It only takes about 30 minutes from downtown Seattle to get to what some people like to call the “Silicon Valley of Ultrasound,” in Bothell, WA. So when I heard about another ultrasound startup company, one with a name that comes from the Latin word for “miraculous,” I figured it was worth checking out.
There’s actually a lot more substance to the story than that. Bothell, WA-based Mirabilis Medica doesn’t claim to have achieved any miracles. But it has a pretty ambitious goal. Its team of engineers are building an ultrasound machine that is supposed to offer a non-invasive way to get rid of uterine fibroids. The technology has potential to help relieve symptoms of these painful growths in the uterus that are the leading reason so many women get hysterectomies after their childbearing years.
The problem, and market opportunity, is a big one. As many as one out of five women in the U.S. suffer from fibroids, according to the National Institutes of Health. Women can take drugs, or get a couple of different surgical procedures, but the only cure is a radical one—complete removal of the uterus, a hysterectomy. About 625,000 women get hysterectomies in the U.S. each year, and about half of the time it is because they have uterine fibroid growths that cause painful cramping and bleeding, says Mirabilis CEO Mike Connolly. So if Mirabilis can come up with a way to get rid of these fibroids, without a doctor having to pull out a scalpel, it forecasts it will tap into a new market worth $1 billion a year.
“Right now, it’s basically like doctors are hitting a fly with a sledgehammer,” Connolly says.
Mirabilis, like practically every ultrasound company in Bothell, can trace its family tree to the University of Washington. The company got started in 2004, by Alex Lebedev on business, Shahram Vaezy on technology, and Michael Lau, a practicing gynecologist in Edmonds, WA, on the medical side. Connolly joined the company in October 2006, after he got an up-close look at the technology when he was a principal with vSpring Capital, an early investor. Besides vSpring, the company has raised about $11 million since the beginning from Charter Life Sciences, Arboretum Ventures, Split Rock Partners, and Dow Chemical.
The Mirabilis technology has two critical components. One uses the diffuse, low-intensity waves of diagnostic ultrasound to help doctors look inside the body and pinpoint the location of the fibroids. The other element is a high-intensity, tightly-focused therapeutic wave of ultrasound. That part is supposed to heat up tissue just enough to kill fibroid cells without causing any collateral damage or side effects.
Mirabilis has about 10 employees, including some engineers from one of the few successful therapeutic ultrasound companies, Liposonix, which uses ultrasound for body sculpting. The technical challenge 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.
“There really haven’t been many success stories with HIFU,” Connolly says. “We hope to be among the first to make it.”