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Zynex Prepares for First Clinical Evaluation of Blood Volume Monitor Medical Device


//health-fitness.news-articles.net/content/2011/ .. tion-of-blood-volume-monitor-medical-device.html
Published in Health and Fitness on by Market Wire   Print publication without navigation


LONE TREE, Colo.--([ BUSINESS WIRE ])--Zynex, Inc. (OTCBB: [ ZYXI ]), a provider of pain management systems and electrotherapy products for medical patients with functional disability, announced that it signed an agreement with OmniaVincit, LLC to conduct the first clinical evaluation for its blood volume monitor medical device, being developed by its Zynex Monitoring Solutions, Inc. subsidiary.

Zynex's CEO, Thomas Sandgaard, commented; "We are very excited about the development and prototyping of our cardiac monitor for blood volume. We are starting the next phase of collecting data to further validate the algorithm used to non-invasively determine changes in central blood volume. We expect to use the data for defining further clinical studies, as well as to provide substantiation for FDA submission and international regulatory clearance."

Zynex Monitoring Solutions, Inc.'s blood volume monitor is a non-invasive medical device for monitoring central blood volume that would be used in operating and recovery rooms to detect blood loss during surgeryand internal bleeding during recovery. This unique medical device application is intended toserve what Zynex believes is a currently un-met need in themarket for safer surgeries and safer monitoring of patients during recovery.

OmniaVincit, LLC, a local Denver, Colorado clinical service organization, specializes in the efficient development of successful clinical research programs, non-traditional clinical studies, as well as investigative site quality support, including standard operating procedure customization ([ www.omniavincit.com ]).

About Zynex

Zynex, Inc. (founded in 1996) engineers, manufactures, markets and sells its own design of medical devices in three subsidiaries. Zynex Medical is a provider of electrotherapy products for home use, Zynex Monitoring Solutions develops products for cardiac monitoring for use in hospitals and Zynex NeuroDiagnostic develops devices for EMG and EEG diagnostic purposes in the neurology clinic markets. Zynex Medical's product line is fully developed, FDA-cleared, commercially sold, and has been developed to uphold the Company's mission of improving the quality of life for patients suffering from impaired mobility due to stroke, spinal cord injury, or debilitating and chronic pain. Zynex Monitoring Solutions and Zynex NeuroDiagnostic are currently both in the development stages without any significant revenues. For additional information please visit: [ http://www.ir-site.com/zynex/default.asp ].

Safe Harbor Statement

Certain statements in this release are "forward-looking" and as such are subject to numerous risks and uncertainties. Actual results may vary significantly from the results expressed or implied in such statements. Factors that could cause actual results to materially differ from forward-looking statements include, but are not limited to, the need to obtain additional capital in order to grow our business, our ability to engage additional sales representatives, the success of such additional sales representatives, the need to obtain FDA clearance and CE marking of new products, the acceptance of new products as well as existing products by doctors and hospitals, larger competitors with greater financial resources, the need to keep pace with technological changes, our dependence on the reimbursement from insurance companies for products sold or rented to our customers, acceptance of our products by health insurance providers, our dependence on third party manufacturers to produce our goods on time and to our specifications, implementation of our sales strategy including a strong direct sales force, the uncertain outcome of pending material litigation and other risks described in our filings with the Securities and Exchange Commission including the aRisk Factorsa section of our Annual Report on Form 10-K for the year ended December 31, 2009.


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