PR95527

SMART Medical Systems' G-EYE (R) Colonoscope is now FDA Cleared on Olympus' PCF Colonoscope Series, Making it Available in the United States on the Commonly Used Models of All Leading Endoscopy Brands

RA'ANANA, Israel, April 19, 2022 /PRNewswire=KYODO JBN/ --

- FDA has approved the use of G-Eye (R) with Olympus' 510(k) cleared PCF

colonoscopes –

SMART Medical Systems Ltd., a developer and manufacturer of innovative

endoscopy products, today announced an additional FDA clearance for its G-EYE

(R) Colonoscope, based on Olympus' 510(k) cleared PCF colonoscope series. With

this additional FDA clearance, G-EYE (R) is now available for use in the U.S.

market on the commonly used colonoscope models of all three leading endoscopy

brands - OLYMPUS, FUJIFILM, and PENTAX Medical.

Logo - https://mma.prnewswire.com/media/1669152/smart_Logo.jpg

"The ability to offer G-EYE (R) on colonoscope brands and models commonly used

and widely available in the United States is an important milestone for SMART

Medical, patients, and endoscopists," said Gadi Terliuc, Chief Executive

Officer of SMART Medical. "The majority of U.S. endoscopists now have the

option to utilize our cutting-edge technology, which has been shown in clinical

studies to improve visualization compared with standard colonoscopy, while

using their preferred brand and model of colonoscope. We are very excited to

have completed our portfolio of U.S. G-EYE (R) offerings and believe that the

widespread availability of the technology on the commonly used colonoscope

models has the potential to accelerate adoption of G-EYE (R) colonoscopy as the

standard of care."

The G-EYE (R) Colonoscope is a 510(k) cleared colonoscope, remanufactured by

SMART to include a proprietary balloon at its distal bending section.

Withdrawal of the G-EYE (R) Colonoscope with the balloon moderately inflated

during colonoscopy assists in controlling the colonoscope's field of view and

positioning. A published study (GIE 2019; 89: 545-53) demonstrated that G-EYE

(R) can improve colonoscopy outcomes compared with standard colonoscopy across

several metrics, including increasing adenoma detection rate (ADR) by 28%,

detecting 47% more adenomas per patient (APP), 62% more advanced and large

adenomas, and 142% more flat adenomas.

"We expect that this FDA clearance of the G-EYE (R) Colonoscope based on

Olympus' PCF scopes, which many Olympus users prefer over traditional

adult-sized colonoscopes, will enhance our ability to capture a substantial

portion of the U.S. colonoscopy market," said Brian Cochrane, Chief Commercial

Officer of SMART's U.S. subsidiary. "We are committed to becoming the standard

of care in colonoscopy, and this FDA clearance is an important step toward

achieving this critical goal."

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.

SMART's unique approach is to address key challenges in contemporary endoscopy

while using available brand name endoscopes. SMART's CE Marked and FDA-cleared

NaviAid (TM) and G-EYE (R) product families are commercially distributed in key

global markets. With its partnership with FUJIFILM and PENTAX Medical, SMART's

G-EYE (R) colonoscopy solution is currently adopted by two of the three

industry leaders in GI endoscopy imaging. SMART is headquartered in Israel, and

operates in the United States through its wholly-owned subsidiary, SMART GI

Inc. For more information, please visit: www.smartmedsys.com/us/ .

Media Contact:

Glenn Silver, Lazar FINN

Glenn.silver@finnpartners.com

+1 (973) 818-8198

SOURCE: SMART Medical Systems