Cosm Medical, a Toronto-based company, has announced its recent FDA clearance for Gynethotics Pessaries, marking a significant milestone in pelvic care. This clearance, following closely on the heels of Health Canada approval, highlights Cosm’s dedication to improving patient outcomes and transforming treatment options for women globally.
Gynethotics Pessaries represent a breakthrough in personalized pelvic care, setting a new standard in the field. The pessaries are the first of their kind to receive FDA clearance in nearly five years, offering clinicians access to almost 10 million customizable configurations that can be conveniently ordered online. This vast array of options far surpasses the approximately 100 configurations provided by other commercially available pessaries. The benefits of personalized Gynethotics Pessaries were demonstrated in a pilot study conducted at Sinai Health Systems and published in Urogynecology, the Journal of the American Urogynecology Society, in 2023.
“Our vision is to become the world leader in precision gynecological devices for unique bodies and needs.” said Derek Sham, Founder & CEO of Cosm Medical. “With our first FDA clearance, we are one step closer to realizing this vision and making a meaningful impact on the lives of over a million patients by 2030. This will set a new standard of care in gynecology like the established billion-dollar markets of custom orthotics, dental and hearing.”
Half of all women will experience a pelvic floor disorder such as prolapse and incontinence in their lifetime. “Aging and women’s health are both severely underserved markets with high clinical unmet needs, demonstrated by the fact that Femtech and Agetech are both projected to be growing at over 15% CAGR.” said Ivneet Bhullar, Investment Partner at Fusion Fund and Cosm Board Member. “It’s been great supporting Cosm over the past 2 years as they’ve achieved major milestones towards driving precision care into gynecology.”
Beyond pessaries, Cosm has signed a strategic partnership with the University of Alabama at Birmingham to work with Holly E. Richter, Ph.D., M.D. and Max Cadena, M.D. on a novel design and indication for Gynethotics. “We look forward to improving surgical outcomes and are currently completing Phase 1 of a clinical study with the goal of implementing a new paradigm for impacting post-operative healing,” Richter said. “This is especially important as there are limited evidence-based options for augmenting vaginal native tissue repairs.”
Cosm Medical, through its dedication to precision care, aims to revolutionize gynecological devices leveraging novel diagnostics, AI, cloud software, and 3D printing, Cosm is committed to providing patient-specific solutions that improve outcomes and enhance quality of life.
