MOUNTAIN VIEW, CA — (Marketwired) — 08/05/13 — Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced that the first patients have been successfully enrolled in the new study design of its ARTISAN-AF Trial, a pivotal clinical trial evaluating the use of Hansen Medical-s Artisan® family of Control Catheters with its Sensei® X Robotic Catheter System for treatment of Atrial Fibrillation (AF), the most common cardiac arrhythmia. In May, the Company announced that it had received conditional approval of the new study design from the U.S. Food and Drug Administration (FDA).
Under the revised protocol, the study will be a single arm, target performance goal study enrolling as few as 125 subjects at up to 14 investigational sites. The principal investigator of the full trial is Andrea Natale, M.D., F.A.C.C., F.H.R.S., executive director for Texas Cardiac Arrhythmia Institute. The co-principal investigator is Joseph Gallinghouse, M.D., electrophysiologist, at the Texas Cardiac Arrhythmia Research Foundation (TCARF) and his team. Dr. Gallinghouse was the first physician to enroll a patient into the study under the revised protocol following IRB approval.
“I am pleased to be the first physician to enroll a patient into this new study,” said Dr. Gallinghouse. “The new study design recently agreed upon with the FDA will greatly facilitate enrollment in the trial, and allow us to evaluate clinical endpoints in an expedited fashion. I look forward to continuing to enroll patients into and completing this critical evaluation of ablation of atrial fibrillation using robotic navigation.”
“The enrollment of patients into this study is an important milestone for Hansen Medical,” said Hansen Medical President and CEO, Bruce Barclay. “If successful, we intend to use the data derived from this study to support a submission to the FDA to obtain approval for a broader label claim for use of our Artisan family of Control Catheters with our Sensei X Robotic Catheter System in atrial fibrillation procedures. The achievement of a broader label claim has the potential to drive further growth of our U.S. EP business.”
Atrial Fibrillation is the most common cardiac arrhythmia, and it affects an estimated 3.3 million Americans and 4.5 million Europeans. This number is expected to increase due to an aging population and a rising number of people with chronic heart disease. AF is associated with increased long-term risk for severe and disabling stroke.
Through continued advancement of medical robotics, Hansen Medical has developed a next generation minimally-invasive, robotic catheter system, the Sensei X Robotic Catheter System, which combines advanced levels of 3D catheter control and 3D visualization. This unique, state of the art technology has been used in over 10,000 patients, and is powered by an accurate, robotically controlled arm that allows for catheter navigation, stability and positioning within the patient-s heart atria, allowing for the following system advantages:
Catheter Stability with Force-Sensing
Instinctive 3D Control
Potential for Reduced Fluoro Time for Physician
Hansen Medical, Inc., based in Mountain View, California, is a global leader in intravascular robotics, developing products and technology designed to enable the accurate positioning, manipulation and control of catheters and catheter-based technologies. The Company-s Magellan Robotic System, 9Fr Magellan Robotic Catheter and related accessories, which are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, have undergone both CE marking and 510(k) clearance and are commercially available in the European Union, and the U.S. In the European Union, the Company-s Sensei® X Robotic Catheter System and Artisan® and Artisan Extend® Control Catheters are cleared for use during electrophysiology (EP) procedures, such as guiding catheters in the treatment of atrial fibrillation (AF), and the Lynx® Robotic Ablation Catheter is cleared for the treatment of AF. This robotic catheter system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. In the U.S., the Company-s Sensei X Robotic Catheter System and Artisan and Artisan Extend Control Catheters are cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in EP procedures. In the U.S., the Sensei X Robotic Catheter System is not approved for use in guiding ablation procedures; this use remains experimental. The U.S. product labeling therefore provides that the safety and effectiveness of the Sensei X Robotic Catheter System and Artisan and Artisan Extend Control Catheter for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including AF, have not been established. Additional information can be found at .
This press release contains forward-looking statements regarding, among other things, statements relating to goals, plans, objectives, milestones and future events. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words “plan,” “expects,” “potential,” “believes,” “goal,” “estimate,” “anticipates,” and similar words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances and other factors that may cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Examples of such statements include statements regarding the timing and potential results of the ARTISAN-AF Trial and statements about the anticipated growth in Hansen Medical intravascular robotics technology for EP and vascular applications. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: factors relating to engineering, regulatory, manufacturing, sales and customer service challenges in developing new products and entering new markets; the commercial viability of our products in the electrophysiology and vascular markets; potential safety and regulatory issues that could slow or suspend our sales; the effect of economic conditions on capital spending by our potential customers; the uncertain timelines for the sales cycle for newly introduced products; the rate of adoption of our systems and the rate of use of our catheters; the scope and validity of intellectual property rights applicable to our products; competition from other companies; our ability to recruit and retain key personnel; our ability to maintain our remedial actions over previously reported material weaknesses in internal controls over financial reporting; our ability to manage expenses and cash flow, and obtain additional financing; and other risks more fully described in the “Risk Factors” section of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 filed with the SEC on May 10, 2013 and the risks discussed in our other reports filed with the SEC. Given these uncertainties, you should not place undue reliance on the forward-looking statements in this press release. The Company undertakes no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Peter J. Mariani
Chief Financial Officer
Hansen Medical, Inc.
650.404.5800
Brian Ritchie
212.850.5683
John Capodanno
212.850.5705
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