Founders of FemTherapeutics – Negin Ashouri, Dr. Mihnea Gangal, and Inara Lalani
1 in every 4 women, and 1 in every 2 women over 80, will suffer from Pelvic Floor Disorders (PFDs), such as incontinence and Pelvic Organ Prolapse (POP) during their lifetime, with both disorders being severely underserved and producing a significant gender disparity in medical innovation. POP is a condition that involves the downward descent of the pelvic organs (i.e. vagina, uterus, bladder, and/or rectum) into or through the vagina. Symptoms include discomfort in the vagina, vaginal bulging, pelvic pressure, leakage of urine, and bowel problems — all of which affect a woman’s quality of life drastically. Vaginal childbirth, advancing age, increasing body mass index, straining due to constipation, and prior hysterectomy are the most consistent risk factors for POP.
“The dynamic behind POP is likely more diverse than any other health condition women will experience, however, it is treated as a “one solution fits all” problem,” shares Inara Lalani, cofounder and CEO of FemTherapeutics, the Montreal-based medical technology company building the world’s first customizable gynecological prosthetic (or vaginal pessary) to provide effective symptomatic relief to pelvic health conditions.
Personalized Approach To Better Pelvic Floor Health
FemTherapeutics announced today that it has raised $1.85 million ($2.5 million CAD) to catalyze its next phase of growth, with 2048 Ventures leading the round with participation from Investissement Quebec, The51 Ventures, Sheboot, and several physicians and angel investors. “The new funds will enable us to further develop our platform and devices, kick off pivotal clinical studies, and expand our team, IP portfolio, and R&D efforts,” adds Lalani.
“Medicine is moving towards a much more personalized approach, including drug delivery, diagnostics, and – as FemTherapeutics envisions – through prosthetics. Given nearly 50% of women suffer from pelvic organ prolapse during their lifetime, we are excited by the impact FemTherapeutics can have on advancing women’s health,” shares Neha Khera, General Partner at 2048 Ventures, with me in an email.
Since its inception, FemTherapeutics has raised a total of $2.3 million ($3.2 million CAD) including non-dilutive financing. The startup was recently named in CIX Canadian Innovation Exchange’s Top 20 Most Innovative Companies in Canada, and was awarded Innovations for Equity by WIN: Women in Innovation.
A Market Ripe For Disruption
According to the Association for Pelvic Organ Prolapse Support, approximately 34 million women suffer from Pelvic Organ Prolapse across the globe currently, and over 120 million women suffer from Urinary Incontinence. Approximately 8 to 10 million women in the U.S. are seriously affected by urinary incontinence and PFDs, and only ~3.5 million are diagnosed with some stage of POP. However, only 1 in every 12 people experiencing pelvic health issues will seek treatment.
Current treatment options for POP include pelvic surgery and vaginal pessaries – intra-vaginal support devices that are mass-manufactured with geometric shapes and sizes. Over half of all pessary wearers discontinue use within the first year due to complications, shares Lalani, and current pessary producers fail to consider that multiple types of POP display a variety of symptoms and that every woman experiences unique childbirth due to their genetics and general health. Furthermore, 20% of women in North America will get pelvic floor surgery which has a 30% failure rate, and a high risk of complications due to certain mesh implants facing lawsuits, as Forbes reported earlier this year.
The challenge today with pessaries is that they have remained largely unchanged for the past 50 years. “Also, 1 in 3 women will fail pessary fittings, and 50% of women will discontinue use after 12 months and ultimately resort to high-risk and expensive surgical procedures. This is because pessaries come in more than 100 shapes and sizes, and doctors fit them to patients through an invasive process of trial and error, and the majority of pessary users still need to visit a physician to have their pessary removed, cleaned, and reinserted routinely, due to most patients being elderly and not having the finger dexterity or the capability to reach that far into their vagina. This presents a huge burden on physicians and makes chronic POP patients dependent on clinical visits for the upkeep of a nonsurgical treatment method,” explains Dr. Mihnea Gangal, cofounder and CMO of FemTherapeutics.
After participating in the Montreal Surgical Innovation Program in 2019, which is a collaborative initiative involving McGill University, Concordia University, and the École de technologie supérieure (ÉTS), the founders of FemTherapeutics – Inara Lalani, Negin Ashouri, and Dr. Mihnea Gangal – were inspired to conceive the idea for their venture. The team delved into extensive brainstorming sessions, exploring numerous surgical and clinical needs in the field of gynecology. Eventually, they narrowed their focus to vaginal pessaries, recognizing a pressing need for improvement due to the lack of innovation in this area since the 1950s. “We realized that there was an evident necessity to enhance the design of vaginal pessaries,” adds Lalani.
“Leveraging the latest advancements in cloud computing and artificial intelligence, we have developed an all-rounded data-driven platform for pelvic health that allows us to visualize each patient’s condition in 3D software and subsequently propose pessary designs that are modeled to the patient’s unique anatomical characteristics. Once the designs have been finalized, we utilize cutting-edge 3D printing techniques to directly print biocompatible silicone devices,” explains Lalani.
FemTherapeutics’ team
According to its cofounders, this technology can be expanded across a breadth of key areas in women’s health, including developing custom cerclage pessaries to prevent preterm birth, custom dilators to treat vaginal stenosis forming from post-cancer therapy, custom menstrual and sexual wellness products, and more.
By operating on a B2B2C model comparable to the billion-dollar markets of custom dental, orthotics, audiology, and prosthetics, FemTherapeutics works with physicians (i.e. OB/GYNs, physiotherapists, nurse continence advisors, etc.) who will buy the system and fit the devices to each patient.
The company recently completed a First-in-Woman feasibility study in February 2023 which sought several prolapse patients being fitted with custom pessary treatment plans. “We recently kicked off a program with the Mayo Clinic Platform_Accelerate to further train our predictive models with high-quality, de-identified clinical data. We’re excited to be working with exceptionally skilled health data scientists and clinicians. Additionally, we are very positive about the prospect of commercializing our proprietary measurement tool which will allow physicians to support patients better with no additional training required,” concludes Negin Ashouri, cofounder and CTO of FemTherapetics.