World’s First Corneal Esthesiometer Approved by the FDA

Brill Engines, a subsidiary of Brill Pharma, specializing in pioneering medical solutions for ophthalmology, announced the FDA approval of its groundbreaking medical device, the Corneal Esthesiometer Brill (CEB).

This approval marks a significant milestone in the field of ophthalmology, as the CEB is the world's first and only handheld, non-invasive corneal esthesiometer designed for measuring corneal sensitivity.

The Corneal Esthesiometer Brill received its registration as a class IIa medical device from the European Medicines Agency (EMA) on April 28, 2023. Following this milestone, the FDA granted its registration on June 15, 2023.

The CEB's FDA and EMA approvals make it the first non-invasive esthesiometer available worldwide for evaluating corneal-nerve status. This innovative biomarker will play a pivotal role in diagnosing and predicting eye health in prevalent conditions such as glaucoma, herpes, and dry eye, among others.

The device will also enable ophthalmologists to differentiate stages of diseases like neurotrophic keratitis, diabetic keratitis, dry eye, and monitor patients who have undergone refractive surgery or corneal transplants, as well as those who wear contact lenses.

Designed as a patented, handheld, non-invasive electromedical device, the Corneal Esthesiometer Brill uses a controlled pulse of air for corneal sensitivity evaluation. The device stimulates the cornea at constant pressures and ascending gradients in five levels of stimulation above and below the physiological level, effectively detecting corneal hyperesthesia and hypoesthesia.

Developed in collaboration with ophthalmologists, researchers, and expert engineers, the CEB will be manufactured in the United States. It has undergone rigorous clinical studies at prestigious institutions such as Bascom Palmer Eye Institute (Miami, Florida) and Duke University (Durham, North Carolina). Additional research is scheduled to commence in 2024 at Harvard Medical School, John Hopkins University, Tufts Medical Center, and Baylor College of Medicine, among others. Esteemed Spanish ophthalmologists, including Dr. Jesús Merayo, Dr. José Manuel Benítez del Castillo, Dr. Jesús Montero, and Dr. Salvador García Delpech, actively contributed to the device's development.

Dr. José Manuel Benítez del Castillo of Rementería Clinic in Madrid, said, "The idea of the Corneal Esthesiometer Brill arose in response to an unmet medical need. Until that time, there were no handheld devices that allowed contactless, precise evaluation of corneal sensitivity. This, along with the convenience of being able to use the device manually or on a slit lamp, makes it unique."

Dr. Jesús Merayo of the Fernández-Vega Ophthalmological Institute in Asturias added, "The Corneal Esthesiometer Brill will allow ophthalmologists to prescribe specific treatment, and we will even be able to evaluate the effectiveness of treatments through assessment of patients’ corneal sensitivity. With the launching of the device, esthesiometry will become a key ophthalmological biomarker, making it an invaluable tool for ophthalmologists."

The Corneal Esthesiometer Brill is set to be launched in Europe and the USA in September 2023, with its official presentation scheduled at the 99th Convention of the Spanish Ophthalmological Society.

Dr. Jordi Martínez Rotllán, founder, and CEO of Brill Engines, said, "The worldwide launching of the Corneal Esthesiometer Brill will provide 40% growth in values in 2024 in addition to the funding needed for further investing in and development of unique and innovative products in different therapeutic areas and the strength we need to continue presenting products in different markets during a period of no more than two years."

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