Ciliatech Receives CE Mark for Intercil Uveal Spacer Implant

Ciliatech has received CE certification under the European Medical Device Regulation (MDR) for its Intercil Uveal Spacer, a novel surgical implant that marks the launch of a new category in glaucoma treatment known as Cilioscleral Interpositioning Devices (CID).

Anterior Chamber-Sparing Technique for Intraocular Pressure Reduction

Unlike traditional glaucoma surgeries that penetrate the anterior chamber or form blebs, Intercil utilizes a “no-bleb-no-cleft” approach, preserving the integrity of the anterior chamber. The device is implanted in the supraciliary space, creating a gap between the ciliary muscle and sclera, which reduces resistance to aqueous humour outflow, facilitating enhanced uveoscleral drainage into the choroidal circulation.

This non-penetrating method allows for a physiological reduction in intraocular pressure (IOP), offering a safer surgical alternative with minimal postoperative complications and shorter recovery times.

“Obtaining CE certification is a pivotal milestone and the culmination of years of hard work. This will allow us to accelerate Intercil’s availability across Europe and prepare for registrations in the US and China,” said Olivier Benoit, CEO, Ciliatech.

Addressing the Needs of Moderate and Narrow-Angle Glaucoma

Ciliatech emphasizes that Intercil is designed to fill a critical treatment gap in moderate glaucoma, a space often underserved between mild cases managed with SLT or angle-based surgeries, and severe cases requiring filtering procedures.

The device is also indicated for narrow-angle glaucoma, a group of patients with limited surgical options under current treatment paradigms.

“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,” said Olivier Benoit.

Key Features of the Intercil Uveal Spacer

The Intercil Uveal Spacer offers a combination of innovation, flexibility, and safety:

       • Anterior chamber-free implantation: No penetration of the anterior chamber; uses the supraciliary space

       • Robust IOP reduction: Effective for both Primary Open-Angle Glaucoma (POAG) and Primary Angle-Closure Glaucoma (PACG)

       • Versatile placement: Can be implanted 360° around the eye

       • Broad clinical applicability: Extends to narrow-angle glaucoma and intermediate-stage patients

According to the company, conventional surgical options such as bleb-forming filtration procedures come with infection risks and require intensive follow-up, while more conservative treatments often fall short in achieving sustained IOP reduction. Intercil offers a novel, minimally invasive alternative with the potential to reshape glaucoma surgery practices.

Market Expansion and Upcoming Presentation

The CE Mark allows for commercialization across the European Union, and Ciliatech has also completed device registration in the UK, with plans for market expansion into other strategic regions, including the United States and China.

Ciliatech will present the Intercil Uveal Spacer at the 4th ESCRS iNovation Day, scheduled for September 12 in Copenhagen.