PROCEPT BioRobotics Announces Milestones in Europe: First Commercial Aquablation Cases Completed in Germany and Initiation of FRANCAIS WATER Clinical Trial

REDWOOD SHORES, Calif.--(BUSINESS WIRE)-- PROCEPT BioRobotics, a Silicon Valley surgical robotics company developing novel and disruptive technologies to treat prostate disease, announced that the first commercial Aquablation^® procedures have been completed in Germany. Additionally, the company has initiated the FRANCAIS WATER clinical trial, a necessary first step in gaining reimbursement for the company’s AquaBeam^® System in France.

First Aquablation Cases in Germany
Professor Thorsten Bach, chief physician of urology at Asklepios Klinik Harburg in Hamburg, Germany was the first in that country to provide Aquablation therapy with the AquaBeam System, the world’s first minimally invasive surgical robot providing autonomous tissue removal for the treatment of benign prostatic hyperplasia (BPH), or enlarged prostate. Aquablation combines the clarity of real-time, multi-dimensional imaging with the accuracy of an autonomous robot and the power of a heat-free waterjet for targeted and precise removal of excess prostate tissue. Approximately 350 men with BPH are treated per year at Asklepios Klinik Harburg.

“Aquablation therapy is an innovative procedure that allows the surgeon to map the exact treatment contour on ultrasound, and then the robot autonomously resects the prostate tissue according to the surgeon’s plan, enabling it to be precise. With this device, our resection time is significantly reduced to less than five minutes, and patients will experience fewer sexual side effects than with traditional treatments,” Professor Bach said. “We believe Aquablation has the potential to positively change the way we treat BPH.”

FRANCAIS WATER Clinical Trial
In France, PROCEPT BioRobotics received approval for and has initiated FRANCAIS WATER (French Aquablation Clinical Investigation using Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue), a single arm, multi-center prospective clinical trial to determine the safety and efficacy of the AquaBeam System in the treatment of BPH in men 45 to 80 years of age. The trial is a requirement in France to support reimbursement.

“We successfully completed our first cases in September and are very encouraged by the procedural outcomes,” said Principal Investigator Aurélien Descazeaud, MD, Centre Hospitalier Régional Universitaire de Limoges. “Aquablation is an exciting development for the treatment of BPH – an inconvenient, painful and often debilitating condition.”

The trial is being conducted at three internationally recognized sites throughout France and is enrolling a similar patient population to the global, double-blind, randomized phase III WATER (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue) study. Data from the WATER study demonstrated very strong efficacy outcomes with a superior safety profile for Aquablation therapy compared to the surgical gold standard transurethral resection of the prostate (TURP), including a near four-fold (10 percent vs. 36 percent) reduction in sexual side effects at three months.

“Before Aquablation therapy, men had to choose between symptom relief and the high risk of sexual side effects. That is no longer the case,” said PROCEPT BioRobotics President, Chief Executive Officer and principal architect of the AquaBeam System Nikolai Aljuri, Ph.D. “It is our hope that this advanced treatment option will become more widely available throughout Europe, allowing men with BPH to experience the same benefits of surgical procedures like TURP, with less risk of side effects that impact their quality of life.”

About PROCEPT BioRobotics
Based in Silicon Valley, PROCEPT BioRobotics is a privately-held surgical robotics company enabling better patient care by developing solutions to treat prostate disease. With an initial focus on benign prostatic hyperplasia (BPH), the company’s first product, the AquaBeam System delivering Aquablation therapy, is the world’s first minimally invasive surgical robot providing autonomous tissue removal to safely and effectively treat BPH. Aquablation offers predictable and reproducible outcomes, independent of prostate anatomy or surgeon experience. The AquaBeam System is currently for investigational use only in the U.S. and is not marketed for sale. The AquaBeam System is commercially available in Canada, Australia, New Zealand and select European markets. www.procept-biorobotics.com.

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