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From ideation to commercialization, Cosm’s journey in advancing women’s pelvic health as it enters the Canadian market and beyond!

Some of the most incredible ventures start from a deeply personal story. The motivation to make a change is a lot stronger when the drive stems from an impressionable moment.

That was the case with Derek Sham, founder and CEO of Cosm Medical. Sham’s grandmother experienced a devastating pelvic floor disorder. Through that experience, he noticed that having access to top-tier healthcare was not enough when it came to treating the ailment. Specifically, the medical device, pessaries which are used for vaginal support, have not seen modern innovation since their development in the ‘70s. Recognizing that it was time for a change, Sham decided to modernize the traditional pessary that was inspired by the established industries of custom orthotics, dental and hearing.

Understanding pessaries and introducing GynethoticsTM 

Pessaries are temporary prosthetics placed within the vaginal cavity to support the pelvic floor organs. It is a common treatment administered to women suffering with prolapsed organs from within the vaginal cavity or stress urinary incontinence. The current standard of care is a difficult ‘trial and error’ process where a physician performs a subjective size assessment of the vaginal cavity by using their fingers and determining the size of the pessary needed from up to 100 different shapes and sizes. Even with multiple clinical visits, about one-third of pessary fittings fail, and approximately fifty percent of the remaining users stop using their pessaries within a year or two due to decreased quality of life. Additionally, complications including vaginal discharge, chronic pain, infections, and tissue abrasion occur in over half of patients that use them for the long term. 

Understanding this gap within the industry, Sham developed Gynethotics™ pessaries. Gynethotics™ is the world’s first personalized pessary using a digital gynecology platform that combines software, AI and 3D printing to personalize devices for a woman’s unique body and needs. The data from clinical trials and other pessary fittings allows AI to effectively predict the type and size of the pessary – eliminating the trial and error process. The AI technology enables the customization of the pessary and contributes to an overall improved experience and less discomfort.

Cosm’s commercialization journey

During Cosm’s ideation phase, Sham was actively looking for a way to develop the technology, form partnerships, and gain guidance to prepare for the company’s seed round raise. While looking for resources, Cosm came across Innovation Factory (iF). Working with iF’s Venture Growth and Expert Advisors, Sham was guided through the process of pitching, fundraising, and building their data room. Cosm was introduced to important investors and key opinion leaders in the industry, while they built their scientific advisory board. Cosm also accessed Innovation Factory’s Southern Ontario Pharmaceutical and Health Innovation Ecosystem (SOPHIE) program, which contributed to its R&D, helping accelerate the product’s commercialization journey. 

Delivered by Innovation Factory, in collaboration with the Synapse Life Science Consortium, the SOPHIE program launched in 2021 with a $6-million investment from the Government of Canada through the Federal Economic Development Agency for Southern Ontario (FedDev Ontario). The SOPHIE program supports high-potential life science companies and enables them to accelerate their path to market. To date, the program has supported 42 commercialization projects, enabled $7.6 million in commercialization investment and helped emerging companies create new jobs and raise capital.

Through the SOPHIE program, Cosm was able to complete a project with the Centre for Data Science and Digital Health (CREATE) team at Hamilton Health Sciences (HHS). Cosm was able to conduct trials to develop its AI digital platform and develop its patient portal while exploring regulatory considerations. Additionally, the team recently started a clinical study with an urogynecology group at McMaster University and further solidified their path to commercialization and beyond. 

Grant program unlocks new opportunities

The growth of the organization has been exponential. From winning 3 pitch competitions to completing its SOPHIE project with HHS’ CREATE, Cosm gained the interest of angel investors, physicians, and venture capitalists in Canada, the US, Asia and Europe. In 2022, Cosm Medical made headlines after raising CAD $4.7 million in an oversubscribed seed round led by Fusion Fund in Silicon Valley with follow-on investment from top-ranked Canadian VCs.

Since the seed round, the Cosm team has grown and now operates with about 20 full-time employees. Sham adds, “We published a paper last year in collaboration with Dr. Colleen McDermott at Sinai Health Systems in Toronto on the world’s first patient-specific pessary for pelvic organ prolapse. In our research, we demonstrated lower symptom scores and improved patient satisfaction on all patients compared to their off-the-shelf pessary.” 

The progress doesn’t stop there. Sham elaborates, “Working through grants like the SOPHIE has been helpful for us and led to new partnerships. As a result, we got to work with both the Ontario Centre of Innovation (OCI) and Next Generation Manufacturing Canada (NGen Canada) to level up our collaboration with the HHS CREATE team and expand our network to develop our digital gynecology software.”

Assortment of Gynethotics™ developed by Cosm Medical.
Assortment of Gynethotics devices. Image courtesy of Cosm Medical.

Cosm’s clinical portal integrates AI to enable healthcare providers to design and order Gynethotics, manage and track patient data, automate patient engagement and has Electronic Health Record (EHR) interoperability. Cosm is also developing a patient portal, which includes a patient education platform, a symptoms tracker and care management support — creating a secure and convenient way to engage patients throughout their care journey. 

“Optimal health is a journey and we’re grateful for the support of Innovation Factory and the HHS CREATE team, for helping us build software that helps manage the care journey and improves access and quality for women suffering from common and underserved issues.”, explained Sham.

What’s next for Cosm and GynethoticsTM

When talking about the future and the next steps, Sham was extremely excited to share that the relationship with HHS’ CREATE has led to Cosm’s latest exciting milestone in their entrepreneurial journey. Cosm has received Health Canada market approval for Gynethotics™ pessaries and will be launching in Canada by the end of this year along with their digital gynecology software platform.

This is a massive achievement for the team and Canadians who will soon have access to Gynethotics™ pessaries, the world’s first personalized pessary.  Beyond Canada, Cosm’s team expects its first FDA market clearance in 2024.  “Having recently presented scientific papers at leading medical conferences, my team and I are humbled by the interest in the clinical community to join us in creating and delivering personalized gynecological devices for precision care.  It’s been a 5-year journey so far and we’re just getting started.  We’re really excited about the next 5 years ahead as we drive towards improving over 1,000,000 lives by 2030,” added Sham.  

The future of femtech is changing one startup at a time, and Cosm is making its mark. A company inspired from a personal experience will go on to impact many lives.

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