High-Resolution Non Invasive Capsule Endoscopy (NICE) Product

In 2007 an overseas medical device products company decided to market a new product, they had developed, in the United States. The product "NICE" utilizes a standard computer, proprietary software, and specialized electronics to capture high resolution images transmitted from a capsule ingested by a patient. The disposable capsules measure only 11 mm (0.43 inches) in diameter and 26 mm (1.02 inches) in length, and are equipped with sophisticated miniaturized lighting, and image gathering and transmission electronics.

The capsule can be utilized for the visualization of the small bowel mucosa. The NICE high-resolution system offers the operational ease and efficiency of a capsule scope while maintaining the outstanding performance characteristics of a traditional colonoscopy based system.

The NICE solution offers unique features that provide physicians with unprecedented imaging capabilities of the small bowel, including high resolution, a wider field of view and an enhanced depth of field, automatic brightness control, advanced color reproduction and structure enhancement. A portable, lightweight real-time viewer conveniently allows physicians to verify its full functionality before the patient ingests the capsule. The capsule can easily be activated or deactivated, if needed, to conserve battery power prior to ingestion. An integrated antenna transmits two images per second to the data recorder. Patients carry the capsule's data recorder in a lightweight harness that is convenient and comfortable to wear, allowing them to conduct daily activities while the capsule is recording images.

CES responsibilities include:

• Stock procurement
• Product assembly and test
• Maintain finished product inventory
• Generate and maintain FDA compliance records
• Delivery and optional installation support

We are currently delivering on average ten systems per month. We have delivered as many as six systems per day to satisfy peak client requirements. We currently maintain an inventory of over $250,000 in critical material to insure there is no disruption in finished product availability.