Company to Embark on Pivotal U.S. Prospective Clinical Trial
BETHESDA, MD. May 4th, 2011 – BrainScope® Company, Inc. today announced that it has reached concurrence with the U.S. Food and Drug Administration (FDA) on the key study design elements for clinical validation of the Ahead™ M-100 medical device. BrainScope’s Ahead™ M-100 is being developed to address the unmet need for a medical device to aid in triage of patients who are suspected of traumatic brain injury (TBI). It will provide objective and timely adjunctive assessment of structural brain injury and functional impairment from TBI. Milder forms of TBI are known as concussions. BrainScope pursued the pre-Investigational Device Exemption (or pre-IDE) process as a mechanism to obtain FDA concurrence on the key design elements of an appropriate pivotal clinical trial for its innovative device, even though the Ahead™ M-100 is a non-significant risk device and does not require a formal IDE approved by FDA.
"This is a major milestone for BrainScope. We are delighted to have successfully concluded this pre-IDE process with FDA on the study design of our upcoming U.S. pivotal trial," said Michael Singer, President and CEO of BrainScope. “It was very important for us to obtain pre-trial input and consensus with FDA, particularly since the technology is unique and innovative. We are looking forward to commencing our pivotal trial in emergency departments across the country.”
The Ahead™ M-100 is a handheld, non-invasive, non-radiation emitting medical device in development that could provide a rapid and objective assessment and categorization of brain injury, based on patterns identified in brain electrical activity. The Ahead™ M-100 could be utilized as an adjunct to standard clinical practice assessment in the United States Military Health System to aid in the triage of injured military personnel.
Backed by Revolution LLC (created by AOL co-founder Steve Case), Alafi Capital, Brain Trust Accelerator Fund, Draper Fisher Jurvetson, Portage Ventures and ZG Ventures, BrainScope is a medical neurotechnology company that is developing a new generation of hand-held, simple-to-use, non-invasive instruments designed to aid medical professionals in rapidly, accurately, and objectively assessing brain function at the initial point of care. BrainScope devices in development are based on a proprietary technology platform, which integrates databases of brainwave recordings with advanced developments in digital signal processing, sophisticated algorithms, miniaturized hardware and disposable headset sensors. BrainScope’s initial focus is on traumatic brain injury (TBI) and its milder forms known as concussion. BrainScope’s unique device is being developed to meet a long-standing clinical need for improved early identification, staging and triage for head-injured patients. BrainScope devices under development for use in the United States for assessment of traumatically-induced head injury and concussions are for investigational use only and have not been submitted to FDA for premarket review. For more information, please visit www.brainscope.com.