FDA Clears Cosm Medical’s Gynethotics Pessaries

The U.S. Food and Drug Administration has cleared Gynethotics Pessaries from Cosm Medical. This product provides a personalized pessary to patients that can be configured with almost 10 million variations.
 
“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.”
 
The company states that half of all women will experience a pelvic floor disorder such as prolapse and incontinence. “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 two years as they’ve achieved major milestones towards driving precision care into gynecology.”
 
In addition, the firm has partnered with the University of Alabama at Birmingham to work with Holly E. Richter, Ph.D., M.D. and Max Cadena, M.D. The goal of the collaboration is to develop a novel design and indication for Gynethotics.