Startup develops device to support women’s pelvic floors

First-of-its-kind technology based on artificial intelligence applies 3D printing process used in the dental industry to treat uterine prolapse

Negin Ashouri is on a mission to elevate women’s quality of life, one medical device at a time. Through her business FemTherapeutics, she created an innovative, made-to-measure, biodegradable, and disposable intravaginal prosthetic called a pessary to help women suffering from pelvic organ prolapse (POP). 

The condition — where one or more of the pelvic organs slip down from their normal position and bulge into the vagina — affects one in 10 women worldwide, representing a US $1.2-billion market for treatment.

Pessaries currently on the market are uncomfortable, must be inserted and removed by hand, and need to be cleaned and reinserted on a monthly basis to avoid infection. They are also fitted by trial-and-error, a process that often involves multiple consultations.

“When we learned that the design of pessaries hasn’t changed in more than 50 years, and that today’s products are not working well for patients, we decided to do something about it,” says Ashouri. “Currently, when doctors prescribe pessaries, they are failing 40 percent of the time, leaving women with no option but to seek invasive reconstructive surgical procedures instead.”

3D printing offers custom solution

FemTherapeutics aims to bring the entire process to 21st century standards by mirroring the same 3D printing process used in the dental industry for custom-fit orthodontic devices. A woman’s vaginal measurements taken by a doctor are input into the company’s innovative software and processed by an advanced algorithm to design a pessary with the optimal fit. The prosthetic is then 3D printed using medical-grade silicone.

The company, which now has 11 employees, is also revolutionizing the industry by providing easy-to-use applicators and products that are biodegradable and disposable. That means a new pessary can be inserted each month in place of being cleaned and reinserted.

“Most women who have this condition are above the age of 40. Many are uncomfortable removing, washing and inserting these devices, and sometimes it can lead to infection or irritation,” Ashouri says. “With our system, once a pessary is removed, it can be disposed of and a new, clean device is easily inserted.”

The company is also actively investigating additional “unmet needs” in women’s healthcare, says Ashouri.  “Unfortunately, women’s health has been neglected in the area of urogynecology. The technology is under-developed, leaving plenty of room for us to expand in the future.”

Path from academic research to entrepreneurship

Ashouri co-founded FemTherapeutics in 2019 along with classmates Lydia Aguirre, Fereshteh Jahangard, and Inara Lalani. They were part of the Surgical Innovation program at McGill University, a cross-disciplinary graduate initiative delivered jointly by McGill, École de technologie supérieure, and Concordia’s John Molson School of Business and Department of Computer Science and Software Engineering. Currently, they count on Dr. Mihnea Gangal’s support as Clinical Supervisor.

As a computer science master’s student, Ashouri’s primary focus on the team was applying artificial intelligence (AI) in the field of medicine.

With support from the Montréal-based Centech incubator and Mitacs’s Accelerate Entrepreneur program, the team created FemTherapeutics. They are on track to deliver the breakthrough medical device to the market by the end of 2024, pending approval by Health Canada and the U.S. Food and Drug Administration.

In recognition of her efforts, Ashouri received the Mitacs Change Agent Entrepreneur Award in June 2021.

“As an international student who came to Canada just three and a half years ago, receiving this award meant a lot to me. It proved that Canada opens its doors and opportunities to everyone, no matter where you come from,” says Ashouri.

For FemTherapeutics, it meant validation.

“We were assured that we were on the right path and all our hard work day and night was paying off. After announcing this precious award, many national and international organizations reached out to us, and led to interest from gynecological clinics for future possible expansion and collaborations.”

Since winning the Mitacs Entrepreneur Change Agent Award, the startup has been able to add a PhD student to its mechanical engineering team, advance production of the pessary, and expand its operations.

“We also obtained a priceless connection that opened the opportunity for understanding the regulatory process and expansion in the U.S., all thanks to Mitacs,” says Ashouri.

Mitacs’s programs receive funding from multiple partners across Canada. We thank the Government of Canada, the Government of Alberta, the Government of British Columbia, Research Manitoba, the Government of New Brunswick, the Government of Newfoundland and Labrador, the Government of Nova Scotia, the Government of Ontario, Innovation PEI, the Government of Quebec, Fonds de recherche du Québec – Nature et technologies, the Government of Saskatchewan, and the Government of Yukon for supporting us to foster innovation and economic growth throughout the country. 

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