Scivanta Medical Corporation Provides Update on the Development of the Hickey Cardiac Monitoring System
Company to commence clinical trials of the Hickey Cardiac Monitoring System
SPRING LAKE, N.J., Oct 14, 2008 /PRNewswire-FirstCall via COMTEX/ -- Scivanta Medical Corporation (OTC Bulletin Board: SCVM), the developer of an innovative product for cardiac monitoring known as the Hickey Cardiac Monitoring System (HCMS), has commenced enrollment of patients for the clinical trials of the HCMS. Scivanta's initial clinical trials will be performed at Kaleida Health/Millard Fillmore Hospital in Buffalo, New York. Scivanta expects to enroll up to 10 patients in this initial study and, upon completion, plans to test at least an additional 40 patients at Kaleida and three other institutions. The clinical trials of the HCMS could be completed as early as December 2008. Upon the successful completion of the clinical trials, Scivanta will submit to the United States Food and Drug Administration (FDA) a 510(k) premarket notification regarding the HCMS. Depending upon the length of the FDA's review, Scivanta estimates that it could have 510(k) clearance from the FDA as early as the beginning of second quarter 2009, which will allow Scivanta to commence sales of the HCMS in the United States shortly thereafter. Scivanta will initially focus its sales efforts on hospitals, for which reimbursement codes currently exist for the procedure performed by the HCMS.
On October 1, 2008, Rivertek Medical Systems, Inc., a medical device development firm located in St. Paul, Minnesota and consultant to Scivanta in the overall development of the HCMS, assumed the development of the hardware component of the HCMS. In connection therewith, Scivanta terminated its development agreement with Sparton Medical Systems, a business group of Sparton Electronics Florida, Inc. Scivanta is currently in discussions with corporate partners regarding the sales and distribution of the HCMS in the United States as well as the manufacturing of the hardware component of the HCMS. Scivanta anticipates that one of its current development partners, Ethox International, Inc., of Buffalo, New York, will manufacture the catheter component of the HCMS.
David LaVance, President and Chief Executive Officer of Scivanta commented, "I am pleased that the HCMS is entering the clinical trial stage of its development. We remain very excited about the prospects of the HCMS and are working diligently to get this product into the United States market. Our product development efforts, which have been done in concert with Ethox International and under the guidance of Rivertek Medical Systems, will continue through the clinical trials, with the expectation that a commercial product will be manufactured and available at the same time as FDA clearance is received."
About Scivanta Medical Corporation
Scivanta Medical Corporation is focused on acquiring and developing medical technologies and products which offer advantages over existing medical procedures and treatments. Scivanta's first product, the Hickey Cardiac Monitoring System, is an innovative cardiac monitoring system that utilizes a two-balloon esophageal catheter to monitor cardiac performance. The HCMS is expected to provide the primary measurements of cardiac performance in a minimally invasive and cost-effective manner and is designed to be used outside of an intensive care setting. The HCMS is currently under development and must receive the appropriate regulatory approvals prior to commercialization. As Scivanta develops the HCMS, it expects to continue to review for acquisition other medical technologies and products that are sold, or capable of being sold, in a specialty or niche market. For more information, visit www.scivanta.com.
Statements about the Scivanta's future expectations and all other statements in this press release other than historical facts are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as that term is defined in the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from expected results. Among these risks, trends and uncertainties are economic conditions both generally and within the industries in which Scivanta may participate; competition within Scivanta's chosen industries, including competition from much larger competitors; technological advances; available capital; regulatory approval; and failure by Scivanta to successfully develop or acquire products and form new business relationships. Scivanta intends that such forward-looking statements shall be subject to the safe harbors created thereby. Since these statements involve risks and uncertainties and are subject to change at any time, the Scivanta's actual results could differ materially from expected results.
Scivanta Medical Corporation
Tom Gifford, Chief Financial Officer
Tel.: (732) 282-1620 x15
Fax: (732) 282-1621
Catalyst Financial Resources
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