First Device to Enable Minimally-Invasive Access to Distant Areas of the Lungs Reaches FDA Milestone

MINNEAPOLIS--(BUSINESS WIRE)--The first device to allow physicians to access smaller, harder-to-reach lung lesions has received 510(k) clearance from the Food and Drug Administration (FDA). The inReach^TM System, developed by Minneapolis-based superDimension (www.superdimension.com), provides electromagnetic navigation and guidance to distant regions of the lungs in a minimally-invasive manner, enabling doctors to diagnose lung cancer at earlier stages and potentially provide treatment sooner. The company recently raised nearly $21 million in venture capital to expand its sales, marketing and operations.

“Traditional bronchoscopy does not readily lead to a diagnosis for small peripheral lesions. As shown in our study and now several others, electromagnetic navigation bronchoscopy is a safe, high-yield procedure by which a lung nodule and central lymph nodes can be sampled at the same time in an outpatient procedure”

Similar to GPS (global positioning system) technology, the inReach System provides a three-dimensional “roadmap” of the lungs, generated from standard CT (computed tomography) images. Once the patient’s lungs have been mapped, physicians use superDimension’s disposable guiding catheters with standard bronchoscopes and tools to reach the targeted lesion. The catheter’s tip contains an electromagnetic location sensor, which allows its location to be overlaid in real time on the pre-generated CT roadmap of the lungs. The physician can steer the catheter 360 degrees to reach distant locations in the bronchial tree.

“Traditional bronchoscopy does not readily lead to a diagnosis for small peripheral lesions. As shown in our study and now several others, electromagnetic navigation bronchoscopy is a safe, high-yield procedure by which a lung nodule and central lymph nodes can be sampled at the same time in an outpatient procedure,” said Dr. Thomas Gildea of Cleveland Clinic. “Electromagnetic navigation bronchoscopy now increases the chances that a patient will safely get a diagnosis and begin treatment."

Current Standard of Care for Lung Cancer

Currently, patients experiencing symptoms of lung disease or those who have suspected lesions can be examined and treated with standard bronchoscopes, needle aspiration or surgery. Patients with lesions too small to reach with standard devices often must watch and wait for changes in the lesion before a definitive diagnosis can be made, sometimes waiting for many years. The inReach System provides a new opportunity to assist physicians in diagnosing patients at earlier stages, which in turn may allow patients to be treated sooner.

More than 1.3 million people die of lung cancer each year around the world. It is the most common cancer-related death in American men and the second most common in women, claiming more lives than breast cancer, prostate cancer and colorectal cancer combined. In 2007 alone, more than 200,000 Americans will be diagnosed with lung cancer, and more than 160,000 will die of the disease. Often, the cancer has already progressed by the time a patient is diagnosed.

“inReach assists physicians in reaching distant locations in the lungs, helping patients avoid more invasive procedures for diagnosing cancer,” said Dan Sullivan, superDimension's chief executive officer. “Many years ago, the angiogram transformed cardiac care because for the first time doctors could diagnose and treat the heart without opening the chest. We believe inReach can have the same dramatic effect on the pulmonology field, providing an option for patients with lesions that previously were unreachable.”

The inReach System is currently available at more than 70 sites in the United States and Europe. More than 2,000 patients have had the procedure to date.

About superDimension

superDimension is a privately-held medical device company that develops and markets minimally-invasive interventional pulmonology devices that enable the diagnosis and potentially the treatment of distal lung disease. The superDimension product line includes both capital equipment and disposables, addressing a total available market of more than 9 million patients. The company was founded in Israel, with its U.S. headquarters in Minneapolis, Minn. For more information, visit www.superdimension.com.

Editors Note: Hi and lo res animations are available online at http://pub.psbpr.com/superDimension/video/videos.htm.