Northstar Neuroscience says IPO provided adequate capital to advance cortical stimulation technology

By Jennifer Lanning Drey

Portland, Ore., Oct. 10 - Northstar Neuroscience, Inc.'s recent initial pubic offering of common stock has provided the company with adequate capital to actively pursue multiple applications for its platform cortical stimulation technology, Alan Levy, Northstar's chief executive officer, said Tuesday during a company conference call.

Levy also said Northstar expects to submit primary endpoint data from its Everest pivotal trial for stroke motor recovery to the Food and Drug Administration one quarter earlier than previously expected. The company now believes it will complete the trial and submit data in the fourth quarter of 2007, Levy said.

He also said Northstar has received FDA approval to add three investigational sites to the Everest trial as requested by the additional stroke centers that will be added. The newly added centers are expected to begin randomizing patients in the first half of next year, he said.

Completion of the study will require data from 151 patients.

Northstar also recently released initial findings from its Chestnut clinical trials of cortical stimulation as treatment for stroke-related aphasia, and Levy said Tuesday that a longer-term follow up to the trial is ongoing.

Once the company has reviewed the primary and secondary endpoints of the study, it will begin working with the FDA to determine the appropriate regulatory path for a product, he said.

"We are pleased with the progress we're making with the Everest pivotal trial for stroke and motor recovery and with our initial results for stroke-related aphasia," Levy said.

Northstar's Sahale study of cortical stimulation for the treatment of tinnitus is also progressing, according to John Bowers, the company's executive vice president.

The company has randomized five of the eight patients in the trial and expects to complete randomization and a primary endpoint analysis by the end of the first quarter of 2007, Bowers said.

In addition, Northstar expects to begin enrolling patients in a feasibility study of cortical stimulation for treatment-resistant depression this quarter and plans to have primary endpoint data from the study by the end of 2007.

The company will report its third-quarter financial results in November, Levy said.

Seattle-based Northstar develops medical devices for the treatment of neurological diseases and disorders.

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