BrainScope has announced the market release of its flagship Ahead 300 product, and will initiate a limited launch to a select group of thought leaders through its Centers of Excellence programme later in the first quarter. These institutions will represent a cross-section of market segments including Urgent Care Clinics, Concussion Clinics, Emergency Medicine Departments, and University and Professional Sports.
According to a company release, BrainScope will also be selling the Ahead 300 to various branches of the US military and government.
Cleared by the US Food and Drug Administration (FDA) in September 2016, the Ahead 300 can be used to help clinicians provide a rapid, objective assessment of mildly presenting head-injured patients across the full spectrum of brain injury at the point of care for up to three days following injury. The Ahead 300 is designed to help the clinician determine the proper disposition of the patient by directly addressing two key questions in making their clinical diagnosis:
Is it likely that the mildly presenting head-injured patient has a traumatic structural brain injury which would be visible on a computed tomography scan, which is the gold standard used in Emergency Rooms?
Is there evidence of something functionally abnormal with the brain after head injury which could be concussion?
The Ahead 300 features BrainScope’s patent-protected electroencephalography (EEG) capabilities which use advanced signal processing, sophisticated algorithms and machine learning to help in the evaluation of head-injured patients with objective biomarkers of brain electrical activity. The Ahead 300 was developed in partnership with the US Department of Defense through six research contracts, and with over 20 clinical studies at 55 sites, and 16 peer-reviewed publications.
“Following an eight year evolution of development, which included four FDA clearances, we are announcing today the launch of the Ahead 300 for sale. The Ahead 300 offers a multi-modal, comprehensive capability to address a vast market need for the epidemic of mild head injury in this country,” states Michael Singer, chief executive officer of BrainScope.
BrainScope further released details of the Ahead 300, which includes four objective tests and sixteen standard concussion assessment tools, all of which can be customised on the Ahead 300 handheld device into a configurable panel:
- The first two tests leverage the use of EEG and BrainScope’s proprietary methodologies, in order to aid clinicians in determining both the need for a computed tomography scan and whether the patient has abnormalities which could reflect mild traumatic brain injury.
- Additionally, there are two rapid, objective cognitive performance tests designed for use by the patient directly on the Ahead 300 at the point of care. These cognitive performance tests are intended to allow clinicians to assess patient performance compared to healthy individuals in the same age group, providing an objective metric of cognitive performance.
Furthermore, the clinician can choose to utilise a number of professional society-based concussion assessment tools, which are incorporated directly on the Ahead 300 device, allowing clinicians to configure the assessment to include any of those desired.
Selected tests performed are displayed on a summary screen as part of a multimodal panel which also includes results of the objective EEG-based and cognitive performance tests.
The Ahead 300 provides the panel information in a summary report which can be shared with both patients and other providers.
“We are thrilled to be introducing the Ahead 300 to the market. We strongly believe this medical device represents a paradigm shift in how clinicians will address the multitude of challenges they face when they assess mildly presenting head-injured patients,” continues Singer. “The Ahead 300 is the first-to-market medical technology capable of providing objective, easily accessible and multimodal information in a panel format for up to three days following injury. As the first line of assessment, the Ahead 300 can have significant impact on helping the clinician make their diagnosis for proper patient disposition.”