We are delighted to announce that Occuity has successfully received CE marking for our groundbreaking first product, the PM1 Pachymeter.
This achievement marks a pivotal moment for the company and a significant milestone in our journey to revolutionise ophthalmic diagnostics. The CE marking certifies that the PM1 meets all European health, safety, and environmental protection standards, allowing us to distribute the device across the European market.
In addition to unlocking the European market, achieving CE marking will also facilitate the sale of the PM1 in non-European countries. Many global markets recognise CE marking as a symbol of quality and compliance with international health and safety standards, making the registration process in those regions more straightforward. CE marking also serves as important support for local regulatory approvals in countries like Australia, New Zealand, the Middle East and parts of Asia, where authorities recognise CE certification as part of their own medical device registration processes. This global recognition highlights the importance of CE marking beyond Europe and sets the foundation for a broader international expansion.
What This Means for Our Business, Shareholders & Investors
The achievement of CE marking for the PM1 Pachymeter is a significant de-risking milestone for Occuity, providing strong validation of the PM1’s safety, efficacy, and the approval of our manufacturing processes. With this regulatory clearance secured, we are now fully prepared for market launch. In preparation for this milestone, Occuity has wasted no time in establishing a global distributor network. We now have 14 distributors covering territories within Europe, Oceania, Asia, and Latin America. With CE marking in place, we will begin shipping the PM1 to these distributors immediately, enabling us to start generating revenue from our backlog of orders.
In addition to this, the PM1 will play a crucial role in building the Occuity brand within the market. The device will demonstrate the quality and ease of use that are the hallmarks of our technology, positioning us strongly for future growth. Even before its official launch, our next device, the AX1 Axiometer, is already generating significant market interest, and we anticipate that its revenue potential will far exceed that of the PM1. Investors can therefore be confident that our ophthalmic product line positions us well for long-term commercial success.
Looking Back & Looking Ahead
For those who have been monitoring our advancements or are familiar with the obstacles involved in bringing a medical device to the market, the effort required to obtain CE marking is truly commendable. I would like to express my gratitude to our dedicated teams who have tirelessly tackled the various challenges and obstacles encountered during the process of obtaining CE marking for a new product.
With CE marking achieved, Occuity is now focused on ramping up production and expanding distribution through our network of trusted partners. Meanwhile, the valuable lessons we have learned along this journey will be instrumental as we progress towards launching new products like the AX1.
This is an exciting time for Occuity, and we also want to extend our sincere thanks to all our shareholders for their continued support.
Investment Opportunity Closing Soon
The securing of CE marking will see Occuity become revenue generating, a major inflection point for the company. For those looking to be a part of this exciting journey, there is still a final window of opportunity for those able to self-certify as HNW or Sophisticated investors to invest through our Convertible Loan Note (CLN), which remains open until 16th October. With CE marking in place, it is anticipated that the remaining headroom in the CLN will fill up rapidly, so please let us know soon if you require any further details.
Alternatively, you can also still invest in tax-efficient EIS-eligible Ordinary Shares or International Preference Shares, which both offer the opportunity to join us in this promising next phase of growth, which will also be closing soon.
For more information, visit our investor page here.
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