Pelvic floor disorders in women are a group of conditions that affect the muscles, tissues and ligaments of the female pelvic floor—impacting the support of organs such as the bladder, bowel, uterus and rectum.
Imagine a medical condition that resembles a sort of hernia where these pelvic organs fall out through the vagina. The downward protrusion of the uterus, bladder or rectum into the vagina—termed pelvic organ prolapse—is caused by a weakening of supporting structures for holding pelvic organs in place inside the pelvic cavity. In many cases, the vagina itself may be pulled down and turned inside out. Pelvic floor disorders constitute problems ranging from discomfort and pain due to constipation, urinary and bowel issues, chronic backaches and sexual dysfunction—resulting in decreased quality of life for millions of women.
“Beyond prolapse, there’s also urinary and fecal incontinence,” explains Derek Sham, CEO and founder of Toronto-based Cosm Medical. “The likelihood of occurrence for women comes down to many factors such as age, activity level, having vaginal child delivery, and suffering from genetic conditions such as Ehlers-Danlos syndrome (EDS).”
Pelvic floor disorders have a high prevalence rate. They affect one in four adult women, and half of all women by the time they reach 80. It’s one of the reasons why adult diapers are expected to surpass baby diaper sales in the near future.
“In the U.S. alone, the direct costs of pelvic floor disorders are $12.4 billion—14 percent of which is essentially nursing home admissions,” states Sham. “Many women end up going to nursing homes because of either pain and discomfort from prolapse, or incontinence that they can’t manage at home.”
According to Sham, pelvic floor surgeries account for over $1 billion of annual surgery costs in the U.S. Over the last decade, numerous issues have arisen with regard to surgical gynecological meshes—leading to the Food and Drug Administration (FDA) banning transvaginal surgical mesh for pelvic organ prolapse repair in April 2019.
One non-invasive option is physical therapy, which focuses on retraining pelvic floor muscles using exercises, internal and external massage, trigger point therapy and joint mobilization.
“Kegel exercises can be used to contract and strengthen the pelvic floor,” says Sham. “But physical therapy obviously has limited effectiveness for many sufferers, such as the elderly. And it’s only really indicated for urinary and fecal incontinence—not for mid- to late-stage prolapse.”
Pessaries have proven to be a solution for both prolapse and incontinence. A pessary is an FDA Class II medical device that is inserted into the vagina, where it serves as a gynecological prosthetic for supporting pelvic organs. Some pessaries also enable the gradual dispensing of medication.
“Pessaries are one of the world’s oldest documented medical devices,” reveals Sham. “They date back to 1,800 B.C.—to the Ancient Egyptians. Pessaries haven’t changed much in the last 50 years since the advent of medical grade silicone. They come in 100 different shapes and sizes fit by trial and error.”
While standard tools in urology, gynecology and colorectal disciplines involve the use of ultrasound, CT scanning and MRI, urogynecology employs clinical assessments using finger measurements for determining the pelvic needs of women.
“Right now, if a woman has prolapse and doesn’t want to get surgery, a clinician uses their fingers to guesstimate the size of the vagina and pick a pessary through trial and error,” describes Sham. “The clinician puts in the pessary, and the patient walks around for 10 minutes. If it works—great. If it doesn’t, then try another one over and over again. Over two to five separate visits, a patient might try up to 10–20 different devices. A third of women fail pessary fittings. Half will stop using them within a year.”
Many women wearing pessaries in the long term suffer complications such as vaginal discharge, bleeding, tissue erosions, infections and pain. Even with all of these issues, over 10 million pessaries are sold every year at a cost of approximately $40–100 per device. Many clinicians and patients have expressed a desire for a custom pessary which could improve the care for women suffering from this common, growing and underserved global women’s health issue.
Introducing Gynethotics
Cosm Medical is creating customized pessaries called Gynethotics by leveraging cloud software and artificial intelligence (AI) in combination with 3D printing and a novel ultrasound technique. The Gynethotics platform serves to personalize pessaries towards patients’ unique bodies and needs.
“We see Gynethotics modernizing urogynecological care by replacing hours of trial and error with data-driven personalization to improve clinical efficacy, while allowing more women to live and age with dignity and grace,” asserts Sham.
The team at Cosm Medical has developed a technique for molding and scanning the female pelvic floor that is currently in clinical studies. Modern advances in AI and medical image analysis are then employed to extract measurements and develop an AI-based prediction model to figure out the optimal design of Gynethotics. Cosm Medical has been working with Autodesk to evolve their parametric models in order to limit the amount of engineering work required for each individual Gynethotic, as well as to manufacture the biocompatible devices.
Cosm Medical is partnered with the Robarts Research Institute at Western University in Ontario, Canada, one of the top five medical imaging research centers in the world. Goli Ameri, Chief Scientific Officer at Cosm Medical, holds a PhD from Robarts—where scientists who pioneered 3D ultrasound and CT scanning continue to advance the field.
“Our scanning is different from standard ultrasound because we need to capture a lot of the measurements that clinicians currently take by palpation and moving pelvic tissue around,” explains Ameri. “We have to find a way to distend the vagina the way a physician would by inserting fingers into the vagina, while improving the quality of the measurement.”
When the vaginal canal is collapsed naturally, it distends to form around an inserted object—in this case, the Gynethotic.
“Knowing how the vagina distends without causing discomfort to the patient is going to be very critical for us to be able to design a patient-specific pessary,” says Ameri. “So we are capturing that information using pressure and volume measurements, and our 3D ultrasound images during different maneuvers.”
Patients are asked to squeeze and perform the Valsalva maneuver, and the resulting shifts in anatomy are studied by the Cosm team with emphasis on the changes to prolapse during the maneuvers.
“As we capture more and more data, we’ll be able to leverage artificial intelligence and deep learning methods to analyze our data and extract what will become the metrics for designing patient-specific pessaries,” concludes Ameri.
Unlike the foot for custom orthotics or the mouth for custom dental devices, the female pelvic floor consists primarily of soft tissue and muscles, which is an important consideration for Cosm Medical. Each biocompatible device must be safely anchored on the delicate tissues while being comfortably supportive and easy to manage. Gynethotics currently uses high-quality medical-grade silicone similar to the materials used in current pessaries but with variability in its rigidity.
Cosm Medical has not released estimated costs of its custom Gynethotics, as these will be dependent on the results of clinical data and the complexity of the final product. However, prices for Gynethotics are expected to be considerably lower than the cost of surgery.
The History of Cosm Medical
Derek Sham was initially using his biomedical engineering background to serve as a general manager for a successful diagnostic company in men’s urological health. He was responsible for creating and commercializing novel medical devices, and is credited with building the most utilized urodynamic system in the world.
“It’s a gold-standard diagnostics system that measures the functionality of the bladder and urethra for determining the type of incontinence that people have, so doctors can prescribe the right therapy for incontinence and urinary obstruction—whether it’s drugs, physical therapy, devices and/or surgery,” says Sham.
After helping to grow the business, Sham was part of the management team which successfully exited the private-equity-backed firm in 2016.
“I got a nice cheque, partied for a couple of weeks and then wondered, ‘What the hell am I going to do with myself now?’” reminisces Sham. “I decided to quit my job and explore something new, challenging and worthwhile. At the time, I was in a part-time MBA as well and decided to take a sabbatical from that. I ended up traveling Southeast Asia for six months. I scuba-dove everywhere and did yoga teacher certification while abroad. During my travels, I got offered the opportunity to stay in Bali to help grow a small business. The next morning, I woke up and drafted what became our lead provisional patent for founding Cosm.”
Sham says he conceived the idea for Cosm Medical after watching his grandmother go through her elderly care issues.
“Because of my work, I knew some of the best doctors in the world for my grandma’s condition,” says Sham. “I was calling doctors in the U.S., France and UK, trying to get her the care that I thought she deserved. She failed many pessary fittings and ended up getting emergency surgeries and being put into a home. I felt powerless at the time and decided to launch Cosm on our mission for personal pelvic health. We’re building a tech platform that I wish existed a decade ago.”
Sham returned home early from the sabbatical and met with more than 20 clinicians in the field, including Dr. Ali Borazjani from Cleveland Clinic.
“Ali and I have known each other for many years while he was doing his PhD and post-doc at Cleveland Clinic, where he was studying the pathophysiology of the pelvic floor. We’ve actually done a great white shark dive outside of Cape Town, South Africa, when we were there together for a conference,” shares Sham. “Ali actually had a patent around a new way to measure the female pelvic floor—i.e., putting a balloon in the vagina and then using ultrasound to scan it. He anticipated using that technology to predict intrapartum trauma and help women have more autonomy when it comes to mode of delivery. Basically, he envisioned creating this device to provide the data needed for patients and clinicians to make shared decisions around the selection between a cesarean and vaginal birth.”
From there, Sham spent a year developing the business while completing his MBA at the University of Toronto’s Rotman School of Management.
“The Rotman School of Management is home to the Creative Destruction Lab,” says Sham. “It’s the fastest-growing university business school startup accelerator that I’m aware of. The major focus is to facilitate AI in driving changes in tech and business through ‘Build something massive’. Toronto is actually where the modern revolution in AI started with Geoffrey Hinton, who’s a U of T professor that developed the framework for modern AI.
“I was part of that accelerator as a student. The following year, I invested my own money into starting Cosm, and hired Goli [Ameri] because of her experience in ultrasound and connections with the Robarts Research Institute in London. We spent eight months incubating, refining, bench testing and driving our technology forward towards clinical studies.”
Sham, Ameri and Borazjani expanded the team by hiring Aye Nyein San—a CTO with extensive experience in engineering and regulatory affairs at a publicly-traded biotech company—along with specialized engineers in 3D printing, biomechanics and data science. These days, Cosm Medical is busy running clinical studies and the company has recently joined the Berkeley SKYDECK Accelerator in conjunction with the CABHI MC2 Program.
Medical doctors are heavily involved in the Gynethotics ideation, design and testing process.
“That is the most critical part,” expresses Sham. “Before I put my own money into this, I talked to over 20 clinicians, and so far we’ve interviewed at least a hundred clinicians. I think beyond just making the best product, we need clinicians to want to prescribe it too.”
Cosm Medical is associated with many leading doctors, such as Dr. Seyed Shobeiri, author of Practical Pelvic Floor Ultrasonography, and Dr. Colleen McDermott, President of the Canadian Society of Pelvic Medicine.
“Our technologists include the inventor of 3D ultrasound, and Cortex Design—the design firm that helped CloudDX win the Qualcomm Tricorder X-PRIZE competition,” adds Sham.
The Autodesk Experience
Cosm Medical have been residents at the Autodesk Technology Centers for the past one-and-a-half years. Autodesk’s technology centers network hosts startups working on projects that support design and innovation, material research and fabrication workflows. Participants are provided with access to Autodesk’s rich series of programs, subject matter experts, training and equipment.
“Our manufacturing process development would have been a lot more time-consuming and expensive, if not less practical and feasible, without the Autodesk residency,” states Sham. “The first Gynethotics that we created utilized Autodesk tools and team to get up off the ground.
“We’ve developed a process to ‘cocoon mold’—or 3D print single-use molds—to create Gynethotics. The technology right now does not exist to 3D print biocompatible silicone devices for medical device applications, and hence we’ve leveraged a process that’s currently used to make custom hearing aids and earplugs out of silicone, where we’ve remodeled the mechanics of the mold and the materials for our application.
“Our entire software platform for designing the molds and the Gynethotics leverages Autodesk’s Fusion 360 software platform. From our end, we’ve built out parametric models using Fusion 360 where we enter anywhere between 6–12 measurements depending on the model, and Fusion 360 auto-generates the 3D model. Without that, it would cost hundreds of dollars per Gynethotic just to design the Gynethotics themselves—so Fusion 360 gives us the capability of semi-automating our Gynethotic mold and product design so we can deliver an economically viable product to the market.”
Rick Rundell, senior director at Autodesk Technology Centers, shares his thoughts about the Autodesk-Cosm engagement.
“The technology centers exist to help us better understand the integration of making physical things with the design of physical things,” describes Rundell. “We have really well-equipped fabrication shops, which Cosm has benefited from. Those have lots of different tools for making and fabricating things, and we have design tools that we’re building to respond to the needs that designers will have in the future.
“Cosm has very forward-looking ideas about how design and fabrication go together, and there are some really interesting trends that Cosm is helping us to understand. Clearly, the technology to enable mass customization is important to our future. There are the challenges of capturing information about the environment—in this case, the environment being the human body. All of the ways of processing information ranging from radiology procedures and ultrasound to laser scanning—taking that raw data and applying artificial intelligence to make sense of it—is very important in terms of integrating design with the physical world.
“These are the kinds of things we get very excited about when a company like Cosm becomes part of our community, and the technology centers serve to build a kind of innovation community that can help us understand the future.”
What’s Next for Cosm Medical?
Cosm Medical is currently conducting two clinical studies in order to evaluate their measurement system. The studies are centered on the scanning technology for developing prediction models around pessary sizing and fit.
“Pelvic floor disorders are a gravity-prone issue, so we need to understand whether to scan women standing, sitting up, lying down,” explains Sham. “So those two clinical studies to refine our measurement system will then lead to our first Gynethotics clinical study in 2021.”
Sham envisions Cosm’s measurement system not only predicting Gynethotics design, but also having a major impact on improving surgery in the long term while developing the world’s largest dataset of the female pelvic floor.
“One of the major issues I had when my grandmother was going through this, was that all I could get were finger measurements on what was going on with her,” says Sham.
“As an overall market, because of how common and underserved this issue is globally, Gynethotics has a billion-dollar product category potential similar to that of customized orthotics, audiology and orthodontics integrated into a complete care pathway which will help all women with pelvic floor disorders.”
The gynecological prosthetic could itself be available under different levels of technology.
“As the product category that we are pioneering evolves, we might accelerate our current R&D to multi-material devices, in a similar approach to a customized orthotic that has a hard heel and a soft layer on top,” suggests Sham. “We have also begun technical assessments around adding sensors for patient monitoring and therapeutic delivery—whether it’s drug delivery or energy delivery—to drive clinical and patient benefits with Gynethotics.”
Cosm Medical is excited to showcase their digital urogynecology platform and solve an impactful problem by bringing pessaries into the 21st century.
For more information about Cosm Medical, visit https://www.cosm.care/.