Contura wins FDA premarket approval for hydrogel injection

Contura announced that it won FDA premarket approval for its Bulkamid hydrogel injection for treating stress urinary incontinence (SUI).

Bulkamid is Contura’s proprietary device designed for treating SUI due to intrinsic sphincter deficiency in adult women with SUI or stress predominant mixed incontinence. According to a news release, the product is currently marketed in more than 25 countries, while an ongoing North American pivotal study on the efficacy and safety of Bulkamid formed the basis of Contura’s approval.

The product is a soft hydrogel consisting of 2.5% polyacrylamide and 97.5% water. Once injected, Bulkamid is designed to offer additional volume to the urethra and act as a scaffold through which cells can grow to provide long-lasting relief for SUI symptoms.

According to Contura, evidence in the U.S. has shown that urethral bulking is the preferred SUI treatment, while the Bulkamid treatment is the No. 1 SUI treatment in the United Kingdom.

The London-based company said it plans to expand its operations into the U.S. and is set to establish a U.S. office in Los Angeles, as well.

“We are extremely proud to have gained Bulkamid’s approval in the U.S.,” Contura director Rakesh Tailor said in the news release. “We are particularly excited that Bulkamid will, in the coming weeks, be available to women in the U.S. suffering from symptoms that significantly affect their day to day lives.”