FREMONT, CALIF. (PRWEB) JUNE 06, 2018
Mynosys Cellular Devices Inc. today announced new clinical results for Zepto®, the Company’s FDA approved, CE marked automated capsulotomy product. Long term follow-up studies showed patients who received Zepto® capsulotomies had significantly less posterior capsular opacification (PCO) compared to a comparable cohort who received conventional continuous curvilinear capsulorhexis (CCC).
Dr. Kevin Waltz, CMO for Mynosys, reported these findings at the AECOS meeting in Berlin Germany on June 2nd, 2018. “The original impetus for examining patients 14-16 months after Zepto® capsulotomy was to investigate the long-term quality of the anterior capsulotomy” says Dr. Waltz. “Not only did we not find any anterior capsular abnormalities, but the first group of patients examined surprised us in how little PCO was present. This lack of PCO was highly unusual for this patient population from El Salvador.” Dr. Waltz further stated “We subsequently re-examined a total of 38 patients who underwent Zepto® capsulotomy and compared them to 23 matched controls that had received conventional CCC. Retro-illumination photos were obtained after dilation and the PCO graded by a masked examiner. Statistical analysis showed patients with Zepto® capsulotomies indeed had significantly less PCO than controls (p< 0.001). Dr. Waltz added that while the exact mechanism remains to be proven, there are some indications that Zepto’s PCO mitigation effect may arise from the 360 degree fluidwave that starts at the anterior capsulotomy edge as a consequence of Zepto’s suction release mechanism. “This fluidwave may help remove lens epithelial cells more efficiently and completely, leading to less biological and inflammatory response overall” explained Dr. Waltz.
“These findings represent new Zepto® data that are being presented for the very first time at the Berlin AECOS meeting” says John Hendrick, CEO and President of Mynosys Cellular Devices Inc. “PCO remains a very common physiological complication of cataract surgery around the world that significantly degrades the benefits and investment of the original cataract surgery.” Mr. Hendrick added, “we are very intrigued by Zepto’s PCO mitigation potential and the benefits it can provide large numbers of patients around the world. A next step is to further validate this data in a prospective randomized bilateral trial involving greater numbers of patients and surgeons.”
Dr. Waltz remarked that Zepto® is turning out to be much more than just a very good automated capsulotomy device, “it also enables surgeons to use the patient’s own visual axis to obtain 360-degree complete capsular overlap and optimized positioning of premium IOLs.” This conversion of the visual axis into a fixed reference landmark to assist surgical outcome is a unique function of Zepto® that will be recognized as a category III CPT code in the United States beginning in Jan. 2019. Mr. Hendrick added that Zepto’s PCO mitigation effect once further supported by additional studies, may significantly alter the practice of cataract surgery. A long-term clinical benefit of PCO reduction that can be provided to patients at the time of surgery will also dramatically alter the dynamics of the IOL market.
Zepto® is CE Marked and FDA cleared. It is available through distributors in selected countries internationally and in the United States.
Contact: John Hendrick
Research was supported by the National Eye Institute / National Institutes of Health under award no. R44EY021023. The content is solely the responsibility of the authors and does not necessarily represent the views of the NIH.