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for Mirabilis is to make the high-intensity, focused ultrasound (HIFU) so that it is mostly automated and easy to use for a gynecologist, and the waves are consistent enough to get effective results among a variety of patients with different body shapes, Connelly says.
The company has shown it can accurately hit fibroids without harming healthy tissue in a trial of about 15 patients, Connolly says. The procedure sounds pretty simple—a patient walks in, lays down on the exam table, gets ultrasound focused over her abdomen, and walks out 30 minutes later. If all goes well, the pain and excess bleeding symptoms should disappear after about one to three months, and the patient should be able to go back to work in a day or two, instead of going through the four-to-six week recovery period of a hysterectomy, Connolly says.
Mirabilis is still refining some technical aspects of its device to make it more commercially viable, which should happen by this fall. Once that’s done, he expects to raise a Series B venture round, which he hopes will be between $15 million and $25 million, he says. That should give the company the runway it needs to start a clinical trial, which will probably require a minimum of 100 to 150 patients, before the FDA will approve this new type of device for the market, Connolly says. He wouldn’t forecast when it could reach the market, but such a trial will require a year’s worth of patient follow-up, to make sure that symptoms don’t return, and that too many patients don’t end up needing a hysterectomy after all, he says.
There are competitors working on less-invasive alternatives to hysterectomy, although none are going the same route as Mirabilis, Connolly says. Framingham, MA-based Interlace Medical raised $20.5 million in venture capital last week for a minimally-invasive surgical procedure for removing fibroids. Rockland, MA-based Biosphere Medical is pushing a procedure known as uterine fibroid embolization, which is a procedure that an interventional radiologist uses to cut off blood flow to the fibroids. An Israeli company, InSightec, aims to use MRI-guided technology to help with minimally-invasive removal of fibroids.
Connolly does know a bit about the gynecology community. He has a background in co-founding several medical device companies—one of which, Novacept, pioneered a minimally invasive procedure to help gynecologists control excessive endometrial bleeding. More than 300,000 of those procedures are done every year, the sort of market adoption that led it to be acquired for $325 million by Cytyc in 2004. The product is now a part of Bedford, MA-based Hologic (NASDAQ: HOLX).
All that looks good, but as Connolly freely acknowledges, high-intensity therapeutic ultrasound has been around for decades without much to show for it in commercial success. Most of the big ultrasound successes in the region—Philips Ultrasound, SonoSite, Siemens—are diagnostic players.