Research and development expenses for the year ended December 31, 2007, totaled $30.9 million, compared to $18.9 million for the same period in 2006. General and administrative expenses for the year ended December 31, 2007, totaled $11.3 million, compared to $7.3 million for the same period in 2006.
"2007 was a year of tremendous progress for XTENT as we reported additional positive clinical data from our CUSTOM I and CUSTOM II trials, and completed enrollment in our CUSTOM III clinical trial," said Gregory D. Casciaro, XTENT's President and CEO. "We expect 2008 to be a very exciting year for the company as we prepare for CE Mark approval and commercial launch in Europe in the second half of the year. We are actively working on responses to the questions we received from the Food and Drug Administration regarding our IDE submission and expect to commence enrollment in our U.S. clinical trial later this year."
In addition to moving ahead with commercialization and regulatory goals, the company expects to announce long-term follow-up data from its CUSTOM I and CUSTOM II trials, as well as six month data and one year data from the CUSTOM III trial.
The company expects to have operating expenses in the range of $25 to
$30 million during the first half of 2008.
2007 Highlights
In 2007, XTENT:
-- Raised over $68 million upon completion of its Initial Public Offering
-- Presented positive six-month follow-up data from the CUSTOM II clinical
trial, which assessed the safety and efficacy of the company's Custom
NX(R) drug-eluting stent (DES) system for the treatment of long and
multiple lesions in patients with coronary artery disease, at a
late-breaking session at the EuroPCR meeting in May
-- Presented positive two-year follow-up data from the CUSTOM I clinical
trial and positive one-year follow-up data from the CUSTOM II clinical
trial, both at TCT i
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