Cosm Medical Achieves FDA Clearance for Gynethotics™ Pessaries, Pioneering the Future of Personalized Pelvic Care

Reno, Nevada ( -- Cosm Medical proudly announces FDA clearance for Gynethotics™ Pessaries, marking it as the first personalized pessary available to patients. This milestone follows a recent Health Canada clearance and marks a significant advancement in pelvic care, emphasizing Cosm’s commitment to enhancing patient outcomes and revolutionizing treatment options for women worldwide.

Gynethotics™ are the first pessary to be FDA cleared in about 5 years with almost 10 million pessary configurations that clinicians can conveniently order online. That is compared to about 100 configurations that are offered by other commercially available pessaries. The benefits of personalized Gynethotics™ Pessaries were demonstrated in a pilot study completed 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.”

Source: Cosm Medical. (2024). Cosm Medical Achieves FDA Clearance for Gynethotics™ Pessaries, Pioneering the future of personalized pelvic care [Press release].