U.S. FDA Clears GI Scientific’s ScopeSeal®, the Only Single-Use Disposable Device Indicated to Significantly Reduce Duodenoscope Contamination During ERCP Procedures

• Seals the complex elevator area of the scope
• Preserves the superior optical, navigation, air/water and instrument delivery capability of reusable duodenoscopes
• Provides a sterile disposable barrier to protect from patient-to-patient cross-contamination
• Integrates easily with current procedure and hospital workflow
• Accessed without capital investment

ARLINGTON, Va.–(BUSINESS WIRE)–GI Scientific, LLC, a developer of transformative innovations for gastrointestinal disease, announced that the U.S. Food and Drug Administration (FDA) cleared its ScopeSeal^® Duodenoscope Protective Device, the first Endoscopic Shield® for protecting the distal end of a duodenoscope from contamination during ERCP procedures. ScopeSeal^® is a single-use disposable infection control device that preserves duodenoscope optics and other key functionality while sealing the infection prone distal end of the Olympus duodenoscope used in ERCP (Endoscopic Retrograde Cholangio-Pancreatography) procedures. ScopeSeal^® is the only device cleared for human use by the FDA that seals the elevator area of the scope and significantly reduces duodenoscope distal end contamination during use.

“It is very difficult to consistently clean and disinfect duodenoscopes between patients because of the intricate moving parts at the distal end of these advanced technology instruments. This is true regardless of whether high level disinfection or terminal sterilization is used to reprocess. Buildup of bacteria and other biomatter in recessed areas on these scopes between patients is almost certainly the cause of recent outbreaks. The best way to truly prevent difficult-to-remove contamination at the distal end of the scope is to protect against contamination in the first place, by sealing the distal end, which is exactly what ScopeSeal^® does. I am excited and relieved that the FDA cleared this device. It will be a game-changer for ERCP infection prevention, complementing existing hospital investments in advanced technology duodenoscopes and sophisticated scope reprocessing,” said Dr. Romney Humphries, former Section Chief, Clinical Microbiology, UCLA Medical System and current Clinical Professor of Pathology, University of Arizona.

Over 700,000 U.S. ERCP procedures and nearly 2 million global ERCP procedures are performed annually as an important less invasive treatment alternative to invasive surgery for assessing and treating critical liver, pancreas, and gallbladder conditions. These highly beneficial, less invasive procedures rely on reusable duodenoscopes as the central enabling technology for these treatments; however, hard-to-clean recessed areas at the distal end of the scope, especially the recessed elevator area, have been linked to failures to remove biomatter contamination from the scope through scope disinfection and reprocessing efforts, resulting in patient-to-patient cross contamination and multiple drug-resistant infections. Significant infection outbreaks and multiple deaths have been reported from drug-resistant infections linked to contaminated duodenoscopes.

ScopeSeal^® easily and securely attaches to the distal end of a reusable duodenoscope to create Two-Way Protection™ for the scope: an “Outside-In” barrier designed to significantly reduce biomatter soiling of the distal end of the scope during use and “Inside-Out” protection which seals the elevator area of the scope and provides a sealed passageway allowing instruments to be passed through the duodenoscope into the patient’s GI tract without contacting the elevator area of the scope. ScopeSeal®’s Two-Way Protection™ is analogous to a physician wearing gloves for surgery, which along with vigorous scrubbing and washing before and after the procedure, protects both the patient and the surgeon from contamination and potential infection.

“The clearance of ScopeSeal^® for human use is a reminder of the FDA’s continued commitment to creating a safe environment for patients undergoing these critical, highly beneficial procedures. We are excited about the introduction of this important single-use disposable technology to address infection concerns with reusable duodenoscopes,” said Scott Miller, CEO and co-founder of GI Scientific.

ScopeSeal^® is cleared for use on the Olympus TJF-Q180V duodenoscope, the duodenoscope used in approximately 85% of U.S. ERCP procedures, and is compatible with instruments used in ERCP up to 10.7 Fr in diameter. ScopeSeal^® is not a replacement for careful adherence to the important and valuable duodenoscope reprocessing steps and related scope maintenance requirements specified by the reusable duodenoscope manufacturer.

The ScopeSeal^® infection control technology is a platform applicable to other scopes and indications, including duodenoscopes with non-sealing disposable caps, which the company is evaluating with respect to pursuing additional, future regulatory clearances.

About ScopeSeal^®

The ScopeSeal^® Duodenoscope Protective Device is the first Endoscopic Shield™, a sterile, single-use disposable device that attaches to the distal end of a duodenoscope to act as a protective barrier to significantly reduce the level of contamination of the scope’s distal end during patient use. The ScopeSeal^® technology includes a proprietary Working Channel Extension™ element that provides an additional protective barrier sealing the duodenoscope’s hard-to-clean elevator area during patient use. ScopeSeal^® provides a further protective benefit after use when kept on the scope during the ScopeSeal^® Pre-Cleaning Procedure™ performed after use, which allows for post-procedure flushing of the scope’s internal instrument channel while sealing the elevator area from biomatter contamination during this important step undertaken prior to reprocessing.

About GI Scientific, LLC

GI Scientific, LLC (www.giscientific.com) is a medical technology innovator, committed to improving patient outcomes by providing new innovations for gastrointestinal procedures. GI Scientific, LLC has multiple technology portfolios for gastrointestinal applications, including technologies focused on enhanced detection and diagnosis of disease, transforming delivery of multiple therapies, and game-changing infection control innovations. The GI Scientific team includes Dr. P. Jay Pasricha, Professor of Medicine at Johns Hopkins School of Medicine, and founding Chair of the AGA Center of Gastrointestinal Innovation and Technology.

Contacts

Karen Sharma

MacDougall

617-571-2733

ksharma@macbiocom.com

Caroline Rufo, PhD

MacDougall

617-921-3258

crufo@macbiocom.com