PROCEPT BioRobotics® Receives U.S. FDA Investigational Device Exemption to Investigate Aquablation® Therapy for Prostate Cancer
REDWOOD CITY, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- PROCEPT BioRobotics Corporation (NASDAQ: PRCT) (“PROCEPT BioRobotics”), a global leader in surgical robotics, announced today the Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to investigate the safety and efficacy of Aquablation therapy for prostate cancer.
The IDE approval allows PROCEPT BioRobotics to initiate a single-arm feasibility study in the United States. The data generated from this IDE study will support future research and regulatory applications in the United States. The study will enroll patients with localized prostate cancer at three prestigious cancer centers, Keck Medical Center of USC, Perlmutter Cancer Center at NYU Langone Health, and Mount Sinai Tisch Cancer Center.
“Aquablation Therapy, recognized for its efficacy and safety in resecting prostate tissue for BPH, offers a potential paradigm shift in how urologists might address localized prostate cancer. The waterjet resection technique has the distinct capability to precisely eradicate prostate tissue, providing the potential of an effective cancer treatment while maintaining the patient's quality of life,” said Dr. Inderbir Gill, founding executive director for USC Urology, part of Keck Medicine of USC. Gill is also Distinguished Professor & Chairman, Catherine & Joseph Aresty Department of Urology and Shirley & Donald Skinner Chair of Urological Cancer Surgery at Keck School of Medicine of USC.
Reza Zadno, CEO of PROCEPT BioRobotics, remarked, "Receiving IDE approval to explore Aquablation Therapy for men with localized prostate cancer marks a pivotal moment for PROCEPT. While our primary commitment is to establish ourselves as the standard of care for the treatment of BPH, we acknowledge the distinctive potential of our robotic system to address other urological indications." Zadno added, "Our aim is to bolster the clinical evidence through this study and collaborate with some of the nation's foremost cancer physicians.”
PROCEPT BioRobotics will post an updated investor presentation to its website, www.procept-biorobotics.com, on the “News & Events” page under the “Investors” tab.
About Aquablation Therapy
This novel technology is backed by numerous peer-reviewed publications demonstrating its safety, efficacy, and the durability of its outcomes. The cornerstone of the data is two, prospective, FDA trials with 5-year data; WATER and WATER II. The WATER study (the U.S. pivotal trial for FDA approval) randomized Aquablation therapy against TURP, which has been the standard of care for resection of prostates smaller than 80ml, in a double-blinded study. The trial demonstrated superior safety and comparable efficacy to TURP in prostates 30ml to 80ml in size and superior safety and efficacy in prostates 50ml to 80ml in size. The WATER II study included men with a prostate size greater than 80ml undergoing Aquablation. The study met its pre-specified performance goal for safety and efficacy. The two, FDA trials with 5-year follow-up have demonstrated consistent results across various prostate anatomy.
About PROCEPT BioRobotics Corporation
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