Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced changes to its Board of Directors. Effective immediately, Stephen L. Newman, M.D. and Nadim Yared have been appointed as Directors. Hansen Medical's Board now consists of nine members, eight of whom are non-executives.
"Stephen and Nadim bring a wealth of experience in the healthcare industry and complement our existing Board," said Bruce Barclay, Hansen Medical's President and Chief Executive Officer. "Together, Stephen and Nadim have a combined 50 years of experience in the healthcare industry, most of which have been spent in senior operational and commercial roles. In particular, Stephen's substantial hospital management expertise and Nadim's significant medical device sales leadership should be instrumental to Hansen as we continue to execute on our commercial strategy for our Magellan Robotic System and Sensei® X Robotic Catheter System."
Having served in increasingly senior positions at Tenet Healthcare Corporation over the past 13 years, Dr. Newman has extensive healthcare operations experience. In his recently completed role as Vice Chairman, Dr. Newman led Tenet's health information technology project deployment, the company's medical staff development efforts and its quality, safety and service initiative. Prior to his appointment to Vice Chairman in January of this year, Dr. Newman served as Corporate Chief Operating Officer, Executive Vice President, for five years, where his responsibilities included strategic and operational oversight of Tenet's 49 hospitals and 100 ambulatory and imaging centers.
Before his tenure at Tenet, Dr. Newman served as President and Chief Executive Officer of HCA's Louisville HealthCare Network, where he had operating responsibilities for three hospitals and 3,000 employees within a $500 million business. Dr. Newman also currently serves on the Federal Reserve Bank of Atlanta's Labor, Education and Healthcare Council and recently completed a five year term on the Board of Directors of the Federation of American Hospitals.
"I am very excited to join the Board of Hansen Medical at such a critical juncture for the Company," said Dr. Newman. "I look forward to utilizing my significant experience in managing hospitals and health systems to help Hansen deliver its compelling value proposition for the Company's Magellan and Sensei Systems."
Mr. Yared's career in the medical device industry has spanned nearly 20 years. He currently serves as the President and Chief Executive Officer of CVRx, Inc., a privately-held medical device company developing the Rheos neo system, an active implantable device for the treatment of hypertension and heart failure. During his six years in this position, Mr. Yared has helped CVRx raise significant funding to develop the company's next generation technology and conduct clinical trials.
Preceding his term at CVRx, Mr. Yared served as Vice President and General Manager of Medtronic, Inc. for four years. During his tenure, he directed sales, marketing, business development, product/technology development and manufacturing of surgical medical imaging products. Until 2002, Mr. Yared held increasingly senior positions at GE Medical Systems over a period of nine years. Much of his focus during this time was medical device sales and marketing management. Mr. Yared also currently serves on the boards of the medical device industry trade group, AdvaMed, and Intio, a privately-held interventional oncology company.
"The recent FDA clearance of Hansen's Magellan Robotic System represents a significant achievement for the Company," said Mr. Yared. "I look forward to lending my sales and marketing expertise to the Board."
About Hansen Medical, Inc.Hansen Medical, Inc., based in Mountain View, California, is the 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, NorthStar 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 Control Catheter 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 US the Company's Sensei X Robotic Catheter System and Artisan Control Catheter were cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in EP procedures. In the United States, the Sensei 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 System and Artisan 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 www.hansenmedical.com.
Forward-Looking StatementsThis 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," 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 about, the potential benefits of our Magellan Robotic System on vascular procedures and the timing and results of commercializing our Magellan Robotic System. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: engineering, regulatory and sales challenges in developing new products and entering new markets; potential safety and regulatory issues that could slow or suspend our sales; the uncertain timelines, costs and results of pre-clinical and clinical trials; 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; the effect of credit, financial and economic conditions on capital spending by our potential customers; our ability to manage expenses 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, 2012 filed with the SEC on May 7, 2012 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. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Hansen Medical, Heart Design (Logo), Hansen Medical (with Heart Design), Sensei and Lynx are registered trademarks, and Magellan and NorthStar are trademarks of Hansen Medical, Inc. in the United States and other countries. Rheos neo is a trademark of CVRx, Inc.