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- W2091031873 abstract "See related article, p 3187.In this issue of Stroke , Hacke et al1 for the NeuroThera Effectiveness and Safety Trial 3 (NEST 3) Committees and Investigators report the results of a phase III, randomized, double-blind clinical trial of transcranial laser therapy for acute ischemic stroke. This was a device trial sponsored and funded by industry via venture capital specifically to PhotoThera, Inc, a privately held medical device company. Once the independent Data Monitoring Committee halted the trial for futility, a little more than halfway through recruitment, a drama full of twists and turns played out like a John Grisham novel.The authors of this editorial received further information about the history of the NEST trials to help frame a perspective (Dr Dilly, personal email communication through the Stroke editorial office to S.R. Levine, MD, and M.D. Hill, MD, unpublished data, July 28, 2014):> NEST 3 was the third clinical study of transcranial laser therapy for stroke conducted by PhotoThera. NEST 1, a phase II study, gave highly encouraging results including a statistically significant improvement in functional outcome 90 days after stroke. PhotoThera raised money from a syndicate of venture capital investors to conduct NEST 2, intended to be the definitive registration trial for transcranial laser therapy. NEST 2 enrolled 660 patients at a cost of ≈$50 million and failed to meet its primary end point. However, further analysis of the trial strongly suggested that a subgroup of the study population with more superficially placed strokes and mild-moderate baseline symptom severity had benefitted from treatment.> > On the basis of these data, PhotoThera raised an additional ≈$60 million from existing and new investors to fund NEST 3, which was aimed specifically at the subgroup. It is important to understand that $10 million was in the form of venture debt …" @default.
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- W2091031873 date "2014-11-01" @default.
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- W2091031873 title "NeuroThera Effectiveness and Safety Trial 3" @default.
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- W2091031873 doi "https://doi.org/10.1161/strokeaha.114.006750" @default.
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