The surgeries will be performed in the format of a clinical trial in 5 centers in Israel in preparation for the approval and marketing of the system in Israel and as part of the FDA requirements
The company has the necessary approvals, including the approval of the Ministry of Health, and the surgeries should begin these days.
The company has very successfully performed about 150 surgeries on patients so far, including an experiment that included 54 surgeries on humans in three centers in Europe (Italy, Moscow and Spain), Mexico City and India. The follow-up of the patients, for periods of up to 18 months, received so far in this trial, indicate better results than the treatments available today for the treatment of glaucoma - both in terms of lowering the intraocular pressure, safety, simplicity and the few side effects of the treatment.
The company has CE approval for the distribution of the device in Europe and other countries and the first systems will start operating in India commercially profitable within about a month. Later this year, the system's commercial activity will expand to Brazil and other territories, including Israel. The company is expected to meet soon with the FDA to regulate the approval process in the US.
The surgeries that will be conducted as part of the trial that will begin soon in Israel will be performed in the advanced and commercial system of the IOIPTIMATE company - the surgeries are a system based on the model in which the trials were performed in Europe, but it is more convenient for the doctor, easy to move around and designed like the marketing product.
The surgeries will be performed in the coming weeks by the leading doctors in the ophthalmology departments at Meir, Sheba, Assaf Harofeh, Carmel and Kaplan hospitals.
In addition, the company expects to soon receive approval from the Ministry of Health in Switzerland to conduct experiments on the system, where the company will begin operations with the two leading glaucoma surgeons in the world.
Glaucoma is the second most common cause of blindness. There are about seventy million glaucoma patients in the world and most of them are expected to go blind due to the lack of simple, cheap and effective treatment with few side effects.
The laser-based technology of the "i-Optima" company meets exactly this need and the developed surgery does not penetrate the eye and is therefore effective, simple, safe and with a minimum of transient side effects.
Glaucoma is mainly caused by an increase in fluid pressure inside the eye. The drugs for the disease are supposed to reduce the rate of fluid production, but their effectiveness is limited, they have side effects, their cost is high, and most patients do not take them properly, so their condition deteriorates.
Today's surgical solutions are expensive and have multiple side effects, so they are not popular with doctors and are only performed in advanced cases of the disease.
According to Dr. Yehoshua Dagani, CEO of "i-Optima": "The operation using the company's IOPTIMATE device, which is performed under local anesthesia and does not involve hospitalization, may eliminate or significantly reduce the consumption of medications or other treatments for glaucoma patients."
Dr. Ami Eil, CEO of "Bio-Lite" adds and says: "Our device is a revolution in glaucoma treatments and may even be a primary treatment for some patients. We are going next week to a big conference in the USA where we will meet again with the leading ophthalmologists in the world who are already familiar with our device and expect to start using it in the near future"
About "I-Optima":
"A-Optima" Ltd., a subsidiary of "Bio-Light", focuses on the development and commercialization of innovative technologies for the treatment of glaucoma. The company developed "IOPTIMATE" - an innovative, non-invasive system based on carbon dioxide laser technology for the treatment of glaucoma. The company believes that the IOPTIMATE system has considerable advantages over traditional treatments for glaucoma and that the availability of a safe surgical procedure is expected to increase the number of surgeries.
As mentioned, the "IOPTIMATE" technology has a CE certificate, which allows the marketing of the product in Europe and other countries. And soon the company will start a dialogue with the FDA in preparation for trials and approval of the product in the USA.
"I-Optima" has an approved patent in the United States, Europe and Japan based on the basic concept of the technology it developed for the treatment of glaucoma, and it has submitted applications for registration of additional patents in various countries.
"Bio-Light" is traded on the Tel Aviv Stock Exchange.
