This start-up 3D prints pessaries on-demand: Cosm Medical achieves FDA clearance
Pioneering the future of personalised pelvic care
Half of all women will experience a pelvic floor disorder such as prolapse and incontinence in their lifetime. Yet this is a severely underserved area of health.
Pessaries are a common option for pelvic issues. But often getting a good fit is an issue. Typically manual finger measurements are taken and then fit is by trial-and-error. Cosm data shows there is a 30% fitting failure rate - meaning lost time and inconvience for the patient and wasted product.
A 3D printed pessary
Cosm Medical instead uses a novel diagnostic system, AI and 3D printing to create patient-specific pessaries in silicone with almost 10million shapes possible.
That is compared to about 100 configurations that are offered by other commercially available pessaries.
Cosm Medical also offers a virtual platform where patients can track symptom progress, access education resources and record results or issues.
FDA clearance for Cosm Medical
Now the FDA has granted Cosm Medical clearance for the product.
This milestone follows a recent Health Canada clearance plus a pilot study completed at Sinai Health Systems and published in Urogynecology, the Journal of the American Urogynecology Society, in 2023.
Cosm Medical now plans to introduce its products through 2024 and 2025.
A new standard for gynaecology
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. This includes a clinical study on post-operative healing - since there are limited evidence-based options for vaginal tissue repairs.
Cosm Medical has a big vision to achieve. Derek Sham, Founder & CEO of Cosm Medical said:
“Our vision is to become the world leader in precision gyneacological devices for unique bodies and needs.
“With our first FDA clearance, we are one step closer to realising 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 gynaecology like the established billion-dollar markets of custom orthotics, dental and hearing.”