superDimension's electromagnetic navigational bronchoscopy device receives AMA Category I CPT code

Nov 4 2009

superDimension, Inc.®, a private company that develops minimally invasive interventional pulmonology devices, announced today that The American Medical Association (AMA) has issued a new Category I CPT® code for the use of the Company's electromagnetic navigational bronchoscopy (ENB) device to navigate to lesions or spots deep in the lungs. The code will become effective January 1, 2010. The AMA also issued a new CPT I® code for the placement of fiducial radiosurgical markers via the ENB procedure.

ENB is a minimally invasive procedure, where a catheter is inserted through the throat or nose and uses Global Positioning System (GPS) like technology to biopsy lung lesions and lymph nodes all in one outpatient procedure. ENB provides a three-dimensional virtual "roadmap" of the lungs that enables a physician to maneuver the catheters through multiple branches of the bronchial tree, extending beyond the capabilities of the traditional bronchoscope to distant, previously inaccessible regions of the lungs. If the targeted lesions are determined to be cancerous, a pulmonologist can use ENB to transbronchially place radiosurgical markers in and around lung tumors (lesions) to help radiation oncologists treat patients with external beam radiation. The outpatient procedure typically leaves the patient with no more than a sore throat.

Previously, the "gold standard" to diagnose lung cancer consisted of two invasive surgeries: wedge thoracotomy (open chest partial lung removal) to biopsy the lung and mediastinoscopy (invasive lymph node surgery) to biopsy the lymph nodes. Patients with poor lung function who could not tolerate these more invasive procedures were left with "watchful waiting" as their only option.

"ENB has completely transformed my medical practice and the way I diagnose and facilitate the treatment of early stage lung cancer patients," said David Wilson, M.D. at Columbus Regional Hospital in Columbus, Indiana. "If we can diagnose and treat lung cancer in its early stages, we should be able to dramatically increase the long-term survival rate for patients."

Dan Sullivan, president and chief executive officer, said, "Early diagnosis and treatment are crucial for improving survival rates in lung cancer. The prior standard of care left patients with the option of either undergoing invasive procedures or watchful waiting for an increase in lesion (spot) size. We believe ENB will revolutionize the way physicians and patients think about the diagnosis of lung cancer. With the introduction of ENB, patients finally gained a minimally invasive alternative for this early diagnosis."

Mr. Sullivan continued, "The establishment of a Category I CPT® code is a major milestone for superDimension. We believe the new CPT code will enable hospitals to more easily submit reimbursement for ENB procedures."

ENB has received FDA 510(k) clearance in the United States, CE Mark in Europe and it has also been approved for use in Australia and Canada. ENB has been performed on more than 9,000 patients in over 200 hospitals worldwide.

Separately, superDimension also debuted today the iLogic(TM) system, its next generation ENB technology, at the American College of Chest Physicians (CHEST) meeting in San Diego (booth number 819) and the American Society for Radiation Oncology (ASTRO) Conference in Chicago (booth number 3216).