Vision-Sciences, Inc. develops, manufactures, and markets innovative products for flexible endoscopy.

The products and accessories are used within two industries: medical and industrial.

Vision-Sciences, Inc. designs, manufactures, repairs, and markets flexible endoscopes for medical use and proprietary single-use sheaths (The EndoSheath^® Technology) that slide over the insertion tube of the endoscope. The sheaths allow for quick, efficient endoscope turnover while ensuring a sterile procedure for each patient. Industrial endoscopes are designed, manufactured, repaired and marketed by the Machida Division located in Orangeburg, NY. These endoscopes (borescopes) are used primarily for aircraft maintenance, jet engine manufacturing and defense.

Vision-Sciences, Inc., was founded in 1990 to develop and market a proprietary line of flexible endoscopes designed to increase practice efficiency and reduce the risk of endoscopic cross-contamination.

Dr. Fred E. Silverstein, a noted gastroenterologist, was convinced that the existing methods of reprocessing endoscopes - elaborate and difficult - could be improved upon. He invented a two-part system consisting of a reusable endoscope and a sterile, disposable sheath that would act as a barrier between the scope and the patient. The concept featured an endoscope containing only the optics, light bundles, and functional mechanisms. The key scope components referred to as the “channels” were not part of the reusable scope. Instead these difficult-to-clean components were incorporated into the disposable sheath unit. This sheath unit – better known as the EndoSheath^® Technology – is the only part of the system that comes in contact with the patient. The reusable endoscope never comes in contact with the patient. Even biopsy and suction material is transferred through the disposable unit. This two-part system allows for quick turnaround time, less capital equipment and repair costs, and a dramatic reduction in the risk of cross-contamination.

Since the company’s founding, Vision-Sciences, Inc. has received FDA Clearance to market EndoSheath^® Technology in several endoscopy specialties:

• Laryngoscopy
• Cystoscopy
• Sigmoidoscopy
• Colonoscopy
• Gastroscopy
• Bronchoscopy
• Esophagoscopy

Vision-Sciences, Inc. is actively pursuing ways to bring the EndoSheath^® Technology to more areas of endoscopy.

Vision-Sciences, Inc. currently has twenty-nine issued patents in the United States, as well as key patents issued in Europe, Japan, Canada, and a number of additional patent applications in process. The Company believes these patents provide very strong protection for its inventions.

During April 2007, our Orangeburg facility underwent an expansion audit which was successfully completed and we were awarded International Organization for Standardization (ISO) 13485: 2003 certification for this location. This certification allowed us to start shipping scopes from our Orangeburg facility, in addition to shipments from our Natick facility. The Natick and Orangeburg facilities are registered with the FDA as medical device manufacturers. As a result, these facilities are subject to the FDA’s QSR, which regulate their design, manufacturing, testing, quality control and documentation procedures. We are also required to comply with the FDA’s labeling requirements, as well as its information reporting regulations.

In August 2005, our Natick quality system certification was updated to establish conformance with ISO 13485: 2003 and continued conformance with Medical Devices Directive (MDD) 93/42/EEC and the Canadian Medical Device Regulations (CMDR). In addition to the three-year certification audits, we undergo annual surveillance audits to confirm that we are maintaining our quality system.