CLPT News & Events

Shares of ClearPoint Neuro (CLPT) are up $4.32, or 32%, to $17.66 in pre-market trading after partner uniQure (QURE) announced during a recent Type B meeting with the FDA that the previously reported three-year data from the Phase I/II study would be acceptable for a BLA submission for the accelerated approval of AMT-130 in Huntington's disease.

ClearPoint Neuro announced plans to enter the focused ultrasound market and demonstrated successful intravenous delivery of tracers across the blood-brain barrier in a preclinical model using a prototype system built in partnership with the SONOCARELAB at Sungkyunkwan University. "This milestone has been nearly four years in the making, and demonstrates our continuous pursuit to be the most complete neuro navigation and therapy enabling company in the world," said Joe Burnett, president and CEO. "By leveraging our 15 years of neuro navigation software development, and by deploying focused ultrasound using our planned robotic platform in a traditional OR setting, we believe the ClearPoint and SONOCARELAB solution will fit perfectly into our four-pillar growth strategy."

ClearPoint Neuro announced that the Velocity Alpha MR High Speed Surgical Drill System has received CE Marking in addition to the existing FDA 510(k) clearance in the United States.