Clinical testing began of the solid-state high-resolution ManoScan 360 system for esophageal manometry. Tests are being conducted under the direction of Dr. Ray Clouse, M.D. at Washington University and Barnes-Jewish Hospital (BJH), St. Louis MO. The first in vivo test was completed within three hours of arrival of the ManoScan equipment, and produced the first ever full-esophagus manometric images using closely spaced sensors. The first patient had a marginally hypotensive LES and slight hypomotility, as was readily identifiable from the real time display. Dr. Tom Parks, President of SSI said, "We were pleased but not surprised that this first testing went without a hitch. We completed a comprehensive laboratory test program before beginning the human subjects phase." Over 20 patients have been studied to date and the system has performed reliably and demonstrated benefits in ease of intubation and simplification of the clinical procedure.

The ManoScan high-resolution manometry system successfully completed independent verification and validation (V&V) testing today. These tests were performed by Certified Software Solutions Inc. (CSS, San Diego, CA), which specializes in medical device software, V&V testing, and regulatory compliance support. The activity included more that 800 line item tests that covered the probe performance, data acquisition and analysis software, and a variety of safety-related items. These tests were passed on the first time through formal testing with no significant anomalies. Mr. Sean Curry, COO at CSS stated, "SSI's due diligence up front was instrumental when it came to executing the formal validation testing. They should be commended!" The successful completion of these tests, in conjunction with receipt of the pending 510(k) clearance are necessary to begin commercial production. FDA clearance is expected in the fourth quarter of this year.

Clinical testing began of the solid-state high-resolution ManoScan 360 system for esophageal manometry. Tests are being conducted under the direction of Dr. Ray Clouse, M.D. at Washington University and Barnes-Jewish Hospital (BJH), St. Louis MO. The first in vivo test was completed within three hours of arrival of the ManoScan equipment, and produced the first ever full-esophagus manometric images using closely spaced sensors. The first patient had a marginally hypotensive LES and slight hypomotility, as was readily identifiable from the real time display. Dr. Tom Parks, President of SSI said, "We were pleased but not surprised that this first testing went without a hitch. We completed a comprehensive laboratory test program before beginning the human subjects phase." Over 20 patients have been studied to date and the system has performed reliably and demonstrated benefits in ease of intubation and simplification of the clinical procedure.