ViaLase Submits IPO Prospectus Following CE Mark Approval of World’s First Femtosecond Laser for Glaucoma

Aug 09, 2024 09:25 CST Updated 09:25

ViaLase

Glaucoma Treatment Developer

Source: Eye Future; Editor: Sophia

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Recently, focusing on the developmentInnovative Glaucoma TherapyofViaLase, Inc.TheViaLase Laser Has obtained EU CE mark approval, this laser is designed to treat patients withPrimary Open-Angle GlaucomaAdult patients.

ViaLase, Inc. utilizes cutting-edgeThe Combination of Femtosecond Laser Technology and Micron-Level Image-Guided Systems, successfully developedIndustry FirstTheFemtosecond Laser, Image-Guided, High-Precision Trabeculotomy (FLigHT), alsoThe FirstFemtosecond Laser Technology for the Treatment of Primary Open-Angle Glaucoma (POAG)，This innovative technology marks a milestone advancement in the field of glaucoma treatment.

Moreover, ViaLase announced that it has partnered with Teleon and Global Surgical Service.Establish strategic distribution partnerships,Pave the way for the commercialization of its products in some European markets。

Founder and CEO of the CompanyDr. Tibor Juhasz"ViaLase laser represents a significant innovation in the field of interventional glaucoma treatment,It can achieve surgical results without the need to open the eyes., significantly reducing the risk of complications associated with traditional invasive surgeries. Early clinical data shows,FLigHT technology can safely and effectively reduce intraocular pressure (IOP)."We look forward to collaborating with our distribution partners to bring this breakthrough technology to doctors and patients in Europe."

Chief Medical OfficerRichard Lewis, M.D.Added: "There is sufficient evidence showing that early non-drug interventions can control the disease more effectively and protect vision, which is crucial for patients. I am excited about the new imaging and precision that ViaLase lasers can bring to glaucoma treatment. Additionally,The patient's lens status will not affect the effectiveness of their FLigHT treatment.", which greatly expands the population suitable for treatment."

# Primary Open-Angle Glaucoma (POAG)

In POAG patients, the anterior chamber angle appears normal and is open.However, the aqueous humor outflow system at the trabecular meshwork undergoes pathological changes, increasing the resistance to aqueous humor outflow and thereby leading to elevated intraocular pressure.

When the lesion progresses to a certain extent, the patient experiencesBlurred vision, eye swelling, and headacheSymptoms such as...
When intraocular pressure fluctuates significantly or is at a higher level, it may lead toPain in the root of the nose, rainbow vision, and foggy vision。
When the lesion progresses to the late stage, it appearsMobility Impairment and Night BlindnessPhenomena such as...

Therefore,ViaLase Laser Technology Has Broad Market Prospects, will provide a new treatment option for hundreds of millions of glaucoma patients worldwide.

# ViaLase Laser Femtosecond Laser System

ViaLase laser is designed to combine the precision of femtosecond laser technology with the accuracy of micron-level image guidance, providing a procedure calledFemtosecond Laser Image-Guided High-Precision Trabeculotomy or FLigHT Non-Invasive Glaucoma TreatmentTechnology。 Different from other glaucoma surgeries,FLigHT does not require the creation of a fistula, which may reduce the risk of associated complications.。

ViaLase Developed by ViaLase^®Laser technology, asThe First ProductFemtosecond Laser for the Treatment of Primary Open-Angle Glaucoma (POAG), representing a significant technological breakthrough in the field of ophthalmic treatment.

The technology throughNon-invasive, Non-surgicalMethod,Utilizing Femtosecond Laser Precision Operation, providing a completely new solution for glaucoma treatment.This innovative approach may revolutionize existing treatment paradigms., improve the treatment outcomes and quality of life for patients.

Another product under ViaLase, Inc. ——ViaLuxe Laser System, used for performing femtosecond laser image-guided high-precision trabeculotomy (FLigHT). The surgery aims to utilize femtosecond laser and micron-level precise anterior chamber angle imaging technology,Creating a customized drainage channel non-invasively through the trabecular meshwork to reduce intraocular pressure.。

The device is divided into four parts.：

ViaLens Patient Interface: Providing a clear field of view in a non-invasive manner, precisely delivering femtosecond laser to the trabecular meshwork;

ViaVue Gonioscope: Display the angular structure of all four quadrants, providing doctors with a comprehensive perspective;

ViaLuxe Laser: Precisely create channels, protecting adjacent tissues from damage;

ViaLink: By connecting to a tablet via Bluetooth, doctors can view program data and diagnostic information in real time;

# ViaLase Laser Clinical Data

In 2023, ViaLase, Inc. announced the 24-month human study safety data of the first FLigHT non-invasive glaucoma treatment using ViaLase technology.
During the 24-month observation period,The patients' mean IOP decreased from a baseline of 22.3±5.5 mmHg to 14.5±2.6 mmHg.A decrease of 34.6%。
In the same year, the results of ViaLase, Inc.'s Phase 1 VIA-001 trial showed that at all follow-up time points (1 month, 3 months, and 6 months post-operation),The average intraocular pressure decreased by 20%, 25%, and 23%.。
68% of the surgical eyes achieved ≥20% intraocular pressure reduction at 6 months without the need for additional glaucoma medications.。
At the 2023 American Glaucoma Society meeting, ViaLase also presented another 12-month study result.The results showThe mean IOP was significantly lower after treatment, and none of the patients required IOP-lowering medications at 1 year., and no scars were found during the anterior chamber angle examination.
In October 2023, ViaLase announced the completion of patient enrollment in the Phase 2 VIA-002 trial.Phase 2 Trial to Compare ViaLase with Selective Laser Trabeculoplasty (SLT)

# Latest Financing

In April 2024, ViaLase, Inc. announced the successful completion$40 million (approximately 289 million RMB)C Round Financing。This round of financing was led by new investors, with Venture Investors Health Fund, Arboretum Ventures, and Falcon Vision, an ophthalmic investment platform under KKR, following up.This financing willTo Advance Key Milestones Such as the ViaLase Laser Clinical Trials, Registration, and Commercialization。

# Company Profile

ViaLase, Inc., a clinical-stage medical technology company located in Aliso Viejo, California, focuses onRevolutionizing Traditional Glaucoma Treatment Methods。

ViaLase has disrupted the traditional glaucoma treatment model, introducing a trueNon-invasive Image-guided Femtosecond Laser Therapy, improve the care of glaucoma patients.

Overview of Main Members of ViaLase, Inc.: