Sierra Scientific Instruments Inc. exhibited the ManoScan 360 Motility Visualization System at the Digestive Diseases Week (DDW)in Chicago. During the meeting, presentations were made Dr's Peter Kahrilas, Ray Clouse, John Pandolfino, Mark Fox, and others that highlighted the clinical benefits of ManoScan and high-resolution manometry. These academic presentations included independent conclusions that this technology "…has improved diagnostic accuracy relative to conventional manometry", "…[provides] the single best parameter for discrimination of achalasia…", and "is easy and quick to implement and [provides] added value to labs and hospitals". The total of eight talks included two oral presentations, one invited session, and two posters of distinction. Dr. Thomas Parks, President and CEO of SSI was a contributing author for three of the presentations. SSI concurrently exhibited ManoScan at the National Society of Gastroenterological Nurses and Associates (SGNA) meeting in Minneapolis and received an enthusiastic reception with over 300 requests for additional product information. Dr. Parks stated: "This highly positive feedback from leading experts and every-day clinicians alike is highly rewarding for the whole ManoScan team." Copies of the publications presented at the meetings are available from SSI.
Contact Sierra Scientific Instruments for copies of publications on ManoScan and high-resolution manometry

Sierra Scientific Instruments (SSI) announced today the commencement of full-scale commercial production of the ManoScan™ Motility Visualization System. This system enables a greatly simplified clinical procedure while providing enhanced diagnostic acuity. Mr. Ronald Tee, SSI Head of Quality Engineering stated, "The completion of our management quality review has confirmed SSI's ability to begin full production operations. This in conjunction with our network of certified subcontractors provides an efficient network for quality-assured production." SSI has established partnerships with major component and subassembly suppliers and performs final integration and acceptance testing in house. Current deliveries are quoted at 3-5 weeks, but are expected to be reduced as production ramps up.

Sierra Scientific Instruments Inc. (SSI) announced the commercial availability of ManoScan, its novel solid-state high-resolution manometry system this week at the American Gastroenterological Association annual Digestive Disease Week (DDW) meeting in New Orleans. SSI provided demonstrations of ManoScan's novel real-time high-resolution data collection and patient case studies seen as unprecedented full-field high-resolution pressure video images. Mr. Dominic Bellino, Director of Sales remarked, "interest was very high among experts and clinicians alike and we were extremely busy showing the system for the entire meeting." Four academic presentations were made involving ManoScan and high-resolution manometry. An oral presentation was made by Dr. Ray Clouse of Washington University School of Medicine that demonstrated SSI's unique eSleeve™ capability, which electronically produces a traditional sleeve sensor signal while simultaneously providing full-fidelity pressure images (patent pending). This function along with other ManoScan features are designed to make the system insensitive to operator technique while providing more reliable diagnostic parameters and new clarity in post-testing analysis. (Abstracts of the presented material and other publications are available from SSI).

Sierra Scientific Instruments received FDA 510(k) clearance today to market the ManoScan 360™ high-resolution manometry system. The clearance covers indications of use for diagnostic examination in virtually all applicable organs of the gastrointestinal tract including the pharynx, esophagus, stomach, antroduodenum, and anorectum. Sierra received a request for clarification of several items and additional information from the FDA in July 2003 in response to the original application. These were provided to the agency in early September. Sierra was notified in October that review of this additional information was slowed due to local staffing issues at the agency. The clearance letter was received today without further questions. Dr. Tom Parks, CEO of Sierra stated, "This is excellent news for SSI as we enter the new year. It opens the door for launching into the production phase and is a key element in securing financing and corporate partnership agreements." Commercial sales of ManoScan are projected to begin in the second quarter of 2004.

Ongoing clinical testing of the ManoScan 360™ high-resolution manometry system has clinically validated its performance and novel capabilities. Over 50 studies have been performed to date under the direction of Dr. Ray Clouse, M.D. at Washington University, Barnes-Jewish hospital. The data demonstrate that the unique pressure imaging probe provides consistent diagnostic results that do not require precise catheter positioning relative to the esophageal sphincters as is required with other devices. Clinical tests have further demonstrated new diagnostic capabilities and the discovery of a previously unreported symptom source. Practical improvements in ease of use and shortening of procedure time have also been documented. Four publications describing these results were submitted to the American Gastroenterological Association for presentation at the Digestive Diseases Week in New Orleans (May 15-20, 2004). More information is available through Sierra Scientific Instruments, Inc., Los Angeles (310-641-8492) or see
ManoScan at www.sierrainst.com

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.

A 36 element full esophagus probe was successfully assembled and tested at Pressure Profile Systems Inc. [SSI parent] in Los Angeles. The fully functional probe was shown to produce vivid images of pressure distributions along its active length in tests that simulated human anatomy and physiology. Test results demonstrated its ability to comply with key performance characteristics including sensor repeatability, dynamic range, bending insensitivity, and durability. The probe features a flexible molded silicone construction for patient comfort, and uniform circumferential transducers for repeatable measurement within asymmetric regions such as the esophageal sphincters.

The ManoView™ data acquisition and visualization software was demonstrated using human subject data. These data, procured from Washington University in St. Louis MO, were collected using a high resolution system in which separate studies of the upper and lower esophagus were undertaken. The data were spliced by engineers at Pressure Profile Systems, Inc. (SSI parent) to reconstruct the record as if it were from a spatially continuous set. The ManoView program produced novel high fidelity imagery that was viewable in several correlated display modes. The ManoView software is an integral element of the ManoScan™ system for high resolution pressure measurement in the gastrointestinal tract.
See ManoView at www.sierrainst.com for more information