Focus on Early Detection: Karl Storz Unveils D-Light Autofluorescence Bronchoscopy System.

Business Editors/Health/Medical Writers

SEATTLE--(BUSINESS WIRE)--May 15, 2003

Advanced Technology Differentiates Suspect Areas from Normal

Tissue, Provides Early Detection of Lung Cancer

Karl Storz Endoscopy-America, Inc., a world leader in diagnostic and operative endoscope technology, announces it will formally launch the new D-Light Autofluorescent (AF) Bronchoscopy System at the opening session of the 99th International Conference of the American Thoracic Society (ATS) in Seattle. Pulmonologists attending the ATS meeting will have the opportunity to witness firsthand the advanced capabilities of the D-Light AF System, including bronchoscopes with proprietary emission filters integrated into their eyepieces specifically for viewing autofluorescence in the green to red portion of the visible spectrum (475 to 800 nm).

Today, most patients who receive an initial diagnosis of lung cancer receive it too late. The lung cancer will already have reached an advanced stage, making permanent remission with currently available therapies unlikely. Fortunately, early diagnosis of bronchial carcinoma provides an increasingly realistic chance for long-term survival. In fact, early detection while the tumor is still localized could increase the five-year survival rate from 5-15 percent to nearly 50 percent.(1,2)

AF technology from Karl Storz differentiates suspect areas from normal tissue, providing earlier detection than is possible with conventional white light (WL) bronchoscopy. The system emits blue light in the range of 380-460nm to induce tissue autofluorescence: normal tissue appears green, whereas abnormal tissue appears brown when viewed through a specially designed Karl Storz flexible bronchoscope and camera system. In multicenter clinical studies, the sensitivity of AF mode to detect histologically positive biopsies increased six-fold over standard white light bronchoscopy (see chart below).

"Lung cancer is the leading cause of cancer death in developed countries, placing pulmonologists on the front lines in the war against cancer. The new Autofluorescence System from Karl Storz provides pulmonologists with an important new tool for early detection, enhancing their ability to detect and locate abnormal lung tissue suspicious for lung cancer," said Dr. Armin Ernst, Director of Interventional Pulmonology, Beth Israel Deaconess Medical Center, who served as a principal investigator in the clinical trials.

The D-LIGHT AF System includes flexible bronchoscopes featuring integrated filter wheels that enable one-touch toggling between WL and AF visualization modes. Larger instrument channels allow the use of instrumentation such as biopsy and grasping forceps. And active tip deflection a full 180 degrees up, 100 degrees down, improves visualization of anatomical landmarks.

"Pulmonologists can now focus on early detection like never before with a compact, ergonomic AF system that incorporates all of the usual characteristics of white light examinations," said Mary Aldrich, product marketing manager, Karl Storz. "The D-Light AF System can target even the smallest changes in morphology for early detection, leading the way to superior outcomes in the diagnosis and treatment of lung cancer."

Special Photodynamic Diagnosis (PDD) camera heads and the fully compatible Tricam SL-IPM Camera Control Unit (CCU) power the D-Light AF System's advanced video imaging capabilities.

More than 60 times as light sensitive as standard cameras, Karl Storz PDD camera heads feature parfocal optical zooms that optimize the view to all endoscopes. Both the PDD camera heads and Tricam CCU come ready for use with the Karl Storz Communication Bus or SCB, enabling seamless use in today's fully-integrated, all-digital operating rooms such as OR1.

Karl Storz is the only company currently marketing a U.S. Food and Drug Administration (FDA) approved diagnostic autofluorescent system for lung cancer. FDA approval followed submission of a Premarket Approval Application (PMA) summarizing multicenter U.S. clinical trials involving three hundred patients and 821 evaluable biopsies. Clinical investigators assessed the sensitivity and specificity of both white light and AF examination in identifying lesions requiring biopsy for histological examination.

In the PMA, investigators concluded that use of the D-Light AF Bronchoscopy System in AF mode could enhance the physician's ability to detect and locate abnormal bronchial tissue suspicious for early signs of lung cancer and decide upon the best treatment modality.

Karl Storz Endoscopy-America, Inc. is an affiliate of Karl Storz GmbH & Co. KG, an international leader for more than 50 years in reusable endoscope technology, encompassing all endoscopic specialties. Based in Tuttlingen, Germany, Karl Storz GmbH & Co. KG is a family-owned company that designs, engineers, manufactures and markets all its products with an emphasis on visionary design, precision craftsmanship and clinical effectiveness. For more information, call [phone] or visit the company's website at www.karlstorz.com.

Summary of Efficacy Results


                        Detection of Tumors in
                   U.S. Multicenter Clinical Trials
----------------------------------------------------------------------
                      Class III Tumors       Class III and IV Tumors
                  (based on 821 biopsies)    (based on 855 biopsies)
---------------- -------------------------- --------------------------
                 WL       AF       WL+AF    WL       AF       WL+AF
---------------- -------- -------- -------- -------- -------- --------
Sensitivity      10.6%(a) 61.2%(a) 65.9%(a) 28.1%(a) 66.7%(a) 71.9%(a)
---------------- -------- -------- -------- -------- -------- --------
Specificity      94.6%(a) 75.3%(a) 72.7%(a) 93.9%(a) 74.9%(a) 72.2%(a)
---------------- -------- -------- -------- -------- -------- --------
Positive
 Predictive
 Value              18.4%    22.2%    21.8%    41.6%    29.0%    28.5%
---------------- -------- -------- -------- -------- -------- --------
Negative
 Predictive
 Value           90.2%(a) 94.9%(a)    94.9% 89.5%(a) 93.6%(a)    94.4%
---------------- -------- -------- -------- -------- -------- --------
False Positive
 Rate                5.4%    24.7%    27.3%     6.1%    25.1%    27.8%
---------------- -------- -------- -------- -------- -------- --------
Relative
 Sensitivity                        6.22(b)                      2.56
---------------- -------- -------- -------- -------- -------- --------
False Positive
 Ratio                              5.03(b)                      4.56
---------------- -------- -------- -------- -------- -------- --------

(a) Estimate is biased because the nature of the study precludes
proper determination of its denominator.

(b) 95% confidence intervals were (95% Cl: 3.15-12:31) for relative
sensitivity and (95% Cl: 3.56-7.09) for ratio of false positive rate.


Sources:

1. American Cancer Society (ACS). "Cancer Facts & Figures"; 2003.
http://www.cancer.org/statistics

2. American Lung Association (ALA). "Trends in Lung Cancer
Morbidity and Mortality"; August, 2002. http://www.lungusa.org/data