Cosm Medical Gets FDA Clearance for Pelvic Care Devices

They include almost 10 million pessary configurations that clinicians can order online.

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Cosm Medical

Cosm Medical announced 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 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.

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.”

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