BETHESDA, Md., March 8, 2011 /PRNewswire/ -- BrainScope Company, Inc. announced today that it is preparing for the introduction of the Ahead™ EU-100, a product in development to aid in the assessment of head injury, in the United Kingdom. This product has the potential to represent a significant advancement in the early identification and assessment of patients with traumatic brain injury (TBI) (including its milder forms commonly referred to as "concussion"). This announcement coincides with BrainScope's recent statement that it is entering the UK market with its "B-Ahead U.K. Clinical Trial", a multi-center, observational clinical study utilizing its technology in development to aid in the assessment of TBI in emergency departments in the UK.
The Ahead™ EU-100 is a portable, non-invasive, point of care, non-radiation emitting medical device in development that utilizes product miniaturization and advanced signal processing methods to provide an objective assessment and categorization of brain electrical activity associated with brain injury, identifying patterns consistent with a traumatically induced structural brain injury and/or clinical manifestations of functional brain injury. The Ahead™ EU-100 consists of three main components: a hand-held device that includes software and algorithms for EEG acquisition and analysis and patient stratification, a disposable electrode headset, and a web-based capability for centralized storage and review of patient data.
"We are excited about the prospect of bringing this much needed product in development to the UK market," said Michael Singer, CEO of BrainScope. "We have been fortunate to have the opportunity to collaborate with top UK hospitals and renowned clinical and scientific thought leaders to conduct our UK-based research. With approximately one million people each year attending the accident and emergency department in the UK following head injuries, we believe that the commercialization of this product in the UK will provide a valuable tool for clinicians in making informed decisions for triage, treatment and care of patients with suspected head injuries."
In conjunction with the launch of the B-Ahead U.K. Clinical Trial in late spring, the company anticipates obtaining CE mark certification in the second half of 2011, which will provide European regulatory clearance to market and sell the Ahead™ EU-100 in the UK and throughout Europe. The company received a CE mark in April 2009 for the ZOOM-100DC, a first generation product that records, measures and displays EEG waveforms that are digitized and processed to produce conventional EEG measures displayed in table format.
In addition, BrainScope recently formed a UK subsidiary, BrainScope U.K. Ltd, representing the first subsidiary set up to commercialize its products outside of the United States. Also, in February 2011, the UK Intellectual Property Office granted registration of the BrainScope trademark.
BrainScope has been working with two prominent UK groups to navigate the UK health system and successfully establish a presence in the UK. Think London, London's official foreign direct investment agency, has provided significant support to help BrainScope set up a UK-based office. UK Trade & Investment, the international development agency for the British Government, provided valuable assistance to BrainScope, enabling them to understand the healthcare landscape and guide the company through upcoming healthcare reform in the UK.
Nick McInnes, Director of UK Trade & Investment USA said, "It has been a pleasure to work with BrainScope and help them establish their presence in the UK. This novel product has the potential to fulfill many public health needs. We are thrilled that such an innovative healthcare company has selected the UK to set up its international operations, providing a springboard for future growth prospects throughout the rest of Europe."
BrainScope executive management will be attending the UK's 2011 Healthcare Innovation Expo and International Business Innovation Zone (IBIZ 2011) this week.
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.
SOURCE BrainScope Company, Inc.