Breakthrough device for pelvic organ prolapse

MONTREAL – Negin Ashouri (pictured) is on a mission to elevate women’s quality of life, one medical device at a time. Even the challenges of a global pandemic haven’t stopped the up-and-coming entrepreneur from advancing her first-of-its-kind technology.

The disruptive product, a made-to-measure, biodegradable and disposable intravaginal prosthetic for women suffering from pelvic organ prolapse (POP), has earned Ashouri, 28, a prestigious award from Mitacs, a national innovation organization that fosters growth by solving business challenges with research solutions from academic institutions.

In recognition of her efforts to advance the technology through her startup, Montreal-based FemTherapeutics, Ashouri – a Mitacs master’s researcher in the computer science department at Concordia University, and FemTherapeutics Co-founder and Interim CEO – will be presented the Mitacs Change Agent Entrepreneur Award on June 10 at a virtual awards ceremony.

Ashouri, whose primary focus is on applying artificial intelligence (AI) in the field of medicine, came up with the idea for the personalized device – called a pessary – as part of her group work in the Surgical Innovation Fellow program at McGill, a cross-disciplinary graduate program delivered jointly by McGill, Concordia, École de technologie supérieure and John Molson School of Business.

After co-founding FemTherapeutics along with three of her classmates in April 2019, and with support from the Montreal-based Centech incubator, she is on track to deliver the breakthrough medical device to the market by the end of 2022, pending approval by Health Canada and the U.S. Food and Drug Administration.

“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,” said Ashouri, explaining that “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.”

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

Currently, available pessaries 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.

FemTherapeutics aims to bring the entire process to 21st century standards by mirroring the same 3D printing process used in the dental industry to provide 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 for her. The prosthetic is then 3D printed using medical-grade silicone.

The company, which now numbers 10 employees, is also revolutionizing the industry by providing easy-to-use applicators and products that are biodegradable and disposable, meaning a new pessary can be inserted each month in place of cleaning and reinsertion.

“Most women who have this condition are above the age of 40 and many are uncomfortable removing, washing and inserting these devices, and sometimes it can lead to infection or irritation,” Ashouri said. “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 four additional “unmet needs” in women’s healthcare, said Ashouri. “Unfortunately, women’s health has been neglected in the area of urogynecology,” she said. “The technology is under-developed, leaving plenty of room for us to expand in the future.”

Ashouri is one of five winners of the Mitacs Entrepreneur Award who are being recognized for their efforts to turn their research into an innovative business that impacts the lives of Canadians.

“Supporting innovation is essential to help Canada rebound from the repercussions of the global pandemic, and Mitacs is extremely proud of the remarkable accomplishments achieved by our network of talented entrepreneurs,” said Mitacs CEO and scientific director John Hepburn.

“We are thrilled that our continued investment in talent, research and development is translating into more and more Mitacs interns successfully turning their groundbreaking research into dynamic startups, helping to boost both Canada’s economy and our country’s position on the global innovation stage.”

About Mitacs
Mitacs is a not-for-profit organization that fosters growth and innovation in Canada by solving business challenges with research solutions from academic institutions. Mitacs is funded by the Government of Canada and the Government of Quebec, along with 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 Saskatchewan and the Government of Yukon. For information about Mitacs and its programs, see mitacs.ca/newsroom.