Procept Biorobotics has recently received 510(k) clearance from the FDA for Hydros, their updated surgical robot designed for prostate procedures. This marks a considerable advancement from their first-generation device, the Aquabeam, which received de novo authorization in 2017 and has been utilized in roughly 400 hospitals, performing 50,000 procedures to date.
The original Aquabeam robot is recognized for its unique aquablation therapy, which employs a pressurized jet of fluid to surgically remove prostate tissue in men suffering from lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH). BPH, or noncancerous prostate enlargement, is a common condition affecting men as they age, potentially leading to significant health complications if left untreated.
Hydros, the latest iteration in Procept’s surgical tech arsenal, incorporates several key improvements and new features intended to support broader adoption and improve procedure efficiency.
One of the most significant updates in Hydros is the integration of artificial intelligence. The device now includes an AI component designed to act as a virtual ultrasound expert alongside surgeons. This feature assists in interpreting ultrasound images more accurately, identifying key anatomical landmarks. Chief Commercial Officer Sham Shiblaq highlighted during a call with analysts that this enhancement is designed to improve the accuracy of landmark identification for surgeons at all levels of experience, from novices to those seasoned in aquablation procedures.
Furthermore, Hydros has transitioned to using a single-use digital scope which eliminates the need for scope reprocessing, potentially reducing setup times and enhancing the ease of operation. This change is particularly geared towards making the system more attractive for mass-market adoption, as it simplifies the technology and reduces operational costs associated with the procedure.
Another notable update is the integration of Hydros with an advanced digital cystoscope, an improvement aimed at enhancing visualization capabilities during surgeries. This could lead to better procedural outcomes and further streamline the operational process.
Shiblaq stated that Procept’s strategy involves initially targeting new customers with Hydros and then gradually transitioning their existing user base to the new system starting in 2025. From the fourth quarter of the current year, Procept plans to exclusively sell Hydros.
The early reception to the news of Hydros’ 510(k) clearance has been positive among financial analysts, with Wall Street showing a buoyant response as the share price of Procept surged by 28% following the announcement. Analysts from Leerink Partners and William Blair have expressed optimistic outlooks regarding the potential for the AI features to drive incremental adoption. They believe these enhancements will serve as significant growth drivers, lowering the barriers to adoption and making the technology a more appealing option for healthcare facilities.
However, some concerns exist about the initial demand and the broader market impact. Analysts from BTIG have pointed out challenges related to the lack of identified specific incremental clinical benefits of the new system compared to the previous generation. They also noted market segmentation by prostate size, which might affect the overall demand and justification for the capital expenditures associated with the new technology.
Despite these reservations, Barry Templin, who leads technology and clinical development at Procept, mentioned on the analyst call that the company anticipates potential clinical benefits from more reproducible ultrasound interpretations, although no specific studies on the new system have been conducted yet. The full impact of these technological advancements will likely be more evident as Hydros is rolled out and more data becomes available from its use in clinical settings.
In summary, the introduction of Hydros by Procept Biorobotics marks a significant step forward in surgical treatments for BPH, with enhancements aimed at improving efficiency, accuracy, and ease of use poised to potentially reshape the landscape of prostate surgery.
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