Press Release

PENTAX Medical and SMART Medical Systems Announce Strategic Pan-European Alliance

PENTAX Medical and SMART Medical Systems Announce Strategic Pan-European Alliance

December 2, 2013

PENTAX Medical and SMART Medical Systems Announce Strategic Pan-European Alliance that will Change the Standard of Care in Colonoscopy. SMART’s G-EYE™ endoscope, which will increase the detection of cancerous polyps in colonoscopy, is now commercially available through PENTAX Medical in EMEA.

Ra'anana, Israel, and Hamburg, Germany, November 27th, 2013. SMART Medical Systems Ltd., a developer and manufacturer of innovative endoscopy products, and PENTAX Medical, an industry leader in endoscopic imaging, announced a strategic pan-European alliance, under which PENTAX Medical will commercialize SMART’s novel G-EYE™ endoscope in Europe, the Middle-East and Africa (EMEA). The G-EYE™ endoscope is a high quality HD+ PENTAX Medical colonoscope onto which SMART’s G-EYE™ balloon is permanently integrated. The Controlled Withdrawal™ of the G-EYE™ endoscope with the balloon moderately inflated centralizes the image in the colon lumen and flattens colon folds, thereby providing enhanced visualization of the colon and enabling an increase in polyp detection.

Colorectal cancer, which evolves from pre-cancerous polyps (adenomas) that develop in the inner layer of the colon, is known as one of the most life-threatening cancer types. Colonoscopy is considered to be the gold standard of care for detecting polyps and preventing colorectal cancer. However, results from a tandem-study in various centers in EMEA indicate that significant number of polyps and adenomas (20-30%) are missed during routine colonoscopy. Due to its enhanced detection and reduced miss-rate, colonoscopy with the G-EYE™ is substantially more efficient in detecting polyps and adenomas than conventional colonoscopy, according to Prof. Neumann (University of Erlangen-Nurumberg, Germany). Beyond detection enhancement, the G-EYE™ balloon is used for endoscope stabilization during the endoscopic treatment, thereby allowing easier and faster polyp removal.

The G-EYE™ endoscope distributed by PENTAX Medical is based on PENTAX Medical’s full HD+ colonoscopes, combining the G-EYE™ technology with state-of-the-art image quality.

“Our alliance with PENTAX Medical provides us with a great opportunity to serve the European medical community, enabling better treatment for patients and enhancing physicians' capabilities during the colonoscopy procedure,” said Gadi Terliuc, SMART's CEO. “The G-EYE™ colonoscope provides optimal visualization and exceptional detection capabilities. Clinical studies show additional adenoma detection yield of over 80%, almost doubled in comparison to standard colonoscopy.

"The agreement with SMART adds unique endoscopic technology to our product portfolio, and is aligned with our mission to provide high quality patient-care,” said Dr. Ismaël Nujurally, President EMEA of PENTAX Medical. "The combination of SMART's balloon-based endoscopy with our state-of-the-art imaging allows us to provide the market with a solution for the most advanced colonoscopy."

“The partnership with SMART further broadens our colonoscopy portfolio”, said Ganesh Ramaswamy, Global President of PENTAX Medical. “We will continue to execute on our commitments to deliver world-class products and services that yield tremendous clinical value propositions and economic value additions for our customers and patients.”

PENTAX Medical and SMART indicated their planned cooperation at the United European Gastroenterology Week (UEGW), recently held in Berlin, Germany.

About SMART Medical Systems

SMART Medical Systems is a pioneer in the development and manufacture of innovative medical devices in the field of gastro-intestinal (GI) endoscopy. Its proprietary technology enhances the performance and capabilities of existing endoscopy equipment, in an intuitive and cost-effective manner. SMART's CE Marked and FDA cleared NaviAid™ product family is commercially distributed in key global markets. Its G-EYE™ product (CE Marked, pending FDA clearance) is presently under commercialization in selected regions. SMART is headquartered in Israel, and operates in the United States through its wholly-owned subsidiary, SMART GI Inc., and in Greater China through its Hong Kong subsidiary, Medico HK Limited. For more information, please visit: www.smartmedsys.com

About PENTAX Medical

PENTAX Medical is a division of Hoya Group. Its mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community. Headquartered in Japan, PENTAX Medical has a worldwide focus and presence with R&D, regional sales, service, and in-country facilities around the globe. For more information, please visit: www.pentaxmedical.com.

Contacts:

David Kanaan – SMART Medical
Kanaan Public Relations
Tel.: +972-54-4255307
e-mail: David@KanaanPR.com


Katharina Meitzler
Project Manager Marketing Communications, PENTAX Europe GmbH
Tel.: +49-40-56192-0
e-mail: meitzler.katharina@pentax.de