Mar 19 2012
ETView Medical Ltd. (TASE: ETVW) announced today that it has entered into a distribution agreement with Amphar b.v. (Amphar). The agreement enables Amphar 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 the Netherlands.
William Edelman, CEO of ETView Medical commented, "We are excited to add Amphar to our expanding distributor network." Mr. Edelman continued, "VivaSight™ is currently being distributed across Europe and the United States. VivaSight™ provides best-in-class airway management solutions for sophisticated thoracic surgical procedures requiring lung isolation."
On March 12, 2012, ETView announced KFDA Pre-Market Clearance for the VivaSight™‐SL line of Innovative Airway Devices.
On March 5, 2012 and February 6, 2012, ETView announced filing of a Technical File, initiating CE Registration and a Pre‐Marketing Notification Application (510(k)) with the FDA 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.
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. VivaSight™-DL 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. 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. It is estimated that over 1.9 million lung isolation procedures are conducted worldwide annually, accounting for over $250mm in single-use medical disposables. ETView has pioneered development of the VivaSight™ platform , 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 bronchoscope imaging during these procedures). Additional pre-market regulatory filings in Europe and Asia are anticipated during 2012.