On January 28, 2020, Contura received FDA approval for its proprietary urethral bulking agent (UBA), Bulkamid. This injectable hydrogel, consisting of 2.5% polyacrylamide and 97.5% water, is currently marketed in over 25 countries worldwide and is approved for the treatment of stress urinary incontinence (SUI).
Bulkamid works as a permanently implanted bulking agent, that helps facilitate improved control of the urethra closing mechanism, in addition to supporting additional local cell growth to help provide long lasting relief of SUI symptoms.
The safety and efficacy of Bulkamid was attested to by a clinical study supporting Contura’s PMA, which found that 75% of women who used Bulkamid experienced a material improvement in their symptoms associated with SUI. This minimally invasive device is already the preferred SUI treatment method for women across the UK, and the Contura team is excited to bring this safe and effective product to the millions of American women suffering from SUI.