) revealed that it has kicked off its CE Mark clinical trial for
HeartMate III with the first human implant at Hannover Medical
School in Hannover, Germany. Shares of the company rose 1.4%
following the announcement of the clinical trial.
HeartMate III is the next-generation continuous flow left
ventricular assist device (LVAD). It is based on fully magnetically
levitated technology in order to reduce adverse event rates through
improved hemocompatibility with a compact size that enhances ease
of surgical placement. HeartMate III is designed for low-power
THOR's previous generation HeartMate II is the rotor driven
continuous flow intermediate-to-chronic LVAD. HeartMate II has been
approved for use in North America and EU.
THOR's HeartMate III CE Mark clinical trial will admit up to 50
patients at nine sites in Europe, Australia, and Canada. The
trial includes a primary endpoint of six-month survival compared
with estimated mortality based on the Seattle Heart Failure Model.
Apart from first implant in Germany, enrollment of the HeartMate
III CE Mark Trial has also started at the Vienna Medical University
in Vienna, Austria.
THOR continues to do well in overseas markets, especially in its
HeartMate lineup. Despite being flat year-over-year, THOR's
2014-first quarter earnings and revenues surpassed the Zacks
Consensus Estimates on both earnings and revenue fronts.
THOR posted flat adjusted earnings of 33 cents per share for the
2014-first quarter compared with the year-ago level but beat the
Zacks Consensus Estimate by 6 cents. Adjusted earnings edged down
1.8% to $19.2 million from $19.5 million in the comparable quarter
a year ago.
THOR's revenues in the quarter rose 6.8% to $125.7 million,
exceeding the Zacks Consensus Estimate of $124.0 million. Revenues
from the U.S. upped 3.6% to $95.6 million while the same from
international business grew 18.5% to $30.1 million.
Revenues from the flagship HeartMate product line came in at $110.0
million, reflecting a 6.9% year-over-year increase due to the
expansion of its international business.
For fiscal 2014, THOR expects revenues in the range of $520-$535
million. The current Zacks Consensus Estimate of $527 million lies
within the guided range.
THOR also expects adjusted earnings per share (excluding stock
based compensation) of $1.39-$1.49 for the year. The current Zacks
Consensus Estimate of $1.31 lies below the guided range.
Currently, THOR retains a Zacks Rank #3 (Hold). Some better-ranked
medical instrument companies that are worth considering at the
Alphatec Holdings, Inc.
). Alphatec and Luminex sport a Zacks Rank #1 (Strong Buy), while
Accuray carries a Zacks Rank #2 (Buy).
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