Latest Study Results Comparing VRI™ To Conventional Procedures Of Assessing Regional Lung Function Measurement

Deep Breeze Ltd, the innovator of the revolutionary pulmonary imaging technology, vibration response imaging (VRI™), announced the latest study results comparing VRI™ to conventional procedures of assessing regional lung function measurement. Prof. Roberto Bossi, Chief of Center of Sleep respiratory disorders of Foundation IRCCS Ospedale Maggiore Policlinico University of Milano, presented his findings today at the 18th European Respiratory Society Congress, Session 57 (New challenges and maintained quality: lung function for the future), Berlin Room. The study measured the effectiveness of VRI™ for the evaluation of lung function compared to functional respiratory tests, before and after thoracic surgery. Data showed that VRI allows better evaluation of lung volume regional variations after chest lobectomy compared to functional respiratory tests. "The advantages having a non invasive, patient's effort independent, easy to handle and readily available imaging modality for pulmonology are numerous," said Prof. Bossi. He goes on to say: "A big benefit is that I can monitor and measure the gain or loss of lung function after chest surgery better than functional respiratory test."


In addition Deep Breeze has launched a strategic program to include the VRIxp™ as an integral part of the guidelines for physiologic evaluation of patients with lung cancer being considered for resectional surgery. The feasibility of this program is currently being investigated by MD Anderson, and the leading investigator of this program Prof. Rodolfo Morice had this to add: "Lung cancer is the leading cause of cancer death in the USA and the world and surgery remains the best treatment option for patients with this condition. Predictions of postoperative lung function are crucial to maximize the number of patients that can benefit from surgery and identify patients with such poor respiratory reserve that lung resection would result in an unacceptable quality of life. These preoperative evaluations currently require radionuclide tests of ventilation and perfusion that require administration of radioactive isotopes and not always readily available." The company is planning to market the VRIxp™ across Europe to Hospitals which conduct lung resection for patients with lung cancer. The initial launch happened in Spain in September and the company will expand their activities to other European countries by the end of 2008.


Results of an additional study that was conducted in a University department at the Asthma and Allergy Center of the Pulmonary Unit in Evgenidio Hospital, in Athens Medical School in Greece will also be presented by Prof. Christina Gratziou at the Congress, on Monday the 6th of October, Europa Room 2, Session 189 (New frontiers in noninvasive assessment of the lungs) at 10:15am. The purpose of this study was to establish whether or not the VRIxp™ has a role to play in the early detection of airway obstruction in smokers. The study population consisted of 25 healthy smokers, 23 known COPD patients & 10 healthy non-smokers. The initial findings of the study showed that in 95.7% of known COPD patients showed dynamic disturbances in their VRIxp™ image. Furthermore 64% of "healthy smokers" demonstrated abnormalities in their VRIxp™ image. Prof. Gratziou declared that "The initial findings of our study on a small population of 58 smoker subjects, is indicative of a potential role of the VRIxp™ as a screening tool of early detection of abnormalities due to smoking exposure. Smoker subjects can be monitored unlimitedly with documentable results that can be analyzed and given as a written report. Thus, the VRIxp™ can be useful also as an effective tool to educate patients on the harmful effects of smoking and furthermore to enhance motivation for quitting tobacco use".















About VRIxp™


The VRIxp™ system is based on Vibration Response generated by the air passing through the lungs. The system records these vibrations and then uses an algorithm to convert the data into images. Changes in tissue composition or alteration in airflow impact how sounds within the lungs vibrate, and subsequently how the VRIxp™ images appear on the system's computer screen. The result offers physicians a dynamic functional lung image obtained passively at the bedside, & without radiation. The Quantitative Lung Data (QLD) results provide an immediate regional assessment of right and left function by quantifying vibration distribution. Patient records and results are documented in the systems' database for future use. 6,000 Patients have been recorded by the VRIxp™ worldwide during clinical investigations without any single adverse event.


The newly appointed CEO of Deep Breeze, Dr. Miki Nagler had this to say: "The results of our extensive clinical investigations being conducted worldwide, is a small indication of the clinical value that our technology holds for a broad line of pulmonary indications. We are now focusing our efforts not only specific markets, but also to create a valid clinical paradigm in which our technology will be applied in a number of clinical applications."


About Deep Breeze Ltd.


Founded in 2001, Deep Breeze is a privately owned medical device company backed by financial partners: SCP, Vitalife VC, Nisko Arden, Aviv Ventures & Union Investment Enterprise. In joint partnership with GE Healthcare, Deep Breeze introduced its Critical Care device VRIICU™ in Europe during October 2007. The VRI™ technology was granted the CE mark in September 2005, received the Medical Device and Accessories approval by the Israeli Minister of Health in January 2006, the Korean Food and Drug Administration Approval in January 2007, and the FDA 510K clearance via the pre-market notification process to for Marketing in the USA in August 2007. Deep Breeze Ltd. is led by an international management team, with extensive experience in medical technologies and imaging, international marketing and operations, regulatory affairs and finance. The Company's Headquarters, Research and Development Center, are located in Or-Akiva Israel, with offices in the US, Germany and Asia-Pacific. International distributors include: UST (China), Neoscan (France), Smartintermed (Greece), Medical Resources India PVT Ltd (India), Daiwha Corp Ltd (Korea), Labs Medikal Elektronik (Turkey) and Rosslyn Medical in Russia. Deep Breeze Ltd. is ISO 13485 Medical Devices Quality Management Systems certified.


Deep Breeze Ltd.