Mirabilis Medica wins CE Mark, FDA IDE for Mirabilis system

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Mirabilis Medica

Mirabilis Medica said today it won CE Mark approval in the European Union and FDA investigational device exemption for its Mirabilis System designed to treat uterine fibroids.

The Bothell, Wash.-based company’s Mirabilis system is designed to use ultrasound to both provide imaging and ablation during procedures to remove uterine fibroids, the company said.

The device uses low-intensity ultrasound waves to locate fibroids within the body, and a high-intensity ultrasound to heat and kill the fibroid tissue to provide relief from symptoms due to the growths.

“The Mirabilis System has been in development for nearly 10 years, and it’s very exciting to now be able to bring this technology to market. This technology holds the promise of helping a large number of women worldwide, and we’re very pleased to be able to begin making it available,” prez & CEO Jens Quistgaard said in a press release.

Mirabilis said it expects to begin a clinical study of the device in the US later this year, with a planned 12 clinical sites across the US, Canada and Europe as it seeks FDA approval.

Last August, Mirabilis raised $5 million in a new round of debt financing, according to an SEC filing.

Money in the round came from 3 anonymous sources, according to the SEC filing. The company noted that the total offering amount does not include principal and accrued interest on previously issued convertible notes that converted into equity, including up to 5.1 million warrants issued with the financing.

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