ETView Medical Ltd. today announced results of a multi-center clinical report on the use of VivaSight™ to achieve One Lung Ventilation (OLV).

As reported in the April, 2015 issue of Anaesthesia1, investigators at VU University Medical Centre, Amsterdam, The Netherlands; Medical Centre Alkmaar, Alkmaar, The Netherlands; Catharina Hospital, Eindhoven, The Netherlands; and Rambam Health Care Campus, Haifa, Israel, reported on “Evaluation of a new double-lumen endobronchial tube with an integrated camera (VivaSight™ DL): a prospective multicentre observational study,” which was performed on 151 patients. The objectives of the evaluation were to (1) monitor correct placement of VivaSight™ DL to achieve OLV, (2) measure flexible fiberoptic bronchoscopy utilization during OLV, and (3) monitor postoperative complaints. The current standard of practice requires the use of flexible fiberoptic bronchoscopy to verify placement of endotracheal tubes during OLV procedures. According to the investigators of the current evaluation, correct placement of VivaSight™ DL was achieved in 148 (98%) patients. Of the 148 successful VivaSight™ DL tube placements, lung collapse was achieved in 147 (99%). As noted following the evaluation, no major complications occurred during VivaSight™ DL placement or throughout the surgical procedure. The authors reported an 87% reduction in fiberoptic bronchoscopy when VivaSight™ DL was employed for OLV, similar to a prior published study2 describing a reduction of 93% in the use of fiberoptic bronchoscopy for OLV cases when VivaSight™ DL was employed. The reduced use of fiberoptic bronchoscopy in the current evaluation was associated with several clinical and economic advantages by the authors. Clinically, the authors identified patients with reduced pulmonary reserve, wherein use of fiberoptic bronchoscopy may lead to hypoxaemia and hypercarbia. Economic analysis by one center (University Medical Center) demonstrated saving of €12,000/$16,000 for every 100 OLV cases where VivaSight™ DL was employed.

William Edelman, CEO of ETView Medical, commented, “The growing body of clinical evidence supports VivaSight™ DL as the best-in-class solution for conducting one lung ventilation procedures. Wherever VivaSight™ DL is implemented, fiberoptic bronchoscopy is significantly reduced and associated economic benefits and improved clinical procedural workflow are achieved.” Mr. Edelman continued, “VivaSight™ is currently being distributed across Europe, Asia and the United States. Single-use VivaSight™ provides best-in-class airway management solutions for thoracic surgical procedures requiring One Lung Ventilation (OLV), and eliminates patient cross-contamination associated with the sterilization3 of imaging devices. ETView's VivaSight™ DL has recently received regulatory clearance for marketing the VivaSight™-DL line of innovative airway devices in China."

Prior Announcements

On March 23, 2015, ETView announced expansion of China distribution with execution of Well Lead Medical Co., Ltd., Distribution Agreement

On February 24, 2015, ETView reported on Clinical Evaluation of VivaSight™ at the University Hospital Zurich (Zurich, Switzerland).

On July 9, 2014, ETView Medical Ltd. reported on 2 Clinical Evaluations of VivaSight™, conducted at MD Anderson (Houston, TX) and Haga Hospital (The Hague, Netherlands).

On May 7, 2014, ETView Medical Ltd. announced exclusive distribution agreements with Technolab CIA LTDA and with MedCARE Medizintechnik Vertrlebs GmbH to exclusively market ETView's VivaSight™ products in Ecuador and in Austria (respectively).

About ETView Medical Ltd.

ETView Medical Ltd. has successfully combined airway management with continuous direct airway visualization for One Lung Ventilation (OLV). OLV is employed to provide one-lung ventilation in patients undergoing thoracic, cardiac, vascular, or esophageal surgeries.4 ETView's VivaSight™ airway management portfolio combines single-use disposable single and double lumen ventilation tubes with integrated continuous high resolution airway imaging. VivaSight™-SL and VivaSight™-DL are sold worldwide to overcome current limitations and associated adverse surgical events during OLV surgeries.

As reported in the January, 2015 issue of the Canadian Journal of Anesthesia5, investigators at University Hospital Zurich demonstrated that flexible fiberoptic bronchoscopy was eliminated when utilizing VivaSight™ to achieve OLV, compared with flexible fiberoptic bronchoscopy required in 85% of the cases which did not utilize VivaSight™ to achieve OLV. Recent literature suggests flexible fiberoptic bronchoscope expenses of $1006 to $2807 per OLV case. Earlier findings by investigators at the Leiden University Medical Center (Leiden, Netherlands) and Haga Hospital (The Hague, Netherlands) reported8 that VivaSight™ reduced time to achieve OLV by 22%, compared to surgical procedures utilizing flexible fiberoptic bronchoscopy. Furthermore, associated expenditures on a per surgery basis were reduced by at least 17% when using VivaSight™-DL due to the elimination of flexible fiberoptic bronchoscopy. Additionally, investigators at MD Anderson (Houston, TX) demonstrated9 in over 93% of patients evaluated that the use of flexible fiberoptic bronchoscopy was not required.

Typically, 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. Such intra-operative surgical maneuvers often require repeated imaging and partial blocking of the airway with a bronchoscope to maintain lung isolation.10 It is estimated that over 1.9 million lung isolation procedures are conducted worldwide annually,11 accounting for over $250 million in single-use medical disposables.12

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 Anaesthesia. doi:10.1111/anae.13068
2 Journal of Cardiothoracic and Vascular Anesthesia 2014; 28: 882–4
3 http://www.reuters.com/article/2015/02/19/us-usa-ucla-bacteria-idUSKBN0LN05J20150219
4 Principles and Practices of Anesthesia for Thoracic Surgery. P. Singer (ed.) 2011
5 Can J Anesth/J Can Anesth, DOI 10.1007/s12630-015-0329-8
6 Journal of Anesthesia and Clinical Research, 3:215. doi:10.4172/2155-6148.1000215
7 Annals of French Anesthesia and Intensive Care, 2013 May;32(5):291-5. doi: 10.1016/j.annfar.2013.01.014. Epub 2013 Apr 3.
8 2014 European Society of Thoracic Surgeons Meeting, Copenhagen, Denmark, June 15-18, 2014
9 J Cardiothorac Vasc Anesth. 2014 Aug;28(4):882-4. doi: 10.1053/j.jvca.2013.11.011. Epub 2014 Mar 20
10 Anesthesia & Analgesia. 2009;108:1097–101
11 National Health Statistics Reports Number 29, October 26, 2010
12 Company estimates on file