ETView Medical, Ltd. announces China State Food and Drug Administration (SFDA) clearance of a pre-marketing notification application for the VivaSight™-SL line of innovative airway devices
Sinopharm granted exclusive distribution rights throughout China.
Tel Aviv, Israel-- ETView (TASE: ETVW) today announced that the Company has received clearance of a Pre-Marketing Notification Application (PMNA) with the China State Food and Drug Administration (SFDA). The Company expects to enter the Chinese market with the VivaSight™-SL immediately. VivaSight-SL will be exclusively distributed throughout China by the China National Pharmaceutical Group Corporation, Sinopharm. Additional pre-market regulatory clearances worldwide are anticipated during 2013.
"We are excited to have reached this milestone," states Bill Edelman, ETView’s CEO. "VivaSight-SL is now available to the Chinese thoracic surgical community following SFDA clearance of our pre-market application. We anticipate significant clinical interest for this innovative technology in the markets where VivaSight-SL is cleared for commercial distribution.”
VivaSight-SL is a single-use disposable single-lumen ventilation tube with an integrated continuous high-resolution video imaging system for use in lung isolation procedures. VivaSight-SL has been cleared for commercial distribution by the US FDA and has received CE pre-market clearance.
Edelman notes, “with our line of VivaSight™ products available in the US, South America, Europe and now China, ETView offers a complete airway management solution for 100% of lung-isolation surgeries. We look forward to additional regulatory clearances worldwide to expand the market for our VivaSight portfolio." Lung isolation is employed to provide one-lung ventilation in patients undergoing thoracic, cardiac, vascular or esophageal surgeries. It is estimated that over 1.9 million lung isolation procedures are conducted worldwide annually , accounting for over $250 MM in single-use medical disposables .
See www.etview.com for addition press announcements.
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 airway management portfolio consists of single-use disposable medical devices, representing either single- or double-lumen ventilation tubes with an integrated continuous high-resolution airway imaging system. VivaSight-SL and VivaSight-DL are currently sold in Europe, Israel, and the US to overcome limitations and associated adverse surgical events during lung isolation surgeries.
About SinopharmChina National Pharmaceutical Group Corporation, Sinopharm, is the largest pharmaceutical and healthcare group under State-Owned Assets Supervision and Administration Commission of the State Council (SASAC) in China. The group has 22 wholly owned subsidiaries and holding companies, one H-share listed company, Sinopharm Group Co., Ltd., and three A-share listed companies, Beijing Tiantan Biological Products Corporation Limited (BTBP), China National Medicines Co., Ltd. (CNCM) and Shenzhen Accord Pharmaceutical Co., Ltd. In 2009, the group’s sale revenue had reached 65 billion yuan. Among the 129 enterprises under SASAC, Sinopharm is ranked 50th and 38th in terms of sales revenue and total profit respectively.
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.
- Principles and Practices of Anesthesia for Thoracic Surgery, P. Singer (ed.), 2011.
- National Health Statistics Reports, No. 29, October 26, 2010.
- Company estimates on file.
- Anesthesiology, 2006; 105:471-477.