Keranova Announces Clinical Study Results for Robotic Laser Technology
Keranova announced the finalization of the regulatory clinical studies of FemtoMatrix, its robotic laser technology. With the positive results, the company said it will now apply for CE marking for this new class of surgical equipment in cataract surgery.
According to Keranova, this is the first time that a new surgical technique, which the company calls "PhotoEmulsification," has been performed, and the latest landmark in cataract surgery since phacoemulsification in the late 1980s.
A randomized comparative multicenter pivotal study was carried out at end of Q2, 2022 in the Czech Republic, with 54 patients enrolled. The contralateral eye of each patient was treated using the traditional method by phacoemulsification to serve as control. The study demonstrated FemtoMatrix’s ability to eliminate the use of ultrasound in the vast majority of cases on a standard population, or to reduce it drastically, according to Keranova.
During this pivotal study, a subpopulation of 20 patients with a cataract of grade ≤ 3 (grade 2 on average) was operated on with FemtoMatrix on one eye and phacoemulsification on the other. The reduction in effective phacoemulsification time (EPT) was 100%, compared to an average of 20-30% in various comparative meta-analyses in the existing literature (Kolb, Meta-analysis, JSCRS 2020).
In two additional studies, on a total number of 35 patients living with a cataract of higher than grade 3 (3.6 on average), approximately 72% of the surgeries were performed without ultrasound. On the ten patients who received ultrasound (grade 4.3 on average), the average EPT was 2.3 seconds--four of them with less than 0.6 second. This result was deemed extraordinary in the context of current literature on cataract surgery, according to Keranova.
"Surgeons will be able to perform perfectly calibrated cataract surgery and reduce the risks associated with handling the ultrasound device used in a classic phacoemulsification. They can now perform cataract surgery without ultrasound as efficiently as current techniques--but with greater precision and reduced risks of corneal/iris damage, capsular ruptures or adverse consequences on the retina, all within the same operating time. Patients will benefit from a safer and less operator-dependent procedure, with more consistent outcomes," according to a Keranova news release.
“These outstanding results, achieved after 6 years of hard work, will soon allow Keranova to offer PhotoEmulsification technology to surgeons. This will be the third generation of cataract surgery technology, after manual extracapsular and phacoemulsification,” Fabrice Romano, founder and CEO of Keranova, said in a company news release. “Keranova will therefore be the first company to provide surgeons with a medical device that complies with today’s standard in cataract surgery, including an ultra-fast laser, an element modifying the laser based on photonic science, a robot, artificial intelligence that automatically adjusts the energy input and a fiber. In short, a device using today’s technologies for the benefit of patients living with cataracts.”
Keranova’s PhotoEmulsification technique is made possible by the unique combination of patented technologies within the FemtoMatrix device, a robotized laser to treat cataract patients.
“The results are extremely promising, as the FemtoMatrix device has proven to be safe to perform phaco-free laser cataract surgery in less than eight minutes in one operating room, something which is impossible to do with current techniques,” said Dr Damien Gatinel, head of the Anterior and Refractive Surgery Department of the Rothschild Foundation (Paris, France) and member of Keranova’s scientific advisory board. “I look forward to continuing working with Keranova on more innovative solutions to ensure surgeons and patients have access to the best possible technologies to treat cataracts.”
Keranova presented the preliminary results of its clinical regulatory studies into robotic laser surgery during iNovation Day at the 2022 European Society of Cataract and Refractive Surgeons (ESCRS) Congress in Milan, Italy. The full results of Keranova’s clinical regulatory studies will be published in several peer-reviewed journals in 2023.
The company aims to secure a CE mark in 2023, which will allow it to market the first version of FemtoMatrix. To meet demand, its production unit will be operational at the end of 2023. Keranova said it will continue to work on the FemtoMatrix technology to include new and innovative features to be released in 2024. Users will be able to perform the update via software upgrades.