Mirabilis Medical has been granted European CE Mark approval to begin marketing their robotically assisted non-invasive focused ultrasound system to treat uterine fibroids. This milestone was accomplished after the company completed their first clinical trial, safely and successfully treating 73 women in Mexico with an average active treatment time of less than 10 minutes each.
The company has also been cleared by the FDA to conduct their pivotal study in the US, which will start in the second half of 2017. A total of 180 patients will participate at 12 sites, including nine in the US, two in Canada, and one in Germany. Mirabilis recently closed a $5 million funding round to support initial development of commercial operations in Europe, and they are currently fundraising to support the US pivotal study and expanded European operations.
They are able to achieve the remarkably short treatment time because their proprietary robotically assisted protocol uses a “shell” ablation technique. This method ablates only outer fibroid tissue, creating a “shell” of ablated tissue; the ablated tissue of the shell interrupts perfusion to tissue inside the shell, leading to death of additional fibroid tissue.
Another key benefit of their ultrasound-guided system is that it is office-based, small, and portable. “Our clinical results to date indicate that we can treat fibroids in a fraction of the time of other devices,” Mirabilis CEO Jens U. Quistgaard commented. “We believe that such a platform finally makes in-office focused ultrasound treatment a practical and attractive option for women, physicians and payers.”