France-based medtech firm Ciliatech has received CE certification for its Intercil Uveal Spacer, a novel surgical implant for the treatment of glaucoma.
Intercil Uveal Spacer was approved under the European Union (EU) Medical Device Regulation (MDR), confirming its compliance with EU standards.
The eye implant leverages the supraciliary space to increase outflow without affecting the anterior chamber, thereby lowering intraocular pressure (IOP).
It is suitable for both primary open-angle glaucoma and primary angle-closure glaucoma, providing a versatile treatment option.
The CE mark approval is a crucial step for commercialising Intercil in the EU, with future expansion to other markets, including the UK, the company said.
Ciliatech CEO Olivier Benoit said: “Ciliatech is thrilled to obtain CE certification for our Intercil Uveal Spacer under the scope of MDR. This critical step is the culmination of years of hard work and significant investment.
“In our steadfast commitment to offering a genuine solution to patients who endure the impacts of glaucoma and thanks to new funding, we can now accelerate the commercial availability of Intercil, roll out its distribution in select European countries and plan for future registrations in key markets, notably the US and China.
“We anticipate that glaucoma surgeons and early adopters of innovation will see the value in our ‘no-bleb-no-cleft’ approach in achieving robust IOP lowering with minimal post-op care.”
Intercil Uveal Spacer is an implant used in the new class of glaucoma surgery, known as the Cilioscleral Interpositioning Device (CID).
The in-house glaucoma device lowers intraocular pressure by enhancing uveoscleral outflow without penetrating the eye’s anterior chamber.
The technique, which aims to reduce complications and promote faster recovery, offers an alternative to traditional methods that carry infection risks.
Ciliatech said the CE mark approval coincides with its fundraising to support its sales development strategy in the EU and planned expansion into the US market.
Furthermore, Intercil’s advanced approach aims to address treatment gaps, especially for moderate glaucoma cases, said the company.
Benoit added: “Intercil addresses the underserved need in treating moderate glaucoma. It bridges the gap between techniques for mild cases and filtering surgeries, providing surgeons with further options to manage disease progression.
“The device’s compatibility with narrow-angle cases further broadens its potential applicability, making it a versatile choice for diverse clinical needs across multiple patient populations.”
