Ekos, Maker of Ultrasound Clot Dissolver, Raises $12.5 Million for Commercial Push

Ekos has been working for more than a decade on a miniature ultrasound probe that slithers inside leg veins, and gently amplifies the effect of drugs that dissolve blood clots. The long slog of research and development is done, the manufacturing is set up, and now Xconomy has learned the Bothell, WA-based company has raised $12.5 million in new venture capital to turn the device into a commercial hit that changes the way physicians think about treating blood clots.

The company’s series D round was led by Chicago-based Crown Venture Fund, and joined by 90 percent of the existing cast of Ekos investors, including Ascension Health Ventures, CID Capital, EDS Healthcare Capital Partners, MedVenture Associates, Mitsui & Co. Venture Partners, NGN Capital, and Protostar Equity Partners. The deal closed Dec. 29.

Ekos has now raised more than $100 million in its history. The company, which has 130 employees, expects the new investment will help it reach break-even for the first time by early 2010, says CEO Bob Hubert. The funding also means doctors and patients are much more likely to be exposed to a novel technique that can reduce hospital stays by several days, and lowers the risks of severe bleeding that can happen when people take clot-dissolving drugs over long periods. It’s no small thing, since blood clots in the legs (deep vein thrombosis) affect more than 250,000 people in the U.S. each year, and associated clots that can break off and flow to the lungs are thought to kill 100,000 people a year, according to a U.S. Surgeon General’s report. Most patients live with secondary effects, like varicose veins, leg pain, heaviness, or ulcers.

“We’re in the business of removing the clot,” Hubert says. “That’s what we do.”

It sounds simple how Ekos got to this point, but it’s not.

Blood clots in the legs are now generally treated with a combination of drugs and devices. The standard treatment involves threading a flexible catheter inside the veins to nestle up alongside the clots. The catheter contains a porous tube, with spotty holes in it like a garden hose, which is supposed to let clot-dissolving drugs like Genentech’s alteplase (Activase) seep through right next to the clot. It generally takes two to four days to fully dissolve the clot, before the patient can leave the hospital, Hubert says. When the patient goes home, they take warfarin to keep new clots from forming.

One of the biggest concerns with this line of treatment is that when patients spend too much time on a clot-dissolving drug, their risk climbs for severe bleeding, or hemorrhaging, in as many as 5 percent of cases, Hubert says. So several companies have been working on devices to speed up the clot-dissolving process.

Competitors like Wilmington, MA-based OmniSonics Medical Technologies and Santa Clara, CA-based Bacchus Vascular have tried to seize on this opportunity with mechanical assisting devices, Hubert says. The OmniSonics treatment whips up the clot so the drugs can dissolve it more quickly. The Bacchus technique runs a screw through the clot and essentially liquefies it for the drug to do its thing, then vacuums out the clot residue.

Both these treatments work, Hubert says, although he insists the Ekos method, marketed as EkoSonic, is superior. The technique uses a catheter loaded with miniature ultrasound probes spread out near those holes in the porous tube for allowing the drug to seep through. The ultrasound frequency is set at a range so that it’s strong enough to loosen up the protein strands that hold clots together, but gentle enough that it doesn’t lacerate the clot and raise the risk of tiny particles breaking loose and causing harm. The ultrasound is also sent in fluctuating pulses, which the company has learned improves the effect. Essentially, it lets the drug seep inside the clot more quickly, so it can do its job more efficiently.

“A physician described it to me once this way,” Hubert says.”If you take an ice cube, and drip water on it, you’ll melt the ice cube. You could also take all that ice, put it in a Cuisinart, and make a sno-cone out of that mass. Now drip water on it. It will melt faster, because more of the water is absorbed, and covers more surface area.”

The data supporting these claims isn’t from gold-standard clinical trials that randomly assign patients to get the Ekos treatment versus those on standard of care. Those trials would have taken years to run, cost millions more, and expert physician consultants for Ekos said they already know what the standard treatment does anyway.

With that caveat, the data was impressive. The Ekos device/drug combination treatment completely wiped out clots in 37 of 53 patients (70 percent) and when partial responders were included, the number rose to 91 percent, according to results published in the Journal of Vascular Interventional Radiology last year. The median time to get rid of the clots was 22 hours. There were no cases of hemorrhaging. The Ekos regimen was comparable or better than other treatments, with a lower drug dose and shorter treatment time than the standards.

That doesn’t mean the treatment is guaranteed to sell, however. Hubert, a veteran of medical device commercial work with General Electric, joined the company as CEO in June 2007 with this in mind. “While I would give them high marks on technology and manufacturing, the commercialization was really lacking (at Ekos). That’s why I was brought here,” he says.

Ekos has a classic razor/razor blade model, in which it essentially loans a pulse generator box (the razor) to a hospital, then makes its money selling the disposable ultrasound-loaded catheters (the razor blades). The disposable ultrasound device costs $2,700, says Doug Hansmann, Ekos’s chief operating officer. The company doesn’t disclose its sales, although it has gotten the pulse generators placed in more than 225 U.S. hospitals, and is approaching the 10,000th sale of its disposable device, Hubert says.

Hubert had to cut our interview short so he could try to talk some more investors into capping off the Series D round with another $2 million to $2.5 million. Before he headed out, he asked Hansmann to play up how Ekos’s ultrasound technology can be used for more than just dissolving clots—it can also be used for transferring genetic material across cell membranes, stroke, and other applications. Ekos can only move so fast on so many fronts, though, so a lot will depend this year on how much it sells.

“With IPOs scarce and difficulty you see for people raising money, we’ve got to get to cash flow break even as fast as we can,” Hubert says. “We’re well on our way. We’ve got the roadmap to do that.”

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