Nine years after its founding, Spiration has gotten its first product cleared by the FDA for sale in the U.S. The Redmond, WA-based medical device maker said U.S. regulators approved its device for patients who suffer from prolonged air leaks after surgery to remove a diseased part of their lungs.
This is the first time the FDA has ever approved a minimally-invasive bronchial valve for the market, says Spiration CEO Rick Shea. The agency gave clearance for the device based on results from 58 patients, which demonstrated that the product is safe and may show benefit for a small patient population of less than 4,000 people in the U.S. The FDA cleared it for that segment of patients under what is known as a “Humanitarian Device Exemption” without having to wait for data from a 250-patient trial that’s expected to last another year, Shea says.
“It’s huge,” Shea says. “For a company like ours, a lot of them don’t ever get to the revenue stage. Now we’re at the revenue stage.”
The Spiration IBV Valve System consists of tiny valves that can be implanted in the airway via a catheter threaded down a patient’s windpipe; the valves block off air flow 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. The device can be removed if necessary. It is being tested now in a randomized, placebo-controlled study of 250 patients with chronic obstructive pulmonary disease, a much larger potential market than the group of patients who suffer from prolonged air leaks after surgery. An estimated 16 million people in the U.S. (mostly smokers) have COPD.
The FDA noted in a statement that most air leaks heal on their own after surgery, but when they last longer than seven days, they can increase the length of hospital stays and require additional surgeries to repair. “This valve may ease post-operative recovery of patients undergoing certain kinds of lung surgery,” said Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health, in a statement.
This wasn’t the only big news of the month for Spiration. Its partner in Europe, Olympus, began marketing the IBV Valve System in those markets this month, Shea says.
Spiration has been working closely with regulators on the FDA application for months, but it wasn’t exactly banking on getting this approval, since it’s just the third humanitarian exemption the agency has granted this year, Shea says. So Spiration’s management team needs to huddle over the next two weeks to work on its marketing and commercialization plans, he says. For now, the company plans to market the device on its own for use among as many as 4,000 patients, Shea says. Spiration has about 54 employees now, and will need to hire some additional marketing staff, he says.
The company should have enough capital to continue running the clinical trial in the bigger patient population, although it may need to raise more money for the commercial roll-out in that group, Shea says.
Spiration’s approval gives it the first-mover advantage with a minimally-invasive valve approach, ahead of Emphasys Medical of Redwood, City, CA, Broncus Technologies of Mountain View, CA, and Seattle-based Uptake Medical.
Shea said he’s been making a habit for the past several weeks, when he arrives at work in the morning, to ask Linda Rismondo, Spiration’s head of regulatory affairs, “Did we get approval today?” This morning, the answer was “You bet we did,” Shea related. The approval letter from the FDA was sitting there on the fax machine. It will be a much bigger deal if they get another letter like that in 2010 that says they can market broadly to patients with chronic obstructive pulmonary disease, but this should give Spiration a boost of cash flow that will make it easier to get there.