The American Urological Association has upgraded its clinical guidelines for Aquablation therapy, strengthening its recommendation and expanding the addressable patient population for PROCEPT BioRobotics’ novel BPH treatment. The move provides a significant clinical endorsement that could accelerate market share gains from legacy surgical procedures and supports the company’s path toward profitability.
"This milestone reflects the growing adoption of Aquablation therapy in clinical practice and the durable outcomes demonstrated across a broad range of patients," said Larry Wood, President and Chief Executive Officer of PROCEPT BioRobotics, in a statement.
The updated AUA guidelines now strongly recommend Aquablation for men with prostate volumes between 30 and 80 mL and state it may be offered for prostates up to 150 mL. This validation is based on a growing body of evidence, including five-year clinical trial data showing durable symptom improvement. The news follows a first-quarter report where PROCEPT announced selling 49 U.S. Hydros systems at a record average price near $485,000 and grew U.S. procedures by 30% year-over-year to roughly 12,200.
For investors, the AUA’s stamp of approval is a critical catalyst that de-risks the clinical profile and strengthens the case for displacing older treatments like TURP. It directly supports the company’s full-year guidance for $390 million to $410 million in revenue and its target of reaching positive adjusted EBITDA by the end of 2026, even as it navigates near-term operating losses to fund its expansion.
PROCEPT’s first-quarter 2026 earnings painted a picture of a company in a high-growth, high-investment phase. Revenue of $83.1 million marked a 20% year-over-year increase, signaling robust demand. The company reiterated its full-year guidance for 60,000 to 64,000 U.S. procedures, a significant jump from 2025.
However, this growth comes at a cost. Operating expenses climbed to $86.6 million from $71.6 million a year prior, widening the Q1 net loss to $31.6 million. Management attributed the higher spending to strategic investments in its commercial teams and the ongoing WATER IV clinical trial. With $249 million in cash, the company has a solid buffer to fund these initiatives as it pushes toward its goal of turning adjusted EBITDA positive in the fourth quarter.
Clinical and Competitive Edge
The AUA guideline is the latest in a series of clinical and regulatory wins. Earlier this year, the European Association of Urology (EAU) also gave Aquablation a strong recommendation. Furthermore, the company secured FDA clearance for its second-generation FirstAssist AI software, enhancing the robotic system's capabilities.
This clinical validation is crucial for competing against entrenched surgical options like transurethral resection of the prostate (TURP) and laser enucleation. Aquablation, a robotic waterjet treatment, is designed to deliver effective outcomes that are independent of prostate size or surgeon experience, a key selling point highlighted in clinical data. The company is nearing full enrollment for its WATER IV trial, with a primary endpoint presentation expected in spring 2027 that could further broaden its market.
This article is for informational purposes only and does not constitute investment advice.
