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Celestra Health Systems Making Strides Worldwide

August 2, 2024

Celestra Health Systems — Leader in AI-based monitoring of multiple sclerosis
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 measuring patient walking quality under real world conditions, at 1/100 the cost of conventional solutions. Our platform helps patients with neurological conditions such as Multiple Sclerosis (MS) and Parkinson’s Disease, as well as their clinicians, by objectively measuring changes in walking quality over time, serving as an early warning system for detecting changes in disease conditions.

Celestra Health continued to make significant progress during the second quarter of 2024, including:

  1. research and development funding was received from the Canadian and German governments, to be shared with our German wearable device partner;
  2. recent progress with the FDA towards achieving medical device certification; and
  3. expansion of our clinical trials to four countries.

We are pleased to announce that we are now receiving advisory services and funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP), to expand the depth and breadth of our AI gait algorithms and to expand our clinical trials. For our hardware partner, funding from the German government will be used to develop their next-generation smart insole designed for two years of continuous use, resulting in significant benefits to Celestra Health.

We held our 3rd meeting with the US FDA in June, in support of our Software as a Medical Device (SaMD) application. Our next meeting with the FDA is scheduled for late July, as we continue to make excellent progress towards our goal of medical device certification by early 2025.

Preparations for our 4th clinical trial are now underway with the largest Multiple Sclerosis (MS) clinic in Germany. Our research collaboration agreement with the Technical University of Dresden (TUD) has now been finalized. Our joint clinical trial will provide Celestra Health with a validated suite of in-clinic MS gait tests eligible for reimbursement by healthcare insurance providers in Germany and beyond.

Our multi-country Multiple Sclerosis (MS) clinical trial (US, UK, Canada) is continuing to yield stellar results, along with excellent patient usability ratings. We are enhancing our AI gait algorithms on an ongoing basis, as we grow our data set of real-world MS walking sessions. We are also hardening our operational capabilities, with the development of a comprehensive suite of platform monitoring tools.

Finally, based on the strong results from our Phase I Parkinson’s Disease study, we are collaborating with The Ottawa Hospital in preparation for a 12-month Parkinson’s clinical trial starting in the Fall.