Occuity, a leading innovator in non-contact optical medical technology, is proud to announce that its pioneering PM1 Pachymeter has received CE marking. This regulatory milestone not only validates the safety, efficacy, and environmental standards of the PM1 but also accelerates the company's entry into the European medical devices market and beyond.
This achievement represents a significant step in Occuity’s strategy to revolutionise diagnostics within the medical technology space. The CE marking will also facilitate global expansion, as many non-European countries also recognise this certification, simplifying the registration process in markets such as Australia, New Zealand, parts of Asia, and the Middle East.
A Key Milestone for Investors and the Future of MedTech
Securing CE marking is not only a testament to Occuity’s commitment to high-quality product development but also a critical de-risking event for existing shareholders and potential investors.
With this approval, the company is set to transition from product development to revenue generation, marking an inflection point in its growth trajectory. Having built a robust global distribution network, Occuity is now primed to ship the PM1 Pachymeter to key markets, generating immediate revenues from pre-existing orders.
Dr. Dan Daly, CEO of Occuity, commented: “Achieving CE marking is a pivotal moment for Occuity. It opens the door to new commercial opportunities and validates the hard work our team has put in. With the PM1 ready for market and a strong pipeline of products following closely behind, all built on an innovative platform that leverages Occuity’s ground-breaking optical technology, we are poised for substantial future growth.”
Innovating Beyond the Status Quo
The PM1 is the world’s first handheld, non-contact optical pachymeter. It leverages patented optical technology to measure central corneal thickness quickly and accurately—an essential metric used to support glaucoma screening and during refractive surgery. This device exemplifies the company’s commitment to solving real-world problems through innovative, user-friendly, and scalable technologies.
While the PM1 sets the stage for Occuity’s market entry, the company’s broader vision is to harness the “eye as a window to the health of the body” — a burgeoning field known as Oculomics. Occuity’s technology will therefore not only impact ophthalmology but will also lay the foundation for advancements in non-invasive screening for chronic diseases like diabetes and Alzheimer’s.
Looking Forward: A Strong Investment Opportunity
As Occuity moves forward, the company is actively scaling production and solidifying its global distribution network.
Investors have a unique opportunity to participate in the company’s growth through an open Convertible Loan Note (CLN) round, set to close on 16th October. The CLN offers a final window for investors to capitalise on this exciting growth phase before Occuity enters full commercialisation. Additionally, there are opportunities to invest via tax-efficient EIS-eligible Ordinary Shares or International Preference Shares.
With an innovative, patented technology platform, solid regulatory foundation, robust product pipeline, and growing market demand, Occuity is well-positioned for long-term success in the MedTech landscape. Investors, partners, and industry leaders alike should take note of this breakthrough moment as the company continues its trajectory towards becoming a global leader in non-invasive medical diagnostics.
For more information about the PM1 and Occuity’s innovative product pipeline, visit www.occuity.com.