press releases

Dec 2011

ETView Medical, Ltd. Announced Filing of a 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for the VivaSight™-DL Line of Innovative Airway Management Devices

The VivaSight™-DL product family provides continuous airway visualization
during thoracic surgical procedures requiring lung isolation.

(PRNewsWire, Tel Aviv), ETView (TASE: ETVW) today announced that the company has successfully completed filing of a 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration (FDA). The Company expects feedback from the FDA during the next quarter and anticipates entering the US market with the VivaSight™-DL Airway Management System during 2012. Additional pre-market regulatory filings in Europe and Asia are anticipated during 2012.

About the VivaSight™-DL Airway Management System
VivaSight™-DL1 is a proprietary, single-use disposable medical device, consisting of a dual lumen airway ventilation tube with an integrated continuous high resolution video airway imaging system permitting airway control and lung isolation during certain surgical procedures. Lung isolation is employed to provide one-lung ventilation in patients undergoing thoracic, cardiac, vascular, or esophageal surgeries.2 During lung isolation, temporary visualization of the patent airway is achieved with a fiberoptic bronchoscope while the patient is ventilated and the target lung isolated. Intra-operative surgical maneuvers often require repeated imaging and partial blocking of the airway to maintain lung isolation.3 It is estimated that over 1.9 million lung isolation procedures are conducted worldwide annually,4 accounting for over $250mm in single-use medical disposables.5 ETView has pioneered development of the VivaSight™ platform (previously known as TVT™), combining an airway ventilation tube with integrated continuous high resolution airway imaging for patient airway control and lung isolation capability (eliminating the need for fiberoptic bronchoscope6 imaging during these procedures).

“We are excited to have reached this milestone,” stated Bill Edelman, CEO. He continued, “VivaSight™-DL will be available to the US thoracic surgical community following FDA concurrence with our 510(k) pre-market application. We anticipate significant clinical interest for this innovative technology in the markets where VivaSight™-DL will be cleared for commercial distribution.”

About ETView, Medical, Ltd.
ETView Medical Ltd. (TASE: ETVW) has successfully combined airway management with continuous direct airway visualization for medical professionals. ETView's patented
VivaSight™- SL, a single-use disposable medical device, consisting of a single lumen ventilation tube with an integrated continuous high resolution video imaging system is currently sold in Europe, Israel, and the US to overcome current limitations and associated adverse surgical events during lung isolation surgeries.7

Forward-Looking Statement
The Company estimations in this press release, including those estimations regarding the Company's predicted scope of business, constitute forward-looking statements, as such term is defined under the Israeli Securities Law (5728-1968), and there is no certainty that such estimations shall materialize. The Company's estimations are based on business assumptions, prior experience, and professional data. Due to various factors, foreseen and unforeseen, including, but not limited to, changes in market trends, competition, global or local economic conditions, and amendments of regulation, such estimations may not materialize in whole or in part, or materialize in a substantially different manner than anticipated by the Company.

References:

1 Patent Pending
2 Principles and Practices of Anesthesia for Thoracic Surgery. P. Singer (ed.) 2011
3 Anesthesia & Analgesia. 2009;108:1097–101
4 National Health Statistics Reports Number 29, October 26, 2010
5 Company estimates on file
6 Minerva Anestesiol. 2009;75(Suppl 1):1-4.
7 Anesthesiology. 2006;105:471-477.

Jul 2011

ETView Announces Appointment of Javier Campos, MD, to its Scientific Advisory Board

TEL AVIV, Israel--(BUSINESS WIRE)--ETView Medical Ltd. (TASE: ETVW), a commercial-stage medical device company traded on the Tel Aviv stock exchange, announced today the appointment of Javier Campos, MD, to its Scientific Advisory Board. Dr. Campos currently holds the positions of Clinical Professor, Executive Medical Director of Operating Rooms; Vice Chair, Clinical Affairs, and Director of Cardiothoracic Anesthesia for the University of Iowa. Dr. Campos has published over 42 peer-reviewed scientific articles in the field of cardiothoracic anesthesia, with over 20 articles devoted to lung isolation surgical technique. Dr. Campos previously held clinical appointments at UCLA School of Medicine Department of Anesthesiology. Dr. Campos received his medical training at the Autonomous University, Guadalajara, Mexico, and performed his residency at the State General Hospital, Hermosillo, Sonora, Mexico. Dr. Campos holds multiple professional society appointments, including American Society of Anesthesiologists, International Anesthesia Research Society, and the Society of Cardiovascular Anesthesiologists. Dr. Campos is a member of the editorial board of the Journal of Cardiothoracic and Vascular Anesthesia.

“We are thrilled to have Dr. Campos join our Scientific Advisory Board. Dr. Campos is an internationally respected clinician focused in the lung isolation surgical market. Dr. Campos will provide valuable counsel to ETView as we continue the commercial expansion worldwide for our TVT™ product line.”

William Edelman, Co-Chairman of the Board for ETView commented, "We are thrilled to have Dr. Campos join our Scientific Advisory Board. Dr. Campos is an internationally respected clinician focused in the lung isolation surgical market. Dr. Campos will provide valuable counsel to ETView as we continue the commercial expansion worldwide for our TVT™ product line." Mr. Edelman continued, “We intend to recruit other clinicians of Dr. Campos' caliber to join him in our Scientific Advisory Board over the next few months." ETView's TVT™ combines high-flow ventilation airway management with continuous video monitoring to overcome current limitations and associated adverse surgical events during lung isolation surgeries.

About ETView Medical:
ETView Medical Ltd. (TASE: ETVW) is a commercial-stage, publicly traded medical device company that has successfully combined airway management with continuous direct airway visualization for medical professionals. ETView's patented TVT™ technology saves physician procedure time and is expected to provide better patient outcomes in multiple thoracic surgical procedures as well as with chronic ventilator dependent patients. Currently selling in Europe, Israel, and the United States, the worldwide distribution network for ETView's lead proprietary product, the TVT™ combines high-flow ventilation airway management with continuous video monitoring to overcome current limitations and associated adverse surgical events during lung isolation surgeries. TVT™ has been shown to be useful in limiting potential surgical injuries resulting from percutaneous tracheostomies. Visit ETView for additional information at www.etview.com.

Forward-Looking Statement
The Company estimations in this press release, including those estimations regarding the Company's predicted scope of business, constitute forward-looking statements, as such term is defined under the Israeli Securities Law (5728-1968), and there is no certainty that such estimations shall materialize. The Company's estimations are based on business assumptions, prior experience, and professional data. Due to various factors, foreseen and unforeseen, including, but not limited to, changes in market trends, competition, global or local economic conditions, and amendments of regulation, such estimations may not materialize in whole or in part, or materialize in a substantially different manner than anticipated by the Company.

Apr 2011

ETView Medical, Ltd., and Stopler Belgium Execute Distribution Agreement

(Tuesday, 12 April 2011, Tel Aviv, Israel) ETView Medical Ltd. (TASE: ETVW) a commercial stage medical device company traded on the Tel Aviv stock exchange announced today that it has entered into a distribution agreement with Stopler Belgium. The agreement enables Stopler to market ETView's lead product, TVT™ for a period of three years in Belgium. ETView’s TVT™ combines high-flow ventilation airway management with continuous video monitoring to overcome current limitations and associated adverse surgical events during lung isolation surgeries. Other terms were not announced.

Stopler Belgium is a division of the SIMED Group (Stopler International Medical), a European-based diversified healthcare provider, with a wide range of activities including distribution of medical equipment in Holland and Belgium.

Arie Ben-Josef, CEO of ETView Medical commented, “We are excited to add Stopler Belgum to our expanding distributor network.” Mr. Ben-Josef continued, “The TVT™ product family is currently being distributed across Europe and the United States. ETView will continue to provide best-in-class airway management solutions for sophisticated thoracic surgical procedures through TVT™ and additional technologies under development.”

About Stopler Belgium:
According to company press releases, Stopler Belgium is part of the SIMED Group (Stopler International Medical, founded in 1902), employing over 600, specializing in two medical equipment distribution divisions, in addition to hospital construction and management in Holland and Germany.

About ETView Medical:
ETView Medical Ltd. (TASE: ETVW) is a commercial-stage, publicly traded medical device company that has successfully combined airway management with continuous direct airway visualization for medical professionals. Critically, ETView’s patented technology saves physicians’ time and is expected to provide better patient outcomes in multiple thoracic surgical procedures as well as with chronic ventilator-dependent patients. Currently selling in Europe, Israel, and the United States, the worldwide distribution network for ETView's lead proprietary product, the TVT™, is being built out. ETView’s TVT™ combines high-flow ventilation airway management with continuous video monitoring to overcome current limitations and associated adverse surgical events during lung isolation surgeries. TVT™ has been shown to be useful in limiting potential surgical injuries resulting from percutaneous tracheostomies. The estimated patient population targeted by TVT™ exceeds one million cases annually. Visit ETView for additional information at www.etveiw.com.

Safe Harbour Statement:
ETview Medical, Ltd., (“The Company”) estimations in this press release including those estimations regarding the Company's predicted scope of business, constitute forward-looking statements, as such term is defined under the Israeli Securities Law, 5728-1968, and there is no certainty that such estimations shall materialize. The Company's estimations are based on business assumptions, prior experience, and professional data. Due to various factors, foreseen and unforeseen, including, but are not limited to, changes in market trends, competition, global or local economic conditions, and amendments of regulation, such estimations may not materialize, in whole or in part, or materialize in a substantially different matter than anticipated by the Company.

Dec 2010

ETView Medical announced today (Wednesday) that William (Bill) Edelman has been appointed Co-Chairman of the Board of the Company. Until recently, Edelman served as president and CEO of TYRX Inc., and prior to that held an executive level position at MicroSense International.

ETView Medical announced today (Wednesday) that William (Bill) Edelman has been appointed Co-Chairman of the Board of the Company. Until recently, Edelman served as president and CEO of TYRX Inc., and prior to that held an executive level position at MicroSense International. The agreement is contingent on the confirmation of ETView's board that will convene shortly.

Bill Edelman, in addition to his expected activities with the company, is chairman of the board of PolyTouch (general surgical device), Stimatix GI (ostomy products) and MediValve (percutaneous aortic valve placement). Mr. Edelman earned a Biomedical Engineering degree from Rensselaer Polytechnic Institute. He has been issued 15 U.S. patents and is an applicant on three additional pending patents.