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.”
