Ultrasound waves can be engineered to do all kinds of nifty things, from creating high-resolution images of developing fetuses to non-invasive ways of busting up kidney stones. Now a Seattle-area startup called Kona Medical has raised a load of venture capital to pursue a big dream—ultrasound that could treat millions of people with high blood pressure.
The Bellevue, WA-based company, which has kept a low profile since its founding in 2009, is making a splash today by announcing a $30 million Series C venture financing. The investment is being led by what Kona calls “a large medical device company” that doesn’t want to be named, while the rest of the money comes from existing investors Essex Woodlands Health Ventures, Morgenthaler Ventures, Domain Associates, and BioStar. The 18-person company, founded by president and CEO Mike Gertner of Essex Woodlands, plans to use the cash to add more R&D staff at offices in the Bay Area and in Bellevue, WA.
Kona’s idea is to use ultrasound to zap overactive nerves around the kidneys that are involved in many of the toughest-to-treat cases of high blood pressure. High blood pressure is already treated with cheap generic drugs that work well for millions of people, which help to minimize their risk of future heart attacks, strokes, and death from heart disease. But an estimated 10 million people have what’s called “resistant hypertension,” which means either that the existing drugs don’t work well enough, or they can’t stick with the treatment schedule.
Researchers have had various ideas over the years, with drugs or devices, on how to treat these resistant hypertension patients, without much success. But Mountain View, CA-based Ardian electrified the field in November 2010, when it showed that its radio-frequency device on the tip of a catheter was able to cauterize those renal nerves, and deliver striking improvements in high blood pressure. Less than one week after presenting that data, Ardian was acquired by medical device giant Medtronic (NYSE: MDT) for $800 million, an impressive sum for a medical device company with no revenue at the time. The clinical findings, and the acquisition, inspired a number of competitors to dive in with similar technologies for treating resistant hypertension, which Bloomberg News recently said is shaping up as a potential new multi-billion market.
“This could be among the biggest medical device markets in history,” says John Bowers, Kona’s new chief operating officer, and a former senior vice president at Bothell, WA-based SonoSite.
For Kona, the news from Ardian provided great timing. That’s because Kona envisions using a different technology to achieve a similar goal. Instead of threading a catheter through the femoral artery in the thigh—a minimally invasive procedure—Kona is attempting to use non-invasive ultrasound waves from the back, that are focused to the precise depth and location to cauterize the renal nerves.
Gertner, an adjunct professor of surgery at Stanford University, was hot on the trail of ultrasound for high blood pressure back in 2009, before Ardian’s breakout moment. He had read scientific literature that said surgical removal of the nerves could be effective for treating resistant hypertension, but obviously that’s too invasive to be a practical option for millions of people with a chronic, not-immediately-life-threatening condition. Ardian was working in those days on its minimally invasive technique, but Gertner wanted to see if he could go a step further. “Ultrasound is the only way to get down there to this depth, with a non-invasive thing,” Gertner says.
As he sought to corral key intellectual property to give this idea a go, his travels led him to Seattle. He licensed in some technology from Seattle-based Therus, a company that had been developing highly focused ultrasound waves to seal off puncture wounds from catheters to the femoral artery—which can sometimes cause serious bleeding. He ended up getting not just the Therus technology for a new application, but also got its founder, Dave Perozek, to join the company. While Therus ran out of cash, Perozek is a widely respected force in the ultrasound business, with deep roots in the industry that stretch back to his days as president of Bothell, WA-based ATL Ultrasound (now part of Philips Healthcare.)
Gertner pulled in $1.5 million in the early days to put together the key technology pieces of the company, but it was really “off to the races,” he says, when Ardian got acquired and other companies were looking to get into devices to treat resistant hypertension. Kona pulled in an $11 million Series B financing in May 2011, which included Morgenthaler Ventures, one of the venture investors that made a bundle on Ardian.
Enthusiasm for various “renal ablation” strategies has continued to build since, Gertner says, citing a series of symposiums he attended at a recent medical meeting in Paris. Kona itself didn’t present there, and still has a long way to go to gather data to show its technique works. Gertner and Bowers also didn’t say much in detail about how the device is supposed to work, although it requires some technology for precise ultrasound imaging of the renal nerve area, combined with a more intense therapeutic setting.
The company has done much of its work thus far on more than 100 pigs, which Bowers says are the best animal model for this kind of application, before entering clinical trials. Kona has done an initial human study which looked at some basic parameters, but it hasn’t yet tried to deliver a therapeutic dose of ultrasound in people yet, Bowers says.
The biggest challenge so far, Gertner says, has been finding enough of the right people with skills R&D, regulatory affairs, and more, to take the company to its next level of growth through clinical trials. But the 18-person team is racing to put together a prototype that it thinks has potential to be a leader in one of the big new markets for medical devices.
“Our goal is to come up with a better, more effective, less invasive way to do it,” Bowers says. “We have the opportunity to build a foundational technology.”
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