eye-light® Device Receives CE (MDR) Mark for Treating Dry AMD and Anterior Segment Pathologies

Espansione Group, a leading innovator in medtech solutions in ophthalmology and beyond and a pioneer in photobiomodulation technologies, is thrilled to announce that it has obtained CE (MDR) approval for a wide array of conditions on its flagship device eye-light®, including both new retinal and corneal conditions.

This milestone marks a new era in providing groundbreaking ophthalmology applications of our light-based technologies, and it’s set to significantly change the landscape for patients and practitioners alike. The clearance represents a significant opportunity in the non-invasive management of several conditions, which cumulatively affect billions of people worldwide across all age groups, ethnicities and genders.

All of these treatment opportunities will be available on the eye-light® device, a treatment platform for which different photobiomodulation terminals have been optimized to treat a wide array of conditions. Specifically, this clearance adds the following set of conditions and pathologies to the existing portfolio of intended uses, from the front to the back of the eye:

Anterior Segment

Chalazion
Blepharitis
Demodex & Demodex Blepharitis
Rosacea & Ocular Rosacea
Post-blepharoplasty Complications (i.e., Ptosis & Ectropion)

Posterior Segment

Age-related Macular Degeneration

This announcement comes shortly after the publication in May 2024 of the first results from the LightWave I clinical trial, focused on AREDS 2 and 3 Age-related Macular Degeneration (Dry), by ARVO (i.e., Association for Research in Vision and Ophthalmology), recently presented during the eponymous 2024 congress in Seattle, USA.

The clearance marks a potential breakthrough in how the workflow of dry AMD patients is currently managed and opens new opportunities to investigate the effectiveness of photobiomodulation on retinal conditions.

Alessandro Fier, Executive Board Member & CEO, commented: “Espansione has been the first player to develop and obtain clearance of a photobiomodulation device in ophthalmology, almost a decade ago, revolutionizing dry eye treatment. These new clearances enable us to offer an unmatched portfolio of effective treatments on our tech platforms to European eye care professionals. This milestone validates Espansione as a key innovator in the ophthalmic medical technologies arena, and is a significant step towards our long-term vision of becoming the global leader in photobiomodulation."

Matteo Corbellino, Executive Board Member and Chief Marketing & Innovation Officer at Espansione Group, noted that “This outstanding milestone is a testament to the team’s relentless focus on clinical development and the strong bond we share with the broader research community, for which we’re deeply thankful—without it, this achievement would never have been possible.” adding also that “This achievement comes out of a couple of decades of work in this field and is a testament to the potential our technology holds. We’re certain it will pave the way for future discoveries and innovations that will make photobiomodulation an essential tool for Eye Care Professionals and other medical specialists.”

Luca Trimigno, Executive Board Member and Chief Strategy & Corporate Development Officer at Espansione Group, concluded: “This achievement formally recognizes the passion and commitment that drive us daily at Espansione Group. We are relentlessly investing with genuine curiosity and determination to be at the forefront of the industry, always striving to enhance patient care and satisfaction in alignment with our core values. The new clearance marks the beginning of our new journey and it is a true reflection of our mission, as we continuously strive to deploy disruptive, non-invasive solutions, backed by our solid pipeline of R&D. ”

In addition to EU27 countries, additional clearances have been obtained and will enable the Group to selectively transfer this clearance to other key countries in the EMEA, LATAM, and APAC regions, making these breakthrough treatment protocols available to a wide number of patient populations.

Espansione Group, with its rich history of pioneering in light-based technologies for healthcare, elevates through this approval the value of its esteemed portfolio of technologies including Light Modulation® Low-Level Light Therapy (LM® LLLT), also known as photobiomodulation (PBM), and Optimal Power Energy® Intense Pulsed Light (OPE® IPL), available across its solutions—i.e., eye-light®, meibomask® / mgd-mask®, my-mask®.

ABOUT CLEARED CONDITIONS

Below global figures and brief descriptions for each condition object of this clearance.

Age-related Macular Degeneration (AMD) is the leading cause of severe vision loss in people over age 50 in the developed world. It is characterized by damage to the macula, affecting central vision. It’s a chronic, degenerative condition to this day with no cure, particularly for its early and intermediate stages (i.e., AREDS 1-3), also referred as dry (dAMD). The dry subtype accounts for 85-90% of total AMD cases. Globally, AMD is projected to affect approximately 280 million people worldwide by 2040.
Chalazion a bump or nodule inside the eyelid, is a common eyelid disorder worldwide, usually paired with inflammation. It’s caused by blockage and swelling of oil glands in the eyelids. Annually it affects millions globally, including hundreds of thousands in the U.S.
Blepharitis: Blepharitis is an inflammatory condition of the eyelids, leading to red, swollen, and itchy eyelids, often associated with a bacterial infection or skin condition. It affects tens of millions globally, with over 10 million cases in the U.S. alone.
Demodex Blepharitis caused by infestation of Demodex mites, results in inflammation and scaling of the eyelids. This subtype is particularly prevalent among the elderly, impacting millions worldwide and a significant population in the U.S.
Rosacea & Ocular Rosacea are chronic skin conditions causing redness and visible blood vessels in the face, with ocular rosacea affecting the eyes, leading to red and irritated eyes and eyelids. Globally, rosacea affects over 45 million people, including more than 16 million in the U.S.
Post-blepharoplasty Complications, such as Ptosis (i.e., drooping of the upper eyelid) and ectropion (i.e., outward turning of the lower eyelid), affect a significant number of the over 200,000 patients undergoing eyelid surgery each year in the U.S., with similar rates observed globally.

Sources: World Health Organization, PubMed

ABOUT ESPANSIONE GROUP

Espansione Group is an established player in the MedTech industry. Since 1981, Espansione Group has delivered the highest standard in the industry. Every day, the company invests heavily in researching and developing the Espansione Ecosystem to achieve its ambition: establishing new paradigms in ophthalmology and beyond, driven by its desire to provide its partners and their patients with the best, certified medical technologies, Light Modulation® Low-level Light Therapy (LM® LLLT) and Optimal Power Energy® Intense Pulsed Light (OPE® IPL). Present in over 50 countries, Espansione Group's aims to continue its strong growth in years to come, relentlessly focusing its efforts on research, development, and customer excellence.    

For more information, see www.espansionegroup.it

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