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Gains Bulkamid, a urethral bulking agent for women.
March 1, 2021
By: Sam Brusco
Associate Editor
Axonics Modulation Technologies Inc. has acquired privately-held Contura Ltd. and its flagship product, Bulkamid, a urethral bulking agent for women with stress urinary incontinence (SUI). The firm acquired London-based Contura Ltd. for of $200 million and potential future milestone of $35 million. SUI affects an estimated 20 million women in the U.S alone. It afflicts women of all ages, with childbirth as one of the main contributing factors. SUI is caused by weakness in the pelvic floor, preventing the urethra from closing fully when sudden pressure is put on the bladder. This can allow urine to leak out during normal daily activities such as coughing, laughing, exercising or lifting an object. The Bulkamid next generation hydrogel is injected into the urethral wall in a minimally invasive, office, or outpatient facility procedure, to restore the natural closing pressure of the urethra. Bulkamid is clinically proven to retain its bulking characteristics and maintain efficacy for many years, providing women with long lasting relief of their SUI symptoms. Bulkamid obtained a CE mark in 2003 and is a covered service from a reimbursement standpoint in most European countries. The U.S. Food & Drug Administration approved Bulkamid in early 2020. The product was introduced mid-2020 in a limited rollout, and is is currently in over 30 international markets globally. Axonics CEO Raymond W. Cohensaid in a press release, “This acquisition is highly synergistic, leverages our expansive commercial footprint and gives us the opportunity to expand our SNM business around the world. Axonics will provide urogynecologists and urologists with a complete suite of clinically differentiated incontinence solutions for their patients, thereby enhancing Axonics’ value proposition to new and existing customers. Interestingly, in many cases, the patient seeking treatment presents with mixed incontinence, meaning with both SUI and urge urinary incontinence symptoms. Similar to SNM, we see the highly underpenetrated SUI market as poised for significant and durable growth in the years ahead, driven by outstanding clinical results and increased patient awareness.” The acquisition leverages Axonics’ existing commercial footprint of over 220 sales and clinical specialists in the U.S. and Europe. Bulkamid addresses the shortcomings of existing particulate-based bulking agents while also offering an alternative to patients who desire to avoid sling surgery and instead opt for a minimally invasive solution.It has been used to treat over 70,000 women treated to date. Bulkamid is still in the initial phase of commercial development in the U.S. Axonics entered into a manufacturing agreement for the supply of the hydrogel. It has rights to a technology transfer after June 30, 2022 that would enable Axonics to insource manufacturing.
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