Procept BioRobotics shares soared 30% on Wednesday after the company said its robotic system designed to treat benign prostatic hyperplasia received clearance from the Food and Drug Administration (FDA).
The company's share price closed slightly over $80 per share on Wednesday.
Procept Biorobotics received FDA 510(k) clearance of its next-generation Hydros Robotic System, which means the product can be marketed in the U.S. The robotic system is an AI-powered platform that delivers aquablation therapy for noncancerous prostate enlargement, according to the company.
The procedure uses real-time ultrasound imaging combined with cystoscopy to provide the surgeon with a multidimensional, detailed view of the entire prostate, enabling personalized treatment planning tailored to each patient’s unique anatomy. With Procept's robotic system, surgeons can use AI to specify which areas of the prostate to resect while avoiding the anatomy that controls erectile function, ejaculatory function and continence. Once the treatment plan is mapped by the surgeon, the predictable robotic-assisted waterjet execution enables prostate tissue to be resected in a precise, targeted, and controlled fashion, according to the company.
“We are pleased to bring the Hydros Robotic System to the U.S. market,” said Reza Zadno, Ph.D., CEO of Procept BioRobotics, in a statement. “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.”
The company said it developed the robotic system using insights from over 50,000 procedures, and the device features the company's FirstAssist AI treatment planning, advanced image guidance, robotic resection and a streamlined workflow. The robotic system is designed to "improve efficiency, enhance surgeon and staff experience and deliver a more accurate and consistent treatment plan for better clinical outcomes," company executives said.
In 2017, the company received de novo clearance from the FDA for its first-generation AquaBeam robotic system that uses a heat-free jet of water to treat the condition.
Wall Street analysts greeted the company's announcement as an "unexpected and positive surprise" for Procept BioRobotics stock.
"We expect this development to help drive continued growth and represent an important milestone supporting management's focus on innovation in the vastly underpenetrated BPH market," Leerink Partners analysts wrote in a flash note. "Management noted that Hydros' efficiency and AI-assisted feature set have received positive early feedback from surgeons to-date, which we expect will be a key driver of incremental adoption as the system is rolled out broadly."
Procept BioRobotics executives highlighted that the immediate commercial focus will be on targeting greenfield opportunities, but trade-in sales to existing users could represent an incremental source of near- to intermediate-term upside to revenue growth, Leerink Partners noted.
Procept also backed financial guidance for 2024, initially provided on its second-quarter earnings conference call on Aug. 1. Procept expects revenue for the full year 2024 to be $217 million, which represents 59% growth over the prior-year revenue. And, it projects full-year 2024 adjusted EBITDA loss of $67.5 million.
“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 Brian Helfand, M.D., NorthShore’s chief of urology and clinical professor at the University of Chicago, in a statement.
“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 at Procept BioRobotics. “Hydros will move to full market release within the current quarter and be available immediately to hospitals across the United States.”