PM1 - Clinical, Technical and Regulatory Update
Following exhaustive internal testing of the PM1, and having now received approval from MHRA, the start of the formal PM1 clinical trials with City University, London has been scheduled for the 19th of December when the orientation day will be held at Occuity’s offices for the optometrists. Due to consist of between 82 to 100 volunteers (163 individual eye measurements are required for the statistics), the trial will continue on into January.
Once complete, the results of the trial will be submitted along with the rest of the technical file for PM1 to DARE, our Notified Body for CE marking and we anticipate also submitting for UK CA marking at the same time. Although we will be able to sell the device in the UK under a CE mark for a period, we will ultimately need the separate UK CA authorisation and, therefore, it makes sense to submit both applications as soon as possible, particularly as the UK CA process may possibly be quicker than the European CE.
The second clinical trial, planned for February, will be of a similar size and held at Portsmouth Hospitals NHS Trust.
Separately, the more peripheral elements of the PM1 such as Instructions for Use (in 5 languages), induction charging cradle and packaging, are all in progress to ensure they are available in time for the product launch in early 2023.
PM1 - Commercial Update
Over the last few months, several pre-production PM1 devices have been provided to distributors to allow them to gain market feedback at various shows and corporate demos throughout Europe.
Feedback from those distributors and potential customers has been extremely positive and confirms our market forecasts - ratifying our confidence in the sales of the device once approval from the regulatory authorities has been received.
In the UK, our partner for PM1 distribution has received impressive feedback from the market. Consequently, for the private Optometry and Ophthalmology market alone they are happy to commit to an initial volume of 150 units. Then their intention is to mailshot their large NHS customer base from Q1 2023.
The early interest from the private Optometry and Ophthalmology markets is such that our UK distributor is happy to commit to an initial minimum volume of 150 units
From a product launch perspective, the regulatory approval for the clinical trials has unfortunately taken quite a bit longer than anticipated with MHRA taking the maximum time allowed under their charter to respond. As a result, we are now forecasting initial sales from the PM1 in Q2 rather than Q1 next year (2023) – although we would hope to catch up sales where possible over the year - so overall we do not see this as a material change to our longer-term forecasts.
New Opportunity
We have also identified a new commercial avenue for the PM1 – its use in eye banks (that store and distribute corneas for transplant). They require accurate measurements of very thin, excised human corneal tissue, which is problematic with existing devices.
We are currently working with one of the UK’s leading eye banks and investigations are continuing regarding what we expect will be small software modifications needed to allow PM1 to take these measurements. Since the use of the PM1 in this area would not require the same level of certification as that for use on live patients, this would represent a new market that could be addressed almost immediately whilst awaiting the full medical device certification.