Hansen Medical To Explore Strategic Alternatives, Incl. Possible Sale

(RTTNews) - Hansen Medical, Inc. (HNSN) said that its board has entered a process to explore strategic alternatives for the company focused on enhancing stockholder value, including, a licensing transaction, a refinancing transaction, a strategic business combination, partnership, a possible sale or disposition of one or more corporate assets or the company itself.

On January 12, 2016, Jack Schuler resigned from his position as a director of the company. In so doing, he expressed confidence in the board and its exploration of potential strategic alternatives, but does not wish to be part of the board's deliberation on these matters due to his significant shareholding position in the company.

As part of its review of strategic alternatives, Hansen Medical has formed a special committee of independent directors. The special committee has retained Perella Weinberg Partners LP as its financial advisor.

In a separate press lease, Hansen Medical provided an update of key corporate initiatives which, if successful, will expand the utility and regulatory labeling of the Sensei and Magellan product lines:

ARTISAN IDE Study: This study is a prospective, single arm study of the Hansen Sensei System for introducing and positioning RF ablation catheters in subjects with paroxysmal atrial fibrillation (PAF). As of January 8, 2016: 148 subjects have been enrolled and treated, and 2 cases are pending to complete full enrollment of 150. In preparation for future commercialization, the initial PMA shell was submitted to FDA, paving the regulatory pathway. This clinical trial includes a Bayesian adaptive design, which permits an interim analysis and incorporates stopping rules to evaluate early success or futility.

Additional key details for the ARTISAN IDE Study are described; the ClinicalTrials.gov Identifier for this trial is NCT01122173: Primary Safety Endpoint: The incidence of Major Complications, including the early onset (within 7 days of the ablation procedure) predefined complications; and the incidence of esophageal injury or pulmonary vein stenosis through day 180. Hypothesis: The study is designed to determine if the Major Complication rate meets the pre-established target performance goal (TPG) of 16%.

Hansen Medical has begun the preparatory process to submit the 510k to FDA for a neurological indication for the Magellan Robotic System. The company anticipates submitting a 510k to the FDA in Q1 2016 for this expanded indication.