HAMILTON, Ontario--(BUSINESS WIRE)--VoxNeuro announces the release of their software as a medical device, the Cognitive Health Assessment Management Platform™ (CHAMP), as they pave their way to the US market. With successful registration with the FDA as a Medical Device Establishment for the distribution of the CHAMP software, a Class II Exempt Medical Device, VoxNeuro is on plan to globally change the way brain health is managed and treated.
CHAMP works in tandem with VoxNeuro’s Cognitive Health AssessmentTM to proactively track cognitive health throughout aging, and to evaluate cognitive function when a brain disorder or symptoms related to cognitive dysfunction are suspected.
Types of brain disorders that can impact cognitive function include concussion, traumatic brain injury, dementia or neurological impacts of COVID-19. Common symptoms tied to cognitive dysfunction include fatigue, memory loss or brain fog.
By analyzing electroencephalographic event-related potential (ERP) data gathered during the 15-minute assessment, CHAMP provides rapid, objective and actionable scores of four key cognitive functions: memory, information processing, attention & concentration.
The data assists clinicians in the diagnostic process, helping them make more accurate diagnoses faster. Clinicians also use the data to inform customized treatments and track how well treatments are working over time, thus helping to ensure the best possible outcomes for patients.
“This is a great day for people suffering from neurological disorders and the dedicated clinicians who are always searching for better ways to evaluate them,” said Dr. John F. Connolly, Chief Science Officer and Co-Founder of VoxNeuro. “Clinicians will have more certainty, with more objective information about how a patient’s brain is functioning. That certainty will help facilitate faster and better diagnoses and more effective treatments for patients.”
The FDA registration enables VoxNeuro to expand the distribution of its technology from where it was developed, the research-intensive McMaster University, across the United States. “Simply put, this technology will empower Americans to take control of their brain health,” Connolly added.
VoxNeuro has worked closely with the Principle of Western New York Medical Imaging Group over the past year on market entrance strategy. "VoxNeuro's technology is the breakthrough the medical field has been looking for, for decades. No other neuroimaging tool can quantify cognitive function with the speed and precision provided by VoxNeuro." said Dr. Joseph Serghany, Diagnostic Radiology Specialist. “This milestone is the trigger to activate our plans to use VoxNeuro across our practice. We’re very excited by the impact VoxNeuro’s technology will have on our industry and our ability to better serve our patients and our network with the most accurate information available on cognitive function.”
“I have enjoyed working with the VoxNeuro team to identify the various options of commercializing their new medical device. FDA registration represents the first step to market in the US and I look forward to continuing to work with VoxNeuro to develop and commercialize future generations of the Company's technology,” said Michael Drues, Ph.D., VoxNeuro Regulatory Consultant.
Ty J. Shattuck, Chief Executive Officer of McMaster Innovation Park (MIP) where VoxNeuro is headquartered, said VoxNeuro is a prime example to highlight how MIP is positioned to help innovation flourish.
“VoxNeuro’s accomplishment is evidence that our ecosystem is leveraging the right resources for our Tenant Ventures,” said Mr. Shattuck who acted as a catalyst for the VoxNeuro team by connecting them with expert industry players at MIP. “Our goal is to drive new collaborations and we rely on the expertise of our advisors and investors who are pivotal in the continued success of MIP’s thriving ecosystem. The team at VoxNeuro is exceptional to work with. They are focused on their mission and receptive to the recommendations we provide. All of MIP is celebrating with them on reaching such an exciting milestone.”
Last September, VoxNeuro was selected by a panel of venture capitalists and leaders in the digital health ecosystem as 1 of 11 companies to participate in the Canadian Technology Accelerators (CTA) Digital Health program. The bi-coastal program was led by the Consulate General of Canada in New York and San Francisco, connecting VoxNeuro with key players and resources to facilitate US expansion.
“VoxNeuro was selected as one of Canada’s most promising early-stage digital health start-ups based on their potential for growth and market impact. It has been a pleasure to witness VoxNeuro’s trajectory and see the impact of the expertise offered by the Canadian Technology Accelerator program in action. The program supported VoxNeuro's introduction to key experts that assisted with their US go-to-market and billing strategy and opened the door to large prospective strategic partners” said Molly Rafelson, Trade Commissioner, Canadian Technology Accelerator. "We look forward to watching VoxNeuro continue to scale into new markets on their journey to improving healthcare globally."
About VoxNeuro – Give the brain a voice
VoxNeuro is positioned to globally change the way brain health is managed and treated. Backed by more than 30 years of peer-reviewed scientific research, the neurotechnology scores multiple core cognitive functions to support proactive brain health, informed clinical decision-making and customized care. By analyzing the electrical activity of the brain, VoxNeuro scores its cognitive performance in memory, information processing, attention & concentration.
VoxNeuro is headquartered at McMaster Innovation Park in Hamilton, ON, Canada. For more information visit www.voxneuro.com