For Immediate Release
November 27, 2007
Enova Medical Technologies Signs Contract Manufacturing Service Agreement with Stereotaxis, Inc.
ST. PAUL, Minn. (November 27, 2007) – Enova Medical Technologies has signed a manufacturing service agreement with Stereotaxis, Inc. (Nasdaq: STXS) to produce the company’s Cardiodrive® Catheter Advancement System (CAS).
Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital's interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. As one of Stereotaxis’ products, the Cardiodrive CAS automatically advances and retracts compatible magnetic electrophysiology (EP) mapping and ablation catheters when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS).
“We are proud to partner with Stereotaxis in manufacturing this state-of-the-art medical device,” said Roger Heegaard, president of Enova. “We consider earning the confidence of an innovative, high-growth medical device company such as Stereotaxis to be an accolade to the quality of our manufacturing services.”
Enova’s role in producing the Cardiodrive CAS will include overseeing, coordinating and managing the procurement process, as well as handling product manufacturing, final assembly work, packaging, labeling, and sterilization procedures.
“Our Magnetic Navigation System is used in some of the most challenging coronary and vascular treatments performed today and safety and performance of every component is critical. When selecting a manufacturing partner, it is essential for us to find a company that shares our commitment to providing the highest quality product with superior customer service and manufacturing practices. Without question, Enova is that type of company,” said Gene Berghoff, Stereotaxis senior director of outsourcing. “We’re pleased to work with an organization that believes quality and responsiveness go hand-in-hand.”
The Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image-guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally-applied magnetic fields that guides the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe, Canada and other countries throughout the world.
About Enova Medical
Enova Medical Technologies, a privately-held company, is engaged in the development and commercialization of proprietary medical devices and is an experienced provider of product development, manufacturing, and commercialization services for the medical device industry. From Class I to Class III devices, Enova understands the technical challenges of product design, engineering, research and development, the regulatory steps required to successfully commercialize products, and the marketing and sales efforts needed to move inventory off the shelf. For more information, visit www.enovamedical.com.
About Stereotaxis
Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital’s interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe and Canada.
Forward Looking Statement
This press release includes statements that may constitute "forward- looking" statements, usually containing the words "believe," "estimate," "project," "expect" or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance of the Company's products in the marketplace, competitive factors, changes in government reimbursement procedures, dependence upon third-party vendors, and other risks discussed in the Company's periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that we will recognize revenue related to our purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of our control. In addition, these orders and commitments may be revised, modified or canceled, either by their express terms, as a result of negotiations, or by project changes or delays.CONTACT:
Kerstin March
Enova Medical Technologies
651-773-3181 x28
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