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The ViaLuxe Laser System

Overview

ViaLase, Inc. is a clinical-stage medical technology company that has developed the ViaLuxe™ Laser System, combining revolutionary femtosecond laser technology with micron-level image guidance for glaucoma treatment. With over 200 years of combined experience in femtosecond laser development, the team is singularly focused on redefining glaucoma management.

ViaLuxe™ Laser System

Technology - FLigHT Procedure

The ViaLuxe Laser System delivers an innovative treatment called FLigHT (Femtosecond Laser, Image-Guided, High-precision Trabeculotomy).

Key Features

Non-Invasive Treatment - No incision required
High Precision - Femtosecond laser technology
Micron-Level Imaging - Real-time HD image guidance
Proprietary Imaging - Advanced gonioscopic capabilities with OCT integration

How It Works

Patient Docking: Secure positioning via ViaLens™ patient interface with vacuum suction
Imaging: High-resolution, real-time video of the iridocorneal angle
Laser Application: Precise drainage channel creation through the trabecular meshwork
Channel Specifications: 500 μm width x 200 μm height, treating only 5 degrees of angle

System Components

Chassis containing laser engine and electronics
Graphical user interface and touchscreen
Optical delivery head
Handheld gonioscopy camera
Proprietary ViaLens™ coupling lens

Clinical Data and Safety

Pilot Study Results (24-Month Follow-up)

Studies have demonstrated that the FLigHT procedure:

Safe and effective in lowering intraocular pressure (IOP)
Minimal complication profile
No pressure spike
Low postoperative steroid requirement
Sustained pressure reduction
Minimal collateral damage to surrounding tissues

Ongoing Clinical Trials

VIA-002 Pivotal Trial: Comparing FLigHT to selective laser trabeculoplasty (SLT) for primary open-angle glaucoma
Multi-center, randomized controlled studies

Indications and Patient Selection

Ideal Candidates

Open-angle glaucoma patients
Visible trabecular meshwork
Clear cornea
Mild, moderate, or severe glaucoma (stable or unstable)
Patients struggling with medication adherence
Patients with adverse reactions to topical medications

Treatment Indication

The ViaLase Laser System is indicated to create apertures through the trabecular meshwork in patients with open-angle glaucoma.

Innovation in Glaucoma Treatment Paradigm

Conventional Treatment Algorithm

Topical eye drops
Laser therapy (SLT)
Minimally invasive glaucoma surgery (MIGS)
Invasive filtration surgery

ViaLase’s Position

FLigHT is positioned as an early intervention option that delivers surgery-like results without opening the eye. This offers patients:

Reduced risk of medication non-adherence
Immediate return to daily activities
Avoidance of complications associated with invasive procedures
Better long-term disease control

Global Access

Distribution Partnerships

Teleon - European markets
Global Surgical Service - European markets
Commercialization preparation in select European markets

Regulatory Status

CE Mark: July 2024 (EU approval)
FDA Approval: Clinical trials ongoing (USA)

About Glaucoma

Global Impact: 76 million people affected
2040 Projection: 112 million people
Significance: Second leading cause of irreversible blindness worldwide
Treatment Principle: Lowering IOP is the only proven method to slow visual field loss

Leadership and Expertise

The ViaLase leadership team has vast experience in developing, designing, manufacturing, and commercializing the first femtosecond lasers for ophthalmic surgery for refractive and cataract patients. The team is now bringing that expertise and innovation to glaucoma patients.

More Information

Website: ViaLase

Note: ViaLase products are currently not for sale pending regulatory clearance (outside EU).

ViaLase is a globally-minded, venture capital-backed company committed to disrupting the conventional glaucoma treatment paradigm.

ViaLase Glaucoma Femtosecond Laser System