Celestra Health Anticipates FDA Certification and Welcomes New Collaborators
November 6, 2024
Celestra Health Systems — Leader in AI-based monitoring of multiple sclerosis
celestrahealth.com
Celestra Health Systems an award-winning healthcare technology company within the Wesley Clover portfolio, has developed a highly sensitive neurological digital biomarker for measuring patient walking quality under real-world conditions, at 1/100 the cost of conventional solutions. The Celestra Health platform combines AI-based cloud infrastructure, smartphone application software and cutting-edge, third-party wearable technology.
Our multi-site Multiple Sclerosis (MS) clinical trial is yielding strong preliminary results, which is translating into high levels of interest from our target customer base. Based on these results, we are now ramping up our business development activities in the US and UK, in anticipation of first revenues in Q4 2024.
We now have 7 clinical trials in 4 countries (US, Canada, UK, Germany) that are either completed, in progress or scheduled to start this Fall, involving both Multiple Sclerosis and Parkinson’s patients. To date, we have collected over 2,500 x 15-minute walking samples under free-living conditions from MS patients, with 7,500 samples forecast by mid-2025; this data will be used to train our increasingly sophisticated AI algorithms that we are continuing to protect with patent filings.
In mid-September, we participated in ECTRIMS 2024 in Copenhagen, the largest MS Neurology conference in the world, with 8,000 attendees. Our clinical trial results generated significant interest from leading pharmaceutical companies, MS neurologists and patient-facing MS organizations, paving the way for upcoming beta trials.
We held our 4th meeting with the US FDA in late July, in support of our Software as a Medical Device (SaMD) application. We continue to make excellent progress toward achieving FDA certification by early 2025.We are preparing for the start of our German clinical trial next month, in collaboration with the
Technical University of Dresden (TUD). As part of this activity, Celestra Health will develop and validate an In-Clinic MS assessment tool that is eligible for reimbursement by healthcare insurance providers in Germany and beyond.
Our objective is to become the standard-of-care in neurology clinics globally, with the US, UK and Germany as our beachhead markets. We have recently hired a UK-based business development executive/former CIO of a London-based hospital, to lay the groundwork for our first beta trials with UK neurology clinics. Similarly, we have now started to engage with leading US neurology clinics.
To learn more, please visit celestrahealth.com.