Alan Moy, MD Pulmonary Associates of Iowa City Mercy Hospital of Iowa City Electromagnetic Navigation Bronchoscopy A New Treatment for Patients with Peripheral Lung Lesions

Lung Cancer: An Epidemic? In U.S.: #1 cause cancer-related death 1 #2 death behind heart disease 1 More than breast, prostate, colon and pancreatic cancers combined 1 87% of lung cancer deaths related to tobacco 2 Sources: 1. Jemal A, et al., American Cancer Society, 2006

Lung Cancer: A Growing Problem 2007 estimates for US: > 213,000 new cases 1 > 160,000 deaths 1 45 million smokers in US Lung cancer risk: 2 20 times higher for male smokers 12 times higher for female smokers The population is aging and the incidence of lung cancer will grow 3 Sources: 1. Jemal A, et al., Ries L et al., American Cancer Society, Surveillance Research, 2006

Lung Cancer: Poor Prognosis >75% of new cases have late-stage cancer (Stage III or IV) 1 5-year survival rate is only 15% % Stage III or IV Only 15% will survive 5 years Sources: 1. Dubey S et al., Ries L et al., 2003

Early Diagnosis Offers Hope If diagnosed at Stage III or IV, 15% survival rate at 5 yrs 1 If diagnosed at Stage I, 88% survival rate at 10 yrs 1 92% survival rate if immediate removal of lesion 1 Only 16% of lung cancer patients are diagnosed at an early, localized stage. 2 15% 88% 92% SURVIVAL RATES Source: 1.Intl Early Lung Cancer Action Program Investigators, Reis L, et al, 2003.

Early Stage Advantage STAGE I OR II LESIONSTAGE III OR IV LESION SMALLER DISTAL LOCATION DISCREET EASIER TO TREAT SURVIVAL RATE = 10 YEARS LARGER PROXIMAL LOCATION ORGANIZED & WIDESPREAD TOO LATE FOR EFFECTIVE TREATMENT LIFE EXPECTANCY +/- 6 MONTHS Source: 1. Intl Early Lung Cancer Action Program Investigators, American Cancer Society, Surveillance Research, 2006

Failure of Bronchoscopy 500,000 bronchoscopies performed annually in the US 1 65% of bronchoscopies fail to reach peripheral lesions 2 Failure of bronchoscopy leads to more invasive diagnostic procedures Source: 1. Ernst et al., Schwarz Y et al., 2006

Current Approaches to Diagnosis MethodLimitations Watchful Waiting Malignant CANCER can ADVANCE stage Sputum, CXR, CT, PET No tissue collection Bronchoscopy Limited reach and low diagnostic yield Transthoracic Needle Aspiration (TTNA) Pneumothorax Not all patients are candidates Surgery Non-therapeutic thoracotomy Highly invasive Not all patients are candidates INVASIVEINVASIVE

Total Bronchial Access & Navigation  Expanding the boundaries of patient care  An electromagnetic navigation system that meets the unmet medical need for a minimally invasive procedure  Improved diagnostic yield of peripheral lung lesions and mediastinal lymph nodes 1 Source: 1. Schwarz et al., 2006

inReach™ Process DICOM CD PLANNING:  Preparing for the Procedure and Learning the Patient’s Anatomy NAVIGATION : Tx Scope (2.8mm)  Bx/Tx CT Scan : 

inReach™ System: Navigation Phase Position steerable navigation catheter near the target Lock guide catheter in place and remove steerable navigation catheter Insert endobronchial instruments through guide catheter Use instruments to remove tissue samples

inReach™ Components inReach™ System Components Guide Catheter Steerable Navigation Catheter

inReach™ System Components Location Sensor inReach Planning Software Patient Sensors

inReach™ System Advantages Extended Reach Access to peripheral lesions Access to central lung lesions and mediastinal lymph nodes Compatible with most endobronchial tools Minimally invasive

inReach™ System Advantages Greater Clarity Diagnostic yield of 69-74% 1,2 Target peripheral lesions Preview and determine path prior to procedure Navigate and steer through multiple branches of the bronchial tree Sources: 1. Becker et al., Gildea et al., 2006

inReach™ System Advantages Multi-Use and Multi-Specialty inReach advantages cross several specialties PULMONOLOGISTS THORACIC SURGEONS RADIATION ONCOLOGISTS

inReach™ System Clinical Results Effective Successful diagnosis of peripheral lesions in 69-74% of inReach cases 1 Even higher success rates for lymph nodes 1. Gildea et al., 2006

inReach™ System Clinical Results Safe Pneumothorax rate of 2.3% (similar to standard bronchoscopy) 1 Published > 1 dozen published papers Used in Multiple Centers > 2000 patient cases worldwide 1. Eberhardt et al., 2007

Why the inReach™ System? For Patients Minimally invasive Enables earlier diagnosis and earlier treatment decisions Potential for lower complication rates

Why the inReach™ System? For Physicians Expanded options for accessing lung lesions Improved steering through multiple branches of bronchial tree Potential for planning multiple procedures Ability to diagnose and stage distal lesions Enhanced decision making for diagnostic and treatment options Improved patient care with minimally invasive procedure Faster route to diagnosis and treatment

Why the inReach™ System? For Hospitals Improved patient care May reduce complication rates that can occur with more invasive options Retained patients for treatment by: Radiation oncologists Thoracic surgeons

Closing Comments Alan Moy, MD Mercy Hospital Iowa City Pulmonary Associates of Iowa City