PROCEPT BioRobotics® Corporation (Nasdaq: PRCT) (the “Company”), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today announced FDA 510(k) clearance of its next-generation platform, the HYDROS™ Robotic System. Leveraging insights from over 50,000 procedures, HYDROS features FirstAssist AI™ treatment planning, advanced image guidance, robotic resection, and a streamlined workflow. HYDROS is designed to improve efficiency, enhance surgeon and staff experience and deliver a more accurate and consistent treatment plan for better clinical outcomes.
“We are pleased to bring the HYDROS Robotic System to the U.S. market,” said Reza Zadno, CEO of PROCEPT BioRobotics. “This milestone marks a pivotal moment for PROCEPT as Aquablation therapy continues its rapid adoption, with over 400 robotic systems now installed across the United States. After years of research and development, HYDROS introduces significant technological advancements designed for mass-market adoption, and we believe will power the next phase of our growth.”
“As a urologist, my goal is to treat my patients’ symptoms while preserving their quality of life. Aquablation therapy has been instrumental in helping me achieve this for patients struggling with BPH,” said Dr. Steven Kaplan, Icahn School of Medicine at Mount Sinai. “The HYDROS Robotic System advances this further by utilizing the power of AI to better read and interpret ultrasound for optimal surgical planning.”
The HYDROS Robotic System represents the next evolution in the delivery of Aquablation therapy, combining cutting-edge technology with user-friendly features designed to deliver better clinical outcomes for patients and healthcare providers.
Key Features of the Fully Integrated HYDROS Robotic System Include:
- AI-Powered Treatment Planning: FirstAssist AI, built from a library of real-world Aquablation therapy procedures, uses advanced image recognition software to accurately identify critical anatomy on ultrasound and suggest an optimal treatment plan for each patient.
- Advanced Image Guidance: The system integrates next-generation ultrasound imaging, digital cystoscopy, and dual high-definition touchscreens providing enhanced visualization of the anatomy and simultaneous viewing of ultrasound and cystoscopy images.
- Robotic Resection: Utilizing a heat-free waterjet, the robot executes the surgeon-defined treatment plan to resect obstructive tissue while protecting critical anatomy. This enables efficient and predictable waterjet execution, standardizing the operative experience across a wide range of prostate sizes and shapes.
- Streamlined Workflow: Designed to improve the surgeon and staff experience at every stage of the Aquablation therapy procedure. With a single-footprint, the integrated tower facilitates efficient operating room setup and turnover. The adjustable touchscreen improves surgeon ergonomics with midline placement, and the instinctive software interface simplifies procedural workflow.
“The HYDROS Robotic System is a game-changer for new surgeons. I believe the streamlined system along with the system’s intraoperative AI capabilities provide a tool to suggest an optimal treatment, helping surgeons learn the procedure faster and with greater precision,” said Dr. Brian Helfand, NorthShore’s Chief of Urology and Clinical Professor at the University of Chicago.
“The HYDROS Robotic System is a testament to our commitment to innovation. By integrating AI and advanced imaging into the robotic platform, we are providing surgeons with the tools they need to deliver precise, efficient, and high-quality care,” said Sham Shiblaq, Chief Commercial Officer. “HYDROS will move to full market release within the current quarter and be available immediately to hospitals across the United States.”
2024 Financial Guidance Update:
In conjunction with today’s announcement, the Company is reaffirming its 2024 financial guidance, which was initially provided on the most recent second quarter 2024 earnings conference call on August 1, 2024.
Webcast and Conference Call Information
PROCEPT BioRobotics will host a conference call on Wednesday, August 21, 2024, at 8:00 a.m. Eastern Time to discuss the HYDROS Robotic System key features, benefits, and commercial launch plans.
Investors interested in listening to the conference call may do so by following one of the below links:
Webcast link for interested listeners:
- https://edge.media-server.com/mmc/p/q3dbybx5/
Dial-in registration for sell-side research analysts:
- https://register.vevent.com/register/BI4959cac15c6540aa97a4d156af947d55