BETHESDA, Md.--(BUSINESS WIRE)--BrainScope Company, Inc. announced today 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 program 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. BrainScope will also be selling the Ahead 300 to various branches of the U.S. military and government.
Cleared by the U.S. Food and Drug Administration (FDA) in September of last year, 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 CT 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?
To answer these two key questions, the Ahead 300 leverages state-of-the-art handheld technology and a proprietary disposable sensor headset. The Ahead 300 features BrainScope’s patent-protected electroencephalography (EEG) capabilities utilizing 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 U.S. 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 4 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,” stated Michael Singer, CEO of BrainScope. “We know the absence of such a capability in current medical practice is a great concern for clinicians as well as for head injured patients and their loved ones. There is now available, for the first time, an FDA cleared medical device – the Ahead 300 – which can help the clinician objectively and rapidly assess and disposition patients, right at the point of care.”
BrainScope further released details of the Ahead 300, which includes four objective tests and sixteen standard concussion assessment tools, all of which can be customized on the Ahead 300 handheld device into a configurable panel:
- The first two tests leverage the use of EEG and BrainScope’s proprietary methodologies. These two exclusive tests can aid the clinician in determining both the need for a CT 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 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 utilize a number of professional society-based concussion assessment tools used in clinical practice today. These 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.
According to recent publications, 95% of all head-injured patients who go to the Emergency Department present with mild symptoms. The vast majority of these head-injured patients receive a CT scan, of whom over 90% are CT negative for structural brain injury, creating needless radiation exposure to patients. The Ahead 300 has the potential to significantly reduce costs and wait times associated with hospital visits and unneeded CT scans. With over five million U.S. patients seen each year with closed head injuries and millions more who do not seek evaluation, the Ahead 300 allows for head-injured patients to be objectively assessed by the clinician at the point of care, thereby significantly improving their clinical diagnosis and ultimately, proper patient triage and medical management. The ability to rapidly identify mild head injury or concussion on the Ahead 300 can meaningfully reduce the morbidity and mortality of head-injured patients, through improved medical management to aid in determining return to work, active service and/or play.
“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,” continued 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.”
BrainScope is a medical neurotechnology company that is developing a new generation of handheld, easy-to-use, non-invasive devices designed to aid medical professionals in rapidly and objectively assessing various neurological conditions, starting with traumatic brain injury including concussion. BrainScope has partnered with the U.S. Department of Defense for the development of its TBI assessment technology, and was named both an original recipient and final awardee of the GE-NFL Head Health Challenge I. BrainScope has also received significant funding from private investors to accelerate its development efforts, with backing from Revolution (created by AOL co-founder Steve Case), ZG Ventures, Maryland Venture Fund, Brain Trust Accelerator Fund, and Difference Capital. BrainScope devices in development are based on a proprietary technology platform, which integrates databases of thousands of brainwave recordings with advanced digital signal processing, sophisticated algorithms, miniaturized hardware and disposable headset sensors, which are all covered by an extensive intellectual property portfolio of over 100 issued and pending patents. BrainScope has received four FDA clearances and ISO 13485:2003 Certification. For more information, please visit www.brainscope.com.
The development of the Ahead 300 was supported by the U.S. Army Medical Research and Materiel Command under Contract No. W81XWH-14-C-1405, and by the U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division under Contract No. W911QY-14-C-0097. The approved funding source is the Defense Medical Research and Development Program (http://cdmrp.army.mil/dmrdp/). Any views, opinions, conclusions and/or findings contained in this press release are those of BrainScope and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation.