RE:10 patients early 2021 for 25 for Breakthrough Designation floatinketucky wrote: Shawn Shirazi, PhD, Chief Executive Officer, Theralase®, stated, "Each CSS Theralase launches for Study II will aid in our objective of enrolling and treating 10 patients in early 2021 to achieve a total of 25 patients for potential Breakthrough Designation Approval and approximately 75 to 100 additional patients in 2021 / 2022."