The medical speciality relating to the female reproductive organs, or gynecology, has traditionally been focused on fertility, leaving gaps to be addressed in other areas of women’s health like pelvic floor disorders (PFDs), one Canadian women’s health startup argues.
One in every four women, and one in every two women over 80 will suffer from PFDs, which involves the downward descent of the pelvic organs into or through the vagina.
This can cause discomfort and bulging in the vagina, pelvic pressure, leaking of urine, and other symptoms that could drastically affect quality of life.
Current treatment options for PFDs come with significant risks. Pelvic surgery, for example, has a high failure rate and rate of subsequent surgeries in North America, according to research published in the American Journal of Obstetrics and Gynecology. Vaginal pessaries, on the other hand, could potentially deliver benefits with fewer risks and complications.
A pessary is a soft, flexible device that is placed inside the vagina to help support surrounding organs such as the bladder, vagina, uterus, and rectum, holding them in place.
“Vaginal pessaries had not changed since the 1950s, and we saw that there was a clear need to improve on that design.”
FemTherapeutics, a startup from Montréal, aims to improve pelvic medicine. Combining artificial intelligence, cloud computing, and 3D printing, the company is developing customizable gynecological prosthetics.
To support its mission, FemTherapeutics has raised a $2.5-million CAD ($1.85 million USD) round. 2048 Ventures led the round, with participation from Investissement Quebec, The51 Ventures, and Sheboot, as well as several physicians and angel investors.
According to FemTherapeutics, the proceeds will be used to further develop its technology, kick off pivotal clinical studies, as well as expand its team, intellectual property portfolio, and R&D efforts.
FemTherapeutics was founded by Inara Lalani, Negin Ashouri, and Dr. Mihnea Gangal, who were tasked with developing innovative solutions for surgical or clinical needs for gynecology as part of the Montreal Surgical Innovation Program at McGill University in 2019.
The Surgical Innovation Program is a “cross-disciplinary graduate program that equips trainees to enter the clinical technology sector.”
As the team focused on vaginal pessaries, they found that the devices’ high failure rate could be attributed to a decades-long drought in innovation.
“Vaginal pessaries had not changed since the 1950s, and we saw that there was a clear need to improve on that design,” said Lalani.
FemTherapeutics software allows clinicians to visualize each patient’s condition in 3D, and subsequently propose pessary designs that are modelled to the patient’s unique anatomical characteristics.
Once the designs are finalized, FemTherapeutics prints the pessary with medical grade silicone. The startup said its technology can be expanded across various areas in women’s health such as custom menstrual and sexual wellness products, among others.
Operating on a B2B2C model, FemTherapeutics works with physicians who design and fit the devices to each patient. Physicians will buy the system and charge the patient’s insurance providers. There is also an opportunity to license the startup’s AI platform and datasets to customize other medical devices.
Though FemTherapeutics claims that it’s building the world’s first vaginal pessary customized specifically for each patient, there are other startups developing similar solutions.
In Canada, there is Toronto-based Cosm Medical, which is preparing to launch its own version of patient-matched gynecological prosthetics for female pelvic floor disorders.
Cosm recently received a $1.9-million investment from INOVAIT in April to integrate AI capabilities into its platform, meant to automate ultrasound image analysis and increase the accuracy of pessary fittings. It also raised a $4.7-million seed round in April 2022.
Cosm told BetaKit that it is currently preparing for product launch as it awaits approval from the US Food and Drug Administration.
As for FemTherapeutics, it plans to spend the next 12 months obtaining regulatory clearance for its devices and platform in Canada and the United States. It also plans to kick off several clinical studies with hospitals and obtain data to further train its predictive models.
With what it calls a science-first approach for its technology, FemTherapeutics also intends to target medical and technical journals to showcase its scientific and engineering breakthroughs.
Featured image courtesy FemTherapeutics.