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Celestra Health Continues to Make Strides

Celestra Health Systems — Leader in AI-based monitoring of multiple sclerosis

Celestra Health continued to make significant progress during the first quarter of 2024, including strong initial results from our in-progress clinical trial, our patent application filing with the US Patent and Trademark Office (USPTO) and the progression of our US medical device certification strategy.

The early results from our multi-country clinical trial (US, UK, Canada) are very promising, with high patient adherence levels and stellar patient usability scores. Adherence is measured as a percent of patients performing three Ad Hoc walking sessions per week, with an overall rate of 80% over the first six months. From a patient usability perspective, 100% of participants indicated “Agree” or “Strongly Agree” with respect to ease-of-use of our smart phone app and their ability to incorporate our technology into their daily lives. Patient adherence/usability is one of the primary objectives of our clinical trial, as it validates our choice of wearable technology, as well as the user-friendly design of our platform.

We have recently filed a patent application with the US Patent and Trademark Office (USPTO), to protect our inventions related to the AI algorithms we have developed and trained to measure walking quality in patients with neurological diseases such as MS. This represents our second filing, building on our initial submission in March 2023. Additional patent filings are planned as we continue to innovate in several key areas related to the analysis of patient gait.

One of our key goals for 2024 is to engage with regulatory authorities in the US, the UK and Europe, in preparation for our 2025 commercial launch. To this end, we are actively engaged with the US FDA to confirm our Software as a Medical Device certification plan, further to our Pre-Submission application filed in November 2023. We have participated in several meetings with the FDA to date and are working closely with a US-based medical device certification consultancy (Medical Device Academy) to ensure we have a clear and expeditious path to market.

And finally, In February we were invited to present at the 2024 Ontario Bioscience Innovation Organization (OBIO) Investment Summit in Toronto, Canada. Our investor presentation received highly positive feedback:

“Just watched your presentation for Celestra Health — what an awesome med-tech business you’ve built, and I see the importance for clinicians in providing early warning for disease progression.”

Attending this event significantly raised our profile within the investor community. As we prepare for our 2025 commercial launch, we will be providing an opportunity for external investors to join our team.