Celestra Health Achieves FDA Certification, Wins SAAS NORTH Pitchfest Top Prize
February 18, 2025
CELESTRA HEALTH SYSTEMS — Leader in AI-based monitoring of neurological conditions
celestrahealth.com
Celestra Health Systems is an award-winning healthcare technology company that has developed a cost-effective and highly sensitive neurological digital biomarker for unobtrusively measuring patient walking quality, under real world conditions, at 1/100 the cost of conventional solutions.
Celestra Health has achieved several key milestones this past quarter. We are pleased with our progress in 2024 and are well-positioned for significant revenue growth in 2025.
We are currently conducting 7 clinical trials in 4 countries (US, UK, Germany, Canada), with Multiple Sclerosis (MS) as our primary focus; MS is one of the most expensive diseases in the world to manage. Throughout our clinical trials, we have achieved a patient usability rating of 85%. We are now well on our way to establishing a new gold standard in neurological clinics globally.
Our platform is now classified by the FDA as a Class II Software as a Medical Device; this represents the culmination of 12 months of discussions with the FDA, opening the door to commercial sales to neurology clinics throughout the US.
We achieved our first revenues of $185K from the UK National Health Service (NHS). The Agreement includes a 2-year software site license and associated professional services, including technical support and training.
Consistent with our strategy to validate our iOS app with patients before introducing our Android app, we are pleased to announce that our Android app is now available for production use.
In October, we were selected as 1 of 8 promising technology companies from across Canada to participate in the SAAS NORTH 2024 Pitchfest. SAAS NORTH is the largest Software as a Service (SaaS) conference in Canada, with over 2,000 attendees, representing a mix of technology companies and investors. We are delighted to announce that we were awarded top prize at this high-profile event.
Our clinical trials are now active in 4 countries (US, Canada, UK, Germany), as we continue to build the world’s largest database of patient walking samples collected under free living conditions. Our hard-to-obtain clinical trial data is being used to train our increasingly sophisticated AI algorithms that we are protecting through ongoing patent filings.
For the next quarter, we will continue to ramp up our business development activities in the US and UK, in anticipation of significant revenues in 2025.
We plan to submit our third round of patent applications, based on a set of manuscripts that we have recently prepared. We will also be submitting our manuscripts for publication in leading scientific journals.
As part of our collaboration with the Technical University of Dresden (TUD) in Germany, we are developing and validating our in-clinic gait measurement tool that will be eligible for reimbursement by healthcare insurance providers in Germany and beyond.
We have been selected to present at the 2025 Ontario Bioscience Innovation Organization (OBIO) Investment Summit in Toronto, Canada’s leading Health Science investment event, with the stated goal to spotlight Canada’s most investable health science companies.
To learn more, visit celestrahealth.com.