. Luneale donates mugs to universities for students and also works with Rules Elementary, a French association fighting period poverty. It also has a partnership with the city of Strasbourg, one of the first French cities to to bring free sustainable menstrual products.

Pivot beyond France

Working with healthcare systems becomes even more complicated once startups look to international markets. For Payen, France is a good place to start, but the country’s market isn’t big enough for these companies to thrive in the long term.

“France is very favorable to emerging startups. But it must rely on Europe to strengthen these nuggets before they are bought up by larger companies, often American,” says Payen.

Trellis Medical has benefited from France’s effort to stimulate the development of new startups. Winner of a French government initiative to “boost” innovation, the startup received a grant to develop its technology. But now Payen is looking out of France.

“Our project has an international scope. French is a small territory — interesting but small. If we want to succeed, we have to turn to exports.