HANSEN MEDICAL, INC. (HNSN, Financial) filed Amended Quarterly Report for the period ended 2008-09-30.
HANSEN MEDICAL, INC., develops products & technology using robotics for the accurate positioning, manipulation and control of catheters & catheter-based technologies. Its first product, the Sensei Robotic Catheter system, is a robotic navigation system that enables clinicians to place mapping catheters in hard-to-reach anatomical locations within the heart easily, accurately & with stability during complex cardiac arrhythmia procedures. The Sensei system is compatible with fluoroscopy, ultrasound, 3D surface map & patient electrocardiogram data & was cleared by the U.S. Food & Drug Administration in May 2007 for manipulation & control of certain mapping catheters in Electrophysiology procedures. The safety & effectiveness of the Sensei system for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including AF, have not been established. In the European Union, the Sensei system is cleared for use during EP procedures, such as guiding catheters in the tr Hansen Medical, Inc. has a market cap of $112.26 million; its shares were traded at around $3 with and P/S ratio of 3.71.
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HANSEN MEDICAL, INC., develops products & technology using robotics for the accurate positioning, manipulation and control of catheters & catheter-based technologies. Its first product, the Sensei Robotic Catheter system, is a robotic navigation system that enables clinicians to place mapping catheters in hard-to-reach anatomical locations within the heart easily, accurately & with stability during complex cardiac arrhythmia procedures. The Sensei system is compatible with fluoroscopy, ultrasound, 3D surface map & patient electrocardiogram data & was cleared by the U.S. Food & Drug Administration in May 2007 for manipulation & control of certain mapping catheters in Electrophysiology procedures. The safety & effectiveness of the Sensei system for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including AF, have not been established. In the European Union, the Sensei system is cleared for use during EP procedures, such as guiding catheters in the tr Hansen Medical, Inc. has a market cap of $112.26 million; its shares were traded at around $3 with and P/S ratio of 3.71.
Highlight of Business Operations:
We have experienced substantial net losses since our inception in late 2002. At September 30, 2008, we had an accumulated deficit of $151.9 million. We have funded our operations to date principally from the sale of our securities and through issuance of indebtedness. For example, we sold 3,000,000 shares of our common stock in April 2008, raising approximately $39.5 million in net proceeds to us, in order to fund expected future losses and, in August 2008, we entered into a $25 million loan and security agreement with Silicon Valley Bank, consisting of a one-year $10 million revolving line of credit and a $15 million term equipment line, of which we had drawn down approximately $12.5 million as of September 30, 2008. While we have recently issued equity and incurred debt, we may at any time sell additional securities resulting in further dilution to existing stockholders and we may at any time incur additional indebtedness. However, we cannot guarantee that future equity or debt financing will be available in amounts or on terms acceptable to us, if at all. The recent turmoil in the global financial and credit markets may limit our ability to raise additional funds. We may face significant challenges if conditions in the financial markets do not improve or continue to worsen. In particular, our ability to access the capital markets and raise funds required for our operations may be severely restricted at a time when we would like, or need, to do so, which could have an adverse effect on our ability to meet our current and future funding requirements and on our flexibility to react to changing economic and business conditions. This could leave us without adequate financial resources to fund our operations as presently conducted or as we plan to conduct them in the future. We expect to incur substantial additional net losses for at least the next several years as we generally scale up our manufacturing, marketing and sales operations to commercialize our products and seek additional regulatory clearances. We expect our general and administrative expenses to increase as we continue to add the infrastructure necessary to support operating as a public company, develop our intellectual property portfolio and incur other intellectual property related legal expenses, including litigation expenses. Because we may not be successful in significantly increasing sales of our products, the extent of our future losses and the timing of profitability are highly uncertain, and we may never achieve profitable operations. If we require more time than we expect to generate significant revenue and achieve profitability, we may not be able to continue our operations. Even if we achieve significant revenues, we may never become profitable or we may choose to pursue a strategy of increasing market penetration and presence at the expense of profitability.Read the The complete Report
