Vaginal prosthetics known as pessaries聽are a critical tool for聽the maintenance of聽pelvic health in women.聽They are used as a聽first-line treatment聽for聽pelvic organ prolapse, a common condition that occurs when the muscles of the pelvis weaken, causing organs to drop into the vagina.聽But聽these devices are聽badly in need of an upgrade.聽Their failure rate聽is high, and聽the designs聽have changed little in聽the last聽70聽years.聽
At聽Montreal-based聽FemTherapeutics, cofounder and Chief Operating Officer聽Inara Lalani (BCom鈥�20)聽is helping聽lead efforts聽to harness聽the power of new聽technologies鈥攕uch as聽3D printing and聽artificial intelligence鈥攖o聽bring聽pessaries聽into the 21st聽century.
An outdated device
The聽FemTherapeutics聽story began in 2018, when Lalani and six other students聽came together as a聽team聽in聽the聽Montreal聽Surgical Innovation Program.聽Jointly聽delivered聽by聽不良研究所聽University聽(Department of Surgery), Concordia University (John Molson School of Business;聽Department of Computer Science聽&聽Software Engineering)聽and the 脡cole de聽technologie聽sup茅rieure (脡TS), the聽cross-disciplinary,聽graduate-level program聽seeks to聽teach and stimulate entrepreneurship聽as well as聽support聽the innovation of novel surgical and medical devices.聽
After brainstorming hundreds of ideas for surgical or clinical needs within the area of聽gynecology,聽Lalani's聽team聽honed聽in聽on聽vaginal pessaries聽as a key area聽in need of聽improvement.聽
Pelvic聽organ聽prolapse, the primary condition for which pessaries are used,聽is prevalent聽among women聽who have聽reached聽menopause or undergone at least one vaginal birth.聽
However, in聽approximately聽40聽per cent聽of cases,聽pessaries are discontinued within a聽year聽due to the pain and discomfort caused by incompatible shapes and sizes.
Through their聽research,聽Lalani and her teammates聽discovered that this high rate of failure聽could be attributed聽to a decades-long drought in innovation. 鈥淰aginal pessaries had not changed since the 1950s, and we saw that there was a clear need to improve on that design,鈥� Lalani said.聽
The team put their heads together to come up with a solution:聽3D-printed聽pessaries that would be custom-designed to fit patients鈥� unique anatomies.聽
The聽FemTherapeutics聽team聽pitched their聽idea聽at various聽competitions in 2019.聽It was a聽hit, winning a聽string of prizes in just four weeks, including聽top prize in the Annual Surgical聽Innovations Pitch Competition. At聽不良研究所,聽it聽took聽second place in the 不良研究所 Dobson Cup聽and also聽received聽聽the聽Steinberg Centre聽Simnovation聽Prize聽at聽the聽2019聽不良研究所 Clinical Innovation Competition (CLIC), a tradition inspired聽by the vision and generosity of聽Dr. Raymond Hakim (MDCM鈥�76).
With these accolades,聽the聽team's聽efforts聽quickly evolved from an academic project to a full-fledged business venture.聽鈥淲ithout that support, things would have likely just ended with the聽Surgical Innovation Program,鈥� Lalani said.
Leveraging artificial intelligence聽
In the years since, the group聽has聽faced ups and downs. Like many others around the world,聽they聽shifted to working remotely聽when the pandemic hit,聽cancelling聽in-person activities,聽such as聽cadaver studies at local hospitals.聽
Although this period was challenging, the team took it as a chance to pivot, Lalani said.聽When it first formed,聽the company聽had聽focused on building聽a device that could accurately scan聽each patient鈥檚聽vaginal canal聽to build a blueprint for a聽custom vaginal pessary. But the lack of access to cadavers聽meant the team had to put this part of the project on hold.聽Instead, they聽turned to existing聽datasets聽of聽medical scans taken with computed tomography and magnetic resonance imaging聽to build an聽artificial intelligence model聽based on pelvic bones. Because pelvic bones聽differ much less聽among聽patients than the muscles of the vaginal canal, this could accurately represent a patient鈥檚 vaginal canal using聽only聽10 to 15聽points of聽measurement聽with basic tools.聽聽
Ultimately, this聽led to a larger shift in聽FemTherapeutics鈥櫬燽usiness model, according to Lalani. The company went from聽hardware聽centric to software聽centric.聽Now, their focus is聽on聽using聽AI to build personalized therapeutics for women.聽Eventually, the team hopes聽to apply聽the technology they built to expand their pipeline聽beyond pessaries to include other聽health聽needs聽for women, such as vaginal stent customization.聽鈥淲hen we built the business, we were focused on one clinical need,鈥� Lalani said. 鈥淏ut over time, it鈥檚 evolved. The vision of the business is to build a pipeline of products in the women's health space.鈥澛�
These developments have earned the company additional accolades, such as聽the聽Bourse+聽StartUp聽Montr茅al award聽this聽April, and interest from investors around the world.聽鈥淲e are really pleased with the traction we鈥檝e received to date,鈥� Lalani said.聽鈥淲e were recently selected by the 2022 CIX Selection Committee as a CIX Top 20 EARLY聽company for 2022, which is a very notable recognition for Canadian聽startups.鈥�
This November, the team聽is聽set to test聽their custom pessary聽in their first patient聽as part of a聽pilot clinical trial with five to ten聽participants聽who will be monitored for four weeks.聽Following that, there聽will聽be a聽larger trial聽with聽40聽patients each at three sites,聽two in Canada and one in the United States,聽which will last聽three months鈥攁fter聽which聽the company plans to聽file for regulatory clearance.聽
As to when will these devices hit the market, that could be as early as 2024鈥攇ood news for women鈥檚 health.聽
This article was written by Diana Kwon and originally appeared in Medicine and Health Sciences Focus on September 15, 2022.
