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New Peer-Reviewed Publication Demonstrates Patient Safety Aspects Of Vision-Sciences' EndoSheath(R) Technology For Flexible Cystoscopes

ORANGEBURG, N.Y., Nov. 6, 2013 (GLOBE NEWSWIRE) -- Vision-Sciences, Inc. (Nasdaq:VSCI) announced today the publication of positive outcomes of a clinical study that evaluated the durability and microbial barrier properties of the Company's EndoSheath ® technology in the flexible cystoscopy setting in the November issue of the peer-reviewed journal BMC Urology.

To assess the efficacy of Vision-Sciences' EndoSheath technology with flexible cystoscopes, study authors tested the barrier integrity of each EndoSheath disposable following clinical procedures and then performed microbiology sampling of the flexible cystoscopes to determine if any bacterial contamination had occurred. Study outcomes and conclusions include:
  • 100% of EndoSheath units tested were leak-free following clinical use. This finding confirms outcomes of a prior study of 875 endoscopic procedures in which no leaks were reported.  
  • 100% of microbiology samples showed a clean flexible cystoscope following EndoSheath technology usage and the Company's recommended cleaning procedure.  
  • The study authors concluded that Vision-Sciences' reprocessing procedure featured a low risk of pathogen transmission, high-patient safety and a valid alternative to the recommended high-level disinfection procedure of competitive flexible cystoscopes.

"This was the first research to assess the microbiology and sheath integrity of our EndoSheath technology in the cystoscopy setting. These highly positive results demonstrate that the EndoSheaths did not break, and that the use of our EndoSheath technology followed by our three-step cleaning process has a low risk of pathogen transmission and high patient safety. This supports our longstanding position that the EndoSheath technology provides an 'always ready, always sterile' endoscope," said Howard Zauberman, Vision-Sciences' Interim Chief Executive Officer.

The study, entitled "A microbiological evaluation of level of disinfection for flexible cystoscopes protected by disposable endosheaths," was conducted by researchers in Denmark at the Frederiksberg University Hospital, Hvidovre University Hospital, and University of Copenhagen. Microbiological samples from 100 cystoscopies performed with flexible cystoscopes ("FC") using disposable sterile EndoSheaths were obtained twice: after removal of the EndoSheath, and after cleaning the scope with a detergent cloth, rinsing with tap water followed by 70% ethanol disinfection, and subsequent drying. 

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