Spiration can now say it has its first marketed product. The Redmond, WA-based medical device maker said today that its partner, Tokyo-based Olympus, has started selling its device for chronic obstructive pulmonary disease in Europe.
Spiration will manufacture the product, called the IBV Valve System, and Olympus will market it initially to select European physicians and then broaden distribution in coming months. The device 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. Financial terms of the partnership with Olympus aren’t being disclosed.
The opportunity is big, with an estimated 16 million people in the U.S. (mostly smokers) suffering from chronic obstructive pulmonary disease, as we wrote back in July. It is the fourth-leading cause of death in the U.S., killing 100,000 people a year, according to the National Emphysema Foundation. 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, said Richard Shea, Spiration’s CEO, when I interviewed him in July. The valve will compete with lung-volume-reduction surgery, in which diseased parts of lung are removed. The surgery leaves some patients with air leaks in the lungs afterwards, so Spiration product will be pitched as an alternative to avoid that complication.
“I am excited that this new treatment option is now available in Europe, where there is a significant unmet need for minimally invasive approaches to improving quality of life for people with emphysema,” said Vincent Ninane, of the St. Pierre Hospital in Brussels, Belgium, in a statement released by Spiration and Olympus.
Spiration, founded in 1999, doesn’t yet have the IBV Valve System approved by the FDA for sale in the U.S. The company has started enrolling patients in a randomized, placebo-controlled study of 250 patients, and should be done with that by March, Shea said in July. 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.