Hansen Medical's CEO Discusses The Receipt Of 510(k) Clearance For The Magellan Robotic System Conference (Transcript)

Hansen Medical, Inc. (HNSN)

Receipt of 510(k) Clearance for the Magellan Robotic System Conference Call

June 4, 2012 17:00 ET


Peter Mariani – Chief Financial Officer

Bruce Barclay – President and Chief Executive Officer

Joe Guido – Vice President, Marketing and Business Development


Brooks West – Piper Jaffray

Jeffrey Cohen – Ladenburg Thalmann



Good day, ladies and gentlemen. Thank you for standing by. Welcome to the Hansen Medical Receipt of Magellan 510(k) Clearance from FDA Conference Call. During today's presentation, all parties will be in a listen-only mode. Following the presentation, the conference will be opened for questions. (Operator Instructions) This conference is being recorded today Monday, June 4, 2012.

I would now like to turn the conference over to Mr. Peter Mariani, Chief Financial Officer. Please go ahead, sir.

Peter Mariani

Thank you, (Camille). Good afternoon everyone. I am Chief Financial Officer of Hansen Medical. With me today is Bruce Barclay, our President and CEO and Joe Guido, our Vice President of Marketing and Business Development. We have scheduled this call to discuss today FDA announcement related to the FDA 510(k) Clearance of our Magellan Robotic System, NorthStar Robotic Catheter, and related accessories for peripheral, vascular interventions.

As we begin today’s call, please remember that our prepared remarks and responses to questions will contain forward-looking statements that are subject to a number of risks and uncertainties. All statements other than statements of historical fact could be deemed forward-looking statements, including statements containing the words; plan, expects, potential, believe, goal, estimate, anticipate and similar words. These statements are based on the current estimates and assumptions of our management as of the date of this call and are subject to risks, uncertainties, changes and circumstances and other factors that may cause actual results to differ materially from the information expressed or implied by such forward-looking statements.

Examples of such statements include statements about the timing of future clinical cases to be performed with the System, the potential benefits of the System on vascular procedures, and the timing of commercializing our Magellan 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 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-K filed 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 forward-looking statements included in our remarks and responses to questions. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future even if new information becomes available.

And with that, I’ll turn the call over to Bruce.

Bruce Barclay

Thank you, Pete. Good afternoon, everyone and thank you all for joining the call today. This is a very exciting day for Hansen Medical and one of the most significant milestones in the company’s history.

Earlier today, we announced 510(k) clearance from the U.S. FDA for our Magellan Robotic System, the NorthStar Robotic Catheter, and related accessories. We received 510(k) clearance prior to June 30th our previously communicated expected outside clearance date delivering on a key commitment of the company. The product was cleared to be used facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.

The Magellan System is a significant technological advancement in the field of intravascular robotics and is a major step forward in the transformation of vascular interventions. Not only does Magellan have the potential to be a significant growth driver for Hansen, but it also offers potential clinical benefits to patients, procedural benefits to physicians, and economic benefits to hospitals. Before going into this in greater detail, let me provide some context around the significant market opportunity we see for the Magellan system in the vascular market.

The global vascular surgery market is large and expanding rapidly, driven by long-term trend such as an aging population, the rising prevalence of type 2 diabetes and obesity and an increase in disease awareness. Of the more than 3 million vascular procedures performed each year, approximately one-third to one-half of them are in the peripheral vasculature, which is the target market for the Magellan Robotic System.

Importantly, we believe the Magellan system is uniquely positioned to penetrate deeply and broadly as adoption of the technology grows and as we launch new products and expanded applications over time. The technology we have developed with the Magellan Robotic System has a number of potentially significant advantages over the current standard of care.

In fact, we believe intravascular robotics has the potential to truly revolutionize the way endovascular procedures are performed. Today, most catheter and catheter-based technologies for vascular disease use blood vessels as highways to guide their movement to specific parts of the body. These technologies are based on manually-controlled, handheld instruments, and physicians often have no ability to accurately manipulate the distal working tips of these devices. This can be particularly challenging and risky when performing procedures that require precise navigation.

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