February marked an exciting milestone in our journey to bring our innovative medical device, the PM1 Pachymeter to market with the successful conclusion of its clinical trials.
Our team has worked tirelessly to design, build, and test the device to ensure that it meets the highest standards of safety, efficacy, and usability.
Initial feedback has been promising and, whilst we are awaiting the final report, appeared to show that the PM1 is very accurate with a high level of precision and repeatability when compared to other gold-standard devices already on the market.
The clinical trials, which were held over four days, saw clinicians from Moorfields Eye Hospital, supported by Occuity staff members, successfully measuring the corneal thickness of 105 participants. John Lawrenson, the Chief Investigator from City University London, was present throughout the trials to oversee the entire process.
Now that the clinical trials are complete, the process of analysing the collected data has begun and we are working with regulatory agencies to prepare for commercialisation.
The clinical trials have produced two sets of data. One set compares how our device performed against three leading pachymeters that are already on the market, with the PM1 Pachymeter showing a high correlation. This data will also be compiled into a report and used as part of our CE marking submission - another key step in getting the PM1 to market.
The second element is that the above report will be independently written, reviewed and then published by City University London with Moorfields Eye Hospital NHS Foundation Trust. Although the published report is not an essential step, we believe it will act as a valuable tool in the company's marketing efforts and future success.
The completion of the PM1 clinical trials is a major achievement for the team and puts us one step closer to getting the device market-ready. As we move forward, we will continue to keep our community updated on our progress and look forward to sharing more news with you in the near future.
To stay up to date with our progress please join our community. We send out newsletters every month with exciting achievements, progress and updates.