Exactly a year after kicking off the randomized controlled pivotal study of our 𝐂𝐮𝐫𝐞𝐒𝐢𝐠𝐡𝐭™ eye tracking based lazy eye treatment system, we are thrilled to announce that we have completed enrollment of the 83rd patient and passed the required number of enrolled patients needed for reaching the trial’s first readout (interim) point! This marks a significant landmark towards 𝐂𝐮𝐫𝐞𝐒𝐢𝐠𝐡𝐭™ FDA 510(K) clearance as potentially the only approved device to replace the patch and our path to commercialization in the US.
The clinical trial is taking place in 6 different medical centers across Israel, including Sheba Tel HaShomer City of Health, ranked as one of the top 10 best hospitals in the world.
We wish to thank the clinical teams that have worked hard to reach this point and strengthen their hands on the way to completing enrolment of the 90th patient.
Sheba Tel HaShomer City of Health Rambam Health Care Campus Soroka Medical Center Maccabi Health care Services
Prof. Tamara Wygnanski-Jaffe, Prof. Abraham Spierer, Prof. Hana Leiba, Dr. Eedy Mezer, Dr. Idit Keinan, Dr. Ronen Rabinowitz, Dr. Ohad Amtirat, Dr. Chiya Barret.