Not many innovations have come along lately for patients with emphysema, a deadly lung disease. There are inhalers, supplemental oxygen, and, if you’re in really bad shape, a risky surgery to cut out damaged lung tissue. Now two competing Seattle-area medical device companies are in the hunt to change the standard of care, with less invasive, and fundamentally different, techniques to help patients breathe better.
Spiration, a privately-held company in Redmond, WA, with 47 employees, has been working on emphysema products since 1999. It is joined in the race by Uptake Medical, a Seattle startup founded three years ago. Spiration’s lead product candidate works by threading a catheter down a patient’s windpipe, and implanting a few tiny valves that block off airways to the diseased lung, so air doesn’t get trapped there, and the patient can better use other parts of the lung that still work. Uptake, which is at an earlier stage of development, is using the same catheter-guided technique, but it delivers steam water vapor that scars and seals shut airways that lead to the bad part of the lung.
The market opportunity for a better treatment is huge. An estimated 16 million people in the U.S. (mostly smokers) have what is called chronic obstructive pulmonary disease, COPD, an umbrella term for emphysema and chronic bronchitis. It is the fourth-leading cause of death in the U.S., killing 100,000 people a year, according to the National Emphysema Foundation. Unlike heart disease or cancer, the death rate from COPD is climbing worldwide. At least 300,000 patients in the U.S. are candidates for the valve implant, making the market worth at least $1 billion a year by almost any financial projection, says Richard Shea, Spiration’s CEO.
“We are getting close here in the U.S.” Shea says. “We’re excited.”
Spiration’s technology is already approved in Europe, and will be marketed there in the fall by its partner, Tokyo-based Olympus, the maker of tiny cameras on bronchoscopes needed for the procedure. More work still needs to be done to get the FDA’s blessing in the U.S., however. Spiration has started enrolling patients in a randomized, placebo-controlled study of 250 patients, and should be done with that by March, Shea says. Patients will be followed for six months after the procedure is done, and success will be determined by both a CT scan to show improvement in the lungs, and a patient questionnaire to verify it. If the trial shows a benefit, the company could have the data it needs to apply for FDA approval later next year, Shea says.
At least two other companies are vying with Spiration to be the first to the U.S. market with a minimally-invasive device for emphysema: Emphasys Medical of Redwood City, CA, and Broncus Technologies of Mountain View, CA. Emphasys has completed its clinical trial, and is awaiting a public hearing in front of an FDA advisory panel that will be closely watched by all the competitors.
Uptake doesn’t really expect to grab the first-mover advantage. The company, founded by Robert Barry, formerly of Spiration, reported in May that early results from a small study of fewer than 20 patients in Australia were promising enough to prompt investment in further trials in Australia, Europe, and the U.S. The company’s CEO, King Nelson, said one of the procedure’s key advantages is that it is simple and easy enough for doctors to do in as little as 30 minutes.
“Our approach is focused on getting good lung volume reductions, and do it more safely, more quickly and more efficiently,” Nelson says.
I reached Nelson in Washington DC after a day of meeting with the FDA to talk about design of the company’s first clinical trial in the U.S. It will likely be a safety study of about 30 patients, and if it succeeds, then the company will file to do a pivotal study, he says. That will take more cash than the $9 million the company raised two years ago, so the company has just started raising a Series B round, Nelson says.
One of Uptake’s first-round investors, Josh Resnick of Needham, MA-based Prism VentureWorks, said he’s hopeful that Spiration and the other companies succeed in getting their products approved by FDA, and persuade insurers to pay for the groundbreaking procedures. Then, he expects a “second-generation” technique like Uptake’s to capture more of the market, because it will be quicker and easier for doctors to do.
“We are hoping that Spiration and those guys are successful and we’ll be a fast follower,” Resnick said.
Not so fast, says Spiration’s Shea. His company’s procedure is reversible, while Uptake’s isn’t, which could be an advantage for patients who may want the lung valves removed at a later date. It’s also difficult in general to get through clinical trials with a fragile, elderly patient population. “We view Uptake as a young company, we don’t view them as a strong competitor yet. They still have to prove their technology,” Shea says. “We’ve been at this a long time.”
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