Tempe, AZ, December 22, 2017 – SDC, a specialized data services Contract Research Organization (CRO) providing scalable clinical trial solutions via strategic partnerships, congratulates PROCEPT BioRobotics (PROCEPT) on their recent announcement that the U.S. Food and Drug Administration (FDA) has granted a De Novo request for the company’s AQUABEAM® System for the resection and removal of prostate tissue for the treatment of lower urinary tract symptoms (LUTS) as a result of benign prostatic hyperplasia (BPH), or enlarged prostate.
“On behalf of the study team and all of us at SDC, I extend our warmest congratulations to PROCEPT BioRobotics,” said Dale W. Usner, Ph.D., President at SDC. “We are proud to have been part of the team that supported the clinical trials for the AQUABEAM® System in BPH.”
“I would like to thank SDC for all of their contributions to help PROCEPT achieve this milestone,” said Angela Lee, Director, Clinical Affairs at PROCEPT BioRobotics.
For more information, please see the full and original press release dated December 21, 2017: FDA Grants De Novo Request for PROCEPT BioRobotics AQUABEAM® System