ETView Medical, Ltd. announced KFDA Pre-Market Clearance for the VivaSight™‐SL line of Innovative Airway Devices
ChinooMTech Company (Seoul) Will Begin Distribution of VivaSight™‐SL In the Korean Market Immediately
March 12, 2012, Tel Aviv, Israel‐‐ETView (TASE: ETVW) today announced that the Korean Food and Drug Administration (“KFDA”) has granted pre-market clearance for VivaSight™‐SL. With KFDA clearance, ETView plans to immediately initiate market launch of VivaSight™‐SL. ETView also announced a distribution agreement with ChinooMTech Company (Seoul). The agreement enables ChinooMTech to market ETView's 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 in Korea for a period of 2 years.
William Edelman, CEO of ETView Medical commented, “We are excited to add ChinooMTech to our expanding distributor network.” Mr. Edelman continued, “VivaSight™‐SL is currently being distributed across Europe and the United States. With a population of over 48 million, Korea represents an important healthcare market. With KFDA clearance, we believe that VivaSight™‐SL will provide best-in-class airway management solutions for sophisticated thoracic surgical procedures requiring lung isolation.”
About the VivaSight™‐SL Airway Management System
VivaSight™‐SL1 is a proprietary, single‐use, disposable medical device, consisting of a single 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 patient 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).
On March 20, 2012, ETView announced filing of a Technical File, initiating CE Registration for the Viva™ EB Line of Innovative Endobronchial Blockers.
On February 20, 2012, ETView announced an exclusive license agreement for two US patents with James S. Simon, M.D., of Tiburon, California.
On February 6, 2012, ETView announced that the company filed a Pre‐Marketing Notification Application (510(k)) with the FDA for the Viva™ EB Line of Endobronchial Blockers.
On February 7, and February 2, 2012, ETView announced distribution agreements with NeuroMed Ltd. (NeuroMed) a surgical products sales and distribution company based in St. Petersburg, Russia, and State of the Art (SOTA) Medical Products, Inc., a specialty surgical products sales and distribution company, based in Cedar Grove, New Jersey.
On December 12, 2011, ETView announced that the company filed a Pre‐Marketing Notification Application (510(k)) with the FDA for the VivaSight™‐DL Airway Management System.
About ChinooMTech Company
Established in 2006, ChinooMTech distributes medical devices across Korea to clinical specialists in anesthesiology, internal medicine and gastroenterology. ChinooMtech currently represents Baxter, I-Flow, and B. Braun.
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 Visit www.etview.com for additional information. 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.
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 2006:105:471–7.