ETView Medical, Ltd., and Amphar b.v. (Amphar), executed distribution agreement
The agreement enables Amphar to market ETView's VivaSight™ platform in the Netherlands.
(March 19, 2012, Tel Aviv, Israel) 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. Terms were not disclosed.
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™-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 , 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). Additional pre-market regulatory filings in Europe and Asia are anticipated during 2012.
About Amphar Ltd.:
According to information provided to the company, Amphar b.v. was founded in 1975 and is based in Amsterdam, the Netherlands. Amphar is engaged in international marketing and distribution of pharmaceutical active ingredients to the generics industry and disposable medical devices to hospitals.
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 It is estimated that over 1.9 million lung isolation procedures are conducted worldwide annually,8 accounting for over $250mm in single-use medical disposables.9
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;105:471-477.
8 National Health Statistics Reports Number 29, October 26, 2010
9 Company estimates on file